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To: Bullish

when I saw this story today, my first thought was this was the EU coup plotters latest attempt to get rid of Trump:

28 May: Reuters: EU governments ban malaria drug for COVID-19, trial paused as safety fears grow
Reporting by Matthias Blamont in Paris, Emilio Parodi in Milan, Marine Strauss in Brussels, Ludwig Burger in Frankfurt, Alistair Smout in London and Michael Erman in New York; Writing by Josephine Mason and John Miller; Editing by Mark Heinrich/Peter Graff and Grant McCool

PARIS/LONDON/MILAN - European governments moved on Wednesday to halt the use of anti-malaria drug hydroxychloroquine to treat COVID-19 patients, and a second global trial was suspended, further blows to hopes for a treatment promoted by U.S. President Donald Trump.
The moves by France, Italy and Belgium followed a World Health Organization decision on Monday to pause a large trial of hydroxychloroquine due to safety concerns.

A UK regulator said on Wednesday that a separate trial was also being put on hold, less than a week after it started. The study, being led by the University of Oxford and partly funded by the Bill and Melinda Gates Foundation, was expected to involve as many as 40,000 healthcare workers...

After early reports that it might help some patients, regulators in several countries had allowed hydroxychloroquine to be used as a potential COVID-19 treatment.
Trump was a particularly strong supporter, describing the drug as a “gamechanger.” He later announced he was taking it to prevent infection.

However, more recent studies have raised serious safety issues. British medical journal The Lancet has reported coronavirus patients receiving hydroxychloroquine were more likely to die and experience dangerous irregular heartbeats.
On Wednesday, France’s health ministry cancelled a decree in place for nearly two months that had allowed hospital doctors to dispense it in specific situations for COVID-19.

Medicines agencies in France and Italy said the drug should not be used for COVID-19 outside clinical trials. Belgium’s regulator said trials aiming to evaluate the drug should also take potential risks into consideration.
Swiss drugmaker Novartis is pushing ahead with its U.S. study involving 440 patients, while French company Sanofi declined to comment on the future of its two trials.

Italian health authorities concluded that the risks, coupled with little evidence hydroxychloroquine was beneficial against COVID-19, merited a ban outside of clinical trials...
Germany is looking at The Lancet study and the WHO’s decision but has not made any decision about new guidance on hydroxychloroquine, a spokeswoman for its drugs regulator said.

The U.S. Food and Drug Administration has allowed healthcare providers to use hydroxychloroquine for COVID-19 through an emergency-use authorization, but has not approved them to treat it. It also warned in April, that for safety reasons, the drug should be used only for hospitalized COVID-19 patients or those in clinical trials.
The agency did not respond to queries asking whether it was reconsidering the emergency-use authorization.
https://www.reuters.com/article/health-coronavirus-hydroxychloroquine-fr/eu-governments-ban-malaria-drug-for-covid-19-trial-paused-as-safety-fears-grow-idUSKBN2340A6

evil.

Australia was all for it until it was all against it!

8 Apr: Brisbane Times Australia: Doctors banned from prescribing potential COVID-19 drug
By Lydia Lynch; with Liam Mannix
Doctors who prescribe an anti-malarial drug being trumpeted as a potential COVID-19 treatment face a $13,000 fine.
New prescription rules, brought into effect in Queensland on Tuesday, mean clinicians are banned from prescribing the drug, hydroxychloroquine, as a COVID-19 treatment...

There is no solid evidence it is effective against COVID-19, but federal Health Minister Greg Hunt said there had been “some promising research so far”.
The new restrictions were introduced after some doctors began prescribing the drug to themselves and their families in February, following early research that suggested the drug might minimise the impact of the disease and help patients recover faster.

Worldwide shortages were caused after US President Donald Trump tweeted about the drug’s potential last month.
Mr Trump spruiked the drug again at the weekend and urged Americans to take it despite a lack of strong evidence the medication is safe to use in COVID-19 patients.
The new law, introduced under public health powers granted to the state’s top doctor, Chief Health Officer ***Jeannette Young, is also aimed at stopping pharmacies and GP clinics from stockpiling the medication...

The University of Queensland is on the verge of starting a large clinical trial, involving 60 hospitals across Australia, with hydroxychloroquine and another a HIV medication.
Infectious diseases expert Professor David Paterson said the drugs proved highly effective when first used against the virus in test tubes.
“Prior to the clinical trials going ahead, the medications were given to some of the first patients in Australia infected with COVID-19, and all have completely recovered without any trace of the virus left in their system,” he said.
“However, we know that most people with COVID-19 recover completely, thanks to their immune system, so random anecdotal experiences of some people need to be replaced by rigorous clinical trials.”

Professor Paterson said the aim was to treat COVID-19 patients as soon as they were admitted to hospital.
“This will enable us to test the first wave of Australian patients and gain real-world experience with this treatment, especially since we expect ongoing infections to continue for many months,” he said...
https://www.brisbanetimes.com.au/national/queensland/doctors-banned-from-prescribing-potential-covid-19-drug-20200408-p54ic1.html

***Jeannette Young is the petty tyrant in Queensland, who says Queensland’s borders should remain shut, maybe until September, which would cost the Queensland tourism industry billions of dollars. Queensland has had six covid deaths.

29 Apr: Youtube: Sky News Australia: ‘No doubt in my mind Hydroxychloriquine is very effective’ against COVID-19: (mining magnate Clive) Palmer
Billionaire Clive Palmer says the reason he bought 32 million doses of hydroxychloroquine to combat coronavirus is because if Australia was going to be severely hit by the virus he “didn’t want to see our nation destroyed in the longer term”.
Mr Palmer acquired in March 32.9 million doses of the anti-malarial drug for treating Australians “free of charge” according to Sky News host Alan Jones.
On April 2 Federal Health Minister Greg Hunt announced the drug will be made available to doctors to prescribe patients of COVID-19 in hospitals if they choose to do so.

Mr Palmer told Sky News he is “a person that had the means, capability, and contacts to get the drugs” which is why he funded the entire project, as well as donating $11 million to fund clinical trials of the drug on coronavirus patients.
Given the drug has a shelf life of three to four years, Mr Palmer said he thought Australia “needed to make sure that we could survive regardless of what happened, and that’s why I did it”.
“There’s no doubt in my mind hydroxychloroquin is very effective”.

COMMENT:
Flash Gordon: It’s all political in the US - the Democrats would rather see people suffer and die than give Trump a win.
https://www.youtube.com/watch?v=NJYSsJN431I

Trump must get re-elected in November, or else the coup plotters win. they are pure evil.


18 posted on 05/29/2020 12:42:34 AM PDT by MAGAthon
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To: MAGAthon

25 May: Stat Modeling (Columbia Uni): This controversial hydroxychloroquine paper: What’s Lancet gonna do about it?
Posted by Andrew
Lancet
A recent paper published in the famous/notorious medical journal Lancet reports that hydroxychloroquine and chloroquine increased the risk of in-hospital death by 30% to 40% and increased arrhythmia by a factor of 2 to 5. The study hit the news with the headline, “Antimalarial drug touted by President Trump is linked to increased risk of death in coronavirus patients, study says.” (Meanwhile, Trump says that Columbia is “a liberal, disgraceful institution.” Good thing we still employ Dr. Oz!)…

All this politics . . . in the meantime, this Lancet study has been criticized; see here and here. I have not read the article in detail so I’m not quite sure what to make of the criticisms; I linked to them on Pubpeer in the hope that some experts can join in...

Almost all the press coverage of this study seemed to be taking the Lancet label as a sign of quality...READ ON

FIRST COMMENT:
25 May: ETH: One additional important development: The WHO announced today that they would be temporarily pausing their trial of hydroxychloroquine, citing the results of The Lancet paper.
SECOND COMMENT:
26 May: Zach: It looks like they’ve already restarted it
https://statmodeling.stat.columbia.edu/2020/05/25/this-controversial-hydroxychloroquine-paper-whats-lancet-gonna-do-about-it/

26 May: RecoveryTrial.net: Recruitment to the RECOVERY trial continues as planned
Prof Peter Horby and Prof Martin Landray, Chief Investigators of the RECOVERY trial, said ‘We have been working over the weekend to understand the implications of the Mehra paper for the safety and welfare of patients randomised to hydroxychloroquine.
‘On Saturday 23 May, the independent Data Monitoring Committee conducted an urgent review of the data that we have collected so far on the effects of hydroxychloroquine on mortality among patients admitted to hospital with COVID-19. The Committee concluded that there is “no cogent reason to suspend recruitment for safety reasons.”

‘The Committee found that the effects of hydroxychloroquine on mortality reported in the analysis by Mehra were not consistent with those observed in the RECOVERY trial. The Committee therefore recommended that the trial continue recruitment without interruption, a recommendation that was endorsed on Sunday by the MHRA.

‘The conclusion of the Mehra paper is that “Randomised clinical trials will be required before any conclusion can be reached regarding benefit or harm of these agents in COVID-19 patients.” The RECOVERY trial is currently the largest randomised controlled trial of hydroxychloroquine and other potential treatments for COVID-19. Enrolment in this trial is the best way to provide definitive evidence on these drugs.’
https://www.recoverytrial.net/news/recruitment-to-the-recovery-trial-continues-as-planned

25 May: StatModeling: Hydroxychloroquine update
Posted by Andrew
The study only has 4 authors which is weird for a global study in 96,000 patients (and no acknowledgements at the end of the paper). Studies like this in medicine usually would have 50-100 authors (often in some kind of collaborative group). The data come from the “Surgical Outcomes Collaborative”, which is in fact a company. The CEO (Sapan Desai) is the second author. One of the comments on the blog post is “I was surprised to see that the data have not been analyzed using a hierarchical model”. But not only do they not use hierarchical modelling and they do not appear to be adjusting by hospital/country, they also give almost no information about the different hospitals: which countries (just continent level), how the treated vs not treated are distributed across hospitals etc. A previous paper by the same group in NEJM says that they use data from UK hospitals (no private hospitals are treating COVID so must be from the NHS). Who is allowing some random company to use NHS data and publish with no acknowledgments. Another interesting sentence is about patient consent and ethical approval:

We emailed them to ask for the data, in particular to look at the dose effect which I think is key in understanding the results. They got back to us very quickly and said

“Thanks for your email inquiry. Our data sharing agreements with the various governments, countries and hospitals do not allow us to share data unfortunately. I do wish you all the very best as you continue to perform trials since that is the stance we advocate. All we have said is to cease and desist the off label and unmonitored and uncontrolled use of such therapy in hospitalized patients.”

So unavailable data from unknown origins . . .

Another rather remarkable aspect is how beautifully uniform the aggregated data are across continents: ...
https://statmodeling.stat.columbia.edu/2020/05/25/hydroxychloroquine-update/

22 May: PubPeer: Hydroxychloroquine or chloroquine with or without a macrolide for treatment of COVID-19: a multinational registry analysis
The Lancet(2020) - 11 Comments
https://pubpeer.com/publications/71DA593B9943638F1ADE6F80696914#1

The Lancet: Hydroxychloroquine or chloroquine with or without a macrolide for treatment of COVID-19: a multinational registry analysis
Mandeep R Mehra, Sapan S Desai, Frank Ruschitzka, Amit N Patel
Declaration of interests
MRM reports personal fees from Abbott, Medtronic, Janssen, Mesoblast, Portola, Bayer, Baim Institute for Clinical Research, NupulseCV, FineHeart, Leviticus, Roivant, and Triple Gene. SSD is the founder of Surgisphere Corporation. FR has been paid for time spent as a committee member for clinical trials, advisory boards, other forms of consulting, and lectures or presentations; these payments were made directly to the University of Zurich and no personal payments were received in relation to these trials or other activities...
Research in context
Evidence before this study
We searched MEDLINE (via PubMed) for articles published up to April 21, 2020, using the key words “novel coronavirus”, “2019-nCoV”, “COVID-19”, “SARS-CoV-2”, “therapy”, “hydroxychloroquine”, “chloroquine”, and “macrolide”. Moreover, we screened preprint servers, such as Medrxiv, for relevant articles and consulted the web pages of organisations such as the US National Institutes of Health and WHO...
Acknowledgments
The development and maintenance of the Surgical Outcomes Collaborative database was funded by Surgisphere Corporation (Chicago, IL, USA). This study was supported by the William Harvey Distinguished Chair in Advanced Cardiovascular Medicine at Brigham and Women’s Hospital (Boston, MA, USA). We acknowledge Jide Olayinka (Surgisphere) for their helpful statistical review of the manuscript...


19 posted on 05/29/2020 12:44:27 AM PDT by MAGAthon
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To: MAGAthon

*** “Trump must get re-elected in November, or else the coup plotters win. they are pure evil” ***

We need the Congress and Senate onboard as well
(not to mention the FBI and CIA Cleaned up ... still waiting for those Whistle Blowers)


23 posted on 05/29/2020 1:05:27 AM PDT by TexasTransplant ( I am going back to work... permission or not)
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