Since pharmaceutical attorney Gregory Rigano appeared on FOX NEWS, others (real MDs) have come forward with more information on recent studies of hydrochloroquine, a newer version of the commonly used antimalarial drug chloroquine, and also remdesivir, which was created to fight the ebola virus. The French study referenced by Rigano is real, and there’s one out of Australia and another out of China.

Rigano had called on President Trump to cut as much red tape as possible to hasten the approval process on new therapies. And on Thursday, the President did just that, calling on the FDA to “eliminate outdated rules and bureaucracy so this work can proceed rapidly, quickly, and I mean...fast.”

He means...FAST. And all the other words that mean fast.


RELATED READING: Is it a cure? Pharmaceutical attorney pushes for off-label use of hydroxychloroquine


"We have to remove every barrier,” the President said, “and they’ve done that, to get to the rapid deployment of safe, effective treatments.”

According to Tennessee Republican Rep. Mark Green, a former Army flight surgeon who appeared with Shannon Bream on FOX NEWS Thursday night, the French study touted by Rigano earlier this week showed that when mixed in a “cocktail” with the antibiotic azithromycin (the familiar “Z-pack” often given to patients who have bronchitis and/or bacterial pneumonia), hydroxychloroquine can completely clear COVID-19 --- it happened in all patients who were in the study --- in as little as three days. The sample size in the study he referenced was small, Green said, “so it’s kind of hard to extrapolate...to the whole population, but it’s very promising. One hundred percent of the virus gone in six days.”

He said that in the French study, hydroxychloroquine and azithromax were tested against hydroxychloroquine alone and also against a control group, and the hydroxychloroquine-alone patients did better than the control group, but the patients who did best were the ones who had received both chloroquine and azithromax. The anti-inflammatory effect of the antibiotic helps not only with bacterial infections but also with the symptoms of viral illness.

All of these drugs are already FDA approved for other uses and would just need to be manufactured in large quantities. (Please don’t tell me that all the manufacturing is currently being done in China!) Hydroxychloroquine is a generic [cheap] drug, Green said, “so the question will be, who’s going to stand up and manufacture it?” In this case, surely some American company would take that on. If there’s no financial incentive, our government might have to do some subsidizing to get this going NOW. Goodness knows, that’s a more productive use of funds than just passing out money to everyone. We need to defeat this virus so people can recover economically by getting back to work.

"I think that the FDA has joined forces in eliminating red tape to ensure that that product could be available to physicians to prescribe to their patients,” said White House coronavirus coordinator Dr. Debbie Birx on Thursday. “But we want to be able to study at the same time --- not limit use but actually study it at the same time to see if it does have he impact that others have reported.”

In other words, the FDA wants to be able to collect data on all patients receiving treatment with these drugs so they can scientifically answer questions of safety and effectiveness. But, as Rep. Green pointed out, a physician doesn’t have to wait for a study –- the doctor can write prescriptions right now for hydroxychloroquine (off-label use) and azithromax, with no restrictions. As I mentioned yesterday, the FDA doesn’t really have a problem with off-label use once a drug has been approved.

"[Hydroxychloroquine] is a drug that we’ve had around for decades,” Dr. Birx said. “So, it’s a pretty straightforward drug to make; there’s a lot of companies who already make it because it’s very important in our malaria fights around the world. And so, we have [the] drug available, and we really just have to see, does it actually work? We know it’s probably safe --- I think the question really is, does it have a therapeutic effect, and that’s going to be studied. It looks promising. We just want to make sure that at the same time that we’re giving this option to physicians, that we’re actually studying its impact.”

You know, if researchers and bureaucrats think it’s safe but want to see if it works, doctors can really help them with that by PRESCRIBING IT, especially for those who are very sick and going downhill.

Even with the President cutting red tape, the FDA is still a bureaucracy and moves slowly. Remdesivir, another antiviral, hasn’t yet completed the approval process, according to Rep. Green, but it’s already in Phase III studies with the FDA, so if it makes it, perhaps it will be available fairly soon.

My researchers turned up something very interesting: a study that compared two maps: one showing the pattern of COVID-19 infection and the other showing malaria. In countries where malaria flourishes, people often take antimalarial drugs such as chloroquine routinely as a preventative, and that may be why those those countries aren’t reporting COVID-19 cases. “This is amazing...” said Dr. Roy Spencer on Facebook. “In all my years of data analysis I have never seen such a stark and strong relationship: Countries with malaria basically have no COVID-19 cases (at least not yet).”

We’re not sure if there’s anything to this, but it certainly is consistent with the theory that antimalarial drugs also fight this coronavirus. Here are the two maps:

https://docs.google.com/document/d/12YDytbAsZaruGlhFO7eTTgxSH_BuxJtwFmbhqpkPPSk/mobilebasic?fbclid=IwAR2wXhG5woobpV5DAuHxnf7YOxalQiCkPMX-rUL2z6SIa0AJGovbJ9ATq7A

Our commentary on Gregory Rigano and his claims about hydroxychloroquine drew letters expressing a variety of points of view. Most fell into the “it’s worth a try!” catgegory. Some readers shared anecdotal evidence that the drug is safe, but a few others noted that it can cause retinal problems and other side effects, particularly serious among those with inflammatory disease such as rheumatoid arthritis. That’s why we can’t just hand out pills. They have to be carefully prescribed by a physician who knows the patient’s condition and medical history and who will be closely monitoring the effects, both intended and unintended. But that should be the case with every prescribed medication.


Commentary continues below advertisement


Antimalarial drugs are very commonly used in other parts of the world –- if you’ve traveled abroad to India or Africa, you likely have taken them –- and might be completely harmless for most people, but there’s hardly any drug that is safe for everyone. There’s also the matter of how much to take for this particular illness, when to take it, how often and for how long. A medication that might be fine at a low dose or in the short term to treat or head off coronavirus might be harmful if taken at a high dose or for months at a time. And, of course, there might be bad interactions with other medications a patient is already taking. That’s why the FDA wants as much data as it can get. If we start giving these medications to patients, we’re essentially initiating a very large-scale human trial. But that appears to be just what we need to do.

Leave a Comment

Note: Fields marked with an * are required.

Your Information
Your Comment
BBML accepted!
Captcha

Comments 1-25 of 90

  • Robin Durham

    03/23/2020 06:00 PM

    Thank you for running this column; it’s time for trying such a “cocktail,” especially since France has had such success.

  • Glynda Mercier

    03/23/2020 02:45 PM

    Hydroxychloroquine and related anti-malarial drugs induce hemolysis and KILL persons with G6PD-deficiency, a genetic condition and the world's most prevalent human enzyme deficiency. This has been documented since advent of antimalarial drugs in the 1950s, which were given by military to soldiers; black soldiers with ancestry from North Africa DIED. There are 2 or 3 major mutations of G6PD-deficiency, some of which affect Orientals and persons of Mediterranean descent. The blood test for G6PD deficiency is FALSE NEGATIVE if the hemolysis occurs during a certain time frame. Italian and Greek doctors and pharmacists are much more informed on G6PD deficiency than are American doctors (who generally would not know a case of G6PD deficiency if it jumped up and bit their behinds). VERY DANGEROUS to give carte blanche to ignorant doctors. We would see many more people die from hemolysis than would die from corona.

    As to co-relation between lack of corona cases reported in countries where malaria is endemic, I am not surprised. Persons in those countries, if they have G6PD deficiency and are being forced by well-meaning health workers to take antimalarial drugs, die from hemolysis caused by the drugs. They don't live long enough to test for, or get, any corona. So the numbers have a skew.(BTW, those same persons, if they have G6PD deficiency and get malaria, don't die because their mutation self-limits the malaria. This is also well-documented, but might be overlooked by those same well-meaning health workers who just do what they're told by ignorant bureaucrats.)
    I have beaucoups information on G6PD deficiency, if anyone is interested - medical studies, etc.

  • Kathy Hirtz MD

    03/22/2020 02:54 PM

    I would not hesitate to prescribe the combo if I knew someone showing symptoms of Covid 19. The rare risk of side effects are way out numbered by the risk of death. As a scientist I understand the importance of scientific proof, however many are dying while we wait for proof. What happened to Trump's right to try?

  • ARTHUR JOHN JACOBS SR.

    03/22/2020 10:08 AM

    FANTASTIC INFO !
    WATCHED THE PRESIDENTS BRIEFING !
    AND A FRIEND OF MIND RECOMMENDED CHECKING OUT HYDROXYCHLOROQUINE AND FRANCE , AUSTRALIA , SOUTH KOREA DID TRIALS AND NOW AZITHROMAX ADDED AND IF NO INTERACTIONS WITH MEDICATIONS

  • Lane Sievers

    03/21/2020 03:21 PM

    I’m an RN, and have explained to many patients that with any drug there are risks, however, the physician believes the benefits outweigh the risks (for any particular illness). I say “go for it!”

  • rodney burke

    03/21/2020 02:58 PM

    Next logical step is remove all NON scientific personnel from the FDA. This has become a revolving door for lawyers and Drug company executives who are NOT scientists or researchers. They have zero business making ANY decision as to drug efficacy or any other scientific decision. That must be the job of scientists and researchers. Too many side effects and PDR warnings are ignored or suppressed by the FDA who is only after profits and to you know where with the patient. This is a criminal org and NOT a scientific one and it needs to be decriminalized NOW! Research determines, not a lawyer or lobbyist.

  • Connie Pritchett

    03/21/2020 11:05 AM

    I have lupus and RA and have been using hydroxychloroquine for 18+ years. No problems or side effects and it is vital to help control my autoimmune issues. For short term use to treat a virus there should be no long term issues for most people.

  • Carlos Rendon

    03/21/2020 10:25 AM

    Where would this world be if not for the humble prayers of God's people, for His intervention in the affairs of man.

  • Judy Johnson

    03/21/2020 09:26 AM

    My daughter takes this drug for Lupus. Has taken for 8 years. Maybe she won't get Covid 19.

  • Bonnie McLaughlin

    03/21/2020 08:23 AM

    I always appreciate all you do to provide valid updates and your perseverance in finding all there is to know about the current situation. It can make a difference to each of us possibly helping a neighbor or friend understand and know that we need to comply with regulations and that help is available if needed and that we're all in this together together, including our president.

  • Lisa Neely

    03/21/2020 06:14 AM

    About the virus: I’m scared about not only it, but even more scared about the total devastating effects it is having upon our country.
    About the medicine: What do we have to lose by trying everything?!

  • Barb Sabin

    03/21/2020 01:37 AM

    Dear Governor and brother Mike! Let us all pray that when this horrendous disease is under control, our President will take the manufacturing of medicinal ingredients out of the hands of our Chinese enemies!!! They are waiting to greatly take advantage of our country's vulnerabilities, and go for our weaknesses, then play the blame game to make USA look like the BAD GUY!!! PLEASE American Christian, Wakeup and vote PRO LIFE, PRO RELIGIOUS FREEDOM, PRO ISRAEL!!!!!!!

  • n

    03/21/2020 01:32 AM

    much info is now also coming out about vit c (usually intravenous) having now brought healing to many who have contracted the china virus....hopefully more exposure can come about that and help fight the illness

  • Barb Sabin

    03/21/2020 01:29 AM

    Help us Lord to get far away from reliance on a communist country like CHINA for medicinal ingredients!!! I hope everyone sees now how they cannot be trusted!!! I know Donald Trump is a genius and given FOUR MORE YEARS, will fix this mess!!! Please pray for our President and all you christians, VOTE YOUR BIBLICAL VALUES!!! PRO LIFE, PRO RELIGIOUS FREEDOM, PRO ISRAEL!!! God please open our spiritual eyes that we can see that we are a needy people, who need JESUS CHRIST AND HIS WORD!!! AMEN

  • Arthur Webb

    03/21/2020 01:10 AM

    This would be the answer to our prayers. As a healthcare worker in the high risk age group, I am really hopeful that this drug combo is as great as it sounds. Thanks for bringing us some good news.

  • Henry Pan

    03/21/2020 12:10 AM

    TEVA make this drug. It will donate 6 millions dosage free. See link below:

    https://www.bizjournals.com/philadelphia/news/2020/03/20/teva-donating-6-million-doses-of-drug-as-potential.html

  • Gale D Rumsey

    03/20/2020 11:18 PM

    Since it is a 70+ year old drug and has been used for malaria and other diseases with success, obviously it is safe, does not need to be "tested" for months or years, and the people who received it went from positive to negative in six days, it sounds to me like this might be the miracle we have been waiting for.

  • Renee Kendrick

    03/20/2020 10:10 PM

    I am reminded of the M*A*S*H episode where the malaria drug, chloroquine, was not available from HQ. A lower-level drug, Primaquine, was sent to the 4077th instead. Klinger (and another guy) had adverse side effects from the Primaquine. Once they were taken off the medicine, they regained their health. At the end of the episode, wording was shown that it was later discovered that people of Mediterranean descent were affected negatively by the Primaquine. (Klinger, Jamie Farr, was Lebanese.)

  • Gary Stilwell

    03/20/2020 08:41 PM

    So there may be a light at the end of the tunnel-the common Z-pack.--When are we going to find out who is funding all the fear tactics and resultant economical meltdown?
    This virus is a mutant of the flu--no-one seems to have done the root cause analysis here--what started it, how did it evolve.--Without root cause, you will always be putting band-aides on it--
    kinda like waking up and finding you have a flat tire---instead of looking for the reason why your tire is flat, you simply add air to it--next day the tire is flat again--next, there are several people who have a flat tire--same as you--nobody looks for the reason why, but suddenly, it's a "flat tire syndrome" it causes folks to not be able to get to work--so the gov't pays you because you are losing income through "no fault of your own"--(when indeed it IS a fault of your own--some construction firm dumped a whole bag of roofing nails on the road--but because nobody actually looked at the root cause, All of the folks who travelled the road are now elligible for gov't subsidies or payments to fix your tires--as soon as you get these payments, you go buy new tires, then drive down the same road and get another flat tire--the "flat tire syndrome" expands to the nation and then the world--people are locked down so they won't go out on the street and get a flat, that the gov't will pay you for---the tire industry is blamed for having faulty tires--since they use petroleum products in their manufacture, that industry is also blamed--the tire stock falls dramatically--the petro industry falls next--it soon morphs into the auto manufacturers' negligence in choosing the "wrong" tire for their autos. Their stock also plummets--And WHO reported all this "fake" news????

    The fuse was lit by the Democrats---they lit it and ran off into the shadows to watch the explosion from afar---
    Pelosi's "test,test,test" statement did not in any way show concern for the American Public---She knew it would finally reveal a larger population of infected folks--this is a fact of ANY flu/disease outbreak(When you start testing for infection, the number of cases ALWAYS goes up)This woman may not be THAT stupid(I believe she is, but has the foresight to listen to the crooked advisors she has(soros))
    Trump's pushback to Fausi's admonition that "more testing" is required to determine if the treatment is classic--he thinks any shred of remission is worth exploring-esp if it is a standard treatment and has been passed by the CDC.--
    The US is under lockdown due to fear-and fear alone----this is what socialism looks like---

  • Sheldon Larsen

    03/20/2020 07:35 PM

    Thank you for continuing to provide us with positive news. On this and all situations.

  • Susan White

    03/20/2020 07:12 PM

    Governor Huckabee

    Thank you for keeping us abreast of daily happenings. I believe what comes from you. The media is a scare tactic.

    President Trump is working tirelessly to help this country. I pray daily for him and his loyal workers. God’s arms are long and strong. He will see us through this and draw people to Him.

  • Steve

    03/20/2020 06:48 PM

    I was in walmart today. The store was packed with shoppers, but not much on the shelves. Reminded me of what used to read about Russia when they were under socialism and dictators. Really makes me wish we had that form of government. NOT!!!

  • Jessie Teddlie

    03/20/2020 06:07 PM

    Novartis has promised 130 million doses of generic hydroxychloroquine.

  • joseph orsini PhD

    03/20/2020 05:32 PM

    I have Lupus, and have been taking hydroxychloroquine for about 6 years; my wife has never used it. A possible effectiveness study is to compare pairs of users and non-users [e.g. me and my wife] to see if Covid-19 is present in the non-users but absent in the users.

  • Carol covington

    03/20/2020 05:31 PM

    Our daughter has been on plaquenil since she was diagnosed with autoimmune disease at age 18. That was 22 yrs ago. Why not study cases like hers and see their response to this pandemic. She is in the medical field in Ohio and so far no signs or symptoms