The Coronavirus thread

[oneforthebus]

There are several global clinical trials now!

There were Phase 3 clinical trials involving 30,000 and 40,000 people for Mrna vaccines before the emergency use authorization.

 

[Badcat]

I have tons of respect for Dan Crenshaw, the decorated military veteran. I have zero respect for Dan Crenshaw, the MAGA politician.

Funny, how democracy works, isn't it? That it's okay to criticize our elected officals.

No, you do not. I didn't agree with Rep Murtha's politics or John Kerry's either, but I never degraded them, labeled them, or called them names. It's one thing to disagree or to question an elected official, it's another to openly disrespect someone individually.

 

[Badcat]

Tibs didn’t disrespect Crenshaw’s military service unlike Trump and his disrespect for John McCain’s service.

What Trump did was just as wrong as what Tibs did. But hey, nice try at deflecting. Maybe someday you'll learn that one person's actions doesn't justify another's.

 

[SteelChip]

I honestly don't know why I try and correct Decaf's endless litany of lies and distortions. Yet another one.

ST....You guys make me laugh. You know he's a troll yet you continue to feed him. We know it's all bullshit, he knows it's all bullshit but yet the libtards have to have that control, without it the stupidity shines through.

 

[Ironcitysteelers]

That sucks. Chinese flu-related, or Biden-related?

The flu action crushed healthcare so restructuring for all. .....god damn what the **** did I type last night lol.

 

[Confluence]

There were Phase 3 clinical trials involving 30,000 and 40,000 people for Mrna vaccines before the emergency use authorization.

Celebrex was much heralded upon approval in 98, Vioxx was soon approved, but finally got removed 6 years later as it became obvious that there were very negative cardiovascular side effects. Celebrex and other COX2 inhibitors got new labels and have seem much less usage than expected.

I am saying that the longer term effects of any new drug/vaccine can bring unwanted sude effects that are unknown. That is why FDA requires longer term studies pre-approval. Fortunately we have an emergency so that the pharma companies can do their long term population health and regression studies openly, with a willing public, and no downside liability risk to the officers, directors or shareholders.

Maybe, in a couple years, we can say that the FDA's time series data for new dugs/vaccines/treatments can be scrapped altogether. That would certainly allow for far more innovative health therapies, holistic approaches and botanical solutions. So maybe there are a few potential upsides for this new FDA approach.

 

[Tim Steelersfan]

Come on man, follow the science! -- Beijing Joe Biden

U.S. Government Flags More Than 500 Scientists In U.S. That Might Be Compromised By Communist China

The U.S. federal government has flagged hundreds of scientists and hundreds of institutions that it has reason to believe might be compromised by communist China.

www.dailywire.com

The U.S. federal government has flagged hundreds of scientists and hundreds of institutions that it has reason to believe might be compromised by communist China.

“More than 500 federally funded scientists are under investigation for being compromised by China and other foreign powers,” The Washington Times reported. “The federal health officials told a Senate committee that they are fighting to keep up with large-scale Chinese efforts to corrupt American researchers and steal intellectual property that scientists hope will lead to biomedical advances.”

-----------

Nothing to see here folks, move along, the consensus has ruled, science has been decreed.

 

[NCSteelerfan]

I don't think they lie, you do? I do think there is not such thing as a perfect clinical trial that studies every med or device in every sector of the population with every possible variable studied in detail.

There are side effects in some number of people to virtually every single medical intervention in existence, and so there is always some acceptable level of risk. I for example had complete vestibular loss due to IV antibiotics. For the 5% or so of people who have inner ear damage it sucks to be one of the acceptable risks. But they would argue my risk of dying from sepsis outweighed my risk of the antibiotic screwing with my balance.

All of them all of the time.......no. Is it done or has it been done to push meds and devices on the market that should have been studied further or had more stringent guidelines/clinical trials testing.........Yes.

I understand side effects, and just about any medication/device has a potential and that the risks are weighed against the benefits. The act of taking an Ibuprofen pill can have some potential to harm someone, and I get that. I'm not admonishing the entire industry/med system.............but there are more than a few examples of manipulative marketing/data, clinical trials and push for things to go on the market that result in the harms/potential for harms outweighing the benefits. Look into the entire story of how opioids were marketed to the public and the outcome. There is a lot of information under reputable sources on this as well as Pharma companies finally being held liable for their part in creating it all in the name of getting in on the pain relief action. Using medications they knew were highly addictive and should not be used for long term issues, but were. A lot of doctors were also held liable for their part.

Also, look into how medical device clinical trials and approvals are handled verses medications. There is far less scrutiny in that arena and way more loop holes. That is not to say that there aren't a lot of devices out that are life saving and sustaining, just that the process allows for devices to go through approvals that should not have been introduced and may not have been approved had they gone through more extensive testing, etc. as well as loopholes available that are only supposed to be used in the most extreme circumstances but are used quite frequently to push devices to market IF there is a similar device already on market EVEN if that device was recalled prior due to safety concerns. They just had to say........hey, we fixed that.

With that I will bring up to discussion one particular device known as Essure. Introduced to the public by Conceptus in 2002 after approval by the FDA via PMA (preemption) as a class III device. What is Essure? It was an alternative permanent birth control device for women to give another option versus the standard tubal ligation. It was mostly pushed as the only non-surgical alternative as it consisted of two metal coils that would be inserted into the fallopian tubes via hysteroscopy through the Uterus. The patient could have this procedure done in the office with no general anesthesia, saddle bloc was usually given, some doctors used sedation and other pain blockers. Procedure was supposed to take no more than 20 minutes. Recovery time was advised to be quick, you could be back up and going the very next day. Immediate side effects were listed at the time as mild cramping, bleeding, headaches, upset stomach. Possible complications at time of insertion or prior to your 3 month check up to run a test to confirm correct placement and occlusion of the tubes were - puncturing of the tubes, coil breakage (from procedure), and possible migration - but these were considered extremely rare. There was a small blurb to physicians in the beginning about testing women for metal sensitivities prior to placing, but then that guidance was removed a few years later.

Now, in 2009 I had the Essure placed after a long discussion with my doctor over the pros and cons of the device verses getting tubal ligation. They were backing Essure whole heartedly, and in their defense, the doctors did not know everything that was going to happen to women, the extreme side effects that were occurring outside of the ones listed by Conceptus. As for the metal in the coils, I was told it was titanium and stainless steel and perfectly safe and all the other things that were so much better than getting a tubal. So, hey, I said sure, let's do this. I wish I had not, and IF I had the proper information that came out in 2016 when the FDA forced them to put a "black box" warning on the product with a stringent check list of the actual issues and side effects that could occur I would not have chosen Essure over Tubal. Oh, and the metals in the coils - sure there is titanium and stainless steel, but it also made up with nickel and tin with a coating of PET, which is what prompts an inflammatory response in your tube to cause scarring and the tube to close up. Without going through all of the issues over the years - this past February it was confirmed via CT Scan that the coil from my right tube had migrated into the endometrial tissue of my uterus. I am now having to get a hysterectomy to have the coils removed, because they just can't cut them out or pull them out as it was found out if you do that the coils break and fragments of the metals and PET spread through your body causing hyper immuno responses and life long debilitating health issues. Great huh.

Geez, this is longer than i wanted,...............but a class action was put against Bayer (they bought Conceptus in 2013/14) that was just settled for 1.6B in August 2020 after several years from the date it first started. 39,000 women were part of this suit. What came out of this action was the findings of changed questionnaires by the survey questioners - from women in the clinical study - changing answers from them advising of intense pain to "very good". Women that were dropped from the study that presented issues from the device. The study itself was only a few hundred women over 1 1/2 to 2 years with only 2% of those being followed for 2 more years. There was findings that Bayer withheld reporting over 16,000 adverse events to the FDA, which these things prompted the FDA to more scrutiny and then ordering the black box warning. The device is no longer available, it was discontinued for sales in 2018 but any kits that doctors already had could still be placed in women. The remaining devices that weren't placed by the end of 2019 had to be returned to Bayer. Bayer cites the reasoning behind stopping sales of the product as marketing issues, not safety. They aren't going to admit their product is ****. Of course, even with 39000 in the suit, there are still many women having issues come up, like me, that didn't present immediately. Hell, mine were placed in 2009 and it took to this year to confirm they were an issue. Considering there were still many women that got implanted up until 2019, well think about it.

Ok, I will stop there on that as that is way longer than I ever want to post, and there are a lot more details about the issues with Essure, the fall out, how having them listed as class III hurts further lawsuit - class III is held for what is considered life saving and sustaining - and has preemption which is supposed to protect the manufacturer from liability. Why would that classification be given to permanent birth control - it is also the classification for breast implants......wtf. All of the problems women have faced, deaths, thousands of hysterectomies, debilitating pain, profuse bleeding, autoimmune disorders, endometriosis, extreme fatigue, metal allergic reactions, hair falling out, teeth falling out, and the list goes on. The worst part...............there are so many doctors out there that are dismissive of this, but only because they still believe in the minimal side effects, and others that have no clue about Essure. Thank God there are some out there that know and listen and take care of their patients.

I know TLDR........sorry.

 

[Troglodyte]

What Trump did was just as wrong as what Tibs did. But hey, nice try at deflecting. Maybe someday you'll learn that one person's actions doesn't justify another's.

So Trump publicly mocks McCain’s service and he gets your vote. Tibs much less publicly mocks Crenshaw for something totally unrelated to his service and he’s way outta line? And it’s “just as wrong”?

Talk about false equivalencies!

 

[Tim Steelersfan]

So Trump publicly mocks McCain’s service and he gets your vote. Tibs much less publicly mocks Crenshaw for something totally unrelated to his service and he’s way outta line? And it’s “just as wrong”?

Talk about false equivalencies!

Your side won't allow criticism of any leader of color on any grounds because it's racist.
Your side won't allow ANY criticism of any leader who's LGBTQRZD because it is homophobic.

Likewise, any criticism of Dan Crenshaw proves you hate people with disabilities and you hate veterans.

------------

I love this game.

 

[Badcat]

So Trump publicly mocks McCain’s service and he gets your vote. Tibs much less publicly mocks Crenshaw for something totally unrelated to his service and he’s way outta line? And it’s “just as wrong”?

Talk about false equivalencies!

Here is an equivalency for you; did you vote for Joe Biden because of all the racist comments that he's made over the years, or did you vote for him because of the ideals that he stood for?

Being a veteran myself, I took offense to what the President said. I penned an email expressing my disgust of his statements and I'll express them in person if I ever get to meet him. But, his positions on issues were more in-line with my own than were Hillary Clinton's

If you don't agree with an elected official's actions then call it out. But men and women who bear the scars and demons of war are not to be looked down upon and called even the most trivial of names.

Got it?

 

[oneforthebus]

All of them all of the time.......no. Is it done or has it been done to push meds and devices on the market that should have been studied further or had more stringent guidelines/clinical trials testing.........Yes.

I understand side effects, and just about any medication/device has a potential and that the risks are weighed against the benefits. The act of taking an Ibuprofen pill can have some potential to harm someone, and I get that. I'm not admonishing the entire industry/med system.............but there are more than a few examples of manipulative marketing/data, clinical trials and push for things to go on the market that result in the harms/potential for harms outweighing the benefits. Look into the entire story of how opioids were marketed to the public and the outcome. There is a lot of information under reputable sources on this as well as Pharma companies finally being held liable for their part in creating it all in the name of getting in on the pain relief action. Using medications they knew were highly addictive and should not be used for long term issues, but were. A lot of doctors were also held liable for their part.

Also, look into how medical device clinical trials and approvals are handled verses medications. There is far less scrutiny in that arena and way more loop holes. That is not to say that there aren't a lot of devices out that are life saving and sustaining, just that the process allows for devices to go through approvals that should not have been introduced and may not have been approved had they gone through more extensive testing, etc. as well as loopholes available that are only supposed to be used in the most extreme circumstances but are used quite frequently to push devices to market IF there is a similar device already on market EVEN if that device was recalled prior due to safety concerns. They just had to say........hey, we fixed that.

With that I will bring up to discussion one particular device known as Essure. Introduced to the public by Conceptus in 2002 after approval by the FDA via PMA (preemption) as a class III device. What is Essure? It was an alternative permanent birth control device for women to give another option versus the standard tubal ligation. It was mostly pushed as the only non-surgical alternative as it consisted of two metal coils that would be inserted into the fallopian tubes via hysteroscopy through the Uterus. The patient could have this procedure done in the office with no general anesthesia, saddle bloc was usually given, some doctors used sedation and other pain blockers. Procedure was supposed to take no more than 20 minutes. Recovery time was advised to be quick, you could be back up and going the very next day. Immediate side effects were listed at the time as mild cramping, bleeding, headaches, upset stomach. Possible complications at time of insertion or prior to your 3 month check up to run a test to confirm correct placement and occlusion of the tubes were - puncturing of the tubes, coil breakage (from procedure), and possible migration - but these were considered extremely rare. There was a small blurb to physicians in the beginning about testing women for metal sensitivities prior to placing, but then that guidance was removed a few years later.

Now, in 2009 I had the Essure placed after a long discussion with my doctor over the pros and cons of the device verses getting tubal ligation. They were backing Essure whole heartedly, and in their defense, the doctors did not know everything that was going to happen to women, the extreme side effects that were occurring outside of the ones listed by Conceptus. As for the metal in the coils, I was told it was titanium and stainless steel and perfectly safe and all the other things that were so much better than getting a tubal. So, hey, I said sure, let's do this. I wish I had not, and IF I had the proper information that came out in 2016 when the FDA forced them to put a "black box" warning on the product with a stringent check list of the actual issues and side effects that could occur I would not have chosen Essure over Tubal. Oh, and the metals in the coils - sure there is titanium and stainless steel, but it also made up with nickel and tin with a coating of PET, which is what prompts an inflammatory response in your tube to cause scarring and the tube to close up. Without going through all of the issues over the years - this past February it was confirmed via CT Scan that the coil from my right tube had migrated into the endometrial tissue of my uterus. I am now having to get a hysterectomy to have the coils removed, because they just can't cut them out or pull them out as it was found out if you do that the coils break and fragments of the metals and PET spread through your body causing hyper immuno responses and life long debilitating health issues. Great huh.

Geez, this is longer than i wanted,...............but a class action was put against Bayer (they bought Conceptus in 2013/14) that was just settled for 1.6B in August 2020 after several years from the date it first started. 39,000 women were part of this suit. What came out of this action was the findings of changed questionnaires by the survey questioners - from women in the clinical study - changing answers from them advising of intense pain to "very good". Women that were dropped from the study that presented issues from the device. The study itself was only a few hundred women over 1 1/2 to 2 years with only 2% of those being followed for 2 more years. There was findings that Bayer withheld reporting over 16,000 adverse events to the FDA, which these things prompted the FDA to more scrutiny and then ordering the black box warning. The device is no longer available, it was discontinued for sales in 2018 but any kits that doctors already had could still be placed in women. The remaining devices that weren't placed by the end of 2019 had to be returned to Bayer. Bayer cites the reasoning behind stopping sales of the product as marketing issues, not safety. They aren't going to admit their product is ****. Of course, even with 39000 in the suit, there are still many women having issues come up, like me, that didn't present immediately. Hell, mine were placed in 2009 and it took to this year to confirm they were an issue. Considering there were still many women that got implanted up until 2019, well think about it.

Ok, I will stop there on that as that is way longer than I ever want to post, and there are a lot more details about the issues with Essure, the fall out, how having them listed as class III hurts further lawsuit - class III is held for what is considered life saving and sustaining - and has preemption which is supposed to protect the manufacturer from liability. Why would that classification be given to permanent birth control - it is also the classification for breast implants......wtf. All of the problems women have faced, deaths, thousands of hysterectomies, debilitating pain, profuse bleeding, autoimmune disorders, endometriosis, extreme fatigue, metal allergic reactions, hair falling out, teeth falling out, and the list goes on. The worst part...............there are so many doctors out there that are dismissive of this, but only because they still believe in the minimal side effects, and others that have no clue about Essure. Thank God there are some out there that know and listen and take care of their patients.

I know TLDR........sorry.

Not too long at all, very interesting. I'm sorry for what you're going through. Obviously unexpected things that didn't show up in clinical trials can happen but the covering up of data sounds like it should be dealt with in criminal courts as well as civil.

Hope it all works out for you.

 

[oneforthebus]

In any case, as I mentioned there are things that can go wrong with any medical intervention and obviously the vaccines are not zero risk.

Because of the nature of vaccines, generally a very tiny amount of some substance designed to make your immune system react in one way or another, adverse effects that happen months or years after a vaccine are extremely unlikely. The vast majority of serious adverse events are auto-immune related and therefore show up pretty quickly. The tiny amount injected in you doesn't stick around to cause damage months or years down the road. That of course would not hold true in things like medical devices implanted in your body or drugs that build up over time in your system. For this reason the clinical trial data that showed a remarkable dearth of adverse events (and virtually no different from placebo) was enough to convince me that the benefit is worth the risk.

Someone mentioned that the vaccine contains a carcinogen, and just like smoking one cigarette is unlikely to cause cancer, the tiny amount of a carcinogen (if it is one) that is in a vaccine would be extremely unlikely to cause cancer.

 

[Superman]

Is there, though? We're a year and a half into this, vaccinations are being rolled out at a pretty decent rate, along with those with antibodies, we should be getting close to where we need to be. Hopefully the new variants won't cause any suprises like the UK one did. And we should all be praying the Indian strain doesn't spread. Until then, I have zero problem wearing a mask when in public. Feel like if we've come this far, we can hopefully ride this out and get on with it.

Not gonna dive down any rabbit holes about the minutiae regarding masks. It seems blatantly obvious to me and basically everyone else on the planet that they do some measure of good. I have no problem with you holding a different view on this. I won't even mock you for it. Don't wear a mask, unless you absolutely have to, if it bothers you to this extent.

 

[NCSteelerfan]

In any case, as I mentioned there are things that can go wrong with any medical intervention and obviously the vaccines are not zero risk.

Because of the nature of vaccines, generally a very tiny amount of some substance designed to make your immune system react in one way or another, adverse effects that happen months or years after a vaccine are extremely unlikely. The vast majority of serious adverse events are auto-immune related and therefore show up pretty quickly. The tiny amount injected in you doesn't stick around to cause damage months or years down the road. That of course would not hold true in things like medical devices implanted in your body or drugs that build up over time in your system. For this reason the clinical trial data that showed a remarkable dearth of adverse events (and virtually no different from placebo) was enough to convince me that the benefit is worth the risk.

Someone mentioned that the vaccine contains a carcinogen, and just like smoking one cigarette is unlikely to cause cancer, the tiny amount of a carcinogen (if it is one) that is in a vaccine would be extremely unlikely to cause cancer.

That I get, and it's really not me saying I am absolutely never taking the vaccine just there is some hesitancy on my end and I'm taking a watch, wait and see before I finally decide on when I will take it or maybe something else comes out, who knows. I get the flu shot every year now, but didn't jump on getting that right away when it first came out either. As more people I know get it and I feel more comfortable I will more than likely take that next step..........when, can't say right now.

Probably the only person I trust right now medically speaking is my PCP. I have been seeing her for over 20 years and she listens, and takes care, you don't feel dismissed with this superior I am the doctor and you are the patient and I know more about what's happening in your body than you do attitude. When I feel more comfortable about it I will discuss with her and take the best course of action for myself. We shall see.

 

[oneforthebus]

That I get, and it's really not me saying I am absolutely never taking the vaccine just there is some hesitancy on my end and I'm taking a watch, wait and see before I finally decide on when I will take it or maybe something else comes out, who knows. I get the flu shot every year now, but didn't jump on getting that right away when it first came out either. As more people I know get it and I feel more comfortable I will more than likely take that next step..........when, can't say right now.

Probably the only person I trust right now medically speaking is my PCP. I have been seeing her for over 20 years and she listens, and takes care, you don't feel dismissed with this superior I am the doctor and you are the patient and I know more about what's happening in your body than you do attitude. When I feel more comfortable about it I will discuss with her and take the best course of action for myself. We shall see.

For people who are on the younger side and healthy I can understand wanting to take a wait and see approach. Covid for me was no worse than a cold and not even a bad one. For other people I know, not so much, but nothing life threatening in anyone who wasn't very elderly. So it's a legitimate debate to have with oneself I think.

Selfishly I'd like more people to get it because life won't really go back to normal until a whole lot more people do.

 

[Ron Burgundy]

Second shot last night. Had chills since lunch. JenZwain isn’t back on the board so it must be the shot.

 

[Ron Burgundy]

We can anticipate further restrictions on travel globally, with intense screenings at airports and ports of entry. The fact so many people were able to move in and out of Italy past two weeks pretty much unchecked - including to sporting events, an IT conference in Milan, etc. - is very concerning.

I guess we’ll have to see what happens.

 

[Steeltime]

Second shot last night. Had chills since lunch. JenZwain isn’t back on the board so it must be the shot.

Yeah, I had a fever, chills the day after the second shot. Nothing from first shot. Odd. Weird.

 

[ZonaBurgh]

Your side won't allow criticism of any leader of color on any grounds because it's racist.
Your side won't allow ANY criticism of any leader who's LGBTQRZD because it is homophobic.

Likewise, any criticism of Dan Crenshaw proves you hate people with disabilities and you hate veterans.

------------

I love this game.

That statement can't be anymore clear of the hypocrisy from the left. Made me chuckle.

 

[Ron Burgundy]

Yeah, I had a fever, chills the day after the second shot. Nothing from first shot. Odd. Weird.

Got chills bad this afternoon, then they went away about 4:30, then came back about 6:30. So far my arm isn't as sore as the first time. Didn't have chills before.

 

[IndySteel]

I don’t have any symptoms. Wonder why?

 

[Ron Burgundy]

I don’t have any symptoms. Wonder why?

Charlie Sheen's tiger blood?

 

[hamster]

Isn’t it funny that you can call variants by their country of origin, but you couldn’t call Covid the Chinese virus? Why is that?

 

[nitsuj1225]

Today’s Post-Gazette had a Kaiser Family Foundation poll that showed 29% of Republicans definitely not getting it and another 6% only getting it if it was required.

Maybe because more Republicans actually understand the severity of the virus (or lack thereof).