March 19, 2020
|

Gregory Rigano, an attorney who says he is an adviser at Stanford University Medical School, appeared on Tucker Carlson’s show Wednesday night to discuss the potential for a widely-used antimalarial drug, hydroxychloroquine, to treat the novel coronavirus. He had already appeared on Laura Ingraham’s show Monday night, where he claimed a study he’d co-authored showed that coronavirus patients who’d taken hydroxychloroquine were testing negative after six days.

On Tucker’s show, he said that President Trump, after having “cut more red tape at the FDA than any other President in history,” has the authority to green-light the use of this drug immediately against coronavirus. He said Trump has expedited drug approval before, in 2017, with a new drug for muscular dystrophy being approved after a very small clinical trial (fewer than 15 patients) that was “generally uncontrolled, in an open setting.”

Being a lawyer himself, I guess Rigano is concerned about liability if doctors prescribe the drug off-label and it causes harm. But doctors do prescribe drugs off-label quite often. The FDA takes a pretty lax attitude about that once it has approved a drug as "safe and effective."


Commentary continues below advertisement


Understanding Unapproved Use of Approved Drugs "Off Label"

https://www.fda.gov/patients/learn-about-expanded-access-and-other-treatment-options/understanding-unapproved-use-approved-drugs-label

Rigano noted that hydroxychloroquine has been on the market and used safely for over 50 years, and said he was breaking news on the air with his announcement that “a well-controlled peer-reviewed study...showed a 100 percent cure rate against coronavirus." (He claims this makes COVID--19 only the second virus in history to be cured, after Hepatitis C.) "The study was recently accepted to the International Journal of Antimicrobial Agents,” he said. We looked that publication up, and here it is:

https://www.journals.elsevier.com/international-journal-of-antimicrobial-agents/

The journal has published other work on the issue of treating COVID-19 with this drug.

https://www.sciencedirect.com/science/article/pii/S0924857920300662

Tucker was understandably skeptical, as we all should be, but expressed gratitude. “I very much want to believe this,” he said, “and I think we need, obviously, to immediately run it down; the federal government needs to find out if this is true, because if it is, that’s the biggest news of this moment.”

It was hard to know what to think about this while watching it, as it just came out of the blue. It didn’t help that Rigano ended the interview oddly, by saying, “Please disseminate it to the scientific community immediately.” It sounded a little like, "People of Earth...take me to your leader."

What could Tucker say? It was the close of his show. “I would hope they’d—they’d be on it,” he stammered.

We looked up Rigano’s bio, and that’s where I saw that he is an attorney, not an M.D. as TV viewers might have assumed. It goes on to say, “Gregory’s experience includes advancing various pharmaceutical assets through laboratory, animal, formulation, manufacturing, clinical trials (Phase I-III), as well as commercialization.” Here’s the whole thing:

https://www.riganollc.com/attorneys/gregory-j-rigano/

There actually is a research paper with his name on it, called “An Effective Treatment for Coronavirus (COVID-19), linked to below. On the other hand, the paper concludes with a grammatically-challenged disclaimer that says in part, “The authors and/or its affiliates does not guarantee the accuracy of or the conclusions reached by this white paper, and this white paper is provided ‘as is.’ It goes on in similar fashion. That doesn’t do much to inspire confidence. It’s impossible to know right now if this is legit, and it appears that they rushed it out.

Whether this study is for real or not, I think perhaps the best attitude to take about trying this drug on the virus is that “it couldn’t hurt.” When something seems too good to be true, it usually is. Still, this is a drug that has been used safely for half a century, so why not fast-track the studies and also approve it now for off-label use to treat coronavirus and see how well it works? Given the circumstances, what have we got to lose?

https://docs.google.com/document/d/e/2PACX-1vTi-g18ftNZUMRAj2SwRPodtscFio7bJ7GdNgbJAGbdfF67WuRJB3ZsidgpidB2eocFHAVjIL-7deJ7/pub

The video from Tucker’s show can be found here:

https://starpolitical.com/report-french-doctor-reports-100-cure-rate-using-malaria-drug-to-treat-corona-virus/

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Comments 26-50 of 58

  • James Evart

    03/19/2020 01:03 PM

    Mike,
    You, Carlson, Hannity, Waters, Dobbs, Solomon, Levin and others are a bubbling, crystal clear spring of honest and forthright journalism which brings comfort, clarity and honesty to an otherwise compromised and corrupt media by giving understanding to what is actually going on in this imperfect yet still beautiful world.
    I have a friend of 65+ years who is like a brother to me and who is totally taken in by today's liberal media. He is an intelligent, experienced and wordly man. I am coming to believe that the difference in being awakened to and aware of the lies of the left is a belief and hope in God which gives a healthy, well ordered and disciplined foundational lense to decifer, without judging, the intentions and motivations of others in seeing things for what they are. That foundation is one of love for Jesus Christ through his Holy Spirit. It is known through the wisdom he gives us to fear God. It reminds us that our reward is not of this world but in its Creator.

    Keep up the good work. WELL DONE!

    Pray.

    PS: If you do not believe in God then you do not believe in his word and these verses will have little or no meaning to you:
    Exodus 20:18-20, Psalms 90: 11-12, Isaiah 8: 11-17, Romans 11: 20-23, Phil. 2:12, Luke 12:1-10 and all throughout his word to us. ('84 NIV).

  • Angel Bakos

    03/19/2020 01:00 PM

    I am delighted to note your skepticism toward the FDA & the new Chief. I noted his eyes during the TV review & found it fascinating that he would spend minutes looking at the back of the President’s head! Further, the long history of the department in politicizing everything they do, I cannot trust anything he says!
    They ignore too many issues & are influenced by money even if it can’t be proven It is an agency that needs to be cleaned with bleach!

  • Patrick McClurkin

    03/19/2020 12:52 PM

    If this was a new drug I would be more than skeptical, but since it has been in use for decades I think we should definitely try it. As someone in a high risk category I would take it....there is nothing else available right now!

  • R Dennis

    03/19/2020 12:46 PM

    I took this pill for arthritis and it played havoc with my immune system. It caused me to have low sodium and iron deficiency. Please use extreme caution if you take this pill. Get regular bloodwork done.

  • Patrick McClurkin

    03/19/2020 12:44 PM

    If this was a new drug I would be more than skeptical, but since it has been in use for decades I think we should definitely try it. As someone in a high risk category I would take it....there is nothing else available right now!

  • Carol Hopper

    03/19/2020 12:42 PM

    I was watching one of many interviews of people who have the virus. One man, I think he was from Washington State, had received a vaccine developed for the Ebola virus several years ago. He was very sick n after taking it he was decidedly better in 48 hrs. I wish I remembered more about it.

  • Floyd A Unger

    03/19/2020 12:42 PM

    Yeah....well I know a guy with good scientific credentials who makes a drug(s) that he “invented” and sells to the “terminal” mostly elderly. Results unknown and the FDA doesn’t intervene.

  • Cheryl Hutchins

    03/19/2020 12:38 PM

    One can only hope that this person is an “honest broker” and not another shyster wanting to insert himself into the narrative for personal gain.

  • Doreen Dunne

    03/19/2020 12:37 PM

    Thank you for this information! I believe I heard similar information from DR. Mark Seigel on Fox news a few days ago. Either he or another doctor said the coronavirus has been being treated in some people with either remdesivir ( Not approved by the FDA yet, it is in clinical trials in China, it is manufactured by American company Gilead), chorloquine plus zinc, or with an arthritis drug that I can't remember the name.
    We need treatments! Remdesivir is also talked about in the Journal article you linked to. They mention how the first coronavirus patient in Washington state was given remdesivir on a compassionate basis( since it is not approved yet) on Day 7 of his hospitaliization and how he remarkably improved and got better! We need these treatments fast tracked to save lives or else to be given out to everyone on a compassionate basis to save lives!

  • Martha Shuping

    03/19/2020 12:34 PM

    CORRECTION TO PREVIOUS COMMENT - In my previous comment I said "But lack of approval is no problem at all..." and what I meant there, meaning to refer to hydrochoroquine which is already approved for malaria, was this:

    But lack of approval for a new condition (when a med is approved already for some other condition) is no problem at all - the FDA has actually made more than one statement about this over the years, and there is nothing illegal or unethical about this - and the FDA admits it is often beneficial. 

    (would you please substitute this sentence above for what I previously said - or edit to show that I am speaking here in this part specifically about hydrochloroquine which is not currently approved for corona virus, but which already is approved for malaria - I believe my original statement lacked clarity and my meaning would be misunderstood - thank you so much.)

  • Martha Shuping

    03/19/2020 12:22 PM

    The UK newspaper, The Telegraph, reported on March 18 that a 79 year old Italian man had recovered from corona virus after being given the drug remdesivir. This drug was originally developed by Gilead Science, an American Company, to treat Ebola. My understanding is that they did all the preliminary safety testing, and did some "clinical trials" as well as "compassionate use" but never proceeded to seek FDA approval - which may be due to a different treatment being more effective for Ebola. But - the big news now is that in a small number of cases, remdesivir has been remarkably effective. In the U.S., it has been given to at least two people in Snohomish County, Washington state, with rapidly beneficial results back in Jan. 2020, and now the report about the Italian man. Three cases does not "prove" efficacy, but - there are currently 5 Phase III clinical trials going on worldwide - Phase 3 is the last step before submitting to the FDA. Two of the clinical trials are going on in China, one with severe cases and one with moderate cases. These two trials should finish in April. Once the results are looked at, if good, this could be submitted to the FDA to request approval. But - once approval is requested, it can still take a long time till a decision is made, and then it can take a while to ramp up production. The FDA has a mechanism to speed up the process for approval, which is what is needed. That is, there is a provision in the regulations called "Sub-part H" which allows approval to be speeded up drastically especially for meds that would treat life threatening conditions for which no other treatment exists. Strangely, RU-486, the "abortion pill" (not morning after pill - this is the pill used for an actual abortion) was approved under Sub-part H, and so was Gardisil, the HPV vaccine, though many would dispute the claim that these drugs save lives. Usually the kinds of drugs approved though Sub-part H are things like, treatments for rare cancers, or more effective HIV meds. In any case, there is in existence a mechanism to speed up the process, and one can hope the FDA would not drag it's collective feet in delaying this medication from reaching the market - unless there is bad news we do not expect from the clinical trials. The story in the Guardian mentions that there was a Scottish nurse who took remdesivir in the past for Ebola, and lived (still alive today) thus, it does apparently have some efficacy for Ebola. Now with the remarkable results with the Italian man, as well as at least two in Seattle, and the Phase III trials soon to complete, hopefully this can be made widely available soon. In addition, there is a federal "right to try" law, and while that right is not absolute, anyone can request even an unapproved med through the FDA or the manufacturer if they have an illness which has no other treatment and they want to try a new treatment. If drug is available, the FDA and the manufacturer can allow for the drug to be made available - though if all the drug is being used in clinical trials (research), then you might not get it, if there is not a supply available. There is a little more to it than this, but this is the gist of it. It can be made available on a "compassionate basis" which is how the two men in Washington state would have gotten it though as yet unapproved. I hope formal approval will be given soon, and actually, it may not need the provisions of Sub-part H at all, since multiple clinical trials are in progress, and if they have two positive trials, then they will have met the criteria for approval and may not need Sub-part H - but the FDA needs to move forward and to the approval without sitting it for a long time or delaying unnecessarily. Meanwhile, it is a fact that hydroxychloroquine does NOT require any FDA approval to be used today - this afternoon, for example, for treating corona virus. Once the original safety testing has been done, and once a med has been approved by FDA as safe and effective, it is perfectly legitimate for any doctor to use that med for any patient for whom the doctor believes it may be helpful. It can be used right now for corona virus. If approval were provided by the FDA that would make more doctors aware of the potential benefit to their patients etc. but generally there should be some testing before actual approval - whether the normal route or the accelerated route by Sub-part H. But lack of approval is no problem at all - the FDA has actually made more than one statement about this over the years, and there is nothing illegal or unethical about this - and the FDA admits it is often beneficial. There have been those "experts" who complain that meds should not be used without approval first, yet other experts show that it is upbiquitous in medicine to use meds off label, and it very often is beneficial. It certainly would be hugely beneficial to try anything that might work considering that many are dying from corona virus, and others are ending up with permanent lung damage. There is no reason that people who want to try hydrochloroquine should not have it. It's actually ethical to give even an untested, unapproved drug if the person is gravely ill and there is no other treatment - but in this case, it's an already approved drug that has already proven it is safe and effective for another condition - and no restriction on using it. Awareness is more the issue - yet some MD's may mistakenly think they are not permitted to use it for an unapproved condition - and the biggest problem is that often today insurances will not pay for unapproved use of established meds. But with hydrochloroquine being an older generic, with or without insurance coverage, cost should not be a huge barrier. (Link to story in Telegraph - https://www.telegraph.co.uk/news/2020/03/18/coronavirus-cure-hope-79-year-old-italian-man-successfully-treated/?WT.mc_id=e_DM1220527&WT.tsrc=email&etype=Edi_FAM_New_ES&utmsource=email&utm_medium=Edi_FAM_New_ES20200319&utm_campaign=DM1220527 )

  • Suzan Saneman

    03/19/2020 12:18 PM

    I agree! Try the drug! Unless there are contraindications because patient is taking other meds that might create side effects, give it to them!

  • Karen Sparks

    03/19/2020 12:11 PM

    I read recently Australia was doing a clinical trial on this and another drug which had been used in the past to treat HIV. True or false?

  • Teresa Edwards

    03/19/2020 12:10 PM

    I’ve been on hydroxychloroquine since January 2010 to treat my RA. Thank you, sweet Lord, for providing this drug to me to treat my condition, but also now to treat this horrible virus.

  • Beth landes

    03/19/2020 12:05 PM

    I admire our President and whatever he decides regarding this issue - I stand behind him.

  • Elaine Knudsen

    03/19/2020 11:57 AM

    Australia is already using it, what looks like effectively. I have heard that this med does work & it works even better if combined with Zinc. If I got the virus, I would definitely use it.

  • TERI NIX

    03/19/2020 11:52 AM

    This is wonderful news about the drug!! I am so thankful to our heavenly father that we have a President who tirelessly works for the good of all American people. I am thankful for a God who loves all of us and gives us the hope and strength that we need to get through this unprecedented time in America. God Bless You Mike!!

  • Lauren MacArthur

    03/19/2020 11:48 AM

    It sure does seem worth a try....after all, it has been used to treat malaria for 50 years...malaria is a zoonotic, as is corona virus. It may have better results in combination with something like azithromycin, because of its known efficacy against complications from bacterial lung disease. Of course, contraindications with other drugs being taken by the patients..like drugs that prolong the QT interval, and other arrhythmogenics, must be monitored because of the potential for inducing cardiac arrhythmias.

  • Virginia Young

    03/19/2020 11:45 AM

    What have you got to lose? Well, almost everything. This drug is notorious for making people sick. Nausea, vomiting, diarrhea. Gut microbiomes turned upside down and almost a quarter of those who take it have abnormal weight gain.The list of side effects is long with skin rashes, itching, hives, hair loss, mood swings, irritability, headaches, vertigo, loss of appetite, anxiety and on and on. For some these side effects are severe and they never fully recover.. I know individuals who have been left disabled. Why don't we take a harder look at the virus itself before jumping into such extreme measures. I am sure the pharmaceutical industry will also want to be completely protected from all liability if this is rushed through in "emergency circumstances". No-one will be safe.

  • Ronald H Davis

    03/19/2020 11:32 AM

    I think this whole thing is just something that shows how easy it is for the politicians to shut down the government and take away all of our rights gun rights and everything else writes to move around to go to gatherings you wait this is just the start of it

  • Michael Hobson

    03/19/2020 11:29 AM

    I read an article this morning on Breitbart News about some success that they are having in S Korea and China with the following anti-malaria drug -
    “ Chloroquine phosphate, an old-fashioned anti-malarial drug, has shown strong results against COVID-19 infections in South Korea and China.”
    Sounds like your author may have been trying to reference this.

  • Bill Sledjeski

    03/19/2020 11:29 AM

    How about Jim Baker's Silver Bullet.?

  • Dobbin Callahan

    03/19/2020 11:28 AM

    It is my understanding that Hydroxychloroquine (sp?) does have significant risks with the wrong dosing.

  • John W Hancock

    03/19/2020 11:27 AM

    Years ago we were advised to take our B and C vitamins with Zinc because that would help our immune center. That advise has proven true as the new stuff I am reading says that Zinc taken with the medicine makes the medicine more effective. Don't forget the Zinc either alone or with the other vitamins. MANY products available on the Vitamin shelf at the Drug store.

  • Sue Lenio

    03/19/2020 11:27 AM

    Thank you for doing the check on this guy. I got a creepy person feeling when I saw him on Tucker, Laura and Varney this morning. His dramatics on Tucker sent my tentacles up last night.

March 19, 2020
|

Gregory Rigano, an attorney who says he is an adviser at Stanford University Medical School, appeared on Tucker Carlson’s show Wednesday night to discuss the potential for a widely-used antimalarial drug, hydroxychloroquine, to treat the novel coronavirus. He had already appeared on Laura Ingraham’s show Monday night, where he claimed a study he’d co-authored showed that coronavirus patients who’d taken hydroxychloroquine were testing negative after six days.

On Tucker’s show, he said that President Trump, after having “cut more red tape at the FDA than any other President in history,” has the authority to green-light the use of this drug immediately against coronavirus. He said Trump has expedited drug approval before, in 2017, with a new drug for muscular dystrophy being approved after a very small clinical trial (fewer than 15 patients) that was “generally uncontrolled, in an open setting.”

Being a lawyer himself, I guess Rigano is concerned about liability if doctors prescribe the drug off-label and it causes harm. But doctors do prescribe drugs off-label quite often. The FDA takes a pretty lax attitude about that once it has approved a drug as "safe and effective."


Commentary continues below advertisement


Understanding Unapproved Use of Approved Drugs "Off Label"

https://www.fda.gov/patients/learn-about-expanded-access-and-other-treatment-options/understanding-unapproved-use-approved-drugs-label

Rigano noted that hydroxychloroquine has been on the market and used safely for over 50 years, and said he was breaking news on the air with his announcement that “a well-controlled peer-reviewed study...showed a 100 percent cure rate against coronavirus." (He claims this makes COVID--19 only the second virus in history to be cured, after Hepatitis C.) "The study was recently accepted to the International Journal of Antimicrobial Agents,” he said. We looked that publication up, and here it is:

https://www.journals.elsevier.com/international-journal-of-antimicrobial-agents/

The journal has published other work on the issue of treating COVID-19 with this drug.

https://www.sciencedirect.com/science/article/pii/S0924857920300662

Tucker was understandably skeptical, as we all should be, but expressed gratitude. “I very much want to believe this,” he said, “and I think we need, obviously, to immediately run it down; the federal government needs to find out if this is true, because if it is, that’s the biggest news of this moment.”

It was hard to know what to think about this while watching it, as it just came out of the blue. It didn’t help that Rigano ended the interview oddly, by saying, “Please disseminate it to the scientific community immediately.” It sounded a little like, "People of Earth...take me to your leader."

What could Tucker say? It was the close of his show. “I would hope they’d—they’d be on it,” he stammered.

We looked up Rigano’s bio, and that’s where I saw that he is an attorney, not an M.D. as TV viewers might have assumed. It goes on to say, “Gregory’s experience includes advancing various pharmaceutical assets through laboratory, animal, formulation, manufacturing, clinical trials (Phase I-III), as well as commercialization.” Here’s the whole thing:

https://www.riganollc.com/attorneys/gregory-j-rigano/

There actually is a research paper with his name on it, called “An Effective Treatment for Coronavirus (COVID-19), linked to below. On the other hand, the paper concludes with a grammatically-challenged disclaimer that says in part, “The authors and/or its affiliates does not guarantee the accuracy of or the conclusions reached by this white paper, and this white paper is provided ‘as is.’ It goes on in similar fashion. That doesn’t do much to inspire confidence. It’s impossible to know right now if this is legit, and it appears that they rushed it out.

Whether this study is for real or not, I think perhaps the best attitude to take about trying this drug on the virus is that “it couldn’t hurt.” When something seems too good to be true, it usually is. Still, this is a drug that has been used safely for half a century, so why not fast-track the studies and also approve it now for off-label use to treat coronavirus and see how well it works? Given the circumstances, what have we got to lose?

https://docs.google.com/document/d/e/2PACX-1vTi-g18ftNZUMRAj2SwRPodtscFio7bJ7GdNgbJAGbdfF67WuRJB3ZsidgpidB2eocFHAVjIL-7deJ7/pub

The video from Tucker’s show can be found here:

https://starpolitical.com/report-french-doctor-reports-100-cure-rate-using-malaria-drug-to-treat-corona-virus/

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Comments 26-50 of 58

  • James Evart

    03/19/2020 01:03 PM

    Mike,
    You, Carlson, Hannity, Waters, Dobbs, Solomon, Levin and others are a bubbling, crystal clear spring of honest and forthright journalism which brings comfort, clarity and honesty to an otherwise compromised and corrupt media by giving understanding to what is actually going on in this imperfect yet still beautiful world.
    I have a friend of 65+ years who is like a brother to me and who is totally taken in by today's liberal media. He is an intelligent, experienced and wordly man. I am coming to believe that the difference in being awakened to and aware of the lies of the left is a belief and hope in God which gives a healthy, well ordered and disciplined foundational lense to decifer, without judging, the intentions and motivations of others in seeing things for what they are. That foundation is one of love for Jesus Christ through his Holy Spirit. It is known through the wisdom he gives us to fear God. It reminds us that our reward is not of this world but in its Creator.

    Keep up the good work. WELL DONE!

    Pray.

    PS: If you do not believe in God then you do not believe in his word and these verses will have little or no meaning to you:
    Exodus 20:18-20, Psalms 90: 11-12, Isaiah 8: 11-17, Romans 11: 20-23, Phil. 2:12, Luke 12:1-10 and all throughout his word to us. ('84 NIV).

  • Angel Bakos

    03/19/2020 01:00 PM

    I am delighted to note your skepticism toward the FDA & the new Chief. I noted his eyes during the TV review & found it fascinating that he would spend minutes looking at the back of the President’s head! Further, the long history of the department in politicizing everything they do, I cannot trust anything he says!
    They ignore too many issues & are influenced by money even if it can’t be proven It is an agency that needs to be cleaned with bleach!

  • Patrick McClurkin

    03/19/2020 12:52 PM

    If this was a new drug I would be more than skeptical, but since it has been in use for decades I think we should definitely try it. As someone in a high risk category I would take it....there is nothing else available right now!

  • R Dennis

    03/19/2020 12:46 PM

    I took this pill for arthritis and it played havoc with my immune system. It caused me to have low sodium and iron deficiency. Please use extreme caution if you take this pill. Get regular bloodwork done.

  • Patrick McClurkin

    03/19/2020 12:44 PM

    If this was a new drug I would be more than skeptical, but since it has been in use for decades I think we should definitely try it. As someone in a high risk category I would take it....there is nothing else available right now!

  • Carol Hopper

    03/19/2020 12:42 PM

    I was watching one of many interviews of people who have the virus. One man, I think he was from Washington State, had received a vaccine developed for the Ebola virus several years ago. He was very sick n after taking it he was decidedly better in 48 hrs. I wish I remembered more about it.

  • Floyd A Unger

    03/19/2020 12:42 PM

    Yeah....well I know a guy with good scientific credentials who makes a drug(s) that he “invented” and sells to the “terminal” mostly elderly. Results unknown and the FDA doesn’t intervene.

  • Cheryl Hutchins

    03/19/2020 12:38 PM

    One can only hope that this person is an “honest broker” and not another shyster wanting to insert himself into the narrative for personal gain.

  • Doreen Dunne

    03/19/2020 12:37 PM

    Thank you for this information! I believe I heard similar information from DR. Mark Seigel on Fox news a few days ago. Either he or another doctor said the coronavirus has been being treated in some people with either remdesivir ( Not approved by the FDA yet, it is in clinical trials in China, it is manufactured by American company Gilead), chorloquine plus zinc, or with an arthritis drug that I can't remember the name.
    We need treatments! Remdesivir is also talked about in the Journal article you linked to. They mention how the first coronavirus patient in Washington state was given remdesivir on a compassionate basis( since it is not approved yet) on Day 7 of his hospitaliization and how he remarkably improved and got better! We need these treatments fast tracked to save lives or else to be given out to everyone on a compassionate basis to save lives!

  • Martha Shuping

    03/19/2020 12:34 PM

    CORRECTION TO PREVIOUS COMMENT - In my previous comment I said "But lack of approval is no problem at all..." and what I meant there, meaning to refer to hydrochoroquine which is already approved for malaria, was this:

    But lack of approval for a new condition (when a med is approved already for some other condition) is no problem at all - the FDA has actually made more than one statement about this over the years, and there is nothing illegal or unethical about this - and the FDA admits it is often beneficial. 

    (would you please substitute this sentence above for what I previously said - or edit to show that I am speaking here in this part specifically about hydrochloroquine which is not currently approved for corona virus, but which already is approved for malaria - I believe my original statement lacked clarity and my meaning would be misunderstood - thank you so much.)

  • Martha Shuping

    03/19/2020 12:22 PM

    The UK newspaper, The Telegraph, reported on March 18 that a 79 year old Italian man had recovered from corona virus after being given the drug remdesivir. This drug was originally developed by Gilead Science, an American Company, to treat Ebola. My understanding is that they did all the preliminary safety testing, and did some "clinical trials" as well as "compassionate use" but never proceeded to seek FDA approval - which may be due to a different treatment being more effective for Ebola. But - the big news now is that in a small number of cases, remdesivir has been remarkably effective. In the U.S., it has been given to at least two people in Snohomish County, Washington state, with rapidly beneficial results back in Jan. 2020, and now the report about the Italian man. Three cases does not "prove" efficacy, but - there are currently 5 Phase III clinical trials going on worldwide - Phase 3 is the last step before submitting to the FDA. Two of the clinical trials are going on in China, one with severe cases and one with moderate cases. These two trials should finish in April. Once the results are looked at, if good, this could be submitted to the FDA to request approval. But - once approval is requested, it can still take a long time till a decision is made, and then it can take a while to ramp up production. The FDA has a mechanism to speed up the process for approval, which is what is needed. That is, there is a provision in the regulations called "Sub-part H" which allows approval to be speeded up drastically especially for meds that would treat life threatening conditions for which no other treatment exists. Strangely, RU-486, the "abortion pill" (not morning after pill - this is the pill used for an actual abortion) was approved under Sub-part H, and so was Gardisil, the HPV vaccine, though many would dispute the claim that these drugs save lives. Usually the kinds of drugs approved though Sub-part H are things like, treatments for rare cancers, or more effective HIV meds. In any case, there is in existence a mechanism to speed up the process, and one can hope the FDA would not drag it's collective feet in delaying this medication from reaching the market - unless there is bad news we do not expect from the clinical trials. The story in the Guardian mentions that there was a Scottish nurse who took remdesivir in the past for Ebola, and lived (still alive today) thus, it does apparently have some efficacy for Ebola. Now with the remarkable results with the Italian man, as well as at least two in Seattle, and the Phase III trials soon to complete, hopefully this can be made widely available soon. In addition, there is a federal "right to try" law, and while that right is not absolute, anyone can request even an unapproved med through the FDA or the manufacturer if they have an illness which has no other treatment and they want to try a new treatment. If drug is available, the FDA and the manufacturer can allow for the drug to be made available - though if all the drug is being used in clinical trials (research), then you might not get it, if there is not a supply available. There is a little more to it than this, but this is the gist of it. It can be made available on a "compassionate basis" which is how the two men in Washington state would have gotten it though as yet unapproved. I hope formal approval will be given soon, and actually, it may not need the provisions of Sub-part H at all, since multiple clinical trials are in progress, and if they have two positive trials, then they will have met the criteria for approval and may not need Sub-part H - but the FDA needs to move forward and to the approval without sitting it for a long time or delaying unnecessarily. Meanwhile, it is a fact that hydroxychloroquine does NOT require any FDA approval to be used today - this afternoon, for example, for treating corona virus. Once the original safety testing has been done, and once a med has been approved by FDA as safe and effective, it is perfectly legitimate for any doctor to use that med for any patient for whom the doctor believes it may be helpful. It can be used right now for corona virus. If approval were provided by the FDA that would make more doctors aware of the potential benefit to their patients etc. but generally there should be some testing before actual approval - whether the normal route or the accelerated route by Sub-part H. But lack of approval is no problem at all - the FDA has actually made more than one statement about this over the years, and there is nothing illegal or unethical about this - and the FDA admits it is often beneficial. There have been those "experts" who complain that meds should not be used without approval first, yet other experts show that it is upbiquitous in medicine to use meds off label, and it very often is beneficial. It certainly would be hugely beneficial to try anything that might work considering that many are dying from corona virus, and others are ending up with permanent lung damage. There is no reason that people who want to try hydrochloroquine should not have it. It's actually ethical to give even an untested, unapproved drug if the person is gravely ill and there is no other treatment - but in this case, it's an already approved drug that has already proven it is safe and effective for another condition - and no restriction on using it. Awareness is more the issue - yet some MD's may mistakenly think they are not permitted to use it for an unapproved condition - and the biggest problem is that often today insurances will not pay for unapproved use of established meds. But with hydrochloroquine being an older generic, with or without insurance coverage, cost should not be a huge barrier. (Link to story in Telegraph - https://www.telegraph.co.uk/news/2020/03/18/coronavirus-cure-hope-79-year-old-italian-man-successfully-treated/?WT.mc_id=e_DM1220527&WT.tsrc=email&etype=Edi_FAM_New_ES&utmsource=email&utm_medium=Edi_FAM_New_ES20200319&utm_campaign=DM1220527 )

  • Suzan Saneman

    03/19/2020 12:18 PM

    I agree! Try the drug! Unless there are contraindications because patient is taking other meds that might create side effects, give it to them!

  • Karen Sparks

    03/19/2020 12:11 PM

    I read recently Australia was doing a clinical trial on this and another drug which had been used in the past to treat HIV. True or false?

  • Teresa Edwards

    03/19/2020 12:10 PM

    I’ve been on hydroxychloroquine since January 2010 to treat my RA. Thank you, sweet Lord, for providing this drug to me to treat my condition, but also now to treat this horrible virus.

  • Beth landes

    03/19/2020 12:05 PM

    I admire our President and whatever he decides regarding this issue - I stand behind him.

  • Elaine Knudsen

    03/19/2020 11:57 AM

    Australia is already using it, what looks like effectively. I have heard that this med does work & it works even better if combined with Zinc. If I got the virus, I would definitely use it.

  • TERI NIX

    03/19/2020 11:52 AM

    This is wonderful news about the drug!! I am so thankful to our heavenly father that we have a President who tirelessly works for the good of all American people. I am thankful for a God who loves all of us and gives us the hope and strength that we need to get through this unprecedented time in America. God Bless You Mike!!

  • Lauren MacArthur

    03/19/2020 11:48 AM

    It sure does seem worth a try....after all, it has been used to treat malaria for 50 years...malaria is a zoonotic, as is corona virus. It may have better results in combination with something like azithromycin, because of its known efficacy against complications from bacterial lung disease. Of course, contraindications with other drugs being taken by the patients..like drugs that prolong the QT interval, and other arrhythmogenics, must be monitored because of the potential for inducing cardiac arrhythmias.

  • Virginia Young

    03/19/2020 11:45 AM

    What have you got to lose? Well, almost everything. This drug is notorious for making people sick. Nausea, vomiting, diarrhea. Gut microbiomes turned upside down and almost a quarter of those who take it have abnormal weight gain.The list of side effects is long with skin rashes, itching, hives, hair loss, mood swings, irritability, headaches, vertigo, loss of appetite, anxiety and on and on. For some these side effects are severe and they never fully recover.. I know individuals who have been left disabled. Why don't we take a harder look at the virus itself before jumping into such extreme measures. I am sure the pharmaceutical industry will also want to be completely protected from all liability if this is rushed through in "emergency circumstances". No-one will be safe.

  • Ronald H Davis

    03/19/2020 11:32 AM

    I think this whole thing is just something that shows how easy it is for the politicians to shut down the government and take away all of our rights gun rights and everything else writes to move around to go to gatherings you wait this is just the start of it

  • Michael Hobson

    03/19/2020 11:29 AM

    I read an article this morning on Breitbart News about some success that they are having in S Korea and China with the following anti-malaria drug -
    “ Chloroquine phosphate, an old-fashioned anti-malarial drug, has shown strong results against COVID-19 infections in South Korea and China.”
    Sounds like your author may have been trying to reference this.

  • Bill Sledjeski

    03/19/2020 11:29 AM

    How about Jim Baker's Silver Bullet.?

  • Dobbin Callahan

    03/19/2020 11:28 AM

    It is my understanding that Hydroxychloroquine (sp?) does have significant risks with the wrong dosing.

  • John W Hancock

    03/19/2020 11:27 AM

    Years ago we were advised to take our B and C vitamins with Zinc because that would help our immune center. That advise has proven true as the new stuff I am reading says that Zinc taken with the medicine makes the medicine more effective. Don't forget the Zinc either alone or with the other vitamins. MANY products available on the Vitamin shelf at the Drug store.

  • Sue Lenio

    03/19/2020 11:27 AM

    Thank you for doing the check on this guy. I got a creepy person feeling when I saw him on Tucker, Laura and Varney this morning. His dramatics on Tucker sent my tentacles up last night.