Thursday - June 18, 2020

Moron the FDA HCQ EUA

When TDS bias becomes lethal ...

  

Yeah, I know. I’m sick of going on about the global tidal wave of purposely inept trials and studies that show how hydroxychloroquine just ain’t no good for treating SARS-COV-2. But when these studies are so poorly done that they kill people, I have to speak up.

The FDA statement does not mention these studies by name, but merely notes who the authors are. As if we can’t figure out what studies they’re associated with. Like I said before, weasel wording, smoke and mirrors.

The first study, now redacted from the FDA’s statement the other day, was the one published in the UK medical journal The Lancet, which is about the most respected medical news stream in the world. That study was so poorly done that hundreds of doctors around the world immediately questioned the validity of it, and within a short time The Lancet retracted it. Turns out the study was done by some shell company called Surgisphere, which had a staff of “highly trained experts” that included a science fiction writer and a whore adult model / “event hostess”. The backlash against Surgisphere was so strong that the company is now out of business.

Remember Surgisphere? That was the name of the company that allegedly gathered data from hundreds of hospitals around the world and subsequently published a research paper claiming people treated with hydroxychloroquine were more likely to die than those who were not. That paper made international news at the time, but dozens of doctors questioned the credibility of its data. The paper was eventually retracted and, as of today, it appears Surgisphere is no more.

So the reference to the Lancet’s report was pulled by the FDA’s EUA statement as the prime evidence that HCQ doesn’t work. Oops.



The second study is the RECOVERY paper from Oxford University in the UK, which is part of the global Solidarity COVID research and trials effort. The RECOVERY study found that HCQ was not just useless but super dangerous, as the patients in the study were dropping like flies. Dying left and right.

Hydroxychloroquine does not treat coronavirus, according to the world’s biggest trial of the anti-malaria drug backed by US President Donald Trump.

Oxford University scientists pulled the controversial drug from the RECOVERY trial today after results showed it had no benefit on patients hospitalised with the virus.

A quarter of NHS patients given hydroxychloroquine died from Covid-19, compared to 23.5 per cent who were not prescribed the drug.

The scientists running the trial, which has recruited more than 1,500 patients from around 170 UK hospitals, said the results were ‘pretty compelling’, adding: ‘This isn’t a treatment that works.’

Professor Martin Landray, lead author of the study, added: ‘If you’re admitted to hospital with Covid – you, your mother or anyone else - hydroxychloroquine is not the right treatment. It doesn’t work.’

He called for doctors around the world to stop using the drug, which can cause a slew of nasty side effects including heart arrhythmias, headaches and vomiting.

But Professor Landray said the results do not necessarily mean the tablets cannot prevent people from catching Covid-19 in the first place, which several studies are still investigating. 

And here comes their OOPS scenario: the brain trust in charge of the study was giving the patients a nearly lethal dose of HCQ. Because some idiot confused hyroxychloroquine with hydroxyquinoline ( Iodoquinol ), which is a medicine used to treat dysentery. The dysentery medicine dosage is much larger - it’s a different drug entirely - and that amount of HCQ is more than enough to get you sent to the poison control centers if you’re in France. Any HCQ dose over 1800mg is potentially fatal , and they were giving patients 2400mg.

The UK “Recovery” trial was very similar to, but not part of, the international Solidarity conglomeration of clinical trials. The Recovery trial ended its HCQ arm on June 4, reporting no benefit. In-hospital mortality of the 1542 patients receiving hydroxychloroquine was 25.7%, or 396 deaths, about 10% higher than those receiving standard care, a non-significant difference.

The UK Recovery trial Study Protocol notes it is funded in part by the Wellcome Trust and the Bill and Melinda Gates Foundation, and by UK government agencies.  The Protocol provides the doses of hydroxychloroquine used, on page 22.  Twitter users began to notice a dosing problem, with hashtag #RecoveryGate. 

The HCQ dosing regimen used in the Recovery trial was 12 tablets during the first 24 hours (800mg initial dose, 800 mg six hours later, 400 mg 6 hrs later, 400 mg 6 hours later), then 400 mg every 12 hours for 9 more days.  This is 2.4 grams during the first 24 hours, and a cumulative dose of 9.2 grams over 10 days.

Even more disturbing than this, babies weighing 5 kg could be given a dose of 300 mg HCQ in the first 24 hours in the UK Recovery trial, which is 233 mg of the base (47 mg/kg), nearly 4 times the recommended maximum.  One to two pills (200-400 mg) is “potentially fatal in a toddler”.

...

Co-Principal Investigators of the Recovery trial, Drs. Peter Horby and Martin Landray, said they followed the WHO dosing. This is what their trial document says as well, on page 23. Landray also claimed in an interview with Paris Soir that the maximum allowed HCQ dose was “6 or 10 times” the dose used in Recovery, and that he was using the hydroxychloroquine dose that is used for amebic dysentery.  However, the accepted use for HCQ in amebiasis is only for a liver abscess and only then in pregnancy, when other drugs cannot be used.  That dose is 600 mg per day for 2 days, then 300 mg per day, considerably less than half the Recovery dose.  Co-Principal Investigator Peter Horby said that Paris Soir misinterpreted Landray’s comments, but Paris Soir said Landray had confirmed what he told them in an email prior to publication.  Landray is a very busy man, too busy, apparently, to look up the proper dose of a drug he gave to over 1500 subjects, who were randomized to the treatment and had no say in the matter.

We know that in Brazil, both a high CQ dose and a low CQ dose were trialed, and by April 17 the high dose arm was stopped prematurely due to an excess of deaths with 39% mortality (16 deaths in 41 subjects).  The high dose arm used 600 mg CQ twice daily for ten days, with cumulative dose of 12 grams. EKG changes typical of toxicity were seen in 25% of high dose subjects. The low dose trial continues in Brazil.

How is the drug hydroxychloroquine normally used?  For chronic daily use in systemic lupus erythematosus or rheumatoid arthritis, patients receive between 200 and 400 mg daily, or a maximum of 5 mg/kg.  In acute Q fever, 600 mg daily may be given at the start of treatment. For acute attacks of malaria, 1,500-2,000 mg may be given over 3 days.  Professor Didier Raoult’s group in Marseille used 600 mg daily for up to ten days in 1061 Covid-19 patients, and reported 8 deaths, a mortality rate of 0.75%, all over 74 years of age.  The mortality rate reported by Landray and Horby in the Recovery trial is 34 times higher.

...

The Recovery trial used 1.86 grams hydroxychloroquine base (equal to 2400 mg of hydroxychloroquine) in the first 24 hours for treatment of already very ill, hospitalized Covid-19 patients.  The Canadian and Norwegian Solidarity trials used 2,000 mg of HCQ, or 1.55 grams of HCQ base in the first 24 hours. Each trial gave patients a cumulative dose during the first 24 hours that, when given as a single dose, has been documented to be lethal. (The drug’s half-life is about a month, so the cumulative amount is important.)

The doses used in these trials are not recommended for therapy of any medical condition, which I confirmed with Goodman and Gilman’s Pharmacology textbook, the drug’s US label, and the online subscription medical encyclopedia UptoDate.

Excessive, dangerous HCQ dosing continues to be used in WHO’s Solidarity trials. These trials are not, in fact, testing the benefits of HCQ on Covid-19, but rather are testing whether patients survive toxic, non-therapeutic doses.

And what a non-surprise, QT elongation and arrhythmia reactions were plentiful in these patients ... patients who were already deathly ill, probably with other serious co-morbidities, and given extreme overdoses of the HCQ drug. But “oops, we misread the label”? That doesn’t wash.

Big Pharma and the TDS medical community are playing with your lives, to discredit our President, keep this pandemic going, and to buy time for some insanely expensive patented therapy to be created. Is it any wonder why nobody trusts them?

Somewhat related ... another cheap common drug might help with late stage patients. Expect it to become instant anathema if President Trump mentions it. This information comes from the same RECOVERY study. Can we trust it?

Dexamethasone, the familiar glucocorticoid, reduced deaths in hospitalized COVID-19 patients with severe disease by one-third compared to those receiving usual care, according to topline interim results from the RECOVERY trial released early Tuesday.

Deaths in the dexamethasone arm were reduced by one-third (RR 0.65, 95% CI 0.48-0.88, P=0.0003) among patients receiving mechanical ventilation, and by one-fifth (RR 0.80, 95% CI 0.67-0.96, P=0.0021) among patients requiring oxygen versus patients receiving usual care, according to a statement from the study’s authors.

But dexamethasone showed no benefit among patients who did not require respiratory support (RR 1.22, 95% CI 0.86-1.75).
...
“Dexamethasone is the first drug to be shown to improve survival in COVID-19,” said RECOVERY trial chief investigator Peter Horby, MD, PhD, of University of Oxford, in the group’s statement. “The survival benefit is clear and large in those patients who are sick enough to require oxygen treatment, so dexamethasone should now become standard of care in these patients.”

Horby described dexamethasone as “inexpensive, on the shelf and can be used immediately to save lives worldwide.”

Sir Patrick Vallance, the U.K.’s chief scientific adviser, characterized the news as a “ground-breaking development” in the fight against COVID-19.

So if you’re already on the edge of death from COVID, in the hospital already, getting oxygen or even on a ventilator - late pulmonary phase - it appears that this steroid can help. Well that’s a good thing. But if you aren’t at that level of illness, it won’t do anything for you. Sad.

~~~~~



And finally, a clear news story about what the FDA statement actually means is out in the media ... assuming you go to the other side of the world and find that article in The Hindu

Doctors can still prescribe HCQ to patients, says U.S. Health Secretary

Doctors can still prescribe anti-malarial drug hydroxychloroquine to patients, U.S. Health Secretary Alex Azar said, hours after the FDA withdrew the emergency use authorisation of chloroquine and HCQ in the treatment of COVID-19 patients.

The US Food and Drug Administration’s (FDA) decision came on Monday after it concluded that the anti-malarial drugs may not be effective to cure the virus infections and lead to greater risks than any potential benefits.

“At this point, hydroxychloroquine (HCQ) and chloroquine are just like any other approved drug in the United States. They may be used in hospital, they may be used in out-patient, they may be used at home, all subject to a doctor’s prescription,” Mr. Azar said.

“In fact, the FDA’s removal of the Emergency Use Authorisation takes away what had been a significant misunderstanding by many that had made people think that somehow it could only be used in a hospital setting, and we’ve tried to make that clear throughout,” he said in response to a question.
...
“If a doctor wishes to prescribe it, working with a patient, they may prescribe it for any purpose that they wish to do so. And, this (FDA’s decision) actually removes a potential barrier to them,” the Health Secretary said…

If you follow just one link from this post, please read the conclusion at the bottom of this linked page.

Posted by Drew458     on 06/18/2020 at 10:16 AM   
Filed Under: • pandemic and epidemic diseases •  
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