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nitflegal

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  1. All true but I really believed that we had decent guardrails and skepticism that would prevent or at least slow corruption. Political and societal pressure had the medical sciences lose their integrity in weeks. It also opens up the terrible question of how much has this been happening below the waves and we (I) were blind to it? I'm kind of glad that I am closer to the end of my career than the beginning because I have no idea how bad the backlash is going to be to the sciences in general and my niche in particular. For society to accept that there are experts who will carefully weigh the data based on experience and education and thus trust that if the FDA says something is safe it is they have to trust that at worst it is flawed people doing their best to protect them. How many people still have that trust?
  2. While I enjoy the dueling of the statistics I frankly happy to see the data emerge that for all the hysteria Covid-19 is just a dangerous virus. Prior infection does provide significant immunity and with the new variant it appears that it is at least as protective as the vaccine which is designed to mimic an infection and create those same antibodies. That's how this sh*t works and the truly infuriating thing is how many scientists and physicians who should have (and I'd bet real money actually did) known better behaved as if they didn't. Including our employees that run the agencies each of our country has to keep us safe and provide sound medical guidance. This is virology 101 and yet the experts who have been trained in this stuff pretended this situation was unique and altered all of our lives based on that. This isn't me trying to be funny or hyperbolic; I cannot describe how crushed I am that the scientific community I believed in has such politicized feet of clay.
  3. The amount of tap-dancing here is pretty impressive. A study from May to November states that from the summer on having Covid but no vaccine offered better case rates than vaccination. However the article says the opposite, presumably because they cited one week in June where there were fewer cases that was true but in the other week is was tracked (when both CA and NY had much higher case rates) it was not only flipped, it was massively flipped. https://www.wdsu.com/article/cdc-study-vaccination-protects-against-covid-hospitalization-significantly-more-than-prior-infection/38818343 Fun fact, all the links in the articles to the papers are now void. If you dig through, you can find where they moved the paper to. https://www.cdc.gov/mmwr/volumes/71/wr/mm7104e1.htm?s_cid=mm7104e1_w Rates among vaccinated persons who had had COVID-19 were 32.5-fold lower (95% CI = 27.5–37.6) than rates among unvaccinated persons without a previous COVID-19 diagnosis in California and 19.8-fold lower (95% CI = 16.2–23.5) in New York. Rates among vaccinated persons without a previous COVID-19 diagnosis were consistently higher than rates among unvaccinated persons with a history of COVID-19 (3.1-fold higher [95% CI = 2.6–3.7] in California and 1.9-fold higher [95% CI = 1.5–2.3] in New York) and rates among vaccinated persons with a history of COVID-19 (3.6-fold higher [95% CI = 2.9–4.3] in California and 2.8-fold higher [95% CI = 2.1–3.4] in New York). COVID-19 hospitalization rates in California were always highest among unvaccinated persons without a previous COVID-19 diagnosis (Table 2) (Figure). In the pre-Delta period during June 13–June 26, for example, compared with hospitalization rates among unvaccinated persons without a previous COVID-19 diagnosis, hospitalization rates were 27.7-fold lower (95% CI = 22.4–33.0) among vaccinated persons without a previous COVID-19 diagnosis, 6.0-fold lower (95% CI = 3.3–8.7) among unvaccinated persons with a previous COVID-19 diagnosis, and 7.1-fold lower (95% CI = 4.0–10.3) among vaccinated persons with a previous COVID-19 diagnosis. However, this pattern also shifted as the Delta variant became predominant. During October 3–16, compared with hospitalization rates among unvaccinated persons without a previous COVID-19 diagnosis, hospitalization rates were 19.8-fold lower (95% CI = 18.2–21.4) among vaccinated persons without a previous COVID-19 diagnosis, 55.3-fold lower (95% CI = 27.3–83.3) among unvaccinated persons with a previous COVID-19 diagnosis, and 57.5-fold lower (95% CI = 29.2–85.8) among vaccinated persons with a previous COVID-19 diagnosis.
  4. Of course they do. That's not even an accusation, its just those companies are heavily bundled in most mutual funds and such.
  5. I'm not on the clinical side but my wife has been for the same 30 years. Experimentation is perhaps a loaded word and I think they prefer individual based medicine but it's effectively the same thing. Take a limited data set and take your best informed guess on what to do, evaluate the results and adjust as needed. Also manage the conflicting advice and guidance given by doing the same. Personally I feel this is a distinction without much of a difference. That has faded a lot in the USA over the last decade as we have moved more towards pre-approved corporate medicine. The doctors are told what to do and they follow the directions. I think that has reduced the impact of crappy physicians (which is good) but has also reduced the impact of good physicians (which is really bad). To the vaccines by any classic definition we are in a very large clinical trials. Which when the EUA's were codified into the regulation is exactly how they were described. Which is a good thing in general, the whole point of it is to make for a much more responsive regulatory atmosphere when the usual 3-5 year regulatory hurdle is just too prolonged. It simply means that we don't have the usual phased rollout to track for ongoing assessments. There is greater risk there and pandemic is both what was kind of planned for but also completely outside of our experience. As of now approximately 4 BILLION people have been fully dosed while we still have gaps in the standard preclinical safety studies. We will likely have upwards of 3/4 of the world's population fully vaccinated before we have the final reprotox, cardiovascular and endocrine studies done and analyzed. To the point, if you had asked the FDA prior to 2019 whether they would consider this an experimental trial they would have said "yes" by their standard definition. Whether the scale would have altered this call I frankly don't know. With fast-tracks or EAU's (and I've worked on a bunch of them even before the EUA was a thing and they were for humane use in single individuals to a few hundred) when a promising drug was available and we knew that target experimental population was going to be long dead before that drug got approved and so they had nothing to lose. BTW, that generally meant not just they had to going to die soon but they also needed to be in consistent unmanageable physical or psychologic pain to make it worth the risk that an experimental compound would do that to them as a side effect and reduce their quality of life if it didn't work. It's weird because the EUA has previously been used to fast track authorization for existing compounds and medical devices but not novel pharmaceuticals. I don't know how much they worried about it, honestly. Until 2018 or so the technologies didn't exist to respond with new drugs in a timeline that we would worry about. There's kind of a perfect storm of possibility and risk with Covid-19. Had it hit in 2017 this would have a been a completely different landscape. There is a masochistic part of me that is genuinely curious to see what happens if the final pre-clin data comes in or we run stats and find out that there are significant wide-spread side effects. With the indemnity for the manufacturers it should get, um, spicy. . .
  6. Same here. Which especially sucks because the thieves either know how to visually identify what is best to steal (maybe weigh it to see if it's heavy?) and leave the normal stuff. Any type of unique personalized packaging or, God forbid, a battery warning on the Amazon box is basically ringing the dinner bell.
  7. The thing is, this is exactly how seasonal influenza looks. The colder and more congested the populace, the higher the infection rates as people are forced inside with sh*t ventilation to share bugs. Put them in a dispersed area and the case load goes down dramatically. What it suggests (but certainly doesn't prove) is that vaccination status has fairly minor effects on transmission. If you combine it with death rates per hospitalizations it looks like the vaccines have significantly lowered fatalities before the birth of our newest variant.
  8. Regarding Biden's FBI I do love how if their is a pull chain at a NASCAR rally or parents advocating for their children they immediately find links to racism and/or domestic terrorism but when a terrorist seizes a Rabbi and congregation in their synagogue on the Sabbath to get his Al Qeada sister who tried to shoot and kill American soldiers and within minutes they know for a fact that it had nothing to do with them being Jewish. I think the FBI has taken a huge risk that will likely blow up in their faces that conservatives would buy that they were overall good hardworking patriots with political actors at the top. Yet strangely none of those hardworking patriots have been whistleblowers to all of the malfeasance that has come out. . .
  9. Mass has a 92% first shot vaccination rate and the high end of covid hospitalizations for 43 out of every 100,000. We're much higher than Alabama which has a first dose rate a bit above 50%. They have a hospitalization rate of 41 per 100, 000 so lower than ours. DC has a 92% rate of the first shot and has blown everyone out with 111 per 100,000. The first vaccination provides approximately 2/3 to 3/4 of the final protection so that's not trivial. Hell, the USA has an overall vaccination rate slightly higher than Germany. Vermont has a >90% fully vaccinated rate and 17 out of 100,000 in hospital. However, Alaska is at 13 out of 100,000 with slightly over 50% vaccinated. Oregon, Utah and Idaho are at 19 out of 100,000 with vaccination rates between 50-60%. MA is way past that in vaccination rates but also has 53 deaths a day compared to their 17, 9 and 5 respectively. NY (73% fully vaccinated) has the highest death total of 183/day while Florida (63% fully vaccinated) has 49/day.
  10. I'd go the other way. I could afford to buy the revolver, I sure as hell couldn't afford a Raquel Welch. . .
  11. He was impeached. He was not convicted.
  12. For what its worth, I have not taken the booster, nor has my wife. My ongoing risk assessments have been to take the vaccine (ModeRNA if anyone cares) but not to take the boosters.
  13. 1) Yes. I think Covid is a dangerous disease and it appears to have a significant chance of long term effects that we currently do not understand. To be a little less general; if you're over 50 I would take it. Outside of some people who are outliers the immune system is less effective by that age, recovery is prolonged, and pulmonary reserve capacity is lowered which means you're less able to fight off a respiratory pathogen. 40-50, I'd take it but if you're healthy and active and not spending large amounts of time in groups inside with crap ventilation I think it's totally reasonable to make the judgement not to take a vaccine without long-term safety data. 20-40? Same as above applies but if I were trying to make a baby I'd really be on the fence. There is nothing in the data that I have seen that indicates a risk. However, when these types of compounds cause subtle or longer term effects that is an area that typically lags in our understanding. 10-20? If you have significant comorbidities maybe. Other than that if you have no choice because of mandates I think the vaccine is less risky than social isolation to a child. However, we don't have a good profile on what this does to adolescent development and in my experience on the testing side if a compound makes it through the toxicology testing unscathed its the reprotox studies where it craps the bed. So if those two conditions don't hold I would not recommend it and my 15 year old is unvaccinated despite an awful lot of school pressure. Under 10? That's f*cking insane. We know Covid is extremely unlikely to harm a child under 10, we know they are generally asymptomatic and thus extremely likely to transmit it even if they get it. We also know from decades of pharm testing that the most dangerous time to give a patient a compound is that window before adolescence. If you're running preclinical trials and you want to see an awful lot of dead baby rats, give them a compound in their first 2-3 weeks (equivalent developmentally to a 1-7 year old human). There is a reason a tremendous amount of drugs aren't routinely given to kids in their single digits even if they are generally approved for use across the population. Hell, it is not recommended to give aspirin to kids under 12. 2) I honestly don't know. The data is really sketchy right now on how much it helps and it is still an EUA compound from a developmental standpoint. Will it hurt you? Dunno but probably not. Will it help much? Dunno, maybe? If you're over 50 and it would make you feel more comfortable? Sure why not. If you have comorbidities? From a risk assessment standpoint its probably the smart move.
  14. Polio is a good representative one. It went through limited testing in children for approximately 14 months before a large 1 year clinical trial was run with 1.8 million volunteer children and ~460,000 getting the actual vaccine. Over about 9 years the majority of children were voluntarily vaccinated and the vaccine became mandated at the school level in the 60's after a multi-year FDA review of the efficacy and complications data and subsequent report. School nurses through the '55-62 timeframe were required to monitor children for adverse events and report them to their local health boards to be transmitted to the agency. For smallpox the first inoculation was heavily pushed in the US in 1790's and the first state mandates went in during WW1 through fear of returning soldiers brining it home.
  15. I'll preface this by admitting that while I have been involved in the EU/UK/Japan regs they are not my primary focus so I don't know that I have good instincts in what their ability to release data is. I will also agree that the information is spotty and prone to availability of the people providing it. However, it is not uniformly spotty. Rather it is spotty in a lot of areas and barren in a few traditionally key areas. As time goes on, the lack of data in key defined boundaries becomes a little bit glaring that the other areas are filling in and those are not. I would expect over time a uniform sloppiness to be evident and that really doesn't seem to be the case.
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