HEALTH & SCIENCE,  U.S.

FDA in Hot Seat by Senators’ Demands on HCQ and HHS Pulling Rank on Tests

On August 18, 2020, Senator Ron Johnson (R-Wis.), Sen. Ted Cruz (R-Texas), and Sen. Mike Lee (R-Utah) submitted a letter to the U.S. Food and Drug Administration (FDA) Commissioner Stephen Hahn, demanding information regarding their actions taken on the use of hydroxychloroquine for COVID-19. “Physicians are concerned that the FDA’s actions regarding hydroxychloroquine (HCQ) may be directly costing lives by limiting outpatient access to this potentially beneficial treatment,” the letter stated.

The senators wrote that the FDA’s actions on HCQ have “led to misinformation and confusion across the country. Some states have restricted the ability of physicians to write and pharmacies to fill HCQ and CQ prescriptions.” The senators are correct in that the FDA has done a fine job of creating confusion, as Corey’s Digs has been documenting their actions on HCQ since the beginning of this “pandemic.” This also comes on the heels of the historical 24-hour censoring takedown of America’s Frontline Doctors, who have been fighting to get critical information out on the benefits of HCQ.

The senators point out that “the licensed physicians we have heard from… have pointed to the low mortality rates in other countries—like India, Turkey, South Korea, and Morocco—that are using HCQ widely on outpatient COVID-19 populations before the disease progresses to more lethal stages of the virus that require hospitalization.”

They have given the FDA a deadline of 5:00 p.m. on August 25, 2020 to submit information on the following requests:

  • Please provide any studies and data that informed the FDA’s apparent determination that giving HCQ or CQ to COVID-19 infected outpatients within seven days from the onset of symptoms, under a doctor’s supervision, will have no clinical effect and may be harmful to the patient.
  • Please provide any scientific studies, medical papers and data involving COVID-19 outpatients that have started HCQ or CQ under a doctor’s supervision and begun in the ambulatory care outpatient setting. This includes post-exposure outpatient treatment and/or pre-exposure prophylaxis. This should not include late stage studies involving patients started on HCQ while in hospital.
  • Please provide and public statements or records that FDA has issued to clarify that the FDA does not regulate the practice of medicine and that state governments may not regulate the sale or prohibit the sale of prescription drugs.
  • Please provide any potential treatments for COVID-19 that have been utilized internationally, whether those treatments are authorized or approved by the FDA, and what steps the FDA has taken to ensure that these treatments are available in the U.S.

The answers to these requests can already be found in Corey’s Digs reports on COVID-19. The fact of the matter is that they do not have any studies to prove that HCQ has no clinical effect or may be harmful to a patient when used in the early stages of onset of symptoms because they only promoted studies on those who were already hospitalized. However, there have been studies to show HCQ does in fact work in early stages. In addition to this, the coronavirus “task force,” the WHO, and all major media outlets persistently reported on studies that were later retracted as bogus studies. Furthermore, the only time Stephen Hahn spoke out about doctors being able to prescribe HCQ, after May 29, was in a very short statement he made on NBC’s “Today” show on July 30, which could be equated to a “false/positive” statement at best. At no point has the FDA clarified this correctly on their website, twitter feed, to the CDC, in documents to medical boards, or by getting the information out on multiple news stations. Nor has the FDA requested that twitter remove their malicious “live news on coronavirus” alerts as though it is new information, when in fact it dates back to June, creating far more confusion.

The very next day, on August 19, Health and Human Services (HHS) announced a “rescission of guidances and other informal issuances concerning premarket review of laboratory developed tests.” Essentially, this removes the FDA from regulating and potentially slowing down lab-developed tests, which some have argued that the FDA does not have this authority to begin with. HHS stated that “the Trump Administration is committed to combating COVID-19, to ensuring that the American people are protected against future pandemics, and to keep duplicative regulations and unnecessary policies from interfering in these efforts.” Whereas this is specific to tests, it is indicative of the FDA losing ground on several fronts.

On August 21, the Texas Medical Board issued a press release on their ongoing COVID-19 response. In it, they addressed misinformation regarding the Board’s previous statement on COVID-19 treatments.

“The Texas Medical Board has never prohibited the use of hydroxychloroquine alone, or in conjunction with other drugs, for the treatment of COVID-19. In fact, the TMB does not prohibit any drug or treatment. The off-label use of hydroxychloroquine as an alternative therapy for COVID-19 patients is completely permissible. As is the case with any alternative therapy, physicians must ensure they comply with Board Rule 200 which requires physicians to provide full disclosure of treatment options, side effects, and obtain informed consent. Licensees should not fear disciplinary action from the TMB simply for expressing their support of specific COVID-19 treatments like hydroxychloroquine. What providers should keep in mind is because there is no definitive cure, claims of a cure may constitute false, misleading or deceptive advertising, which is prohibited by law and may prompt an inquiry from the TMB.”

On August 22, four days after the senators submitted this request to the FDA, President Trump tweeted that “the deep state, or whoever, over at the FDA is making it very difficult for drug companies to get people in order to test the vaccines and therapeutics. Obviously, they are hoping to delay the answer until after November 3rd. Must focus on speed, and saving lives!” He made it a point to tag FDA Commissioner Stephen Hahn in this tweet.

While all of this was taking place over the past week, reports emerged that the FDA is putting a hold on convalescent plasma to treat COVID-19 after NIAID Director Dr. Anthony Fauci and two other federal health officials argued that there is not enough data to show that it is working. On Sunday afternoon, President Trump, HHS Secretary Alex Azar, and FDA Commissioner Stephen Hahn announced in a press conference that the FDA is issuing an emergency use authorization (EUA) for blood plasma as a coronavirus treatment, stating that scientists have concluded that it is safe, and there has been a 35% increase in survival of COVID-19 patients, which they deem to be very successful. They will continue to gather data moving forward, as they do with all EUA’s.

Corey’s Digs will update this developing story on HCQ when new information is released.

Corey Lynn is an investigative journalist. Support her by becoming a Patron. Follow her at coreysdigs.com, on twitter, and YouTube.

13 Comments

  • Karen Bracken

    We all need to call these 3 Senators and show them our support. Then call YOUR own US Senators and request they support this effort. If enough people speak up we might be able to end the mandated poison jab that is coming. They cannot mandate this vaccine if there are viable alternatives and THAT is why the big pharma whores are shutting down HCQ.

  • Carol Ewing

    What Karen Bracken said! So true! I’ve been researching it and the Deep State for years. Those controlling HCQ are killing Americans daily by keeping the drug from us – as well as ivermectin regimen.

  • Tricia Eagon

    I am a big fan of Trump but sometimes it’s disconcerting when he speaks about a vaccine. I hope he’s just placating those out there that are vaxxers who will never question what’s in it!! They will have to apprehend me before I get jabbed. I recently read Plague of Corruption and found out that lab techs seem to disappear around Big Pharma like politicians do around the Clinton’s! Btw, if any of you have CFS like me, you can thank the MMR vaccine for that!!

  • Morton Winner

    My reading of earlier use of chloroquine for another epidemic shows that it was enhanced by concomitant use of ammonium chloride, just as we now advocate use of zinc sulfate , along with either azithromycin, or doxycycline if needed. A comparison study of the two protocols, with the addition of the antibiotic of choice, in early onset CCP disease, might be useful.

  • Lonelle Madsen

    I did it! I did what Karen Bracken suggested!

    I wrote a thank you to all the senators from this letter AND I wrote my state senator too asking him, pleading him to do the same! (CA)

    Thank you Corey for your post! And thank you Karen for your simple suggestion!

  • Gabriel Mas

    This is good information, but I have to add that there are many more good and easy treatments for this virus disease. There is a good study made recently in Ecuador and now Approved for treatment in Bolivia with consent from the patient, and the name of the product is CDS (chlorine dioxide solution ), this product is used in the water treatment plants of the city and in swimming pools, completely inoffensive no toxic element in the right proportions. You can interview Dr Andreas Kalcker , He is from Germany and have a web https://andreaskalcker.com/en/ . Now I have to say that I tried this in water like is prescribed in his website and is super effective to cure any problems related to bacteria, virus and even parasites. I tried with my mother and Father 87 and 91 respectively and work like magic. Also I know Dr Brownstein and he was using a nebulizer in which he added some 3% peroxide water and 1 drop of lugol’s iodine as breeding vaporizing into the longs of pageants and he published his founding in his Web and got warn by
    FDA that he could not publish any study or treatment not approve by them https://www.drbrownstein.com . It Would be of big help for your audience if you could research this people and put the info in your place. Thank you! Ho one more product is called Paximune (Naturally produced Interferon Alpha) recommended by Dr Judy Mikovits in an interview that I saw in February .

  • Dave Butler

    That Texas Medical Board rule 200, should be passed on to “anti-vaxxers”.
    Those who administer vaccines never do full disclosure and therefore don’t get informed consent.
    In TX this should also apply to the new Covid vaccination!

  • Barry R. Smith

    Thank you for the informative fact-based article. It clarified in my mind the reasons for the delays in an HCQ specific FDA endorsement for COVID-19 (CCP Flu) as a treatment.

    Everyone should ask themselves why the resistance by the media, big Phama and government entities when so many front line doctor provide over approximately 50 peer reviewed studies showing 85% effectiveness when applied In early treatment of COVID-19?

    What am I missing, if anything?

    It is my opinion it is being suppressed and censored for geopolitical and financial reasons. That is what my research points to, but you do not have to accept my point of view. Do your own research, trust your own instincts, and draw your own conclusions.

    Will you use your abilities to reason and think logically for yourself?

  • Barry R.Smith

    Thank you for the informative fact-based article. It clarified in my mind the reasons for the delays in an HCQ specific FDA endorsement for COVID-19 (CCP Flu) as a treatment.

    Everyone should ask themselves why the resistance by the media, big Phama and government entities when so many front line doctor provide over approximately 50 peer reviewed studies showing 85% effectiveness when applied In early treatment of COVID-19?

    What am I missing, if anything?

    It is my opinion it is being suppressed and censored for geopolitical and financial reasons. That is what my research points to, but you do not have to accept my point of view. Do your own research, trust your own instincts, and draw your own conclusions.

    Will you use your abilities to reason and think logically for yourself?

  • Waters Under Earth

    Hmm… with the mention of Lugols, my mind harkened back to my finding that iodised salt these days is no longer in regular use…

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