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Post by onelasttime on Jan 28, 2022 4:30:19 GMT
The last 14 years I worked before I retired part of my job involved placing insurance for our biotech clients clinical trials. There are at least three phases and in each phase involves I believe a new group of people. Sometime the FDA may require a 4th phase. The insurance companies need to know how many subjects per phase. Both those getting the drug and those getting a placebo. None of the trails insurance I worked on came close to tens of thousands of subjects used during the three phases or even if there was a fourth phase of a trial. So I thought maybe I’m not remembering correctly so I asked my friend google and found this description of clinical trials which is the way I remember it. ”Clinical trials of drugs are usually described based on their phase. The FDA typically requires Phase I, II, and III trials to be conducted to determine if the drug can be approved for use. A Phase I trial tests an experimental treatment on a small group of often healthy people (20 to 80) to judge its safety and side effects and to find the correct drug dosage. A Phase II trial uses more people (100 to 300). While the emphasis in Phase I is on safety, the emphasis in Phase II is on effectiveness. This phase aims to obtain preliminary data on whether the drug works in people who have a certain disease or condition. These trials also continue to study safety, including short-term side effects. This phase can last several years. A Phase III trial gathers more information about safety and effectiveness, studying different populations and different dosages, using the drug in combination with other drugs. The number of subjects usually ranges from several hundred to about 3,000 people. If the FDA agrees that the trial results are positive, it will approve the experimental drug or device. A Phase IV trial for drugs or devices takes place after the FDA approves their use. A device or drug's effectiveness and safety are monitored in large, diverse populations. Sometimes, the side effects of a drug may not become clear until more people have taken it over a longer period of time.” And from what I understand since COVID is a Sars virus the drug companies already had a foundation to work from and that was one of the reason it didn’t take longer then it did to come up with vaccines. In other words they drug companies didn’t have to start from scratch. Yes sometimes after a vaccine/drug has been approved new side affects make themselves known. In most cases the side affects only affect a small % that doctors can work around. Sometimes the side affects are serious enough the drug is removed. But the reality is there is risk in everything we do. Every time you get in a car, every time you walk down a flight of stairs there is risk involved but we do it anyway. The only way we can get this virus under control so we can go back to a normal life or the new normal is if people get vaccinated, But more importantly for the unvaccinated they are personally taking a greater risk by not being vaccinated then if they did get vaccinated. I mean seriously who wants to be potentially hooked up to a ventilator for weeks. And who wants to potentially be a long hauler? And then those who have died. Over 800,000 Americans have died and many didn’t have to if they had just done the right thing instead of stamping their little feet and claiming “ you can’t tell me what to do”. The fact that there has to mandates involving COVID-19 just shows how messed up some people are. Honestly sometimes you post stuff that is so bizarre I wonder if you're just trolling us. Surely if you were actually a professional insuring companies you'd realize that depending on the drug/trial the potential group varies tremendously. If you expected a Phase II or III trial for a condition that effects 1000 people a year to be comparable to a vaccine for 300 million - you're bonkers. Yes thousands, literally thousands of treatments are approved with small sample sizes every year as the number of people with the condition is tiny - that is so beyond irrelevant to the discussion of the vaccine roll out I am dumbfounded that you brought it up. I'm a HUGE proponent of the vaccine - me, my husband and two teens were vaccinated the second they were eligible - this isn't about doubting the vaccine, it's a continued frustrating that people just say the most random shit and think it's helpful. I will be the first to admit I had no idea how these biotech companies determine the number of subjects per phase of a clinical trial. And I will hazard a guess neither do you. But I did do some reading. What determines the number of subjects in clinical trials for vaccines is the cost basically. The more subjects the greater the cost to the trial and the higher the price per dose of the vaccine if approved. Your reasoning made no sense. Any drug maker wants to make sure whatever drug/vaccine they create is going to be safe for those who take it no matter the size of the market. But at the same time the drug/vaccine has to be affordable otherwise they will have a limited market. Kind of like that new high priced drug for Alzheimer’s that has been in the news lately. And let’s face it, with COVID -19 the drug companies already had their markets who would pay what was charged. The government. I don’t what what other countries did but the US bought millions of doses of vaccine before they were even through their trials. The other thing about these vaccines was how fast they went through the three phases of trials. Having a large number of subjects could have help speed things along. Especially if the cost is not necessarily a problem. But it also helped that both vaccines are a mRNA vaccine. Of course you are going to think this is all nonsense and that’s fine. I feel the same about the stuff you post and put you on ignore a long time ago. I just have to stop peaking when you post on one of my threads. You know, really ignore you. |
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Deleted
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Nov 24, 2024 15:04:34 GMT
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Post by Deleted on Jan 28, 2022 12:14:59 GMT
I am fully vaccinated and boostered and grateful for the science that made it possible. However. We have a doctor friend with a degree in public health. He earned his medical degree from Harvard with a specialty in Epidemiology. This pandemic is exactly what he trained for. The development of this vaccine goes against everything he learned about the way vaccines should be developed. Instead of the four or more years that vaccines should take, we had it in one. Clinical trials normally involve tens of thousands of people. This vaccine testing did not. Our friend is a very healthy man in his 40s. He received his vaccine in January of 2020 (CORRECTION: January 2021). He developed myocarditis from the vaccine and was hospitalized. He says this is a known side effect for 2% of young adult men who receive the vaccine. His risk of hospitalization for covid was .1%. He questions whether it was worth the 2% risk to avoid the .1% chance. With no disrespect to your Doctor friend but his qualification in Epidemiology does not qualify him to be an expert in virology. An epidemiologist deals with the incidence, distribution, and possible control of diseases and other factors relating to health. A virologist is a medical researcher or scientist who studies viruses and the diseases caused by them and in turn has the possibility of developing, in the case of Covid, a vaccine or other therapeutics in this instance, to lower the risk of a serious illness or death. Myocarditis is not unique to Covid vaccinations. It is a known side affect of any virus. Unlike the virus itself, Myocarditis is usually pretty mild and is treatable and is not such a high risk of serious illness and possibly death to the same degree as catching Covid is for the unvaccinated. Generally it has been found that there is usually another underlying cardiological cause for Myocarditis to be a serious risk and possibly death. I'd be interested to know where he got the data for his 2% compared to his 1%. ETA . The main reason that the vaccines have taken a much shorter tome to come to use is that the mHRA has been in research for a number of years, particular in the field of cancer. Added to that, the main cause of a delay for vaccines to be produced in the past is the lack of financial backing. Various Governments and pharmaceuticals have provided unprecedented financial backing to the development of the vaccines which in turn reduced the delay in research. |
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Deleted
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Nov 24, 2024 15:04:34 GMT
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Post by Deleted on Jan 28, 2022 12:51:46 GMT
I am fully vaccinated and boostered and grateful for the science that made it possible. However. We have a doctor friend with a degree in public health. He earned his medical degree from Harvard with a specialty in Epidemiology. This pandemic is exactly what he trained for. The development of this vaccine goes against everything he learned about the way vaccines should be developed. Instead of the four or more years that vaccines should take, we had it in one. Clinical trials normally involve tens of thousands of people. This vaccine testing did not. Our friend is a very healthy man in his 40s. He received his vaccine in January of 2020. He developed myocarditis from the vaccine and was hospitalized. He says this is a known side effect for 2% of young adult men who receive the vaccine. His risk of hospitalization for covid was .1%. He questions whether it was worth the 2% risk to avoid the .1% chance. He recommends the vaccine for anyone over 60 or with underlying conditions. By law he is prohibited from suggesting anyone should *not* get the vaccine. It's illegal for him as a doctor to make a recommendation that any one of his patients *not* be vaccinated. I get it. We're not just vaccinated to protect ourselves but to protect others. Hospitals are overwhelmed. I get it, I do. But there is another actual, logical, medically supported point of view worth considering. Our government will not allow us to consider it. To do so is both unpatriotic and illegal. And that does bother me. Truly. Even though I chose to be vaccinated and was first in line for a booster shot. Even though I have lost friends to this disease. I think doctors should be allowed to make the recommendations they deem appropriate for their patients. I don't like the government making those decisions instead. I’ll just leave it at there is a whole lot of misinformation in this post. Including that it’s illegal for a dr to make a recommendation to not vaccinate I totally agree. Doctors are not facing any consequences for advising against vaccines. Please try to find any legit example of this happening. You can't. |
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Deleted
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Nov 24, 2024 15:04:34 GMT
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Post by Deleted on Jan 28, 2022 13:03:22 GMT
This is a little off topic but Michael Moore was recently on the podcast smartless And it cheered me up. He thinks the country is going to be okay. And I know that is hard to believe but when I think of how many good sensible reasonable people I know it does seem possible. Even you all trying to reason with misinformation. Every little bit helps. We can't give up.
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sassyangel
Drama Llama
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Post by sassyangel on Jan 28, 2022 13:37:17 GMT
I am fully vaccinated and boostered and grateful for the science that made it possible. However. We have a doctor friend with a degree in public health. He earned his medical degree from Harvard with a specialty in Epidemiology. This pandemic is exactly what he trained for. The development of this vaccine goes against everything he learned about the way vaccines should be developed. Instead of the four or more years that vaccines should take, we had it in one. Clinical trials normally involve tens of thousands of people. This vaccine testing did not. Our friend is a very healthy man in his 40s. He received his vaccine in January of 2020 (CORRECTION: January 2021). He developed myocarditis from the vaccine and was hospitalized. He says this is a known side effect for 2% of young adult men who receive the vaccine. His risk of hospitalization for covid was .1%. He questions whether it was worth the 2% risk to avoid the .1% chance. He recommends the vaccine for anyone over 60 or with underlying conditions. By law he is prohibited from suggesting anyone should *not* get the vaccine. It's illegal for him as a doctor to make a recommendation that any one of his patients *not* be vaccinated. I get it. We're not just vaccinated to protect ourselves but to protect others. Hospitals are overwhelmed. I get it, I do. But there is another actual, logical, medically supported point of view worth considering. Our government will not allow us to consider it. To do so is both unpatriotic and illegal. And that does bother me. Truly. Even though I chose to be vaccinated and was first in line for a booster shot. Even though I have lost friends to this disease. I think doctors should be allowed to make the recommendations they deem appropriate for their patients. I don't like the government making those decisions instead. Seeing as a ton of the misinformation in this has been addressed, I’ll just add this. Harvard produced Ted Cruz. I always remember that when people post stuff like this. Like a Harvard education somehow makes someone infallible, or more credible. It’s produced it’s share of disingenuous crackpots after the fact, too. |
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Post by Darcy Collins on Jan 28, 2022 14:38:24 GMT
Honestly sometimes you post stuff that is so bizarre I wonder if you're just trolling us. Surely if you were actually a professional insuring companies you'd realize that depending on the drug/trial the potential group varies tremendously. If you expected a Phase II or III trial for a condition that effects 1000 people a year to be comparable to a vaccine for 300 million - you're bonkers. Yes thousands, literally thousands of treatments are approved with small sample sizes every year as the number of people with the condition is tiny - that is so beyond irrelevant to the discussion of the vaccine roll out I am dumbfounded that you brought it up. I'm a HUGE proponent of the vaccine - me, my husband and two teens were vaccinated the second they were eligible - this isn't about doubting the vaccine, it's a continued frustrating that people just say the most random shit and think it's helpful. I will be the first to admit I had no idea how these biotech companies determine the number of subjects per phase of a clinical trial. And I will hazard a guess neither do you. But I did do some reading. What determines the number of subjects in clinical trials for vaccines is the cost basically. The more subjects the greater the cost to the trial and the higher the price per dose of the vaccine if approved. Your reasoning made no sense. Any drug maker wants to make sure whatever drug/vaccine they create is going to be safe for those who take it no matter the size of the market.But at the same time the drug/vaccine has to be affordable otherwise they will have a limited market. Kind of like that new high priced drug for Alzheimer’s that has been in the news lately. And let’s face it, with COVID -19 the drug companies already had their markets who would pay what was charged. The government. I don’t what what other countries did but the US bought millions of doses of vaccine before they were even through their trials. The other thing about these vaccines was how fast they went through the three phases of trials. Having a large number of subjects could have help speed things along. Especially if the cost is not necessarily a problem. But it also helped that both vaccines are a mRNA vaccine. Of course you are going to think this is all nonsense and that’s fine. I feel the same about the stuff you post and put you on ignore a long time ago. I just have to stop peaking when you post on one of my threads. You know, really ignore you. Feel free to ignore me - but I actually DO know as I had a loved one in multiple trials. Of course they want to make sure it's safe, but surely you can understand that it's not possible to have the same trial size when there are very, very few people with the disease. My loved one had a rare disease. There's just no possible way to have the same trial size. |
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Post by malibou on Jan 28, 2022 15:50:26 GMT
I am fully vaccinated and boostered and grateful for the science that made it possible. However. We have a doctor friend with a degree in public health. He earned his medical degree from Harvard with a specialty in Epidemiology. This pandemic is exactly what he trained for. The development of this vaccine goes against everything he learned about the way vaccines should be developed. Instead of the four or more years that vaccines should take, we had it in one. Clinical trials normally involve tens of thousands of people. This vaccine testing did not. Our friend is a very healthy man in his 40s. He received his vaccine in January of 2020 (CORRECTION: January 2021). He developed myocarditis from the vaccine and was hospitalized. He says this is a known side effect for 2% of young adult men who receive the vaccine. His risk of hospitalization for covid was .1%. He questions whether it was worth the 2% risk to avoid the .1% chance. He recommends the vaccine for anyone over 60 or with underlying conditions. By law he is prohibited from suggesting anyone should *not* get the vaccine. It's illegal for him as a doctor to make a recommendation that any one of his patients *not* be vaccinated. I get it. We're not just vaccinated to protect ourselves but to protect others. Hospitals are overwhelmed. I get it, I do. But there is another actual, logical, medically supported point of view worth considering. Our government will not allow us to consider it. To do so is both unpatriotic and illegal. And that does bother me. Truly. Even though I chose to be vaccinated and was first in line for a booster shot. Even though I have lost friends to this disease. I think doctors should be allowed to make the recommendations they deem appropriate for their patients. I don't like the government making those decisions instead. I graduated from Berkeley with a degree in Molecular and Cell Biology with a load of specialties within that degree nearly 30 years ago. I worked in the lab that was key in the development of mRNA vaccines. At that time they had it developed to the point that they testing on lab animals. When SARS hit years ago, they thought it might lead to a pandemic, and an mRNA vaccine was in development, but SARS didn't get enough of a foothold to need a vaccine. However, it has given them loads of time to continue working on it. This vaccine has been in development for a very long time, and the science is well understood. Clearly your Dr friend has something else blowing smoke up his ass, because he is very misinformed about the covid vaccine when as a Dr he should not be. |
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Post by onelasttime on Jan 28, 2022 16:32:12 GMT
This is exactly why mandates are needed when you are dealing with a stupid populace when it comes to being vaccinated.
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Gem Girl
Pearl Clutcher
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Posts: 2,686
Jun 29, 2014 19:29:52 GMT
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Post by Gem Girl on Jan 28, 2022 20:26:15 GMT
Justice Breyer says the US was an experiment The US is currently in a kind of civil war Only the people can decide if the experiment should continue (not sure what kind of experiment??) Justice Breyer hopes it can continue. (Hopes the experiment can continue? The kind of civil war?) I don't understand. "The establishment of our new Government seemed to be the last great experiment for promoting human happiness." George Washington, January 9, 1790 |
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Post by Merge on Jan 28, 2022 21:33:26 GMT
I am fully vaccinated and boostered and grateful for the science that made it possible. However. We have a doctor friend with a degree in public health. He earned his medical degree from Harvard with a specialty in Epidemiology. This pandemic is exactly what he trained for. The development of this vaccine goes against everything he learned about the way vaccines should be developed. Instead of the four or more years that vaccines should take, we had it in one. Clinical trials normally involve tens of thousands of people. This vaccine testing did not. Our friend is a very healthy man in his 40s. He received his vaccine in January of 2020 (CORRECTION: January 2021). He developed myocarditis from the vaccine and was hospitalized. He says this is a known side effect for 2% of young adult men who receive the vaccine. His risk of hospitalization for covid was .1%. He questions whether it was worth the 2% risk to avoid the .1% chance. He recommends the vaccine for anyone over 60 or with underlying conditions. By law he is prohibited from suggesting anyone should *not* get the vaccine. It's illegal for him as a doctor to make a recommendation that any one of his patients *not* be vaccinated. I get it. We're not just vaccinated to protect ourselves but to protect others. Hospitals are overwhelmed. I get it, I do. But there is another actual, logical, medically supported point of view worth considering. Our government will not allow us to consider it. To do so is both unpatriotic and illegal. And that does bother me. Truly. Even though I chose to be vaccinated and was first in line for a booster shot. Even though I have lost friends to this disease. I think doctors should be allowed to make the recommendations they deem appropriate for their patients. I don't like the government making those decisions instead. I graduated from Berkeley with a degree in Molecular and Cell Biology with a load of specialties within that degree nearly 30 years ago. I worked in the lab that was key in the development of mRNA vaccines. At that time they had it developed to the point that they testing on lab animals. When SARS hit years ago, they thought it might lead to a pandemic, and an mRNA vaccine was in development, but SARS didn't get enough of a foothold to need a vaccine. However, it has given them loads of time to continue working on it. This vaccine has been in development for a very long time, and the science is well understood. Clearly your Dr friend has something else blowing smoke up his ass, because he is very misinformed about the covid vaccine when as a Dr he should not be. Thank you - one of my closest friends here has a background similar to yours. She worked on mRNA technology here at MD Anderson 20 years ago, and has a fit every time she hears someone say, "it's too new!" (Oh and another friend's sister, MIT PhD grad, same thing. This is NOT new technology.) |
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Post by onelasttime on Jan 29, 2022 20:53:45 GMT
He has a point. Too bad it’s not understood by the “you can’t tell me what to do” crowd.
He is talking about Maryland but it can be applied not only to the United States but the rest of the world as well…
From the article in the Washington Post..
Here’s why I support a vaccine passport: Because it’s time for people who follow best practices and science — a vast majority of our state by any measure — to be able to return to their daily lives and routines. As the coronavirus evolves, so must our strategies.
We cannot continue in this climate where the small percentage of the unvaccinated determine the course of life for the overwhelming majority of people who did the right thing and got vaccinated. We must work collaboratively to find the best solutions that ensure the safety of all Marylanders.
There have been numerous, well-intended campaigns to counter misinformation about vaccines. However, the reality is that even though a small minority of Maryland adults remain unvaccinated, these unvaccinated individuals perpetuate unnecessary challenges and have allowed variants such as omicron to develop at faster rates. To date, these actions have directly contributed to the 938,314 confirmed cases and 12,904 deaths our neighbors have suffered. More than 2,000 Marylanders are hospitalized from the effects of covid-19, the disease caused by the coronavirus. The overwhelming majority of those hospitalized are unvaccinated patients.”
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