SARS-CoV-2 is having a mixed impact across the globe. The WHO is tracking more than 100 subvariants of Omicron, and each country has a different makeup of “subvariant soup,” but two are winning the race: XBB and BQ.1.1. Couple this with changing behaviors and different immune histories (which wave hit and when; booster uptake), and country-to-country comparisons are getting harder than ever.
"(Keep in mind that reported cases remain flat; these no longer accurately reflect transmission due to at home antigen testing.) The City University of New York system is 24 colleges. across the 5 boroughs and the students and employees live not only in NYC but also outside of it in NJ, Long Island etc. They do randomized testing of faculty, staff and students (all who have at least had the initial vaccine) weekly.
It's a good way to track infection rates. During Omicron, the positivity rate was over 20%. It has stayed at 1.5% for the past two weeks. It is probably one of the best ways to consistently track transmission since people are picked at random.
We must congratulate the City University of NY system. It is not a minor feat to maintain a randomized sampling-based and tightly structured diagnostic testing rigmarole in some defined population, accumulate data accurately over and over, and report those data lucidly in carefully crafted language free of buzzwords, blarney, and BS. Unfortunately, most states during the pandemic (as far as I can determine) resorted to various home-brewed *shortcuts* in their flawed attempts to calculate FNCIR (Faux New Case Incidence Rates) for "following the pandemic" and for "setting policies" et cetera. As an unintended consequence in my state (MN), there has been weird confusion amongst both our doctors and lay folks since the earliest days of the pandemic, all because of this one public health publicity gaffe. Frequent citation of the latest "Computed Test Positivity Rate" in newspapers and during frequent TV press conferences (featuring cameo shots of both our nervous Governor and the concerned Commissioner of Health), became laughably (and literally) so misleading, so cryptic, and so gummed-up that even old soybean farmers out in the remotest parts of our state would joke about FNCIR while sitting around in their barns with neighbors on rainy days.
I presume that "jury summoning" involves a random sampling process already on standby per some in-force legislation, and thus is well-oiled and ready to rumble in most every county in the country. Good suggestion, which would garner adults only of course! When I first read your idea here I thought about folks I have known who avoided jury duty like the plague so I guess some epidemiologist might need to think about potential biasing effect(s) of drawing Mrs. Jones' name, but having her dodge duty with some excuse like, "I cannot leave my elderly parent alone at home" or "I have severe allergies to dust", etc. and then Mr. Smith gets plugged into what was ostensibly Jones' place for both jury work and a PCR test, etc. Just doing even a few basic thought experiments about this whole process should be good for stirring enough grist into the mill to cook up several journal articles or meeting abstracts that could help pump up the C.V. of an eager beaver instructor seeking to become an assistant professor. I never detected serious discussions in MN about how we might design fair random sampling of our 5.6 million souls at regular intervals -- about half of our folks do not live in the four largest cities here, but are spread all over "greater Minnesota". I do recall reading or hearing the boilerplate issued frequently by Our Authorities who said things like, "Getting representative samples of our citizens would be operationally expensive and oh my goodness, just logistically a nightmare". I nearly vomited my traditional Minnesota Lutheran green bean/mushroom soup/fried onion hot dish every time the two top worthies from our Dept. of Health would make their joint statements on TV because for some odd reason those Health Bureaucrats simply could not resist uttering -- just as often as humanly possible -- two of the leading au courant healthcare managerial buzzwords ("nimble" and "robust") in their public statements. You cannot make this stuff up. I feel deep in my heart that all of our corn and soybean farmers listening on the radio or watching the evening news on Channel 4 since December 2019 must have guffawed mightily, wheezing and slapping their knees every single damned time "robust" or "nimble" came over the airwaves.
I asked my GP here in Germany about getting a booster in December since my fiancé and I both had Covid in June. He is strictly following guidance of the Standing Commission for Immunization, which currently only recommends boosters for people over the age of sixty with at least 6 months since an infection or last immunization. Same applies to at risk persons with certain chronic diseases (which my coronary artery disease apparently is not). You’d think with the information in this report they would be thankful for every person looking to get boostered.
What is the current state of affairs on the All Variant vaccine that the Army and others were working on? I read that we won't be out of the playing catch-up mode until we develop a pan-sarbecovirus immunization.
Thank you! I felt like we should have an update nowish and I think I was just recalling that the trial ends in Oct, forgetting the finer detail of it being Oct 30th (then of course, analysis to follow and that's *if* they even release any findings ahead of the actual projected completion date, listed presently as Oct. 30, 2023. Siiiiiiiigh).
How long after having been infected with COVID would you recommend waiting to get your fall booster? I suspect a lot of people haven't gotten the fall booster because they were infected during this summer's wave and the CDC is recommending waiting 90 days after infection to get boosted.
First of all, I enjoyed listening to your podcast with Andy Slavitt!
I understand social networks as a concept with monkeypox, but these new variants (which sound like Star Wars droid names) seem to spread quite easily beyond networks.
The possible correlation between low booster rates, Oktoberfest, and German health system collapsing does not bode very well for us here in the US. (Low boosters, holidays, health care workers down 20%). I continue to think that experts like Paul Offit here in Philly need to up their game.
The “our world in data” graph showing “number of COVID-19 patients in ICU per million people” is a total nightmare for people like me with color blindness. I can’t even try to comprehend that! Not your fault but we 8% of males get no ADA love.
Riding the wave. Working overtime to persuade patients. Ever masking in office, stores. Thanks again for the great update 👌
Oh how I hate to hear this and thank you for making sense of all the various variants! When will we know if we are getting more severe symptoms again? It scares me to think of variant like Delta with zero masks being worn!
Thanks for this update! I've heard the term "variant swarm" to describe the plethora of Omicron variants now out in the world, but "subvariant soup" seems more apt to me, especially since not all subvariants will proliferate in any given country or region. I'm doubly glad I received my fall bivalent booster last month. I'm continuing to mask up in public indoor spaces with a high quality N95 or KN95 mask. To echo Dr. Jetelina, definitely get the fall booster if you haven't already.
Agreed - it seems it's vaccines to reduce the probability of severe disease if infected and masks (etc) to reduce the probability of getting infected or transmitting. Assuming masks are at least KN95 and worn correctly. Maybe it's just my (seemingly-normal) anatomy but I can't get a good fit from KN95s with ear loops - so I feel like N95s (with the 2 loops) are giving me better protection. We probably need some simple evidence-based advice on mask care since the $ says they are going to be reused.
Thanks ! Timely update of crucial stuff, an example of an excellent epidemiological post that features accuracy plus concision. Sinclair Lewis' mythical George Babbitt would have been tickled greatly and probably would have boomed, "This update has punch, pow, and zip".
It's everywhere - the pandemic fatigue that is. So many of my neighbors are tired of sitting at home, wearing masks and going for that nth booster. I suspect that many have the mindset that natural immunity is the way to go because none of their immediate friends, family or relatives died - the Barrington Declaration mindset. Well, I don't accept that. I've read the science. My wife and I are vulnerable and we have had our 5th shots without significant incidents. But, then again we are not that significant cohort that gave up being cautious after the 1st shot and decided to play roulette. There are lots of folks at risk and will need treatment. Believe it or not not everyone has access to that EUA product Paxlovid. Germany may be the next big reservoir to spur the latest variant across the Pond. Let's hope not. After the debacles with the HCQ and Ivermectin there hasn't been a whole lot about repurposed drugs. I/we believe others are untapped nuggets that hasn't had a fair shake. Only those 2 highly politicized candidates made the ClinicalTrials. Both found to be inefficacious. On the CURE ID website one can review the efforts of the NIH, FDA, CDC, NCATS, and C-path to promote other repurposed drugs for treating COVID19. Many on the list are familiar but a number are not. Some are even more difficult to obtain than the Paxlovid and they surely are not EUA (= subsidized/free). On the CURE ID COVID-19 list of drugs being actively promoted the top drug - HCQ is a no-show. Trials showed no benefit. The 2nd drug on the list is a newcomer, but not new to our total pharmacopoeia. Our local experience with hydroxyurea (HU) spans over 2 years and counting. It's has a tried and true safety profile and multi-thousands of Sicklers benefit from using it DAILY over a period of years, yet it's under-utilized for this genetic disorders according to many Hematologists. The drug also carries a LOT of baggage as an antimetabolite. But it also has anti-viral activities and was well studied during the heyday of the HIV research. It's not new at all. HU has been shown to be safe and beneficial for more than one disease. HU enhances tissue oxygenation, reduces thromboembolisms, it increases HgbF. Lots of these pharmacodynamics beneficial in early and advanced COVID19. It's really unreasonable that this drug is labeled as a one drug one disease product, more so in the oncology and hematology areas and not immunomodulatory or infectious disease areas. Remember thalidomide? One drug, one disease but MAJOR fetal abnormalities resulting from its intended use as a soporific for some pregnant German women decades ago. It was shelved it for years and years. It's reincarnation as levalidomide for myeloma was a boon for those patients in need of therapy. Certain drugs can be useful for many disorders because there are common organ and cellular dysfunctions that have a common theme. COVID19 and Sickle Cell Disease have those commas themes for example. Check the case reporting under COVID19 in the CURE ID website: <https://cure.ncats.io>. People should not die or suffer the progression of the disease. Too often family, friends and physicians are standing by a COVID19 victim's bedside wringing their hands and cursing the virus and how futile is our current treatment approach. Think outside the box. Apply sound physiological principles. We have seen successes numbering nearly 2,000 prescriptions and counting. 5 days of HU at standard doses with 2mg folic acid x5 days is consistently efficacious in aborting the symptoms. As few as 2 days of HU has eliminated the need for hospitalization for progressive hypoxia or treatment of the cytokine response associated with many other organ dysfunctions. The T 1/2 for the drug is only 2-4 hrs. Toxicity and ADRs are unheard of by the recipients in our region. There have been NO reports of rebound/relapses. It appears to be efficacious for all the COVID19 lineages thus far. If you are a prescriber, please consider it. This is not misinformation. It's inexpensive, readily available, brief and SAFE. It's been used for only 3 days with inpatient advanced COVID19 cases followed by anticholinesterase inhibitor pyridostigmine titrations with tremendous success in restoring cognition from a comatose state, restoring swallowing, mobility, etc. All the typical myaesthenic deficits seen with MG are addressed with the immunomodulatory effects of HU and subsequent AChEI sequence of therapy. The other option is to watch the victim slowly succumb when other options have been exhausted. Do nothing? Comfort care is all that is left to do? Not so. Think outside the box. Be a patient advocate and not a demigod.
KB, thank you for providing the package insert (PI) required by the FDA for all drugs regardless of class. Therein lies the problem given the concept of repurposing. Have you ever taken an NSAID for a tendinitis or arthritic condition? Have you ever read the PI for that particular NSAID whether it oral or topical? Would you be cavalier and ignore the PI after reading all of the cautions extending throughout most organ systems? Would you immediately tear up the prescription after reading it? A neighbor of mine was recently prescribed one such topical NSAID in the form of diclofenac gel. As a prescription it must also include a PI from the pharmacy. After reading the two pages, he elected not to use it because he feared the consequences more than the benefits. HU is not to be underestimated in its potential for ADRs but neither should getting the Covid vaccines or the EUA drug Paxlovid (Not FDA approved but temporarily given a pass for use and provided “free” at only $561/5 days of Rx, assuming it’s even available). Paxlovid purposefully “turns down/off/suppresses certain normal enzyme liver functions to allow the active component ritonivir to remain in the system longer and boost its antiviral effect. Recall that this drug was primarily used as an HIV drug and has its own toxicities recorded in its PI. Further, I would be happy to send you references about the use of hydroxyurea in sickle cell patients (not a PI to be sure. HU remains a valuable therapy over the past 30–40 years and is fully approved by the FDA down for Sickle suffered even down to the age of two years old. One study attempted to clarify the toxicity over a long period of HU use and was unable to find any serious adverse events in the areas of oncology or hematology for up to 17 1/2 years of continuous or discontinuous use. Hematologists routinely prescribe this drug for the long haul for sickle cell patients. It greatly reduces their transfusion requirements, exchange transfusions during painful crises, it stimulates levels of hemoglobin F and production of nitric oxide to reduce vasoconstriction thus reducing the painful crises of acute chest syndrome that is almost indistinguishable from an impending myocardial infarction. Hospitalization rates greatly decline in chronic SCD users. Further, even when there are some decreases in the white blood cell counts during use, drug holidays or adjusting doses is a typical strategy because the benefit for outweighs the risk over the long term. Any and all marrow distresses have been shown to be temporary and they resolve by the adjustments described above. On a global basis, hematologists routinely decry the underutilization for multi-thousands of sickle cell sufferers. as described in my previous note. HU in contrast, is only used for three to five days. On a rare occasion a second round is prescribed but that’s typically when a new infection appears many months later. When sickle patients are prescribed HU and subsequently have routine laboratory studies the labs are performed only after weeks or months of therapy as a routine. Five days is really minuscule in terms of exposure and risk. I do hope you would be open minded for yourself or your family should one of you become seriously ill with COVID-19. Personally, I have seen and heard of enough people (nearly 2000 and counting at the present time) that are convinced their lives were spared when they initiated the treatment. Some had symptoms resolving within hours of ingesting the first two doses others within two and three days but all were over their symptomatology within one to two weeks. Certainly, a dozen or so people providing anecdotes would not be very convincing but you would probably agree it becomes less of a coincidence with the number of Covid19 treatments I/we we have experienced - approaching 2000 on four continents. Would I take it if I were pretty ill and not feeling better after 3–5 days while still debating whether I should take it? By really ill I’m referring to Temp >102, severe myalgias to the point of being bed fast with an unrelenting cough and congestion, an oxygen % sat in the 70-80 range, dyspnea, weak, headaches, diarrhea, loss of taste& smell. The whole COVID19 spectrum and all of this in the context of a community whose only hospital is overwhelmed with patients and ICUs unavailable. I’m not exaggerating. This was the reality in 2020-2021 and early this year in Central NC and So. VA. Chesapeake Bay Vets also succumbed in large numbers esp those in congregate living except for those that accepted the HU protocol. You might ask if I would take 5 days of HU - you bet. I’ve documented that in my HCPOA documents that I have re-drafted recently. Those package inserts discourage a lot of well-conceived and valid therapies. Pharmacies and pharmaceutical companies are obligated to provide them. As you have read, even a minor unexpected adverse effect must be reported It’s always good to question. It’s always better to do your own in-depth research and weigh the benefits vs risks of any therapy. I heard some real horror stories from acute care ICUs about the EU product remdesivir routinely given in ICUs around this country. Many Advanced COVID19 patients got several rounds of it even as their respiratory and cardiac functions were declining. Some developed serious cardiac (arrhythmias and coronary ischemia). Some suffered renal complications after one, two or three rounds of it as their COVID-19 advanced and yet many still wound up on dialysis and/or a ventilator prior to transfer to the recovery facility whereupon the lead hospitalist routinely “resurrected” these people out of coma starting with HU and after 3 days utilized titrated pyridostigmine dosing. Should a physician stand idle and impotent when “official” protocols are futile? Apparently so in many instances as we observed. A closed mind and one that fails to innovate in the face of an impending death isn’t a very good care giver in my opinion. Again, thank you for your “warnings” as they are presented under mandate in the PI. They should be heeded but the novel disease of COVID19, the HU dosing, safety for long durations of use (years and decades and not days), as well as the mere 5 days of therapy should be emphasized. In our experience HU works. The FDA is asking for these success stories. Clinical Trials are needed and necessary. Vaccines are needed and necessary. Unnecessary COVID19 and COVID19 related organ failures as well as “long term” COVID19 effects don’t have to continue if this HU is proven with a high degree of certainly to treat and prevent complications. Please review the case reports and discussion on <https:cure.ncats.io> if you haven’t already.
Goodness knows we would dearly love to see a RCT for HU. Despite dozens of contacts and inquiries no one has any interest in a dirt cheap generic drug that costs, in our area with a discount coupon, $5.71 for a five day course. The folic acid is a brief marrow support type drug and may be in the same price range. The RCT is the gold standard but in the face of someone dying right before your eyes and someone declares “everything that has been done that we can do “, we would declare that statement premature and incomplete. Without exaggeration I can tell Of multiple patients that were at deaths door and recovered. One gentleman with a persistent advocate, his wife, went from dying recovered sufficiently to enter a rehab hospital, then home and back to work after an 8 th month ordeal. Multiple hospitalist and sub specialist gave him a zero chance of surviving. I understand anecdotal cases are not the gold standard but right now, there is no gold standard for COVID-19. HU needs each day in the sun. Big Pharmas aren’t interested because it doesn’t help their bottom line. Generic manufacturers don’t have the resources for clinical trials. Only the NIH and other federally sponsored research organizations or private funding can do the job. Our current contact through the CURE ID, NIH and FDA is doing all that he can to generate some interest in those RCTs. Stay tuned. thanks for your input and your helpful information. If you are a prescriber, please be open minded about treatments that are not gold standards and have great promise. We think HU is one of them.
I have three friends who have recently come down with colds. They have done at home and PCR tests. Their results are negative for Covid. They all live in different cities.
I suppose it’s possible they all truly do have colds, or even the flu. Yet isn’t it also possible that as new variants emerge, the tests become less effective at detecting Covid?
With regard to timing on testing, if the test is an antigen test performed in the home setting, testing too early and without a follow up may give a false negative. The free test kits that were distributed clearly state they need to repeat the test after 48–72 hours for confirmation if negative. Many people interchange the term antigen with a PCR when describing home tests. (In our experience gathering data for case reports). While there are some PCR kits available the cost is a significant barrier ($40-99) as I note on AMZN. Those with classic URI sxs that got PCR’s in a clinic that tested negative after a 2-3 day illness most likely did have URIs. Its a good reminder that masking is also an excellent strategy for preventing or transmitting infection from a common URI virus.
Is there any kind of easy-to-read "family tree" site for the various lineages of SARS-CoV-2, possibly one that's searchable? I somehow missed the rise of BQ.11 and would like to figure out how it's connected back into things that I've at least heard of...
Well...yeah...since I asked. @yle actually had a good one in a post a month or so ago. This link is readable, but it's over a year old, so not particularly helpful today. I care far less about the ones that used to be active, but rather the lineage of the ones that are active at any given point in time--particularly now and on the rise.
"(Keep in mind that reported cases remain flat; these no longer accurately reflect transmission due to at home antigen testing.) The City University of New York system is 24 colleges. across the 5 boroughs and the students and employees live not only in NYC but also outside of it in NJ, Long Island etc. They do randomized testing of faculty, staff and students (all who have at least had the initial vaccine) weekly.
It's a good way to track infection rates. During Omicron, the positivity rate was over 20%. It has stayed at 1.5% for the past two weeks. It is probably one of the best ways to consistently track transmission since people are picked at random.
https://www.cuny.edu/coronavirus/safety-tracker/
Thank you for this. The wonderful community of commenters here is yet another reason this newsletter is such a valuable resource.
We must congratulate the City University of NY system. It is not a minor feat to maintain a randomized sampling-based and tightly structured diagnostic testing rigmarole in some defined population, accumulate data accurately over and over, and report those data lucidly in carefully crafted language free of buzzwords, blarney, and BS. Unfortunately, most states during the pandemic (as far as I can determine) resorted to various home-brewed *shortcuts* in their flawed attempts to calculate FNCIR (Faux New Case Incidence Rates) for "following the pandemic" and for "setting policies" et cetera. As an unintended consequence in my state (MN), there has been weird confusion amongst both our doctors and lay folks since the earliest days of the pandemic, all because of this one public health publicity gaffe. Frequent citation of the latest "Computed Test Positivity Rate" in newspapers and during frequent TV press conferences (featuring cameo shots of both our nervous Governor and the concerned Commissioner of Health), became laughably (and literally) so misleading, so cryptic, and so gummed-up that even old soybean farmers out in the remotest parts of our state would joke about FNCIR while sitting around in their barns with neighbors on rainy days.
Population wide random sampling could be accomplished if it were combined with jury summonses
I presume that "jury summoning" involves a random sampling process already on standby per some in-force legislation, and thus is well-oiled and ready to rumble in most every county in the country. Good suggestion, which would garner adults only of course! When I first read your idea here I thought about folks I have known who avoided jury duty like the plague so I guess some epidemiologist might need to think about potential biasing effect(s) of drawing Mrs. Jones' name, but having her dodge duty with some excuse like, "I cannot leave my elderly parent alone at home" or "I have severe allergies to dust", etc. and then Mr. Smith gets plugged into what was ostensibly Jones' place for both jury work and a PCR test, etc. Just doing even a few basic thought experiments about this whole process should be good for stirring enough grist into the mill to cook up several journal articles or meeting abstracts that could help pump up the C.V. of an eager beaver instructor seeking to become an assistant professor. I never detected serious discussions in MN about how we might design fair random sampling of our 5.6 million souls at regular intervals -- about half of our folks do not live in the four largest cities here, but are spread all over "greater Minnesota". I do recall reading or hearing the boilerplate issued frequently by Our Authorities who said things like, "Getting representative samples of our citizens would be operationally expensive and oh my goodness, just logistically a nightmare". I nearly vomited my traditional Minnesota Lutheran green bean/mushroom soup/fried onion hot dish every time the two top worthies from our Dept. of Health would make their joint statements on TV because for some odd reason those Health Bureaucrats simply could not resist uttering -- just as often as humanly possible -- two of the leading au courant healthcare managerial buzzwords ("nimble" and "robust") in their public statements. You cannot make this stuff up. I feel deep in my heart that all of our corn and soybean farmers listening on the radio or watching the evening news on Channel 4 since December 2019 must have guffawed mightily, wheezing and slapping their knees every single damned time "robust" or "nimble" came over the airwaves.
Plus I figure it could help make discharging one's civic duty a little bit safer!!!
Full disclosure, I was recently on a jury
This is a great resource, thank you.
I asked my GP here in Germany about getting a booster in December since my fiancé and I both had Covid in June. He is strictly following guidance of the Standing Commission for Immunization, which currently only recommends boosters for people over the age of sixty with at least 6 months since an infection or last immunization. Same applies to at risk persons with certain chronic diseases (which my coronary artery disease apparently is not). You’d think with the information in this report they would be thankful for every person looking to get boostered.
What is the current state of affairs on the All Variant vaccine that the Army and others were working on? I read that we won't be out of the playing catch-up mode until we develop a pan-sarbecovirus immunization.
Yes! Would love more info on this, the Walter Reed coronavirus vaccine.
Thank you! I felt like we should have an update nowish and I think I was just recalling that the trial ends in Oct, forgetting the finer detail of it being Oct 30th (then of course, analysis to follow and that's *if* they even release any findings ahead of the actual projected completion date, listed presently as Oct. 30, 2023. Siiiiiiiigh).
Agreed, universal flu would be a boon.
My profound thanks -- once more -- for trying to make sense of an increasingly complex situation.
How long after having been infected with COVID would you recommend waiting to get your fall booster? I suspect a lot of people haven't gotten the fall booster because they were infected during this summer's wave and the CDC is recommending waiting 90 days after infection to get boosted.
That's me. I may wait a little longer to be boosted closer to the Christmas holidays.
Thanks. Normally I would do this, but I am not doing anything or seeing for Thanksgiving beyond my usual activities.
First of all, I enjoyed listening to your podcast with Andy Slavitt!
I understand social networks as a concept with monkeypox, but these new variants (which sound like Star Wars droid names) seem to spread quite easily beyond networks.
The possible correlation between low booster rates, Oktoberfest, and German health system collapsing does not bode very well for us here in the US. (Low boosters, holidays, health care workers down 20%). I continue to think that experts like Paul Offit here in Philly need to up their game.
The “our world in data” graph showing “number of COVID-19 patients in ICU per million people” is a total nightmare for people like me with color blindness. I can’t even try to comprehend that! Not your fault but we 8% of males get no ADA love.
Riding the wave. Working overtime to persuade patients. Ever masking in office, stores. Thanks again for the great update 👌
Oh how I hate to hear this and thank you for making sense of all the various variants! When will we know if we are getting more severe symptoms again? It scares me to think of variant like Delta with zero masks being worn!
Thanks for this update! I've heard the term "variant swarm" to describe the plethora of Omicron variants now out in the world, but "subvariant soup" seems more apt to me, especially since not all subvariants will proliferate in any given country or region. I'm doubly glad I received my fall bivalent booster last month. I'm continuing to mask up in public indoor spaces with a high quality N95 or KN95 mask. To echo Dr. Jetelina, definitely get the fall booster if you haven't already.
Agreed - it seems it's vaccines to reduce the probability of severe disease if infected and masks (etc) to reduce the probability of getting infected or transmitting. Assuming masks are at least KN95 and worn correctly. Maybe it's just my (seemingly-normal) anatomy but I can't get a good fit from KN95s with ear loops - so I feel like N95s (with the 2 loops) are giving me better protection. We probably need some simple evidence-based advice on mask care since the $ says they are going to be reused.
Thanks ! Timely update of crucial stuff, an example of an excellent epidemiological post that features accuracy plus concision. Sinclair Lewis' mythical George Babbitt would have been tickled greatly and probably would have boomed, "This update has punch, pow, and zip".
It's everywhere - the pandemic fatigue that is. So many of my neighbors are tired of sitting at home, wearing masks and going for that nth booster. I suspect that many have the mindset that natural immunity is the way to go because none of their immediate friends, family or relatives died - the Barrington Declaration mindset. Well, I don't accept that. I've read the science. My wife and I are vulnerable and we have had our 5th shots without significant incidents. But, then again we are not that significant cohort that gave up being cautious after the 1st shot and decided to play roulette. There are lots of folks at risk and will need treatment. Believe it or not not everyone has access to that EUA product Paxlovid. Germany may be the next big reservoir to spur the latest variant across the Pond. Let's hope not. After the debacles with the HCQ and Ivermectin there hasn't been a whole lot about repurposed drugs. I/we believe others are untapped nuggets that hasn't had a fair shake. Only those 2 highly politicized candidates made the ClinicalTrials. Both found to be inefficacious. On the CURE ID website one can review the efforts of the NIH, FDA, CDC, NCATS, and C-path to promote other repurposed drugs for treating COVID19. Many on the list are familiar but a number are not. Some are even more difficult to obtain than the Paxlovid and they surely are not EUA (= subsidized/free). On the CURE ID COVID-19 list of drugs being actively promoted the top drug - HCQ is a no-show. Trials showed no benefit. The 2nd drug on the list is a newcomer, but not new to our total pharmacopoeia. Our local experience with hydroxyurea (HU) spans over 2 years and counting. It's has a tried and true safety profile and multi-thousands of Sicklers benefit from using it DAILY over a period of years, yet it's under-utilized for this genetic disorders according to many Hematologists. The drug also carries a LOT of baggage as an antimetabolite. But it also has anti-viral activities and was well studied during the heyday of the HIV research. It's not new at all. HU has been shown to be safe and beneficial for more than one disease. HU enhances tissue oxygenation, reduces thromboembolisms, it increases HgbF. Lots of these pharmacodynamics beneficial in early and advanced COVID19. It's really unreasonable that this drug is labeled as a one drug one disease product, more so in the oncology and hematology areas and not immunomodulatory or infectious disease areas. Remember thalidomide? One drug, one disease but MAJOR fetal abnormalities resulting from its intended use as a soporific for some pregnant German women decades ago. It was shelved it for years and years. It's reincarnation as levalidomide for myeloma was a boon for those patients in need of therapy. Certain drugs can be useful for many disorders because there are common organ and cellular dysfunctions that have a common theme. COVID19 and Sickle Cell Disease have those commas themes for example. Check the case reporting under COVID19 in the CURE ID website: <https://cure.ncats.io>. People should not die or suffer the progression of the disease. Too often family, friends and physicians are standing by a COVID19 victim's bedside wringing their hands and cursing the virus and how futile is our current treatment approach. Think outside the box. Apply sound physiological principles. We have seen successes numbering nearly 2,000 prescriptions and counting. 5 days of HU at standard doses with 2mg folic acid x5 days is consistently efficacious in aborting the symptoms. As few as 2 days of HU has eliminated the need for hospitalization for progressive hypoxia or treatment of the cytokine response associated with many other organ dysfunctions. The T 1/2 for the drug is only 2-4 hrs. Toxicity and ADRs are unheard of by the recipients in our region. There have been NO reports of rebound/relapses. It appears to be efficacious for all the COVID19 lineages thus far. If you are a prescriber, please consider it. This is not misinformation. It's inexpensive, readily available, brief and SAFE. It's been used for only 3 days with inpatient advanced COVID19 cases followed by anticholinesterase inhibitor pyridostigmine titrations with tremendous success in restoring cognition from a comatose state, restoring swallowing, mobility, etc. All the typical myaesthenic deficits seen with MG are addressed with the immunomodulatory effects of HU and subsequent AChEI sequence of therapy. The other option is to watch the victim slowly succumb when other options have been exhausted. Do nothing? Comfort care is all that is left to do? Not so. Think outside the box. Be a patient advocate and not a demigod.
KB, thank you for providing the package insert (PI) required by the FDA for all drugs regardless of class. Therein lies the problem given the concept of repurposing. Have you ever taken an NSAID for a tendinitis or arthritic condition? Have you ever read the PI for that particular NSAID whether it oral or topical? Would you be cavalier and ignore the PI after reading all of the cautions extending throughout most organ systems? Would you immediately tear up the prescription after reading it? A neighbor of mine was recently prescribed one such topical NSAID in the form of diclofenac gel. As a prescription it must also include a PI from the pharmacy. After reading the two pages, he elected not to use it because he feared the consequences more than the benefits. HU is not to be underestimated in its potential for ADRs but neither should getting the Covid vaccines or the EUA drug Paxlovid (Not FDA approved but temporarily given a pass for use and provided “free” at only $561/5 days of Rx, assuming it’s even available). Paxlovid purposefully “turns down/off/suppresses certain normal enzyme liver functions to allow the active component ritonivir to remain in the system longer and boost its antiviral effect. Recall that this drug was primarily used as an HIV drug and has its own toxicities recorded in its PI. Further, I would be happy to send you references about the use of hydroxyurea in sickle cell patients (not a PI to be sure. HU remains a valuable therapy over the past 30–40 years and is fully approved by the FDA down for Sickle suffered even down to the age of two years old. One study attempted to clarify the toxicity over a long period of HU use and was unable to find any serious adverse events in the areas of oncology or hematology for up to 17 1/2 years of continuous or discontinuous use. Hematologists routinely prescribe this drug for the long haul for sickle cell patients. It greatly reduces their transfusion requirements, exchange transfusions during painful crises, it stimulates levels of hemoglobin F and production of nitric oxide to reduce vasoconstriction thus reducing the painful crises of acute chest syndrome that is almost indistinguishable from an impending myocardial infarction. Hospitalization rates greatly decline in chronic SCD users. Further, even when there are some decreases in the white blood cell counts during use, drug holidays or adjusting doses is a typical strategy because the benefit for outweighs the risk over the long term. Any and all marrow distresses have been shown to be temporary and they resolve by the adjustments described above. On a global basis, hematologists routinely decry the underutilization for multi-thousands of sickle cell sufferers. as described in my previous note. HU in contrast, is only used for three to five days. On a rare occasion a second round is prescribed but that’s typically when a new infection appears many months later. When sickle patients are prescribed HU and subsequently have routine laboratory studies the labs are performed only after weeks or months of therapy as a routine. Five days is really minuscule in terms of exposure and risk. I do hope you would be open minded for yourself or your family should one of you become seriously ill with COVID-19. Personally, I have seen and heard of enough people (nearly 2000 and counting at the present time) that are convinced their lives were spared when they initiated the treatment. Some had symptoms resolving within hours of ingesting the first two doses others within two and three days but all were over their symptomatology within one to two weeks. Certainly, a dozen or so people providing anecdotes would not be very convincing but you would probably agree it becomes less of a coincidence with the number of Covid19 treatments I/we we have experienced - approaching 2000 on four continents. Would I take it if I were pretty ill and not feeling better after 3–5 days while still debating whether I should take it? By really ill I’m referring to Temp >102, severe myalgias to the point of being bed fast with an unrelenting cough and congestion, an oxygen % sat in the 70-80 range, dyspnea, weak, headaches, diarrhea, loss of taste& smell. The whole COVID19 spectrum and all of this in the context of a community whose only hospital is overwhelmed with patients and ICUs unavailable. I’m not exaggerating. This was the reality in 2020-2021 and early this year in Central NC and So. VA. Chesapeake Bay Vets also succumbed in large numbers esp those in congregate living except for those that accepted the HU protocol. You might ask if I would take 5 days of HU - you bet. I’ve documented that in my HCPOA documents that I have re-drafted recently. Those package inserts discourage a lot of well-conceived and valid therapies. Pharmacies and pharmaceutical companies are obligated to provide them. As you have read, even a minor unexpected adverse effect must be reported It’s always good to question. It’s always better to do your own in-depth research and weigh the benefits vs risks of any therapy. I heard some real horror stories from acute care ICUs about the EU product remdesivir routinely given in ICUs around this country. Many Advanced COVID19 patients got several rounds of it even as their respiratory and cardiac functions were declining. Some developed serious cardiac (arrhythmias and coronary ischemia). Some suffered renal complications after one, two or three rounds of it as their COVID-19 advanced and yet many still wound up on dialysis and/or a ventilator prior to transfer to the recovery facility whereupon the lead hospitalist routinely “resurrected” these people out of coma starting with HU and after 3 days utilized titrated pyridostigmine dosing. Should a physician stand idle and impotent when “official” protocols are futile? Apparently so in many instances as we observed. A closed mind and one that fails to innovate in the face of an impending death isn’t a very good care giver in my opinion. Again, thank you for your “warnings” as they are presented under mandate in the PI. They should be heeded but the novel disease of COVID19, the HU dosing, safety for long durations of use (years and decades and not days), as well as the mere 5 days of therapy should be emphasized. In our experience HU works. The FDA is asking for these success stories. Clinical Trials are needed and necessary. Vaccines are needed and necessary. Unnecessary COVID19 and COVID19 related organ failures as well as “long term” COVID19 effects don’t have to continue if this HU is proven with a high degree of certainly to treat and prevent complications. Please review the case reports and discussion on <https:cure.ncats.io> if you haven’t already.
FYI: (egads! RS 😊)
Ref PI Diclofenac
https://www.drugs.com/pro/diclofenac-gel.html#s-34084-4
Goodness knows we would dearly love to see a RCT for HU. Despite dozens of contacts and inquiries no one has any interest in a dirt cheap generic drug that costs, in our area with a discount coupon, $5.71 for a five day course. The folic acid is a brief marrow support type drug and may be in the same price range. The RCT is the gold standard but in the face of someone dying right before your eyes and someone declares “everything that has been done that we can do “, we would declare that statement premature and incomplete. Without exaggeration I can tell Of multiple patients that were at deaths door and recovered. One gentleman with a persistent advocate, his wife, went from dying recovered sufficiently to enter a rehab hospital, then home and back to work after an 8 th month ordeal. Multiple hospitalist and sub specialist gave him a zero chance of surviving. I understand anecdotal cases are not the gold standard but right now, there is no gold standard for COVID-19. HU needs each day in the sun. Big Pharmas aren’t interested because it doesn’t help their bottom line. Generic manufacturers don’t have the resources for clinical trials. Only the NIH and other federally sponsored research organizations or private funding can do the job. Our current contact through the CURE ID, NIH and FDA is doing all that he can to generate some interest in those RCTs. Stay tuned. thanks for your input and your helpful information. If you are a prescriber, please be open minded about treatments that are not gold standards and have great promise. We think HU is one of them.
Thank you
I have three friends who have recently come down with colds. They have done at home and PCR tests. Their results are negative for Covid. They all live in different cities.
I suppose it’s possible they all truly do have colds, or even the flu. Yet isn’t it also possible that as new variants emerge, the tests become less effective at detecting Covid?
With regard to timing on testing, if the test is an antigen test performed in the home setting, testing too early and without a follow up may give a false negative. The free test kits that were distributed clearly state they need to repeat the test after 48–72 hours for confirmation if negative. Many people interchange the term antigen with a PCR when describing home tests. (In our experience gathering data for case reports). While there are some PCR kits available the cost is a significant barrier ($40-99) as I note on AMZN. Those with classic URI sxs that got PCR’s in a clinic that tested negative after a 2-3 day illness most likely did have URIs. Its a good reminder that masking is also an excellent strategy for preventing or transmitting infection from a common URI virus.
Hubby and I recently got our bivalent boosters. I wish we knew more about how much protection those vaccines will provide against XBB and BQ.1.1.
Are the Omicron variants still detected with at-home antigen tests?
What are we to make of Dr. Paul Offit’s comments? Should he still be an FDA advisor?
https://youtu.be/b5ehD3KLxc4
Is there any kind of easy-to-read "family tree" site for the various lineages of SARS-CoV-2, possibly one that's searchable? I somehow missed the rise of BQ.11 and would like to figure out how it's connected back into things that I've at least heard of...
Well...yeah...since I asked. @yle actually had a good one in a post a month or so ago. This link is readable, but it's over a year old, so not particularly helpful today. I care far less about the ones that used to be active, but rather the lineage of the ones that are active at any given point in time--particularly now and on the rise.