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Hydroxychloroquine wars, 5: The China tests (and report, Feb. 18)–U/D: FDA Emergency Use Authorisation announced . . .

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Now that France has approved Hydroxychloroquine after Prof Raoult’s second test, it is helpful to go back and roll the tape. We need to understand why we are where we are now, over a month after China — which, unsurprisingly, did a lot of the early work on Covid-19 that we are all relying on now — published information on promising drugs.

Here is Clinical Trials Arena, February 18th:

18 February 2020 News

Coronavirus: Chloroquine yields positive data in Covid-19 trial

Early data from clinical trials being performed in China has revealed that chloroquine phosphate could help treat the new coronavirus disease, Covid-19.

China National Center for Biotechnology Development deputy head Sun Yanrong said that chloroquine, an anti-malarial medication, was selected after several screening rounds of thousands of existing drugs.

Xinhua reported that the drug is undergoing clinical trials in more than ten hospitals in Beijing, Guangdong province, and Hunan province . . . .

Data from the drug’s studies showed ‘certain curative effect’ with ‘fairly good efficacy’.

According to Sun, patients treated with chloroquine demonstrated a better drop in fever, improvement of lung CT images, and required a shorter time to recover compared to parallel groups.

The percentage of patients with negative viral nucleic acid tests was also higher with the anti-malarial drug.

Chloroquine has so far showed no obvious serious adverse reactions in the more than 100 participants in the trials.

The China National Center for Biotechnology Development head Zhang Xinmin said that chloroquine is one of the three drugs that have a promising profile against the new coronavirus, reported China Daily.

The remaining two drugs are anti-flu medicine favipiravir and Gilead’s investigational anti-viral candidate remdesivir . . .

The list is familiar.

And, a 100+ patient trial by a country with a fairly serious medical and academic infrastructure . . . never mind, issues about a totalitarian, Communist regime and fairly ugly police state tactics . . . should not be sneezed at or taken lightly. Certainly, that is a tad more than dismissively “anecdotal.” Yes, we want to move to replication to confirm reliability and will wish to apply peer reviews, but that is already a significant result.

Fair comment: the recent media party-line is immediately unjustifiable and irresponsible.

Where, yes, Chloroquine is indubitably prone to damaging side effects [usually due to long term use] and can be lethal if an overdose is taken. A classic phrase is, “pharmacology is the study of poisons in small doses.”

All that such means, is that amateur self-doctoring is ill advised. The man who killed himself with fish tank cleaner should have known better.

We can set aside these and other distractors and focus the key point: by February 18th, serious information in answer to a then threatened global pandemic was released by officials of the country at ground zero. The MEDIA response in the six weeks since then was irresponsible. That needs to be faced. END

F/N: BREAKING — FDA Emergency use authorisation announced:

FDA authorizes emergency use of anti-malarial drug touted by Trump on COVID-19 patients

Patients would be given the option to take hydroxychloroquine sulfate or chloroquine phosphate, which are still undergoing clinical trials.

Author: Travis Pittman (TEGNA), Associated Press Published: 6:05 AM CDT March 30, 2020 Updated: 6:08 AM CDT March 30, 2020

The Food and Drug Administration has issued an emergency use authorization (EUA) for two anti-malarial drugs on coronavirus patients which President Donald Trump has touted as potential game-changers. Experts have warned the drugs have only anecdotal evidence in treating COVID-19 and the drugs are not yet approved by the FDA as a treatment.

The EUA allows hydroxychloroquine sulfate and chloroquine phosphate that have been donated to the Strategic National Stockpile “to be distributed and prescribed by doctors to hospitalized teen and adult patients with COVID-19, as appropriate, when a clinical trial is not available or feasible,” according to the Department of Health and Human Services. That would mean patients who are at least 110 pounds, according to the FDA fact sheets . . . .

HHS issued a press release Sunday saying it has accepted 30 million doses of hydroxychloroquine sulfate from Sandoz and 1 million doses of chloroquine phosphate from Bayer to go to the Strategic National Stockpile. HHS says the drugs are available for the possible use in treating patients hospitalized with COVID-19 or for use in clinical trials . . .

We need to now have a very different conversation.

6 Replies to “Hydroxychloroquine wars, 5: The China tests (and report, Feb. 18)–U/D: FDA Emergency Use Authorisation announced . . .

  1. 1
    kairosfocus says:

    Hydroxychloroquine wars, 5: The China tests (and report, Feb. 18)–U/D: FDA Emergency Use Authorisation announced . . .

    –> Let’s talk . . .

  2. 2
    kairosfocus says:

    F/N: Spelling hydroxychloroquine, pardon. KF

  3. 3
    Ed George says:

    This sounds like good news.

  4. 4
    Truthfreedom says:

    @3 Ed George

    This sounds like good news.

    An it is good news too that Didier Raoult has written several articles against the darwinian evolution p***y ‘paradigm’ :
    – ‘Tree of life’/ gradualism: p**p
    – Vertical gene transmssion only + RM + NS: p**p
    – Common ancestry: p**p

    Multiple scenarios have been proposed to explain the origin of living beings. Regardless of which scenario is the most accurate, it has become obvious that the large diversity among species cannot be logically explained only by mutations that occurred on a unique ancestral genome (“descent with modification”).
    Vicky Merhej and Didier Raoult

    Darwin did not have a clue about microbiology and its implications.
    https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3428605/#!po=27.5974

  5. 5
    kairosfocus says:

    F/N: Here is Am Th on the arc of media coverage:

    March 29, 2020
    Once again, Trump was right and the media were wrong
    By Andrea Widburg

    In February, China reported that chloroquine could fight coronavirus, which led to a burst of media optimism. However, when President Trump said he hoped that chloroquine might cure coronavirus, the media instantly turned on the drug. Unsurprisingly, the media were wrong. The lead doctor of the latest study on the drug says chloroquine is so helpful it would be unethical to deny it to control groups.

    We first learned about chloroquine in mid-February, when Sun Yanrong, the deputy head of the China National Center for Biotechnology Development, announced that it was one of three drugs that the Chinese had successfully used to treat coronavirus. For a month, the media thought chloroquine could be the answer.

    For example, in early March, UPI reported favorably that South Korean experts recommended anti-malarial drugs to treat coronavirus. On March 17, NBC News reported that chloroquine was one “of the options being explored” because it was “useful in blunting the effects of coronavirus.”

    Everything changed, though, on March 20 when, in a press conference, President Trump said he was optimistic that chloroquine would be a magic bullet against coronavirus . . .

    A typical sampler, here is Huff Po, March 21:

    Trump Touts ‘Game-Changing’ Drug Cocktail For Coronavirus Linked To Fatal Arrhythmia
    The president, who is not a doctor, recommended a potentially dangerous drug combo to his 74 million Twitter followers. “What do we have to lose?” he asked.

    By Mary Papenfuss

    President Donald Trump touted a two-drug cocktail Saturday to battle the coronavirus. But the medicines together have been linked to cardiac arrhythmia and sudden death.

    Concerned physicians responded to Trump’s tweet crowing about what could be “one of the biggest game-changers in the history of medicine” with warnings about the serious side effects — and urgent pleas not to try to obtain the drugs without a medical prescription in consultation with a doctor . . .

    Of course, “pharmacology is the study of poisons in small doses” and essentially any serious antibiotic [I don’t count sulfa drugs in OTC skin creams as “serious”] is to be taken only under medical supervision. At no point do I parse a recommendation for amateur self medication such as by self-dosing with fish tank cleaner in the US President’s remarks. Let’s clip his Tweet as Huff Po cites:

    HYDROXYCHLOROQUINE & AZITHROMYCIN, taken together, have a real chance to be one of the biggest game changers in the history of medicine. The FDA has moved mountains – Thank You! Hopefully they will BOTH (H works better with A, International Journal of Antimicrobial Agents)…..
    10:13 AM · Mar 21, 2020

    Donald J. Trump
    @ realDonaldTrump
    ·
    Mar 21
    Replying to
    @ realDonaldTrump
    ….be put in use IMMEDIATELY. PEOPLE ARE DYING, MOVE FAST, and GOD BLESS EVERYONE!

    Relevant context A (from an earlier UD OP):

    Actually, as Pharmacy Times reported, Thu March 19:

    Pharmacy Times

    FDA Announces Two Drugs Given ‘Compassionate Use’ Status in Treating COVID-19
    2020-03-19 17:40:00
    Kristen Coppock, MA, Managing Editor

    Two drugs, chloroquine and remdesivir, are being designated for Expanded Access, or “compassionate use,” by the FDA to address the novel coronavirus (COVID-19) pandemic, according to FDA Commissioner Stephen Hahn, MD, and President Donald Trump.1

    Chloroquine and remdesivir are not FDA-approved for a COVID-19 indications, but Expanded Access allows patients with serious or life-threatening cases of the virus to have access to them as investigational medicinal products.2

    Chloroquine, or hydroxychloroquine, is currently approved by the FDA for treatment of malaria, lupus, and rheumatoid arthritis, although not for COVID-19. A heme polymerase inhibitor, the drug is being tested for possible COVID-19 use to improve virologic clearance.3

    Remdesivir is an investigational nucleotide analog with broad-spectrum antiviral activity, according to its maker, Gilead Sciences, and it is not approved by the FDA nor any other countries for any use. However, remdesivir has demonstrated activity against MERS and SARS, indicating that it may have potential activity against COVID-19. The drug has been used in a small number of patients with COVID-19 in an experimental manner, according to Gilead.4

    During a White House press conference on Thursday, Hahn said that although remdesivir is still in its investigational phase, the unprecedented pandemic warranted action. “Remdesivir is [still] going through the normal process. We do need to know about the safety and effectiveness,” he said.1

    According to Hahn, the FDA is providing regulatory flexibility and guidance, but is also continuing to ensure products are safe. He said the agency has been working with the CDC since January on combating the virus.1

    “An important part of that work is expanding therapeutic options for the coronavirus,” Hahn said.1

    Trump said these medications will be made available by prescription. Hahn declined to say when both drugs would become available for use in patients with COVID-19.1

    Got that? >>Trump said these medications will be made available by prescription >>

    Notice the date & timestamp? >>2020-03-19 17:40:00>>

    Yes, March 19th. Mr Trump [for all his sins] was speaking in the context of the degree of permission already given and with hope. A hope that we can see was based on evidence, both current and longstanding. Evidence that is actually a few diligent Internet searches away, and which has formed the basis for my recent newswatch articles.

    Let me add, on tone of language:

    CED: tout (ta?t)
    vb
    1. (Commerce) to solicit (business, customers, etc) or hawk (merchandise), esp in a brazen way
    2. (Horse Racing) (intr) . . .
    3. (tr) informal to recommend flatteringly or excessively

    In short, loaded language with a built in sneer at a populist, blue collar billionaire building contractor.

    We need to do a lot better than this with lives on the line.

    KF

  6. 6
    kairosfocus says:

    EG, yes. France has approved and FDA is moving a step up the approvals ladder. KF

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