Guest essay by Eric Worrall
The FDA has just revoked emergency approval of HCQ for Covid-19 patients, a decision criticised by President Trump. IMPORTANT – a tweet provided by MP puts a different spin on today’s events.
Hydroxychloroquine: US revokes emergency approval of malaria drug for Covid-19
Food and Drug Administration says drug is unlikely to work against coronavirus and notes heart risks.
Guardian staff and agencies
Tue 16 Jun 2020 10.19 AESTUS regulators revoked the emergency authorization for malaria drugs championed by Donald Trump for treating Covid-19, amid growing evidence they don’t work and could cause serious side effects.
The Food and Drug Administration (FDA) said on Monday the drugs hydroxychloroquine and chloroquine were unlikely to be effective in treating the coronavirus. Citing reports of heart complications, the agency said the drugs’ unproven benefits “do not outweigh the known and potential risks”.
Trump criticized the FDA decision. “I took it and I felt good about taking it. I don’t know if it had an impact, but it certainly didn’t hurt me,” Trump said on Monday.
Trump said there had been “great reports” out of France, Spain and other places, without offering any evidence or further explanation. France is one of the countries that has already stopped using the drug for Covid-19 patients.
In a separate announcement, the FDA also warned doctors against prescribing the drugs in combination with remdesivir, the lone drug currently shown to help patients with Covid-19. The agency said the anti-malaria drugs could reduce the effectiveness of remdesivir, which the FDA cleared for emergency use in May.
…
The drugs can cause heart rhythm problems, severely low blood pressure and muscle or nerve damage. The FDA reported on Monday that it had received nearly 390 reports of complications with the drugs, including more than 100 involving serious heart problems. Such reports represent an incomplete snapshot of complications with the drugs because many side effects go unreported.
…
Read more: https://www.theguardian.com/world/2020/jun/15/hydroxychloroquine-coronavirus-fda-emergency-authorization
The FDA are correct that there is no definitive proof Hydroxychloroquine works, but many doctors who have tried it have been impressed.
There has been an unseemly scramble to try to claim Hydroxychloroquine does not work, including a now retracted study based on questionable data.
The apparent irregularities surrounding oversight of Hydroxychloroquine, a drug which was widely used for decades in Malaria prone regions, in my opinion undermine the credibility of the entire medical oversight establishment.
h/t Gary Ashe – The Association of American Physicians and Surgeons filed a lawsuit 2 weeks ago to overturn the FDA restrictions on hydroxychloroquine.
h/t MP – IMPORTANT It appears the Guardian may have misinterpreted the actions of the FDA, or perhaps I misinterpreted what the Guardian was trying to say. It appears that doctors are now free to provide Hydroxychloroquine however they see fit.
The most comprehensive look at lockdowns, the hammer and the dance
https://medium.com/@tomaspueyo/coronavirus-should-we-aim-for-herd-immunity-like-sweden-b1de3348e88b
Yes, that is a very good article.
He lays it on a bit thick in places, but it’s quite interesting
Clyde Spencer: Your logic then must proceed as follows. “No one should treat anyone with any kind of treatment that is not 100% without side-effects. No surgery, nothing with any risk, no matter how low. Take the aspirin and Tylenol off the shelf too, people die every year from these two widely beneficial drugs.
Advice, to reduce the dilution of excellent posts here, think before you write such nonsense. When you know you don’t know what you’re talking about, pause and think, what harm can my baseless assertions do to the conversation.
That said, there have been cogent statements against the use of HCQ and Zn, but your statements are not among them.
Hydroxychloroquine sulfate and some versions of chloroquine phosphate are FDA-approved to treat malaria. Hydroxychloroquine sulfate is also FDA-approved to treat lupus and rheumatoid arthritis.
Does Hydroxychloroquine have Artificial Intelligence so that it can recognize the underlying illness being treated ?
May be that could be the reason for Hydroxychloroquine not to adversely affect in treatment of Malaria, Lupus and Rheumatoid Arthritis and intelligently adversely affect in the treatment of COVID 19 !
Because chloroquine phosphate and hydroxychloroquine may possibly help very sick patients, the FDA is allowing these drugs to be provided to certain hospitalized patients under an Emergency Use Authorization (EUA) issued March 28, 2020. Under the EUA, health care providers and patients are provided with information about the risks of these drugs. However, more data from clinical trials are necessary for us to determine whether chloroquine phosphate or hydroxychloroquine sulfate are safe and effective in treating or preventing COVID-19.
In a Drug Safety Communication, the FDA cautions against the use of hydroxychloroquine or chloroquine for COVID-19 outside of the hospital setting or a clinical trial due to the risk of heart rhythm problems. Read more about the emergency use authorization for chloroquine phosphate and hydroxychloroquine sulfate for COVID-19.
Q. FDA has approved HCQ to treat lupus and rheumatoid arthritis. Is it in Hospital setting ? If not why HCQ for COVID 19 should require Hospital setting ?
Mods
The following should be removed from my above post:
“Because chloroquine phosphate and hydroxychloroquine may possibly help very sick patients, the FDA is allowing these drugs to be provided to certain hospitalized patients under an Emergency Use Authorization (EUA) issued March 28, 2020. Under the EUA, health care providers and patients are provided with information about the risks of these drugs. However, more data from clinical trials are necessary for us to determine whether chloroquine phosphate or hydroxychloroquine sulfate are safe and effective in treating or preventing COVID-19.
In a Drug Safety Communication, the FDA cautions against the use of hydroxychloroquine or chloroquine for COVID-19 outside of the hospital setting or a clinical trial due to the risk of heart rhythm problems. Read more about the emergency use authorization for chloroquine phosphate and hydroxychloroquine sulfate for COVID-19.
Q. FDA has approved HCQ to treat lupus and rheumatoid arthritis. Is it in Hospital setting ? If not why HCQ for COVID 19 should require Hospital setting ?”
There is a danger in using HCQ to treat all patients who have Covid 19. There is speculation that those men who have G6PD (estimated to be about 400 million worldwide and to constitute 10% of the African American population are more susceptible getting Covid 19. But these are precisely those for whom the ingestion of Quinine can be highly dangerous.
In the UK there is no evidence that any patients suffering from Covid 19 have ever been tested for G6PD which may be one of the reasons why the BAME population has been the most vulnerable.
Screening patients for glucose-6-phosphate dehydrogenase (G6PD) deficiency before prescribing hydroxychloroquine (HCQ) is unnecessary and may limit the beneficial use of the drug for individuals with systemic lupus erythematosus and other autoimmune diseases, a team of Duke rheumatology researchers reports.
You are conflating HCQ and Quinine. They are not the same thing. That’s like saying eating salt will kill you because eating pure sodium (metal) is poison and would explode and burn in your mouth.
The BAME population is more susceptible most likely because of vitamin D deficiency. Getting outside and letting the sun shine on the skin at sun levels where our ancestors evolved from is beneficial… Dark skin at high latitudes require vit supplementation or a diet high in fatty fish.