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14 minutes ago, JohnLocke said:

We'll have much better data in six months.

The data are sufficient to reject HCQ as the miracle drug in all of this.  If there is an effect, the effect size is very small. We need to focus on other therapeutics. We have wasted too much time and trial bandwidth already chasing a dead end lead that was based on the wrong animal model to begin with.

 

It really fails me what the fascination is and the fixation on HCQ.   

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Just now, Anastasis said:

The referenced subset being discussed, which you brought up, is by definition a set aside group where different thresholds of evidence are used for compassionate use situations. You make it really hard to take you serious. 

If you want to stop being a clown, I am happy to read your critical review of the methods and SAP of the last observational study you posted.  

Ah, the formidable double-down dodge.   What difference, if there is one, exists between the threshold RR for this subset and other drugs and devices outside of it needed for FDA approval based off of non-RCT observational studies?  Or are you suggesting that other doesn't exist?  That would be something.

 

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44 minutes ago, JohnLocke said:

Ok, I'll bite. There is not RCT results available that A) use hydroxychloriquine with zinc and azithromycin and B) are given early as an outpatient and C) have a large enough sample size of high risk patients to yield statistically significant results.

I tend to be influenced when I see dishonesty and what I have seen is HCQ being discarded as a treatment based on the fact A) it doesn't work well on very sick patients and B) statistically insignificant results, although positive, and needing larger sample sizes, are reported in the mainstream media as if they were negative results.

The 2nd layer of dishonesty has been the attack on the safety of HCQ, a widely used and well understood drug that is OTC in much of the world.  In Harvey Risch's words: The combination of hydroxychloroquine and azithromycin has been used for decades in hundreds of thousands of people with rheumatoid arthritis. There is a concern that these medications do change the heart pacing a little and could cause cardiac arrhythmias. However, these arrhythmias are still very rare in people using these medications. People who already have heart arrhythmias or are predisposed to them or have family histories of them should discuss this with their health care providers and see if using hydroxychloroquine plus doxycycline or some other medications would be a better choice. 

There is almost no downside to trying this drug if you are at high risk. In Dr. Risch's words again: Hydroxychloroquine alone is not the whole story. It needs to be combined with azithromycin or doxycycline and probably with zinc to make it most effective. The game changer is to aggressively treat people as soon as possible, before they are hospitalized, to keep them from becoming hospitalized in the first place. Hydroxychloroquine plus the other medications is what we know about now. In a few months we may have data on other medications that also work. We just have to start with something now.

The medical profession has been slow to act on data that is not based on RCT's. Shamefully so, when the data can be conclusive in and of itself. I point again to the rather shameful behavior of the medical profession in adopting antibiotics to treat ulcers as exhibit A.

When you are in the middle of a pandemic, you don't have time for RCT results. However, there is a huge mass of data available to sift through that is significant. I give the CDC an F for being prepared and able to do the heavy lifting in that regard. 

We'll have much better data in six months. And hopefully, better treatment options to go along with a vaccine.

Keep in mind that AZ was not used with HCQ in the most recent raft of positive studies showing large benefit.  Current understanding is that the beneficial mechanism of HCQ in Covid is anti-inflammatory, with the greatest effect being a dampening effect on covid driven maladaptive inflammation.  It follows that when you can inhibit it early, you help prevent the process from gaining steam which can lead to a total collapse of medical stability.  FWIW, the common pathway they share that I've seen relates to massive concentration of both AZ and HCQ into intracellular lysosomes due to very high volumes of distribution and acid/base properties of their respective amide groups.  Lysosomal activation of inflammasomes (increased IL-18 and IL-1B) is a key pathway driving the highly inflammatory process of pyroptosis.  Elevated IL-18 is the immuno-regulatory cytokine most associated with mortality in Covid per Yale Med.

Edit: Importantly, keep in mind that the maladaptive immune response this virus drives doesn't just flip on like a light switch in 10-20% of the population.  The studies showing abnormalities in cardiac MRI in a high percentage of patients with outpatient uncomplicated illness, and abnormal brain scans in non-hospitalized patients tells us that potential inflammatory damage begins right away in most everyone.  It's a race for how fast you can clear the virus before the maladaptive immune inflammatory response overwhelms you.  Various factors and pre-existing conditions make one more susceptible to variable levels of inflammation or have an inability to reduce viral load.

 

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18 minutes ago, Anastasis said:

It really fails me what the fascination is and the fixation on HCQ.   

It shouldn't fail you.  It's readily apparent when you look at the mouthpieces for it.  It's entirely political.  I will do all I can to avoid going CR here, but the interest is in there being a magic bullet treatment that renders COVID a non-issue, so that 1) we can blame paranoid science-types for ruining the economy for no good reason (blame someone else for the fallout), and 2) go back to normal immediately, so the folks in power can get credit for a recovery right now.

The problem is, wanting the magic bullet to be true doesn't protect you from 3) reality, which is that if we go forward with the "COVID is cured, all is well" path, the shit will really hit the fan.

I want there to be a fucking cure, I want there to be a vaccine - my family has a strong vested interest in this being the case.  All of my desire won't change the reality that there ain't one of either ready to go.  If real, proper studies end up showing HCQ to be a real-deal effective treatment, I'll be fucking thrilled.  But there haven't been any yet.  Yet there are folks who are selling it as a solution with everything they've got.  See the correlation above.  There's literally fucking nothing we won't politicize anymore.

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2 minutes ago, Brisketexan said:

It shouldn't fail you.  It's readily apparent when you look at the mouthpieces for it.  It's entirely political.  I will do all I can to avoid going CR here, but the interest is in there being a magic bullet treatment that renders COVID a non-issue, so that 1) we can blame paranoid science-types for ruining the economy for no good reason (blame someone else for the fallout), and 2) go back to normal immediately, so the folks in power can get credit for a recovery right now.

The problem is, wanting the magic bullet to be true doesn't protect you from 3) reality, which is that if we go forward with the "COVID is cured, all is well" path, the shit will really hit the fan.

I want there to be a fucking cure, I want there to be a vaccine - my family has a strong vested interest in this being the case.  All of my desire won't change the reality that there ain't one of either ready to go.  If real, proper studies end up showing HCQ to be a real-deal effective treatment, I'll be fucking thrilled.  But there haven't been any yet.  Yet there are folks who are selling it as a solution with everything they've got.  See the correlation above.  There's literally fucking nothing we won't politicize anymore.

You present the choices as mutually exclusive.  They're not.  You can have treatment interventions to reduce morbidity and mortality while maintaining masking, distancing, and phased re-opening to further and more rapidly extinguish the virus.

When you say  "if proper studies end up showing HCQ to be a real-deal effective treatment, I'll be fucking thrilled.  But there haven't been any yet."  That carries about as much truth, right now, today, as saying HCQ used appropriately under medical guidance in covid is unsafe.  

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 In 2016, Congress passed the 21st Century Cures Act which formalized the FDA's use of Real World Evidence (RWE) to support regulatory decision making, including approval of new indications for approved drugs.  RWE includes an expanding landscape of non-RCT derived data, including use of observational studies.  I'm sure some posters here are way more familiar with FDA integration of RWE than me, and perhaps they can add meaningful insight. 

I reference this act of Congress to show that the FDA's use of observational studies making drug approval decisions is an actual initiative.  It's increasingly accepted that RCT orthodoxy has real world limitations in optimizing health care decisions (particularly during a novel pandemic).  There does not appear to be a well defined set of limits for what clears the bar for adding a new indication for use of an already approved drug.  The meta-analysis of FDA drug and device approvals I linked  appears to only apply to a subset of new drugs and devices that have no prior approval.  FDA approval in their study showed a higher bar for non-RCT data which is entirely understandable in order to account for potential bias and covariates in non-RCT studies.

So what is the pattern of FDA granting approval for a new indication of an already approved drug using non-RCT data?  The FDA does this.  An act of Congress sanctions it.  I'd expect that the threshold for a new indication for an already approved drug is lower than that for a new drug with no prior approval involving basic safety with use.  In the meta I linked, the new drugs and devices they examined gained FDA approval using non-RCT data at a 1 in 10 clip.  FDA approval is happening when a treatment effect with a positive Relative Risk of 5 or 10 is demonstrated.  How generalizable is this rate of FDA approval based off of observational studies  across the range of applications, not just for drugs with no prior approval, but for approved drugs seeking approval for a new indication?

In this covid pandemic, I'm also interested to better understand how RWE and non-RCT data overlaps with FDA granting a new emergency use authorization, especially with already approved drugs.  Realize remdesivir got EUA based off a single study that showed no mortality benefit, only a 4 day shorter hospital stay.  Today's subject is weak evidence in support of pushing ahead with convalescent plasma.  In contrast, today we have dozens of studies, many but not all of which are observational, providing consistent and overwhelming evidence that early use of FDA approved HCQ can lower risk of death by 30-40% in Covid- when there are no early alternatives.

Right now more than anything, this leads to it being hard to see that much of anything matters as it relates to prior standards.  When you take a step back, what is happening now in the US does not compute.  Across a variety of examples related to policy implementation, testing, data reporting and transparency, drug approvals, and so on, the CDC and FDA have been co-opted and are not functioning the way we have come to know and trust.

 

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5 minutes ago, Bevo said:

Fuuuuck. Disengage. The next time I see someone mention HCQ, I'm passing on their address to Junior Miller and TexasTow.

 

 

Yeah this thread has devolved from generalized covid medical advice to Triples Everlasting Advocacy for Borderline Adequate Group Studies...Operation TEA BAGS. 

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2 hours ago, Bevo said:

Fuuuuck. Disengage. The next time I see someone mention HCQ, I'm passing on their address to Junior Miller and TexasTow.

 

 

 

1 hour ago, Homercles said:

Yeah this thread has devolved from generalized covid medical advice to Triples Everlasting Advocacy for Borderline Adequate Group Studies...Operation TEA BAGS. 

eh, 'Murica fuck yeah!  There is no medical discussion.  /thats the joke.

 

Today, it's good to see that individual states are coming around in real time and letting docs and patients consult and decide.  I just now realized Oregon lifted its outpatient use restriction in July.  Texas' outpatient use restriction ended in July as well.  Resource for actively updated state regulations and medical contact information.

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I hope your advocacy of HCQ goes better than the narrative that you were pushing regarding the investigation of certain orange president.  I mean, gosh, you had me practically convinced that he was going to rot in prison.

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On 8/29/2020 at 9:35 AM, triplehorn said:

 the CDC and FDA have been co-opted and are not functioning the way we have come to know and trust.

 

LO motherfucking L. You think this is some deep state controversy? They have been horrible to deal with FOREVER. They haven't been co-opted, they are just a bureaucracy in this country that has been tasked with small job of protecting public health by ensuring the safety, efficacy, and security of drugs and medical devices. They are, with good reason, the most risk averse organization in the country because you know... if they fuck up, people die.

I want to neg myself for even engaging in this conversation and I'm sure as shit not going into all your retarded HCQ stuff, but you are operating under the misguided assumption that the FDA approval process is something applicable across the board, regardless of what you are testing. It just doesn't work like that. That's not how the Agency does things and that's why they issue guidance documents that are as general as can be and include every possible caveat under the sun to give them as much leeway to cover their ass as possible

And honestly, there is a reason for that because you can't make comparisons in the approval process from drug to drug because each one is different and each one is subject to different criteria based on an almost innumerable amount of variables (chemical composition, mechanism of action, risk, disease state, etc.). What I'm trying to say is that there are no apples to apples comparisons in the eyes of the FDA, even when you are arguing a granny smith vs. a fuji. To them, a granny smith might as well be a banana. 

Also, please stop making the comparison to devices. The overwhelming majority of devices don't require any pre-market approval and most of the ones that do are 510(k) applications that only require substantial equivalence to a currently marketed device. Those trials are completely different than what you would find in a new drug trial. Not to mention that devices range from things like band aids to software to pace makers to diagnostics. The device trials that are most comparable to new drug applications are PMAs, and the Agency issues very few new PMAs in a year -- something like fewer than 20 annually IIRC (although it's been a long time since I've looked at that stuff).

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Mitch - Just pointing out what everybody already knows - the CDC's pandemic messaging and established policy implementation has been politically subverted since the beginning of this ordeal.  It sounds like you have a more familiarity with the longer arc.  No bones there.  The FDA is a different animal because of the influence of big pharma.  Harvey Risch at Yale school of Pub Health commented recently that FDA receives a third of its funding from big pharma.  I can't verify that.  Even if the FDA is walled off from the influence of big pharma, if you have a cheap generic that looks to be a slam dunk for a new indication going up against a patented product that is x200 more expensive per pt. and is less effective than the generic, pharma's less effective expensive drug wins out.  I expect this happens mainly because there is NO ONE who is going to spend the time and effort to promote the generic option.  Trump is inept at it.  And if you heard his convention acceptance speech, he made a comment about being worked over by big pharma and gave a facial expression suggestive of someone being rectally probed by an unapproved medical device.

The relevant HCQ data is in:

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That is a massive treatment effect for low dose with early administration before pneumonia sets in.  6 independent studies from 5 western nations, meaning different potential biases and covariates between studies, yet highly consistent results in direction and magnitude among all 6 studies.  Over 35,000 subjects combined.  No new safety issues observed with HCQ in Covid using low doses of a med that has had FDA approval for 65 years and is used off label for tens of thousands of patients daily in the US. 

Given the US covid caseload since March, best case is that those study results would translate into tens of thousands of Americans being alive today had this been utilized from the beginning.  

 

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On 8/31/2020 at 4:03 PM, triplehorn said:

The FDA is a different animal because of the influence of big pharma.  Harvey Risch at Yale school of Pub Health commented recently that FDA receives a third of its funding from big pharma.  I can't verify that.  Even if the FDA is walled off from the influence of big pharma, if you have a cheap generic that looks to be a slam dunk for a new indication going up against a patented product that is x200 more expensive per pt. and is less effective than the generic, pharma's less effective expensive drug wins out.  I expect this happens mainly because there is NO ONE who is going to spend the time and effort to promote the generic option.  Trump is inept at it.  And if you heard his convention acceptance speech, he made a comment about being worked over by big pharma and gave a facial expression suggestive of someone being rectally probed by an unapproved medical device.

Again, not going to address your HCQ stuff but FDA funds itself via user fees (~50% of their budget IIRC) when you submit for device or drug approval. It's not like they are taking kickbacks or lobbyist money. You can decide for yourself whether it is a conflict of interest, but PDUFA is no joke -- something like $2.5 million for a new drug. 

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I haven't dug into it.  Perhaps the language is more nuanced in terms of how and where the money flows, but if you search 'big pharma funding FDA', just lifting up a corner of that to see what's underneath is pretty illuminating.

This article jumped out:

Quote

[...]  The FDA approved Oxycontin, the powerful narcotic pill that set off the opioid epidemic, in 1995 without clinical trials. The drug’s maker, Purdue Pharmaceuticals, convinced the FDA–and then doctors–that the drug was safe for widespread use in treating less-than-severe pain. The FDA then approved Fentanyl in 1998.

Dsuvia, which is a more potent version of Fentanyl that comes in pill form, was developed by the California pharmaceutical company AcelRx in cooperation with the U.S. Department of Defense. In 2017, the FDA rejected the drug on the advice of an advisory committee, the Guardian reports, but when the company resubmitted the drug a year later it was approved. And members of the advisory board who had pointed out the drug’s potential for abuse, including Brown, were not invited to the approval proceedings the second time around.

The most alarming part of the Guardian report is the idea that a crucial aspect of the FDA–the part that protects patients from harm from dangerous opioids–has effectively been privatized. A legal change in the 1990s allowed for more industry funding, and now the FDA division that approves new opioid drugs receives 75% of its funding from the industry. This, critics suggest, puts the FDA in the posture of a business partner of Big Pharma rather than a regulator.

The story behind how we arrived at over $1B in US taxpayer dollars being used by Trump Admin to purchase the world's immediate supply of Gilead's remdesivir is another multi-layered story that will take time to unpack.  Gilead's stock value falling back to pre-pandemic levels should tell you how that worked out.  Swift maneuvering for a cool taxpayer Billion in exchange for piss.

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16 minutes ago, triplehorn said:

I haven't dug into it.  Perhaps the language is more nuanced in terms of how and where the money flows, but if you search 'big pharma funding FDA', just lifting up a corner of that to see what's underneath is pretty illuminating.

This article jumped out:

The story behind how we arrived at over $1B in US taxpayer dollars being used by Trump Admin to purchase the world's immediate supply of Gilead's remdesivir is another multi-layered story that will take time to unpack.  Gilead's stock value falling back to pre-pandemic levels should tell you how that worked out.  Swift maneuvering for a cool taxpayer Billion in exchange for piss.

That stat about 75% of budget is misleading to the extent it implies that pharma donates that money.  As indicated by Mitch, it's PDUFA, the user fee act, that raised NDA application fees tenfold over less than 20 years.

The issue with FDA, if anything other than being a bureaucracy, is user capture.

The USPTO is entirely funded by patent application fees.  It is not subject to capture per se (its users are mostly pro-patent, true, but it is not beholden to any one company or industry), to the extent that Google had to insert its chief patent counsel, Michelle Lee, as Director, in order to pursue bigtech's agenda.  

That is one thing that Trump has achieved that is actually better than Obama:  a better PTO director and a better PTO. No real idea how that happened, except that patents aren't really a grifty area. /noCR

Edited by TwiceHorn
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On 8/31/2020 at 10:51 PM, jimmyjazz said:

Pro tip:  the last two pages went quite quickly when I scrolled through without reading anything.

Nice throw, Fauci.

All you missed was triple posting the same misleading graphic 3 or 4 times, ignoring any calls for him to engage in some critical thinking, and throwing up a smoke screen claiming others are dodging. 

In other words...

1l0smh.gif

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3 minutes ago, TwiceHorn said:

That stat about 75% of budget is misleading to the extent it implies that pharma donates that money.  As indicated by Mitch, it's PDUFA, the user fee act, that raised NDA application fees tenfold over less than 20 years.

The issue with FDA, if anything other than being a bureaucracy, is user capture.

The USPTO is entirely funded by patent application fees.  It is not subject to capture per se (its users are mostly pro-patent, true, but it is not beholden to any one company or industry), to the extent that Google had to insert its chief patent counsel, Michelle Lee, as Director, in order to pursue bigtech's agenda.  

Thanks.  It sounds like pay to play.  Generally speaking, when NDA app fees increase tenfold in less than 20 years, it would appear that the result is one of culling the player pool and concentrating the the process to involve those companies that can afford to have a seat at the product approval table.  If I'm one of the big pharma heavies, I'm in favor of jacking up NDA application fees even more if it diminishes competition.  Again, this is not my lane, but that's one interpretation I make.

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3 hours ago, triplehorn said:

Thanks.  It sounds like pay to play.  Generally speaking, when NDA app fees increase tenfold in less than 20 years, it would appear that the result is one of culling the player pool and concentrating the the process to involve those companies that can afford to have a seat at the product approval table.  If I'm one of the big pharma heavies, I'm in favor of jacking up NDA application fees even more if it diminishes competition.  Again, this is not my lane, but that's one interpretation I make.

Yeah, no. If you can afford to get a new chemical entity through preclinical testing and tox, phase 1-3 clinical trials, do all the chemistry manufacturing controls, etc. the pdufa is a drop in the bucket. The player pool is already culled long before the pdufa kicks in. The agency also has reduced fees for small businesses, not that many of them are submitting ndas. 

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Couldn’t read it due to paywall but came across an article summary in google news saying a randomized study found no differences in outcome vs those on ACEI vs ARB.  As someone who takes an ACEI that works well with no discernible side effects, that calms my jimmies.  
 

Waiting how Triple to tell me this is good for HCQ.  

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In non-clown related medical news, PFE saying they will have initial data end of October and will seek immediate approval if the data read out is good.

https://uk.reuters.com/article/us-health-coronavirus-drugs/pfizer-targets-end-of-october-for-covid-19-vaccine-update-idUKKBN25U22M

ZURICH (Reuters) - U.S. drugmaker Pfizer said it should know by the end of October whether a COVID-19 vaccine it is developing is successful, and will submit it for approval immediately if that is the case.

Pfizer has enrolled 23,000 patients in vaccine tests as of Wednesday, its Chief Executive Albert Bourla said in an online briefing sponsored by drug industry group International Federation of Pharmaceuticals Manufacturers & Association.

Pfizer is in the race to come up with a vaccine with its partner, Germany’s BioNTech.

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9 hours ago, Mitch Cumsteen said:

Yeah, no. If you can afford to get a new chemical entity through preclinical testing and tox, phase 1-3 clinical trials, do all the chemistry manufacturing controls, etc. the pdufa is a drop in the bucket. The player pool is already culled long before the pdufa kicks in. The agency also has reduced fees for small businesses, not that many of them are submitting ndas. 

Somewhere credible, I read that the average cost of an approved pharmaceutical from conception to approval was $1.6B.  I forget if that number included the cost of "failed" drugs that didn't receive approval or didn't go far in the process.

"User capture" isn't a wholly "corrupt" phenomenon, but it is inefficient and throws into question whether the agency is really fulfilling its mission and doing so efficiently.  That is, user capture doesn't mean the FDA is doing its "customers'" bidding, but that the "dance" between agency and customer has become so routinized that its functions aren't being properly carried out.

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On 9/3/2020 at 7:48 AM, TwiceHorn said:

Somewhere credible, I read that the average cost of an approved pharmaceutical from conception to approval was $1.6B.  I forget if that number included the cost of "failed" drugs that didn't receive approval or didn't go far in the process.

"User capture" isn't a wholly "corrupt" phenomenon, but it is inefficient and throws into question whether the agency is really fulfilling its mission and doing so efficiently.  That is, user capture doesn't mean the FDA is doing its "customers'" bidding, but that the "dance" between agency and customer has become so routinized that its functions aren't being properly carried out.

Outside of the large built-in costs of developing an all together new drug, what I'd like to understand is how these costs translate to working with the FDA to get use approval for substances that are naturally occurring and can't be patented, or use approval for older generics.  Ordinarily new use for older generics does't require additional FDA approval as off-label use is routine once initial approval occurs for any use, but that approval would ultimately be helpful wrt insurance coverage and patient affordability (with effects on the landscape of drug competition).  But for the former example, it wouldn't take  much of a cost increase working with the FDA to block availability and approval for a medical use when it's not big pharma's project.  This might come up where you have a naturally occurring substance that only has distinct therapeutic effects if given IV.  That can necessitate compounding by a pharmacy.  The FDA regulates what things are approved for compounding, and if the costs of doing that through the FDA are too high for anyone other than the big pharma co's, it likely gets smothered.

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Ivermectin as a prophylactic in a study of healthcare workers in Argentina:  (n=1,195) with zero infection in the treated arm vs 58% in the other.

Interestingly, they also give nasal spray and oral drops to inhibit the virus at point of contact.  They provide the dose ranges used when treating patients with active covid illness - totals about $15/day, cheaper than a partial* hospital bill.

Ivermectin for people is readily available with an Rx from a PCP.  I give my dog ivermectin every month.

My dog after 3 years of continuous Ivermectin:

Spoiler
35F5EB69-3307-4E99-AC73-021A99EF1737

 

 

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On 9/5/2020 at 10:08 AM, triplehorn said:

Ivermectin as a prophylactic in a study of healthcare workers in Argentina:  (n=1,195) with zero infection in the treated arm vs 58% in the other.

Interestingly, they also give nasal spray and oral drops to inhibit the virus at point of contact.  They provide the dose ranges used when treating patients with active covid illness - totals about $15/day, cheaper than a partial* hospital bill.

Ivermectin for people is readily available with an Rx from a PCP.  I give my dog ivermectin every month.

My dog after 3 years of continuous Ivermectin:

  Reveal hidden contents

35F5EB69-3307-4E99-AC73-021A99EF1737

 

 

These results are so good it's hard to believe.  Strange how these things can be ignored.  This study needs to be replicated. It seems absolutely conclusive on it's face.

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On 9/5/2020 at 10:08 AM, triplehorn said:

Ivermectin as a prophylactic in a study of healthcare workers in Argentina:  (n=1,195) with zero infection in the treated arm vs 58% in the other.

Interestingly, they also give nasal spray and oral drops to inhibit the virus at point of contact.  They provide the dose ranges used when treating patients with active covid illness - totals about $15/day, cheaper than a partial* hospital bill.

Ivermectin for people is readily available with an Rx from a PCP.  I give my dog ivermectin every month.

My dog after 3 years of continuous Ivermectin:

  Reveal hidden contents

35F5EB69-3307-4E99-AC73-021A99EF1737

 

 

That white paper sucks.

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May be nothing...may be something,,,

https://www.statnews.com/2020/09/08/astrazeneca-covid-19-vaccine-study-put-on-hold-due-to-suspected-adverse-reaction-in-participant-in-the-u-k/

AstraZeneca Covid-19 vaccine study put on hold due to suspected adverse reaction in participant in the U.K.

Alarge, Phase 3 study testing a Covid-19 vaccine being developed by AstraZeneca and the University of Oxford at dozens of sites across the U.S. has been put on hold due to a suspected serious adverse reaction in a participant in the United Kingdom.

A spokesperson for AstraZeneca, a front-runner in the race for a Covid-19 vaccine, said in a statement that the company’s “standard review process triggered a pause to vaccination to allow review of safety data.” 

It was not immediately clear who placed the hold on the trial, though it is possible it was placed voluntarily by AstraZeneca and not ordered by any regulatory agency. The nature of the adverse reaction and when it happened were also not immediately known, though the participant is expected to recover, according to an individual familiar with the matter. 

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1 minute ago, Anastasis said:

 

May be nothing...may be something,,,

https://www.statnews.com/2020/09/08/astrazeneca-covid-19-vaccine-study-put-on-hold-due-to-suspected-adverse-reaction-in-participant-in-the-u-k/

AstraZeneca Covid-19 vaccine study put on hold due to suspected adverse reaction in participant in the U.K.

Alarge, Phase 3 study testing a Covid-19 vaccine being developed by AstraZeneca and the University of Oxford at dozens of sites across the U.S. has been put on hold due to a suspected serious adverse reaction in a participant in the United Kingdom.

A spokesperson for AstraZeneca, a front-runner in the race for a Covid-19 vaccine, said in a statement that the company’s “standard review process triggered a pause to vaccination to allow review of safety data.” 

It was not immediately clear who placed the hold on the trial, though it is possible it was placed voluntarily by AstraZeneca and not ordered by any regulatory agency. The nature of the adverse reaction and when it happened were also not immediately known, though the participant is expected to recover, according to an individual familiar with the matter. 

Maybe Stevens-Johnson syndrome or anaphylaxis would cause a temporary stoppage. What was the mechanism of this vaccine? Was it adeno?

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Apparently a case of transverse myelitis (I have no idea what that is beyond what I just learned on google.). 

A person familiar with the situation, who spoke on the condition of anonymity, said that the participant who experienced the suspected adverse reaction had been enrolled in a Phase 2/3 trial based in the United Kingdom. The individual also said that a volunteer in the U.K. trial had received a diagnosis of transverse myelitis, an inflammatory syndrome that affects the spinal cord and is often sparked by viral infections. However, the timing of this diagnosis, and whether it was directly linked to AstraZeneca’s vaccine, is still unknown.

Transverse myelitis can result from a number of causes that set off the body’s inflammatory responses, including viral infections, said Dr. Gabriella Garcia, a neurologist at Yale New Haven Hospital. But, she added, the condition is often treatable with steroids.

 

https://www.nytimes.com/2020/09/08/health/coronavirus-astrazeneca-vaccine-safety.html

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I’m not going to be fully dismissive because it’s certainly a (very slim) possibility, but it’s been a recurring conspiracy theory perpetuated by a collective of ‘news outlets’ pushing a narrative...but with the words virologists being 95% against it being synthetic, imma trust those over what ZH or the NY Post have to say.  

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4 minutes ago, Homercles said:

I’m not going to be fully dismissive because it’s certainly a (very slim) possibility, but it’s been a recurring conspiracy theory perpetuated by a collective of ‘news outlets’ pushing a narrative...but with the words virologists being 95% against it being synthetic, imma trust those over what ZH or the NY Post have to say.  

This is the part where I stopped reading..

The natural origin theory, although widely accepted, lacks substantial support. The alternative theory that t he virus may have come from a research laboratory is, however, strictly censored on peer-reviewed scientific journals.

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20 minutes ago, Anastasis said:

This is the part where I stopped reading..

The natural origin theory, although widely accepted, lacks substantial support. The alternative theory that t he virus may have come from a research laboratory is, however, strictly censored on peer-reviewed scientific journals.

"Scientists have discovered limitless renewable energy, but the Globalists don't want you to know about it!  Watch our video to find out more!"

The internet is a chocolate fountain of bullshit.

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Potentially of interest Bevo... a peer-reviewed manuscript that gets into the mechanics of how a natural origin is compatible with some of the observations of the paper being cited by ZH.

https://link.springer.com/article/10.1007/s00705-020-04750-z?

A palindromic RNA sequence as a common breakpoint contributor to copy-choice recombination in SARS-COV-2

 

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1 minute ago, Anastasis said:

The text I quoted is in the abstract of the paper. 

 

2 minutes ago, Anastasis said:

The natural origin theory, although widely accepted, lacks substantial support. The alternative theory that t he virus may have come from a research laboratory is, however, strictly censored on peer-reviewed scientific journals.

It may be true but it is a dumb thing to say if you are trying to get published. Technically, the data looks pretty sound although, I would have to give it a lot of thought to determine if her conclusions are correct.

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