America’s Frontline Doctors Founder Dr. Simone Gold last July personally implored Vice President Mike Pence to advocate a presidential executive order making hydroxychloroquine available for over-the-counter purchase as a means to drop death rates to “near-zero” and incidentally enhance President Donald Trump’s electoral advantage in last November’s elections, it was revealed.
In an interview last week on the Brad Barton Podcast, Dr. Gold expressed “frustration” that President Trump was not given the chance to decide on the move himself, concluding that “it would have changed the outcome of the world.” Dr. Gold also revealed that a draft of the executive order prepared by legal experts was presented to Pence, saying “it’s tragic that the President himself never heard this.”
“When you looked around the world, hydroxychloroquine was over-the-counter in much of the world,” said Dr. Gold. “So I was advocating for making hydroxychloroquine over-the-counter. And I was being, thankfully, put forward in Washington D.C. to talk to more and more people, and I eventually got up to the Vice President of the United States, and we had more than an hour together.
“And I said, ‘Mr. Vice President: The way you win the election in November is that the President signs an executive order making hydroxychloroquine over-the-counter. He can do that, he can have Secretary [of Health and Human Services Alex] Azar do that, and then if he makes it over-the-counter, there’s nothing that Congress can do, there’s nothing that doctors and pharmacists could do to stop it, and if you do that, once hydroxychloroquine’s over-the-counter, people will go buy it – if you don’t want it, you don’t get it, but if you do want it you’ll get it – and cases will go down to essentially zero, and Mr. Vice President, you will sail into November if you take that plan, path, that approach’.”
Relevant section begins at 5:34 of the video:
She continued: “That is actually what I was working on for months. That message did not reach the President, and to this day I feel tremendous sorrow that the President was not able to make the decision himself. Had he – I believe he would have made that decision had he heard that option, and life would have been different.
“I want everyone listening to know that I was sitting with him for an hour, and I specifically said, let’s say it again: ‘Mr. Vice President, please ask the President to have an executive order making hydroxychloroquine over-the-counter. In this way, death rates within a month of that will go to near zero, just like they are in Africa – near zero – because hydroxychloroquine is over-the-counter there. And if you do that, you will sail into November.
“That meeting was the end of July… I specifically said that the reason this is critical information, it’s life saving information: When you looked at other nations where hydroxychloroquine was over-the-counter – you knew they were going to hold the coronavirus thing over him – the death rate went down to zero. It would have been beautiful. And I didn’t understand how I met obstruction at every, every level, and as hard as I tried, let me tell you, I tried really, really hard.”
“This is the first time I’m saying it in this sort of public setting. I’ve said it individually to people, there were many witnesses, there were about six doctors with me, plus the Vice President, plus two of his staff people. This is not a secret, there’s records of it. But it’s tragic that the President himself never heard this. And the reason it’s especially tragic is I know that the President himself was an advocate of hydroxychloroquine, he knew this in his heart, and he knew this in his soul. He ended up tweeting me out – he doesn’t know me – a couple months later on something that had to do with hydroxychloroquine, so I knew the issue was still in his mind. It was around October, he retweeted something that I had said about hydroxychloroquine, so I know the issue was still at his mind.
“I would like to say to anybody who has the reach, to maybe share with the President, if you can reach him, that I sat with the Vice President, and I begged and I said, ‘Please, ask the President if he’s interested in an executive order making it over-the-counter. In this way he will sail through November.’
“And by the way, we had written up the executive order – I hired attorneys who wrote it up; we had an executive order ready, actually presented it to the Vice President, it was ready to go.”
In June, Dr. Gold contracted with a Texas law firm to research and assist in drafting an executive order for the President to sign, saying that doctors may prescribe hydroxychloroquine off-label, just as doctors have always done. About 20-30% of FDA-approved drugs are used off-label, which refers to the manufacturer’s ability to market an item, not safety or efficacy.
The executive order draft submitted by Dr. Gold for the President’s signature said: “American doctors have discovered a safe, legal, inexpensive, and effective prophylactic and treatment plan that pressure within the medical community has stopped people from getting. The American people deserve to choose, with the advice of doctors they trust, to try any and all possible effective treatments for COVID-19. People trust their doctor with their personal health decisions, not bureaucrats. I will empower America’s doctors with as many tools as I have at my disposal to get our people well. Together, we will defeat this disease and get the economy going again.”
The draft continues: “Despite the proven safety and effectiveness of hydroxychloroquine in treating COVID-19, doctors who have used this treatment have experienced opposition and negative pressure from state Governors, state departments of health, and state medical licensing boards.”
For example, in an April 2, 2020 Statement Regarding Improper Prescribing of Medications Related to Treatment for Novel Coronavirus (COVID-19), the Medical Board of California wrote: “The California Department of Consumer Affairs (DCA) is aware of recent news and social media reports of prescribers wrongfully hoarding and prescribing for themselves and family members certain medications referenced in the media relating to the novel coronavirus (COVID-19).”
The email continued: “Several states have recently issued emergency restrictions on how the drugs can be dispensed. Many require that medications be prescribed and dispensed only to patients with a legitimate and current medical condition. Further, the FDA recently issued an Emergency Use Authorization to allow for the use of hydroxychloroquine sulfate and chloroquine phosphate products donated by the Strategic National Stockpile for certain hospitalized patients with COVID-19.
“DCA, the Medical Board of California, and the California State Board of Pharmacy remind health care professionals that inappropriately prescribing or dispensing medications constitutes unprofessional conduct in California. Prescribers and pharmacists are obligated to follow the law, standard of care, and professional codes of ethics in serving their patients and public health.”
In contradiction to the threatening actions the States were taking toward physicians, federal law for decades has clearly permitted the off-label use of hydroxychloroquine even in the absence of emergency authorizations. The executive order draft handed to Vice President Pence would have had the President merely affirm the status-quo, that off-label use is valid and patients have a right to the drug under federal law.
After observing no change in FDA policy following her meeting with Pence, Dr. Gold and ten other physicians later submitted an independent Citizen’s Petition to the Department of Health and Human Services. Their attached declaration stated: “HCQ has the potential to reduce the transmission of SARS-CoV-2 as well as reduce hospitalizations and deaths from COVID-19.
“As a prophylactic, HCQ may prevent up to 75% of individuals from becoming infected with SARS-CoV-2. This can be an additional layer of protection for not just healthcare workers and first responders, but also for the American people as they go back to work. Early treatment with HCQ can decrease viral load, hospitalization and mortality.
“By decreasing viral load, there will be a decreased chance and shorter period of time that an infected person can transmit the disease to healthy persons. By reducing need for hospitalization, hospital systems will be less likely to become overwhelmed with COVID-19 patients—effectively “flattening the curve” without the need for lockdowns and stay-at-home orders.
“Lastly, HCQ will decrease mortality, particularly in older vulnerable populations such as those in nursing homes.”
Indeed, a multi-national database with almost one million cases of hydroxychloroquine use concludes there is no excess risk
of serious adverse events identified with 30-day usage, and that short-term hydroxychloroquine treatment is safe.
This is the largest-ever analysis of the safety of such treatments worldwide, examining over 900,000 hydroxychloroquine and more than 300,000 hydroxychloroquine + azithromycin users respectively. The results on the risk of serious adverse events associated with
short-term (1 month) hydroxychloroquine treatment as proposed for COVID-19 therapy are reassuring, with no excess risk of any of the considered safety outcomes compared to an equivalent therapy.
The CDC has an information sheet about HCQ. That sheet includes the following questions/answers:
Q: Who can take hydroxychloroquine?
A: Hydroxychloroquine can be prescribed to adults and children of all ages. It
can also be safely taken by pregnant women and nursing mothers.
Q: Who should not take hydroxychloroquine?
A: People with psoriasis should not take hydroxychloroquine.
Q: What are the potential side effects of hydroxychloroquine?
A: Hydroxychloroquine is a relatively well tolerated medicine. The most common
adverse reactions reported are stomach pain, nausea, vomiting, and headache.
These side effects can often be lessened by taking hydroxychloroquine with food.
Hydroxychloroquine may also cause itching in some people.
Q: How long is it safe to use hydroxychloroquine?
A: CDC has no limits on the use of hydroxychloroquine for the prevention of
malaria. When hydroxychloroquine is used at higher doses for many years, a
rare eye condition called retinopathy has occurred. People who take
hydroxychloroquine for more than five years should get regular eye exams.
Interviewer Tim Greer to Dr. Gold: “What was his reply?”
Dr. Gold: “It was noncommittal. He heard what I said, and said something along the lines that he would take it under advisement; it was very frustrating. I was working on this for three months; I’m still upset about it. As a physician – I’m a doctor and a lawyer – so I was upset for the patients, really upset for the patients, because there’s no question it works.
“By the way, right now there’s more than 300 studies that show hydroxychloroquine or budesonide or ivermectin early treatment works. More than that, there’s tens of thousands of physicians who have attested to this, there’s many physicians who have attested, under oath, in Congress, that it works. Of course it works. So on the human level we had to do this, we had to make it available. Countries where hydroxychloroquine or a version of are over-the-counter have very low death rates. That’s a fact. Facebook which was censoring you and censoring me for saying this finally retreated themselves, like ‘Oh, I’m sorry,’ they did that back in January, February. They said, ‘Oh, we shouldn’t censor doctors saying this,’ but the damage was done.
“And then on the policy level, it would have changed the outcome of the world if we had done this. And I’d love the President to hear this message.”
Do you think the other doctors who were there with you would testify to what you said?
“Oh, of course, absolutely; there were many witnesses. I don’t think the Vice President would deny it… We have records of the meeting. There is a paper trail of what I was advocating. You can’t deny this. Definitely not. And if you’re looking to find me and you think I’m not saying the truth, my name is Dr. Simone Gold, Stanford University-educated lawyer and board-certified emergency physician. I stand by what I’m saying.”
Former Vice President Mike Pence did not respond to an America’s Frontline Doctors request to comment on the report.