The Briefing Room
General Category => Editorial/Opinion/Blogs => Topic started by: mystery-ak on March 30, 2020, 02:05:18 pm
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Hydroxychloroquine: Help Is On The Way!
Kevin McCullough
Posted: Mar 29, 2020 11:10 AM
Over the past couple of days I’ve lost literal count of how many people have written to me asking about the clinical trials in New York State regarding the use of Hydroxychloroquine.
The trials began last Tuesday.
In this column’s space and much more liberally on my Twitter feed I have attempted to stay up-to-date on the rapidly developing reports of the effectiveness of Hydroxychloroquine. I’ve also dedicated a considerable percentage of my radio show over the last two weeks highlighting these developments.
It’s strange that I should need to.
Before the drug was mentioned by President Trump there had been a robust interest in looking at the replicated results from China, India, South Korea and France. Sadly, American medical authorities didn’t really give any credence to the claims until the controlled study in southern France, which returned a one in 10,000 chance that the results were anecdotal or in anyway not possible to replicate repeatedly.
more
https://townhall.com/columnists/kevinmccullough/2020/03/29/hydroxychloroquine-help-is-on-the-way-n2565926?utm_source=thdaily&utm_medium=email&utm_campaign=nl&newsletterad=03/30/2020&bcid=97dc8fe5a9df89459253d395805be70e&recip=19803445
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The refusal of the FDA to consider properly controlled studies (like the one in France) conducted overseas is one of the main failings of the American health care system. It is easy to fix: Congress simply needs to require by law that controlled studies of pharmaceuticals and medical devices conducted overseas always be used as the basis for expediting approval. In emergency situations they should also require the FDA to grant temporary approvals based on sufficiently broad reports of successful use in the field.
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The refusal of the FDA to consider properly controlled studies (like the one in France) conducted overseas is one of the main failings of the American health care system. It is easy to fix: Congress simply needs to require by law that controlled studies of pharmaceuticals and medical devices conducted overseas always be used as the basis for expediting approval. In emergency situations they should also require the FDA to grant temporary approvals based on sufficiently broad reports of successful use in the field.
But even controlled experiments/studies do not always emerge with the final truth.
I remember when the AMA condemned chiropractic and acupuncture as being fake treatments. (I personally had good results from chiropractic after getting no help from medical doctors.)
A while late they had to retract that and say both can be beneficial.
Remember the urgings of food "experts" who said you'd die if you ate more than one egg a week or consumed butter?
They retracted that after a number of years.
I like it when new treatments are studied by professionals, but we can't always rely on their word.
This furor over hydroxychloroquine and related medicines are an example.
If numerous doctors across the pond report excellent results with its use from many thousands of infected people, do we really need the AMA to do a huge study before American doctors can prescribe it?
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The refusal of the FDA to consider properly controlled studies (like the one in France) conducted overseas is one of the main failings of the American health care system. It is easy to fix: Congress simply needs to require by law that controlled studies of pharmaceuticals and medical devices conducted overseas always be used as the basis for expediting approval. In emergency situations they should also require the FDA to grant temporary approvals based on sufficiently broad reports of successful use in the field.
Thalidomide and DES were tested first in Europe. Thalidomide did not get FDA approval, but DES did. So FDA skepticism is based on more than Not-Invented-Here Syndrome.
At this point the FDA is allowing off-label use of Chloroquine. At least two Dem goobernors have threatened the licenses of doctors and pharmacists if they prescribe and dispense Chloroquine for Covid-19. The FDA, possibly in response to these #Resist goobernors, has given "Emergency Use Authorization" for use of Chloroquine to treat Covid-19.
If the results are as good as seems likely, Chloroquine and/or Hydroxychloroquine paired with that antibiotic might be approved by July or August for treating Covid-19. This is the political "disaster" the Dems and MSM are trying to push out past the November election (my opinion, of course).
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Zelenko said that he has been using a cocktail of drugs on his patients: hydroxychloroquine, in combination with azithromycin — an antibiotic to treat secondary infections — and zinc sulfate, which studies have suggested slows down virus replication in the body.
https://forward.com/news/national/442285/coronavirus-hydroxychloroquine-trump-doctor/ (https://forward.com/news/national/442285/coronavirus-hydroxychloroquine-trump-doctor/)
This combionation appears to be the game changer, administered early to prevent the replication of the virus, ward off ARDS (when 50% die), and keep patients from needing to be intubated because of lung damage. It can be administered orally, the full course is over 5 days. As described, 200mg of Hydroxychloroquine, twice daily for the five days with 500mg Azithromycin (Zithromax) once a day for 5 days, and the Xinc Sulfate 200mg once a day for the five days.
He reported success in that none died, only a handful of several hundred patients were hospitalized with pneumonia.
Note, many of these patients, presented with symptoms and were treated without waiting for test results. The logic behind this is that the three days delay in treatment would allow the disease to progress, possibly to critical levels.
I'm just a scientist, not a doctor, so nothing contained in this post is to be considered medical advice.
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Note, many of these patients, presented with symptoms and were treated without waiting for test results. The logic behind this is that the three days delay in treatment would allow the disease to progress, possibly to critical levels.
I'm just a scientist, not a doctor, so nothing contained in this post is to be considered medical advice.
One of the aftermaths of this disaster, must be a full review and revamping of FDA pharma rules as it applies to urgent patient care. The combination of pencil d__ked regulators, and an over litigious society/lawyers have hamstrung us for long enough. I sure hope someboday is compiling a body count on red-taped lives lost. And that accountibility is administered 100%.
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So here is the deal. Novel coronaviruses are nothing new. And or just old "plain" coronaviruses.
Has anyone seen any literature that the drugs aforementioned had any efficacy on those other previous viruses?
If no, then why not?
If no, does this point another finger at an engineered virus?
If this was Friday instead of Monday I would have the time to research this. But, if some of you do have the time...
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One of the aftermaths of this disaster, must be a full review and revamping of FDA pharma rules as it applies to urgent patient care. The combination of pencil d__ked regulators, and an over litigious society/lawyers have hamstrung us for long enough. I sure hope someboday is compiling a body count on red-taped lives lost. And that accountibility is administered 100%.
In a rapidly evolving pandemic such as this, red tape kills.
While still using chloroquine or hydroxychloroquine, they should be preparing other options including remdesivir, which is not yet FDA-approved for anything and still needs studies. That way, if the chloroquine derivatives don't work, there are other options. But given the relatively short-term nature of the virus, these studies need to be expedited. NYC will provide a valuable testing ground for randomized trials.