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The FDA got out of its own regulatory way and has swiftly approved the use of the malaria drug Hydroxychloroquine. President Trump announced that it can be prescribed to Covid-19 patients immediately.
This is great news in the midst of what our country and the world is facing with this Chinese Virus.
President @realDonaldTrump announces HUGE news‼️
Hydroxychloroquine, a drug used to treat malaria, has shown encouraging early results against the #coronavirus.
By eliminating red tape, President Trump will be able to make this drug available almost immediately.
— Kayleigh McEnany (@kayleighmcenany) March 19, 2020
Finding out that a drug that was used to treat malaria decades ago is able to treat this Wuhan virus is a plus in that it can be rolled out immediately. That saves time, time that is in short supply right now.
What is even more important about this? The FDA has gotten out of their own regulatory way and fast-tracked the testing and approval process. The FDA has long been known to drag their feet, so for them to move this fast, it’s a combination of things in my opinion.
Both of those are key here. Especially since idiots have tried or succeeded in breaking into hospitals to steal masks, and medical personnel around the country are dealing with mask and other medical equipment shortages. As new technology comes online to help combat this disease, whether it is equipment or drugs, some if not a vast majority of the regulations that are in place hinder our ability to move swiftly in times like this.
Italy is really in peril due to the age of their population, density of the country, and health. However, some very innovative techies used 3-D printing to quickly design and manufacture crucial ventilator valves given current manufacturer was unable to ramp up that quickly.
In terms of medications to combat the Chinese Virus, medical professionals all over the world are working overtime to identify drugs that can be used to combat this. Interestingly, this morning I read three blog posts via Powerline discussing this very thing.
“Generic drugs do not offer sufficient profit margin for the manufacturer to justify investment in clinical trials. For these generic drugs, public health authorities or healthcare institutions need to fund the clinical trials required to evaluate their effectiveness. Chloroquine phosphate, the anti-malarial drug, and lopinavir-ritonavir, the HIV drug combination, are examples of reasonably priced generic anti-viral agents that should be evaluated immediately in clinical trials. Trials of these drugs are underway in China and South Korea. An example of a US healthcare institution stepping up is the University of Minnesota. They are just now kicking off two clinical trials to study losartan, a generic high blood pressure drug, in Wuhan virus patients.
For drugs that are still on-patent, pharmaceutical companies have sufficient economic motivation to sponsor and fund the trials of their drugs. Gilead Sciences, the manufacturer of Remdesivir, already has at least two clinical trials underway to study Remdesivir’s effectiveness in patients with either moderate or severe disease. This is the drug US Patient 1 responded to so well.”
Other drugs currently on the market may very well be of great use in combatting this crap. So, the FDA needs to be watching and respond as quickly as they did with the Hydroxychloroquine.
HOWEVER, as Powerline points out here, the accuracy of the testing is crucial.
“As Dr.Birx (White House COVID Coordinator) said on Tuesday, “Quality testing,” she said, is “paramount.” “It doesn’t help to put out a test where 50 percent are false positives.” This is a very crucial point — with significant political implications. The CDC’s methodological and quality concerns are being mistaken for a “botching,” rather than a quality concern and a very basic epidemiological principle.”
That is very true. Quality control and accurate reading of results is an absolute must through this process. That said, if the tests perform as hoped, then the approval by the FDA must not be hindered by the regulatory merry-go-round.
French scientists found with that treatment with the malaria drug combined with Azithromycin was highly effective.
“After each day of treatment, patients were tested to determine whether they still had the virus. After six days of treatment:
• 90% of patients treated with hydroxychloroquine in combination with the antibiotic Azithromycin tested negative for the virus
• 60% of patients treated with the anti-viral hydroxychloroquine tested negative
• Only 10% of the patients who received no treatment tested negative”
UPDATE:
Full peer reviewed study has been released by Didier Raoult MD, PhD https://t.co/DzFTv13wYn.
After 6 days 100% of patients treated with HCQ + Azithromycin were virologically cured
p-value <.0001https://t.co/vttAIWbPwJ
— Gregory Rigano (@RiganoESQ) March 18, 2020
While the media throws snit fits about saying the words Chinese Virus and mayors want the military to do the job they refuse to do; people behind the scenes are working around the clock to save lives and combat this thing. While the idiots and jerks are coming out of the woodwork, President Trump and an amazing number of people have rolled up their sleeves and gotten to work in finding any and every tool feasible that can be used to drop kick this virus shit to the curb.
Yes, we are in a National Emergency, and yes it sucks. But this news regarding hydroxychloroquine as treatment is the shot in the arm we needed right now. Yes, stay vigilant, but celebrate the wins along the way.
Feature Photo Credit: fotoblend on Pixabay, cropped and modified
GWB says: Someone, likely President Trump along with Vice President Pence lit a bonfire under their bureaucratic butts
Someone said “Do it, or … you’re FIRED!”
Get back to me when they’ve stopped regulating the manufacture and sale of alcohol-based hand cleanser. (They’re still investigating the efficacy!)
What amazes me? This shouldn’t have taken even this long. Hydroxychloroquine was already known to be a successful anti-viral for pneumonia-causing virii. And what is killing people with Winnie The Flu? The pneumonia.
So, in honor of quinine – the original – I’m drinking vodka (Tito’s!) and Indian tonic water. With a bit of lime. I’m fighting malaria and coronavirus at the same time! 😉
chloroquine phosphate is not the same thing as hydroxychloroquine sulfate (HCQ), yet both are anti-malarial drugs, given that they were originally derived from quinine. The NIH released a study just the other day that HCQ was many times more effective at stopping COVID-19 in vitro than chloroquine, This ties in well with the study released by France yesterday you mentioned. HCQ is being widely used in China and South Korea with great success, and is part of the drug package that the Australians are pushing to trial.
The whole darn world is going to be part of the WHO’s large scale drug test called Solidarity, whether the local media reports this or not. We don’t have time to mess about with tiny studies that take decades.
To us not in the medical field, HCQ is the common medicine Plaquenil, and azithromycin is the common antibiotic called Z-Pack. Both are inexpensive, generic, and widely available. Both can be taken by just about everyone with no ill effects (as long as you don’t overdose), even by people with compromised immune systems.
Kaletra, the brand name of the combination lopinavir-ritonavir drug, was tried alone in China with almost NO positive results, but I don’t know at what dosage or for how long, what patient conditions were, or whether drug purity tests were done first. There is another HIV drug, retsivir (IIRC) that shows more promise than this.
GWB says: That “don’t overdose” bit is important for quinine-related drugs. You can end up blind. But it requires either taking WAY too much in each dose, or taking it for years and years.
And I’m sticking with the vodka and tonics until they make the others OTC.
(It’s important to note, imo, that at least one of those studies showed preventative effect from the cloroquinine [one version or the other].)
Well, if you are taking in six liters a day of tonic water (to equal the dose of quinine in the daily antimalarial pill), and are still able to even find your keyboard, much less type – you are either not mixing it with the Tito’s – or you have the highest alcohol tolerance I have ever encountered.
Overdosing is also a bad thing for anyone with cardiac arrhythmia.
ONE thing, which I am repeating everywhere I can, since I’m seeing it suddenly being pushed hard by shady operators – DO NOT buy any of the cinchona bark snake oil. Very dangerous stuff, if you use enough to get the recommended quinine uptake; mostly harmless but completely useless if you don’t.
GWB says: Oh, and I think – if the Chinese press (ABC, NBC, CNN, etc.) is going to get its collective panties in a bunch over “Wuhan Flu” or “Winnie The Flu” or “Chinese virus” – we should take to calling it Covfefe-19. I think the resulting meltdown could be good enough for 4th of July celebrations.
Scott says: I still prefer “Kung Flu”…
Politically Ambidextrous says: The next run at Costco, Walmart, and Target: Tonic water!!!
GWB says: I’ve already stocked up!
Tito’s vodka, too!
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