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triplehorn

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Posts posted by triplehorn

  1. 6 minutes ago, ChiTownDoc said:

    Overall I don’t have an issue with this article but this type of shit drives me insane:  

    ‘Experts have warned, however, the coronavirus is novel. It is therefore unclear how long immunity lasts or even if it exists at all.’

    Just STFU, to act like NO immunity might exist is dumber than buttchugging bleach to cure the virus.  At least that will potentially kill you AND the virus.  

    It's more relatable when read with a Geordie Brit accent.

  2. 11 minutes ago, jimmyjazz said:

    One of the great ironies about this whole mess is that, had Trump just listened to the experts and tackled this problem with authority, he would have gone a long way towards offsetting 3 years of abject malfeasance in office.  He's not wired that way, though.

    seen on his golf cart bumper

    st,small,215x235-pad,210x230,f8f8f8.lite

  3. 44 minutes ago, washparkhorn said:

    . Sourced Twitter is awesome, by the way.

    If I read you right, yes it’s great for that.  But when someone chooses to ignore the source by attacking the twitterer, it’s a different kind of red herring all together. lol

    • Like 1
  4. Gilead to start testing inhaled remdesivir, eyeing earlier COVID-19 use

     

    Quote

    The company’s intention is very clear: reaching patients earlier, before their disease worsens and becomes harder to treat. “An inhaled formulation would be given through a nebulizer, which could potentially allow for easier administration outside the hospital, at earlier stages of disease,” O’Day said.

    [...]

    What he didn’t mention was that the drug’s benefits actually decreased in mild or moderate patients—though that patient population was too small to be conclusive—just as it didn’t much help those critically ill patients on invasive ventilation. The company recently said in its own phase 3 Simple trial, moderate patients on remdesivir were 65% more likely to see their clinical symptoms improve than those on standard treatment alone.

    But as Evercore ISI analyst Umer Raffat noted at the time, the ACTT-1 readout is still missing data on whether patients who take remdesivir soon after symptom onset fare better.

    Getting an antiviral early to potentially stop disease progression is an appealing idea, and it will be the focus of Gilead’s next wave of clinical development. New studies will also test the IV formulation in the outpatient setting at places such as infusion centers and nursing homes.

    “For patients who are at high risk of disease progression, it could be particularly beneficial to start treatment outside the hospital,” O’Day argued. “Our hope is that earlier intervention could help patients avoid hospitalization altogether.”

    yep. This is a direct attempt to work around that Achilles heel I mentioned just above. 

  5. 18 hours ago, triplehorn said:

    It's the latest information on very relevant NIH research. It's a medical discussion thread.  I've been posting on this thread from the beginning.   Try the ignore function instead of thread shitting.

    I'm not going to be initiating any more HCQ research, news, or opinion after this post on this or any thread.  I'm open to dispassionate discussion about it in the future, but that won't be until others are on board, which isn't now. 

    Why it matters?   Understanding HCQ applies beyond this pandemic.  That is because of its potential importance fighting RNA viruses as a class.  One common shared trait of RNA viruses essential for viral replication is the use of RNA-dependent RNA polymerase (RdRp).  If you find agents that inhibit the function of this enzyme, you potentially have a tool with a broader spectrum to fight a variety of pathogenic RNA viruses.   Remdesivir inhibits this enzyme, and this is also a mechanism of action enhanced by and demonstrated for HCQ in vitro. 

    The Achilles heel of Remdesivir, for one, is that it has to be administered IV and is very expensive.  The major limitations of technical IV use and high cost make it unsuitable for broad application to mild/mod severity, non-critical cases - a large percentage of whom would develop no complications without any intervention.  But what if attacking RdRp for meaningful life saving and organ protecting is dependent on hitting the infection early and hard, where doing so means you have to expose a lot of people early to a treatment who would otherwise not develop complicated illness and hospitalization?  In that case you need something that is safe, easy to administer, and inexpensive (cheaper per day than OTC TheraFlu)   HCQ checks those 3 boxes.  The most important question to be answered is if early application is a key clinical outcome differentiator for RdRp inhibiting meds. This key question relates to all the 'vir meds in the current mix and HCQ.  How many other meds in the mix check those boxes, or even two of them?  

    Because of the active threat of recurrent deadly pandemics for years to come from various RNA viruses beyond this novel coronavirus, there is a huge amount of medical money in the balance globally.  Some are primarily motivated by profit. We rely on publicly funded research to answer these questions about checking those 3 boxes, because Big Pharma has no interest in offering a helping hand or paying for studies that could tip the scale towards a safe, cheap, easy to take generic like HCQ.  It's why the NIH early intervention study getting shut down is such a setback.  It's not stopping other studies being done here and internationally though.

    Stalled and late-start domestic studies notwithstanding, today the results of a randomized controlled trial (the elusive RCT) became public from a Chinese study which demonstrate superiority of both Chloroquine and Hydroxychloroquine over control when used for early intervention in Covid-19:

    Efficacy and safety of chloroquine or hydroxychloroquine in moderate type of COVID-19: a prospective open-label randomized controlled study

     

    Quote

    EbJHlZ9WoAABR_F?format=png&name=900x900

     

    When you get this degree of decreased recovery time, it follows that peak severity of illness should also be less.  Less of everything bad.

     

  6. After expecting to rapidly enroll 2000 subjects, NIH early intervention study gets shuttered due to only enrolling 20 patients since the start of May.  

    BULLETIN—NIH Clinical Trial Evaluating Hydroxychloroquine and Azithromycin for COVID-19 Closes Early

    Quote

    June 20, 2020

    The National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health, has stopped enrollment in its clinical trial evaluating whether hydroxychloroquine and azithromycin can prevent hospitalization and death from coronavirus disease 2019 (COVID-19). This action was taken because NIAID, the study leadership and the independent data and safety monitoring board (DSMB) overseeing the trial determined that the rate of participant enrollment has been inadequate for the trial to meet its objectives in a timely manner. No safety concerns were associated with the trial.

    Launched in May 2020, the NIAID-sponsored Phase 2b trial aimed to determine whether a short course of hydroxychloroquine and azithromycin could safely and effectively prevent disease progression among adults with mild-to-moderate COVID-19. Hydroxychloroquine is approved by the Food and Drug Administration to treat autoimmune diseases and to prevent and treat malaria. Preliminary evidence had suggested that the drug, alone or in combination with the FDA-approved antibiotic azithromycin, might benefit people with COVID-19. 

    Although recent research suggests that hydroxychloroquine may not be an effective treatment for patients hospitalized with COVID-19, the question of whether it offers benefit when given early in the course of the disease remains unanswered. The NIAID study, conducted by the AIDS Clinical Trials Group (ACTG), sought to fill this knowledge gap by testing it in a randomized, placebo-controlled trial—considered the gold standard for determining whether an intervention can benefit patients.

    The study, conducted at ACTG sites across the United States, planned to rapidly enroll approximately 2,000 adults who had laboratory-confirmed infection with SARS-CoV-2, the virus that causes COVID-19, and were experiencing symptoms consistent with COVID-19. Participants were randomly assigned to receive either hydroxychloroquine and azithromycin or matching placebo pills to take at home for seven days.  

    Since its launch in May, however, the study had enrolled only 20 participants, despite efforts by the study sites to enhance recruitment, raising concerns that it would not be feasible to continue the trial to full enrollment. On June 15, FDA revoked an Emergency Use Authorization(link is external) that had allowed hydroxychloroquine and the related drug chloroquine to be prescribed to hospitalized adolescents and adults with COVID-19. This revocation does not apply to clinical trials and is specific to hospitalized individuals rather than outpatients. However, the decision could further dampen enthusiasm for enrollment in studies evaluating these drugs.

    Based on these considerations and in close consultation with the study team, NIAID determined that it is highly unlikely that the ACTG trial, known as A5395, would be able to enroll to completion and meet its intended objectives. The DSMB concurred with this assessment and agreed it would be best to close the trial. Participants, site investigators, institutional review boards and regulators are being notified of this decision. The study team is working with the clinical trial sites to ensure that participants in the trial receive appropriate care.

    NIAID remains committed to identifying safe and highly effective treatments for COVID-19. The Institute recently launched a trial evaluating remdesivir plus the anti-inflammatory drug baricitinib for treatment of hospitalized adults with COVID-19. Additional studies, including outpatient studies, are in the planning stages.

     

     - "No safety concerns were associated with the trial."

    - "Preliminary evidence had suggested that the drug, alone or in combination with the FDA-approved antibiotic azithromycin, might benefit people with COVID-19." 

    - "Although recent research suggests that hydroxychloroquine may not be an effective treatment for patients hospitalized with COVID-19, the question of whether it offers benefit when given early in the course of the disease remains unanswered."

     

    what in the hell. unfortunate doesn't begin to describe it.

    • Fuck You 3
  7. 29 minutes ago, gmr548 said:

    Yeah, there's been a lot of reporting on this study recently. My understanding is that humans are typically only immune to other coronaviruses for a short period too, so this has always been a concern.

    We don't know if B cells are able to create new antibodies upon a subsequent exposure. It was also reported that antibodies targeting the spike protein of the virus held up pretty well. So it's certainly not conclusive, but I continue to think that it's premature to think that you get it once and are done forever.

    The more that comes out I honestly think this might end up endemic like the flu. Especially with out shoddy containment measures. Eventually the severity may lessen with a vaccine (more along the lines of a flu vaccine) and some level of population exposure/immunity, but I am not convinced this is ever going away. It may just be flu and COVID season from now on.


    Beyond this novel coronavirus, maybe we should be looking at common ways to attack all RNA viruses.  This article puts it into some perspective.  About 2-3 novel zoonotic RNA viruses per year are identified, each possibly poised to go pandemic.  From 2017:

    Are RNA Viruses Candidate Agents for the Next Global Pandemic? A Review

    So more than a vaccine, targeting ways to disrupt replication of RNA viruses as a class may pay big public health dividends.

     

     

    • Like 1
  8. Turns all year Part 2 🤘

    I summited Mt. Adams (elev 12,281) yesterday for the first time and did a ski descent with two buddies.  Almost a 7000 ft vertical climb up, and an uninterrupted 4000 ft ski down via the SW chutes.  Our route took us about 11 hrs and 14 mi round trip.  At the summit, the visibility allowed seeing Mt. Baker 178mi to the north, just south of the Canadian border, and Sisters mountains 150 mi to the south in central Oregon.  I am completely wrecked today, but the ski descent is an epic 10/10.

    VVV heading up to Piker's peak (aka the false summit)

    CECD271A-9031-4078-AC3F-10BC10AD1EA1

     

    024807F1-1846-4AA0-A7A7-9D434FBCF678

    VVV top of Piker's (still over 700 ft. elev. to gain to reach summit) 

    B773427D-42C0-4D1F-B803-3C9F0936C7AB

     

    VVV SW chutes descent 

    CBB3A561-9E2F-400E-BC2C-1E08D9948CEC

     

    1076C0A2-5A42-4D6D-8DE7-CF1F5D9CAD87

     

    2F376991-D6AC-4D97-8560-4E8A697AB03B

     

    VVV Looking back up from about 5000ft below summit and start of SW chutes between/below the two snowy peak bumps at top.

    641575BF-3424-4F86-816F-C8A080288CEC

     

    VVV The brutal part was not picking a higher elevation to traverse back over to the South Climb route we ascended .  When the snow ended, we bushwhacked down another 500ft with boots and skis on our backs to find the round-the-mountain trail and hiked 2 more mi on that (more like a steeplechase this time of year) before finding the path to base.  Start of bushwhack with Mt. Hood on the horizon VV

    A9A489BB-CE47-4789-9C62-917CD50B912F

    Probably the biggest plus about this climb and descent is that it's generally not technical, with minimal fatal fall risk.  And I can't think of another peak in the PNW that lets you view so many other major peaks spanning hundreds of miles.

    I highly recommend this mountain 🤘

     

    • Like 2
  9. 1 hour ago, 4th&Five said:

    You had to post that didn’t you? Might as well be a bat signal. 

    🎯   lol.

    Spoiler

    "A data and safety monitoring board (DSMB) met late Friday and determined that while there was no harm, the study drug was very unlikely to be beneficial to hospitalized patients with COVID-19."   [for the 60th time, late stage initiation = no benefit]

     

     

     

  10. This question has come up here previously - is there a difference in incidence and/or clinical course of Covid in patients with Rheumatic Diseases who are on disease-modifying antirheumatic drugs (DMARDs)?  Based on this report, there appears to be a pre-exposure preventative effect as well as illness severity mitigating effect for Covid:

    Clinical Rheumatology:  Impact of anti-rheumatic drugs and steroids on clinical course and prognosis of COVID-19

     

    Quote

    "Our data show a small incidence of COVID-19 among RD outpatients and a small presence of RD patients among subjects hospitalized for COVID-19. When COVID-19 occurred in RD patients, it had a better course and a good prognosis. DMARDs seem to protect against a worse prognosis, as no hospitalized patient was taking DMARDs and the percentage of RD outpatients treated with DMARDs was significantly lower among subjects with COVID-19. Interestingly, our study first shows that hospitalized patients taking steroids for RDs or other diseases may have clinical parameters and a prognosis better than other hospitalized patients."

     

  11. Sensible give and take:  Tomorrow, the heavily populated tri-county area surrounding PDX begins Phase I re-opening, but starting next Wednesday, a mask wearing mandate begins for all people entering public indoor places involving any and all types of business - a requirement only in a limited number of qualifying counties across the state.  

    Quote

     

     

  12. 1 hour ago, Dahobbs said:

    Your post reveals a significant misunderstanding of how the practice of medicine is regulated.

    The federal government does not directly regulate the practice of medicine. That job is left to the states and to the medical profession itself. Accordingly, no federal entity is ever going to directly "block" a physician's choice of treatment. Rather, the federal government, through the FDA, regulates the entities that manufacture, label, and distribute medical devices and pharmaceuticals. The FDA tells them what products they can sell, how they can manufacture them, what uses they can advertise for their products, and what they can and must tell the public about the products.

    Sometimes the FDA prevents a device or pharmaceutical from being sold at all. Other times the FDA allows the product to be sold, but only for specifically approved purposes. In that latter scenario, since the FDA doesn't regulate the practice of medicine, physicians are not restricted by the federal government from using a product "off-label," that is for purposes other than specifically approved by the FDA. The entity selling the device can't advertise the product for that use, but a physician may still use it. 

    Further, while the federal government does not regulate the practice of medicine, entities within the federal government do often provide non-binding guidance for physicians on how to practice medicine. There is no legal penalty for not following this guidance, except for the fact that guidance from the federal government gets incorporated with guidance from within the medical profession (e.g., professional associations like the American Heart Association) into the professional standards expected of healthcare providers. 

    Those standards are then enforced by the states, directly through licensing boards, and indirectly through medical malpractice litigation.

    Given that context, here is what HCQ stands: (1) it is not approved by the FDA for treating Covid-19, (2) the FDA has concluded that "it is no longer reasonable to believe that oral formulations of HCQ and CQ may be effective in treating COVID-19, nor is it reasonable to believe that the known and potential benefits of these products outweigh their known and potential risks", (3) the NIH has said HCQ should be used only in the setting of a clinical trial; (4) the WHO and other organizations have halted study of HCQ in hospitalized patients; (4) the only studies currently indicating any potential benefit of HCQ generally show a weak benefit and are largely small observational studies and not reliable indicators; (5) a recently published trial on post-exposure prophylaxis shows no benefit.

    While continued investigation of HCQ as a prophylaxis should continue for now (and is continuing), the currently available data would not support a physician's decision to prescribe HCQ for Covid-19 (treatment or prophylaxis). Prescribing it now with no demonstrated benefit and given known risks is outside the bounds of the standard of care in the medical community. Accordingly, HCQ use for Covid-19 should be limited to investigation in clinical trials. 

    https://www.fda.gov/media/138945/download

    https://arstechnica.com/science/2020/06/who-gives-up-on-hydroxychloroquine-for-covid-19-stops-trials/

    https://www.nejm.org/doi/full/10.1056/NEJMoa2016638

     

    Thanks for taking the time.  Regarding questions around how the practice of medicine is regulated, I'm not aware of anything I've previously said that contradicts what you posted or that reveals a misunderstanding on my part.  A few posts above I specifically drew attention to States playing a primary role in regulating medical practice which naturally creates differences between States in what is available.  Obviously this spans a number of different medical procedures and for what purposes various treatments can be prescribed.  I pay attention to what my State authorizes and have always observed that.  Off label-use of the med under scrutiny is permitted in some States at this time.   

    Regarding the links you posted, there's nothing new in there.  The WHO and NEJM articles relate only to studies done in hospitalized patients and post-exposure prophylaxis.   The fda.gov letter is interesting in that the general language around the FDA/EUA for use in "hospitalized" patients is dropped.  Not sure if that is a result of the letter-writer being casual or not.   

    Of note from your second link:

    "The WHO noted in its announcement today’s decision to end hydroxycloroquine’s use in the Solidarity trial, which looks at stopping COVID-19, “does not apply to the use or evaluation of hydroxychloroquine in pre- or post-exposure prophylaxis in patients exposed to COVID-19.”

    First, what your link coveys is that this medication still remains under active investigation as a viable intervention albeit with a more narrowed focus.  So yes, it's relevant for consideration and discussion.  It leaves pre-exposure prophylaxis and early post-exposure mitigation of illness severity to be elaborated.  Internationally, there are positive signs in both contexts, but nothing definitive at this time.  Until results of additional ongoing studies are produced, positive or negative, I'll leave it that.  

     

     

  13. 1 hour ago, Dahobbs said:

     There is no reliable evidence that HCQ provides any benefit in relation to Covid-19. Accordingly, it fails that criteria. As stated by the NIH, HCQ should be given for Covid-19 only in the setting of a clinical trial.

    I disagree with your first sentence but don’t know how you’re slicing it.  Even so, it’s obviously changing by the day in the US as more trial results come out, including with notable leaking of positive news in this Michigan based early use study.  
     

    Regarding your last sentence, do you have an updated link ?  There’s a lot of mixed messaging.  NIH serves a big research function, not so much a regulatory function.  The feds are not blocking it.  However the governing bodies of individual States have a heavy say in what is available for use locally.

    My Oregon Governor put a hold on community off-label use of (H)CQ for Covid in late March, which was after off-label use was recognized within the State.  At the time, it was understandable and I have observed it.  I haven’t revisited it lately but do know a person who is hands on with State level public health research and policy.  That person indicated that they are well aware of positive international studies generally and the 2 pre-exposure prophylaxis studies out of India in particular as they seek ways to best protect the front line Oregonians and other high risk groups.  If this Michigan study, or others, support pre-exposure prophylaxis or early application for mitigation, I’d expect there to be some state level shifting here.  There’s very real reason to be hopeful about this pre/early phase use.

  14. Following up on the above, this is the Detroit Metro Times reporting on a local ongoing FDA-approved study being conducted by Henry Ford Health System.  They are looking at the effects of early application or a prophylactic effect of HCQ on Covid infection in medically stable people.  The CEO of HFHS, Dr. Steven Kalkanis, says "We have analyzed our data and have seen a significantly improved outcome in a group of COVID-19 patients who received hydroxychloroquine." 

    That's a heads up.

    Re this statement in the reporting: 

    Quote

    "The FDA's decision bars the use of hydroxychloroquine sulfate and a similar drug called chloroquine phosphate from the Strategic National Stockpile for hospitalized COVID-19 patients. But the use of the drug as a prophylaxis, or preventive measure, is not impacted by the FDA decision.

    I take that to mean the feds are sitting on a stockpile of (H)CQ at the SNS that will no longer be available to supply hospitals for hospitalized patients w Covid.  However, the federal SNS stockpile of (H)CQ will be available to distribute to States should they request it for use in some outpatient form of early prevention/intervention.  If we're finally headed there, and this reporting is a real sign, it has the potential to be a morbid exercise to see if there's enough and, if not, where it gets funneled.  Today, some States are more pre-disposed and have been more prepared to adopt this than others.

     

    * just a note on prescribing for off-label uses of medication: it is common and it is legal.  the google tells me 1 in 5 prescriptions written in the US is for an off-label use.  20% of scripts written every day in the US are for off-label purposes.  As a separate matter, it doesn't excuse gross incompetence, but nothing should.

     

     

  15. 17 minutes ago, Horn Under a Bad Sign said:

    16 friends go to a bar in Florida and come down with the 'Rona.

    https://www.msn.com/en-us/health/health-news/16-friends-test-positive-for-coronavirus-after-an-outing-at-a-florida-bar/ar-BB15BpD1?ocid=spartandhp

    Because of course they did. And because Florida.

     

    It's like seeing some ants running around in the yard, then you decide to lift up a flagstone

    Quote

    TALLAHASSEE, Fla. – Gov. Ron DeSantis said 260 workers at the Orlando International Airport have tested positive for the coronavirus after nearly 500 employees were tested.

    “[An]Airport in Central Florida had a couple of cases, they did the contract tracing. They looked [at] almost 500 workers [and] 260 people working close together were positive, 52 percent positivity rate on that one,” DeSantis said.

    More than 2,780 new cases of coronavirus were reported in Florida on Tuesday.

     

  16. Midstream sneak peek:

    WHIP COVID-19 study is an FDA-approved study looking at hydroxychloroquine as a potential preventative medication for healthy, pre-screened individuals

     

    "The FDA's decision bars the use of hydroxychloroquine sulfate and a similar drug called chloroquine phosphate from the Strategic National Stockpile for hospitalized COVID-19 patients. But the use of the drug as a prophylaxis, or preventive measure, is not impacted by the FDA decision."

    ^^^ Folks can wait for the peer reviewed publication to come out to get the complete presentation, but this intervention is available today for anyone interested.  

  17.  

    12 hours ago, Mitch Cumsteen said:

    It doesn't look like the study has been published yet,  but there is a lot of buzz on dexamethasone reducing mortality in patients on ventilators and oxygen. 

    https://www.bbc.com/news/health-53061281

    https://nypost.com/2020/06/16/life-saving-coronavirus-drug-dexamethasone-discovered-through-trial/

     

    This French flowchart (Dr Raoult) is pre-dexamethasone findings, but observable benefits of dexamethasone probably would start somewhere between late Phase II and Phase III.  The chart shows that Phase II is associated with some lab markers that could help narrow who to give it to and how to time it if there's benefit in detecting the leading edge of the crash. 

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    On 6/8/2020 at 7:55 AM, bullzak said:

    Same here. Thought that was always the deal but dont see reference to it in testing. 

    Know zinc has been hard to find. 

    There's quite a bit of international evidence to support application of zn/hcq/az as early as possible to reduce illness severity and need for hospitalization, but in the US today, most of the data that would speak to that is sequestered away in private practices.  Even in countries where early application is the current national standard of care, late application has been formally abandoned due to lack of benefit and potentially greater metabolic risk for an adverse event.

     

     

    • Like 1
  18. 26 minutes ago, Biff Tannen said:

    I mean, they have to realize having him ramble like a mental patient on national tv only pushes people further away, other than the 40% right?  

     "They" are acting out of self preservation, not re-election.  Who wouldn't leap at anything that would make a single day of handling him more bearable.  Rallies are his milk and cookies.

     

  19. 2 hours ago, MC Fresh Breath said:

    Welp, so far Central Oregon has managed to get by unscathed.  However, there are certainly some issues in the rest of the State:

    https://apnews.com/2306ec25bf15f2529cf44471d5131556

    I think Oregon has a pretty intact contact tracing effort underway.  I know the state put out a notice of recruitment to fill 600 newly created positions for statewide tracing the other month.  The days in the last week that have spiked are associated with discovering clusters at food processing plants (Bob's Red Mill near PDX and one or two fish canneries near Newport and Lincoln City on the coast.  Now there's the bunch of singing Pentecostals at the church way out in La Grande.  Multnomah County (Portland) has been steadily in the 20-40 new cases per day for a couple months.  So it's in the community, just not blowing up (yet).  Widespread mask wearing around here has to be helping.  Also, Gov. Kate Brown postponed shut down restrictions for PDX to enter Phase 1 re-opening.  Not much protest over that that I can see.

  20. 4 minutes ago, Bama Chick said:

    Dude, read the room.

    Make a HCQ thread. You’ve been slapped down repeatedly by smart people who are correcting your fantasies and your attempts to twist the data.

    Or take it to the DT COVID thread - you’ll fit in just fine.

    It's not fantasy and it's not twisting data.  See my post above yours.  My condolences on the tragic loss of your close friend to this plague.  

    To your other point, direct some of your attention to those on this thread who continue to talk about it while sending me notifications indicating they're drawing a disagreement.  I'm responding, not randomly showing up to lob shit.

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