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Here’s my conspiracy theory for the day - hydroxychloroquine


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One of my musings (definitely not really a theory, and possibly not even a hypothesis) is that maybe HcQ works for people who had an underlying autoimmune disorder, and didn't know it, since it is effective at calming down the immune system for different disorders. So many of the ways CoVID acts seem familiar to me as someone with an autoimmune disorder that has had different symptoms at different times that I'm wondering if that makes a difference in how it is presented. If so, maybe testing for at least the more common antibodies that indicate autoimmune disorders (via bloodwork) would let us know who would best benefit from taking HcQ, especially for people who are in jobs where they have to have close contact with other people. 

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Our VA hospital is using it, so I don't think there's a conspiracy to keep it for the elite.  How about an alternative conspiracy theory in which a different "they" want Trump to be wrong more than th

Back in early April or whenever Donald Trump went on television to talk about hydroxychloroquine, the Israeli government immediately purchased an enormous amount of the stuff.  Doctors here had been e

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30 minutes ago, happysmileylady said:

Does anyone have any experience with how a drug moves from research into clinical trials?  I don't, but another poster mentioned having experience with clinical trials, maybe she has some more info on that transition?  

My assumption is that in order for a drug to enter a clinical trial, there has to be some research on it first.....there has to be enough data to make starting a clinical trial worth it, right?  Clearly, HCQ and remdesivir and some other drugs have shown enough positive data in that research to get trials started, right?  Or is there usually very little data before the trials are started?  

 

ETA:  Should have googled first, I found this

https://www.fda.gov/patients/drug-development-process/step-2-preclinical-research

Presumably, because HCQ is not something brand new from scratch, but something we already had, I would presume that step 1 was skipped, but I would presume that they would have had to do the preclinical research before the trials were actually started.  

This might be helpful

Most drugs would have animal studies done and then move on to a Phase 1 clinical trial in people.

 

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6 minutes ago, dmmetler said:

One of my musings (definitely not really a theory, and possibly not even a hypothesis) is that maybe HcQ works for people who had an underlying autoimmune disorder, and didn't know it, since it is effective at calming down the immune system for different disorders. So many of the ways CoVID acts seem familiar to me as someone with an autoimmune disorder that has had different symptoms at different times that I'm wondering if that makes a difference in how it is presented. If so, maybe testing for at least the more common antibodies that indicate autoimmune disorders (via bloodwork) would let us know who would best benefit from taking HcQ, especially for people who are in jobs where they have to have close contact with other people. 

A registry has been set up to try to study how people with rheumatological diseases react to Covid 19. I would hope that would help researchers sort through whether HCQ or other common medicines used to treat AI illnesses might help (or hurt) those who become infected with Covid 19. At this point I think all we have are guesses and conjecture. My own rheumy thinks the medication I'm on might reduce the likelihood of a cytokine storm reaction if I contracted Covid 19. But he was very clear that's just a guess.

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13 minutes ago, dmmetler said:

One of my musings (definitely not really a theory, and possibly not even a hypothesis) is that maybe HcQ works for people who had an underlying autoimmune disorder, and didn't know it, since it is effective at calming down the immune system for different disorders. So many of the ways CoVID acts seem familiar to me as someone with an autoimmune disorder that has had different symptoms at different times that I'm wondering if that makes a difference in how it is presented. If so, maybe testing for at least the more common antibodies that indicate autoimmune disorders (via bloodwork) would let us know who would best benefit from taking HcQ, especially for people who are in jobs where they have to have close contact with other people. 

 

Interesting idea! 

 

As a person with autoimmunity etc, I have had a tendency to meet or particularly bond with (out of many people met ) some others with similar problems too.  I think it may be that the irl people I know who have had particular success with HCQ have had either AI or porphyria which is also related to HcQ action, and has some overlap in heme/porphyria disregulation with CV19.  This may explain why I might tend to know people for whom HCQ seems to have worked really well and why it might also for me. 

Perhaps different than general population. 

 

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41 minutes ago, Pawz4me said:

This might be helpful

Most drugs would have animal studies done and then move on to a Phase 1 clinical trial in people.

 

Thank You.

So the in vitro is in cells, in the little dishes right?  And then the in vivo are the animal studies?  So, generally, before moving on to phase one trials, a drug would have some research done, both in dishes, and in animal testing, am I understanding that right?  

 

 

 

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1 minute ago, happysmileylady said:

Thank You.

So the in vitro is in cells, in the little dishes right?  And then the in vivo are the animal studies?  So, generally, before moving on to phase one trials, a drug would have some research done, both in dishes, and in animal testing, am I understanding that right?  

 

 

 

That's my understanding for new drugs. I don't know how it applies to a new use for a drug that has already been FDA approved for treating other conditions.

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2 minutes ago, Pawz4me said:

That's my understanding for new drugs. I don't know how it applies to a new use for a drug that has already been FDA approved for treating other conditions.

I had heard that they had done some of the in vitro research.  However, I hadn't heard anything about animal testing.  Maybe that wasn't as important because it wasn't a new drug.  Or, I suppose maybe they did it but we haven't heard of it.  Unfortunately when I try to search for the preclinical stuff, it's hard for me to sort through all the other media stuff about it.  

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2 hours ago, happysmileylady said:

Thank You.

So the in vitro is in cells, in the little dishes right?  And then the in vivo are the animal studies?  So, generally, before moving on to phase one trials, a drug would have some research done, both in dishes, and in animal testing, am I understanding that right?  

 

 

 

 

2 hours ago, Pawz4me said:

That's my understanding for new drugs. I don't know how it applies to a new use for a drug that has already been FDA approved for treating other conditions.

 

Generally a brand new compound is studied in vitro on cells, if that is appropriate, then animal studies, safety studies, efficacy studies, large-scale studies, and post release studies.    Some drugs can skip various of these steps for various reasons.  Drugs for conditions that have no current treatments but are fatal or life-debilitating may be fast-tracked.   Sometimes a drug is being studied for one thing, isn't going well but they notice it works for something else (viagra is a good example of this).   If a drug is already available for a different indication, what trials are needed will depend on the differences in the how it is being used.  A big increase in dosage or frequency of dosing or method of administration (in hospital under close monitoring versus by prescription versus OTC) may require additional safety trials before going to efficacy trials.   Sometimes all that's needed is a Phase III trial to make sure it works well for the new indication.   

I worked on a drug that had an indication as an alternative to heparin for anticoagulation during heart surgery for patients with heparin-induced thrombocytopenia.  Since there were limited options for this indication, and it could be a life-threatening situation, they were able to get approval for this comparatively easier.   They then went for a bigger indication ($$$$) as an acute treatment for patients with acute ischemic stroke.   They were able to use the data from the previous Phase I and II studies and start with Phase III studies on stroke patients.  

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Case study series on 17 patients with lupus who had been taking HCQ for an average of 7.5 yrs before they contracted Covid-19. The results were not good:

Over the course of hospitalization, 76% of the cohort developed viral pneumonia, 65% experienced complications due to respiratory failure, and 29% had acute respiratory distress syndrome. A total of 65% of patients required oxygen therapy, including nasal cannula in five individuals, mechanical ventilation in five, and high-flow nasal cannula in one. Data for the cohort were collected between 29 March and 6 April, and on 7 April half remained in hospital, 36% had been discharged, and 14% had died.

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34 minutes ago, Corraleno said:

Case study series on 17 patients with lupus who had been taking HCQ for an average of 7.5 yrs before they contracted Covid-19. The results were not good:

 

 

I was wondering if they were seeing patients already taking HCQ for other things and then coming down with Covid-19 and how that looked.   

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5 hours ago, Pen said:

 

Otoh, Lots of people have taken HCQ prophylactically for malaria over the years without knowing which person would develop malaria .   Sometimes even chloroquine which had more risks was taken for months by missionaries and others in malarial areas (before malaria developed resistance), and many did  just fine with it. 

 

In Oregon it may not be prescribed as a preventative. You have to be admitted to a hospital to receive it.

https://www.oregon.gov/omb/statutesrules/Documents/855.007.0085 Prescriptions for Chloroquine.pdf

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49 minutes ago, Corraleno said:

Case study series on 17 patients with lupus who had been taking HCQ for an average of 7.5 yrs before they contracted Covid-19. The results were not good:

 

 

Thank you for sharing.  I was wondering if they had done any looking at people already taking HCQ and how that was playing out.  

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WHO temporarily pauses studying hydroxychloroquine due to safety concerns

From CNN's Jacqueline Howard

A bottle and pills of Hydroxychloroquine sit on a counter at Rock Canyon Pharmacy in Provo, Utah. George Frey/AFP/Getty Images

The World Health Organization has temporarily halted studying hydroxychloroquine as a potential Covid-19 treatment in its Solidarity Trial due to safety concerns, WHO Director-General Tedros Adhanom Ghebreyesus said during a briefing in Geneva on Monday.

The decision was made after an observational study was published in the medical journal The Lancet on Friday, which described how seriously ill Covid-19 patients who were treated with hydroxychloroquine and chloroquine were more likely to die.

Tedros said that an independent executive group is now reviewing the use of hydroxychloroquine in WHO's Solidarity Trial. The trial, which involves actively recruiting patients from more than 400 hospitals in 35 countries, is a global research effort to find safe and effective therapeutics for Covid-19.

"The Executive Group of the Solidarity Trial, representing 10 of the participating countries, met on Saturday and has agreed to review a comprehensive analysis and critical appraisal of all evidence available globally," Tedros said on Monday.

"The review will consider data collected so far in the Solidarity Trial and, in particular robust randomized available data, to adequately evaluate the potential benefits and harms from this drug," Tedros said. "The Executive Group has implemented a temporary pause of the hydroxychloroquine arm within the Solidarity Trial while the data is reviewed by the Data Safety Monitoring Board." 

Tedros added that the other arms of the trial are continuing.

"This concern relates to the use of hydroxychloroquine and chloroquine in Covid-19," Tedros said. "I wish to reiterate that these drugs are accepted as generally safe for use in patients with autoimmune diseases or malaria."

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Conclusions in India seem to go back and forth

(Some Quotes From articles and google:) 

 

 

New Delhi: A revised government advisory on Friday recommended use of hydroxychloroquine as a preventive medication for asymptomatic healthcare workers working in non-COVID-19 hospitals, frontline staff on surveillance duty in containment zones and paramilitary/police personnel involved in coronavirus infection related activities.

...

Highlighting the studies on prophylaxis of SARS-CoV-2 infection, the advisory stated that a retrospective case-control analysis at ICMR has found that there is a significant dose-response relationship between the number of prophylactic doses taken and frequency of occurrence of SARSCoV-2 infection in symptomatic healthcare workers who were tested for coronavirus infection.

...

 

As was mentioned in the earlier advisory, the drug against the infection is also recommended for all asymptomatic healthcare workers involved in containment and treatment of COVID-19 and household contacts of laboratory confirmed cases.

...

Another investigation from three central government hospitals in New Delhi indicates that amongst healthcare workers involved in COVID-19 care, those on HCQ prophylaxis were less likely to develop SARS-CoV-2 infection, compared to those who were not on it.

The benefit was less pronounced in healthcare workers caring for a general patient population. ...

Besides, an observational prospective study of 334 healthcare workers at AIIMS, out of which 248 took HCQ prophylaxis in New Delhi also showed that those taking HCQ prophylaxis had lower incidence of SARS-CoV-2 infection than those not taking it.

 

...

3 days ago · The revised advisory issued by the ICMR, however, cautioned that the intake of the medicine should not instill a sense of false ...
 
 
 
16 hours ago · According to the guidelines laid by the Indian Council of Medical Research (ICMR) on the prophylactic use of hydroxychloroquine on ...
 
 
 
3 days ago · Three studies find that hydroxychloroquine reduces chances of contracting Covid, so ICMR allows more frontline workers to take it as ...
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So, looking at what we have, seems it is showing it may work for prevention, in people not yet sick, but not good in patients who are already symptomatic. THAT is helpful information. It also looks like it was only worth it as a preventative in high risk situations - those directly caring for COVID patients, or those living with people who are positive, etc. 

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23 minutes ago, Ktgrok said:

So, looking at what we have, seems it is showing it may work for prevention, in people not yet sick, but not good in patients who are already symptomatic. THAT is helpful information. It also looks like it was only worth it as a preventative in high risk situations - those directly caring for COVID patients, or those living with people who are positive, etc. 

 

Which is also what I was trying to explain was largely the thrust of the in vitro evidence. HCQ seemed to be able to stop the spike protein, the crown tips that fit like a key into the lock key hole of the ACE2 receptors and allow the virus to enter cell where it can replicate, HCQ first of all seems to be able to stop it from being able to do that key fitting into lock bonding thing. That’s prophylactic very best probable thing it can help with.  Not a complete stop 100% of time, but hugely reduced such that illness could be expected to be milder. 

(ETA not sure how to say this clearly—when it stops the virus from connecting it is apparently a complete stop as far as that virus’s affected protein spike goes, but some other virus / protein spike might still do the bonding.

Still, virus reduction, whether by SD, or masks, or stopping spike protein-ACE2 bond so that virus can’t enter cells, all likely to help outcome.  The HCQ seems probably to change the viruses ‘ protein spikes by ? adding a sugar molecule ? so they no longer fit the receptor so perfectly, not by changing the ACE2 receptors.  Since ACE2 receptors are important for various life functions I prefer treatment to change the virus spike, not wipe out the ACE2 receptors. There is also an acid-base change that seems significant in terms of likely mode of action.) 

2nd, for virus that does get in, the in vitro studies strongly suggest that HCQ can reduce replication speed.

So both of these start as early events in course of illness.  Though they do continue as disease progresses and more cells are affected. 

And it does look like real world evidence is fitting the in vitro studies even in vitro evidence on similar viruses. 

 

It would probably help most the earlier it can be given.  It would help least late and in cases already severe (which is what it was used for in most studies) or bad enough to be in hospital as has been pointed out is all being allowed as “compassionate “ use I guess in my state. I don’t see that there is much compassionate about giving a medicine when it is at a probably too late for it point. And when reading the in vitro studies would show that late stage (and being in hospital is pretty much already late stage in my state) is too late. 

Which, idk, @Quill — how does that fit with your thread title and op?

 

 

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@Pen, it jibes. I don’t know what will happen when the dust settles but I will not be surprised if HCQ *does* have a medically-acknowledged role. 

I do think “they” don’t want people to clamor for the drug; that has already happened at least once. 

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18 minutes ago, Quill said:

@Pen, it jibes. I don’t know what will happen when the dust settles but I will not be surprised if HCQ *does* have a medically-acknowledged role. 

I do think “they” don’t want people to clamor for the drug; that has already happened at least once. 

 

It **is** really bad if people who can get access buy it up and stockpile maybe in a garage like some were doing with TP and hand sanitizer etc .  And that supply then probably doesn’t even ever get used because the stockpiles don’t need it and who would want to buy a black market drug that’s been in some jerk’s garage stockpile. .

And I’d not be at all surprised if we someday were to learn that Beijing has been prophylactically treating VIPs with it. 

 

In re stockpiling, or people randomly using it when not needed, I’d just as soon people think it doesn’t work at all when it does help significantly 

But I would like to be able to more easily obtain it ***at right time, which is to say at first serious inkling that even thoytrying to be careful I have been exposed ***  if I feel aI need it.  

It almost seems like opioid pain relievers where actions of criminals and addicts result in people with real pain needs not being able to get it. 

 

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From the long thread:

 

o,  Ausmumof3 said: 

https://www.the-scientist.com/news-opinion/disputed-hydroxychloroquine-study-brings-scrutiny-to-surgisphere-67595
 

significant questions raised over the data In the lancet hydroxychloroquine study.  
 

On May 28, an open letter, which has now accrued more than 180 signatories at research institutions around the world, laid out multiple other problems with the study data and analyses. In addition, readers of the study are beginning to ask about the nature and history of Surgisphere, and how it managed to obtain such a complex dataset in a relatively short period of ti

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On 5/23/2020 at 8:33 AM, Quill said:

You have a point. But clearly, he must believe it’s protecting him, unless he’s straight up lying about taking it himself, which is certainly possible, but I think, not likely. 


The dude is a pathological liar.  As of April 14, 2020 he has made 18,000 verifiably false or misleading statements since the start of his presidency.

 

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14 minutes ago, Amy in NH said:


The dude is a pathological liar.  As of April 14, 2020 he has made 18,000 verifiably false or misleading statements since the start of his presidency.

 

He is a pathological liar, but I doubt he's lying about this.  Given that there have been some decent studies out of South Korea about its efficacy used as prophalaxis for people exposed, and given when he said he was finishing up a two week course, it lines up with exposure to his valet, who tested positive.  I could totally see a White House doctor prescribing it for that purpose under that circumstance, especially given how excited Trump is about the stuff.  

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5 hours ago, Amy in NH said:


The dude is a pathological liar.  As of April 14, 2020 he has made 18,000 verifiably false or misleading statements since the start of his presidency.

 

Well, sure. No disagreement from me there. But, as they say, even a broken clock is right twice a day. 

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10 minutes ago, Danae said:

Yes.

Just wondering if you saw this part:

"There are some big caveats: The study enrolled people through the Internet and social media, relying on them to report their own symptoms rather than having them tracked in a formal way by doctors. Participants were not all tested for the coronavirus but were diagnosed as COVID-19 cases based on symptoms in many cases. And not all took their medicines as directed."

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29 minutes ago, Joker said:

I’m sad it didn’t show to be helpful against Covid but happy it didn’t show to be deadly like so many have been saying. 

Yeah me too.  There might be a couple caveats, but I think this is probably more trustworthy than most of the other stuff I have seen.  

This was a post exposure study, right?  But, there's a pre exposure study going on too that isn't quite finished, right?  Also, did this study look at severity of the illness with, vs without the HCQ or was it only looking at straight prevention?  Something that doesn't prevent illness, but makes it less severe if someone does get ill would still be really good.  

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2 hours ago, Danae said:

So, what part of my post do you think makes it look like I didn’t see that part?  
 

I’d say I was dead on.

That you thought there were some sort of advocates of the drug that would find a reason to discount the study when the flaws are reported right in the article. Those things seem significant and I'm not an advocate of any particular drug. Or are they not significant?

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37 minutes ago, Penelope said:

The Lancet meta analysis has been retracted. Big scandal.

https://www.thelancet.com/lancet/article/s0140673620313246

just about to post this.  They've been dupped and it was a lie.  The "company" putting out data was a front.  Good grief.  It wasn't just the WHO, etc... but also several prestigious peer-reviewed medical journals. 

"A Guardian investigation can reveal the US-based company Surgisphere, whose handful of employees appear to include a science fiction writer and an adult-content model, has provided data for multiple studies on Covid-19 co-authored by its chief executive, but has so far failed to adequately explain its data or methodology."

https://www.theguardian.com/world/2020/jun/03/covid-19-surgisphere-who-world-health-organization-hydroxychloroquine

Edited by PrincessMommy
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14 minutes ago, PrincessMommy said:

just about to post this.  They've been dupped and it was a lie.  The "company" putting out data was a front.  Good grief.  It wasn't just the WHO, etc... but also several prestigious peer-reviewed medical journals. 

"A Guardian investigation can reveal the US-based company Surgisphere, whose handful of employees appear to include a science fiction writer and an adult-content model, has provided data for multiple studies on Covid-19 co-authored by its chief executive, but has so far failed to adequately explain its data or methodology."

https://www.theguardian.com/world/2020/jun/03/covid-19-surgisphere-who-world-health-organization-hydroxychloroquine

Well, dang. Curiouser and curiouser. 

I am beginning to think there is no such thing as the truth. Or, that none of us can really expect to get it from any quarter. 

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10 minutes ago, PrincessMommy said:

just about to post this.  They've been dupped and it was a lie.  The "company" putting out data was a front.  Good grief.  It wasn't just the WHO, etc... but also several prestigious peer-reviewed medical journals. 

"A Guardian investigation can reveal the US-based company Surgisphere, whose handful of employees appear to include a science fiction writer and an adult-content model, has provided data for multiple studies on Covid-19 co-authored by its chief executive, but has so far failed to adequately explain its data or methodology."

https://www.theguardian.com/world/2020/jun/03/covid-19-surgisphere-who-world-health-organization-hydroxychloroquine

Jeez, who is doing the peer review on these studies and why are they only being investigated after they're published??? The French study that started the whole thing was also rushed through "peer review" in less than 24 hours, and the journal later admitted that it "did not meet expected standards."  These journals need to slow the hell down and start vetting these studies fully before publication. They are messing with people's LIVES.  🤬

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Two new items on hydroxychloroquine today:  

https://www.nejm.org/doi/full/10.1056/NEJMoa2016638   New England Journal of Medicine essentially saying HCQ was not effective prophylaxis.  Note:  it was not given with zinc, nor were zinc levels tested, so this study is not of much use.  

https://www.thelancet.com/lancet/article/s0140673620313246   Retraction of the Lancet article that showed such horrible results for use of hcq.  Data unable to be peer-reviewed; the company that collected it would not release the data.   General embarrasment and apologies from the co-authors.  

ETA:   oh, #$%^&^%$ !!!  I just found out that the NEJM study used the SAME data set, from the same company, Surgisphere, for their recently published study that is the basis for the FDA recommending no use of HCQ.   Gaaaah! 

https://www.nytimes.com/2020/05/29/health/coronavirus-hydroxychloroquine.html?action=click&module=RelatedLinks&pgtype=Article

 

 

Edited by Halftime Hope
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56 minutes ago, Corraleno said:

Jeez, who is doing the peer review on these studies and why are they only being investigated after they're published??? The French study that started the whole thing was also rushed through "peer review" in less than 24 hours, and the journal later admitted that it "did not meet expected standards."  These journals need to slow the hell down and start vetting these studies fully before publication. They are messing with people's LIVES.  🤬

 

Or keep on with “”pre-review” releases which tells people information is not reviewed, but gets it out sooner in case it can help.

 

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26 minutes ago, Halftime Hope said:

ETA:   oh, #$%^&^%$ !!!  I just found out that the NEJM study used the SAME data set, from the same company, Surgisphere, for their recently published study that is the basis for the FDA recommending no use of HCQ.   Gaaaah! 

https://www.nytimes.com/2020/05/29/health/coronavirus-hydroxychloroquine.html?action=click&module=RelatedLinks&pgtype=Article

 

 

🤯 gah!

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4 minutes ago, Halftime Hope said:

 

It's worse than I thought.  The NEJM that used the same data was a study on cardiac meds, not on HQC.  I misread the NYT article and didn't click through the actual study.  Stink! 

 

Yeah, thanks.  that group led by Mehra is seeming very fishy and publishing a bunch of high profile articles in high profile places which are changing research and patient care with what’s increasingly seeming to be bogus and self serving 

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