Jump to content

When offered the Vaccine, will you take it?


Recommended Posts

16 hours ago, fufkin said:

BTW, and I know I said I was out, but based on your '5 point categorization'  post, very laden with heavy deductions, a cursory glance at this thread should remove Miffy, NeedAClew, Bristol Cruiser and Short for Bob from the 'unequivocal' YES without reservation category. You should also re read the VOX article that I posted from another thread that you lifted to start this thread. It specifically mentions the false bias of answering a survey vs actually taking the first shot. 

Adjust your numbers on your 21 person fantasy survey that is totally un representative of the GP accordingly and knock yourself out.

This survey and your willful interpretation of it, might be...if you're keeping as open a mind as you say you are...pause for reflection.

 

I realize the sample size is meaning less.  According to reports, distrust of vaccine is much higher which is a negative for economy.

Me?  I will trust a vaccine approved by OVRR and FDA and when my number comes up, I will take it.  It is that simple.

If you think that means I trust Trump , (a guy who wishes a know pedophile "I wish her well"), then you are very much mistaken.  You have deduced something from my medical position on the process for approving vaccines to my position on politics...and for me....unlike some, they are not connected. That is the nub of our disagreements.  I wont be drawn into politics. I realize you think he can influence the approval process. I simply do not think that he can. Lets just agree to disagree.   

Link to post
Share on other sites
  • Replies 2.3k
  • Created
  • Last Reply

Top Posters In This Topic

Top Posters In This Topic

Popular Posts

The private sector has embarked on a major campaign to reassure the public that they will not release a vaccine until they are confident it is safe and effective. We can expect a joint statement from

As many of you know I am right of center politically.  I dont think vaccines are a political issue or at least they should not be.  My family are all vaccinated. I tried to think of how I should

You are such a bag of shit wrapped in a thin veneer of pseudo self esteem. You are a walking around killer of strangers free riding on those who got vaccinated. Sponger.

Posted Images

25 minutes ago, EYESAILOR said:

You have deduced something from my medical position on the process for approving vaccines to my position on politics...and for me....unlike some, they are not connected. That is the nub of our disagreements.  I wont be drawn into politics. I realize you think he can influence the approval process. I simply do not think that he can. Lets just agree to disagree. 

Whether or not he can influence the approval process, you and other medical professionals can potentially influence the election, intentionally or not.  For me, that is the nub of our disagreements.

Link to post
Share on other sites
57 minutes ago, EYESAILOR said:

I am sorry if I have got your viewpoint wrong.

So should I add a category of people who think the OVRR  will have rushed the review of phase 3 trials and there is a risk that the results are unreliable?   Would that fit the reason you would decline a vaccine?  A kind of combination of 3 (dont want to go first) and 4 (Dont trust FDA and OVRR)

If you want to add categories, be my guest, though this is an unscientific survey and the number of categories is approaching the 1/3 the number of responses. I'm not sure what you're trying to achieve by categorizing the responses but go for it. 

Link to post
Share on other sites
54 minutes ago, EYESAILOR said:

I realize the sample size is meaning less.  According to reports, distrust of vaccine is much higher which is a negative for economy.

Me?  I will trust a vaccine approved by OVRR and FDA and when my number comes up, I will take it.  It is that simple.

If you think that means I trust Trump , (a guy who wishes a know pedophile "I wish her well"), then you are very much mistaken.  You have deduced something from my medical position on the process for approving vaccines to my position on politics...and for me....unlike some, they are not connected. That is the nub of our disagreements.  I wont be drawn into politics. I realize you think he can influence the approval process. I simply do not think that he can. Lets just agree to disagree.   

The Justice Department has been influenced. 

DHS has been influenced. 

EPA has been influenced.

NOAA has been influenced.

CDC has been influenced.

FDA has been influenced.

This is just a partial list and the fact that an agency is ostensibly science-based has not protected them.

  • Like 1
Link to post
Share on other sites

normally I tend to figure that anti vaxxers are fucking idiots at best or ignorant self centered pricks at worst, but with the enormous financial and political pressure on big pharma in this instance I'm more than a little wary, I'm content to self isolate/social distance/wear a mask for 6 months to a year and let others be the guinea pigs.

 

2b

  • Like 1
Link to post
Share on other sites
20 hours ago, EYESAILOR said:

they think he has the power to override the usual checks and approval process for approving a safe vaccine. 

They do not 'think' he has that power.  He has that power.  Do you not understand this?

Link to post
Share on other sites
2 hours ago, EYESAILOR said:

I realize you think he can influence the approval process. I simply do not think that he can. Lets just agree to disagree.   

I don't understand how an evidence-based person can invent a fantasy like this. Do you really not understand the hierarchy of US executive agencies? Your faith in the independence of these agencies is, well, faith-based.

Link to post
Share on other sites
2 hours ago, EYESAILOR said:

I realize the sample size is meaning less.  According to reports, distrust of vaccine is much higher which is a negative for economy.

Me?  I will trust a vaccine approved by OVRR and FDA and when my number comes up, I will take it.  It is that simple.

If you think that means I trust Trump , (a guy who wishes a know pedophile "I wish her well"), then you are very much mistaken.  You have deduced something from my medical position on the process for approving vaccines to my position on politics...and for me....unlike some, they are not connected. That is the nub of our disagreements.  I wont be drawn into politics. I realize you think he can influence the approval process. I simply do not think that he can. Lets just agree to disagree.   

1 Not sure where I inferred that because you trust the FDA you therefore trust Trump. You have stated that you believe the FDA is autonomous and 100% neutral. Based on the timing of both chloroquine approval and plasma approval, I will agree to disagree agree. Your politics, frankly, are irrelevant to the discussion  in that you implicitly trust the FDA against outside influence.

2. I broached the subject of multiple vaccines of varying efficacies receiving approval, and foreign research efforts(and approvals)both beating US efforts to markets. What is to stop the administration from promoting one approved drug over another and is this optimum? On this I will agree to disagree.

3. Your main concern is uptake among citizens yet you want to look at things in a vacuum, casting aside the burden of optics. If the admin is perceived as over promising  a delivery date, that could be the biggest negative influence on initial uptake, regardless of whether or not the FDA followed things to the letter. The average person will NOT base their trust by studying the FDA approval process. I’d suggest their trust will be based on an amalgam of factors, mainly based around their baseline trust of institutions, their trust in executive leadership, what they read watch or listen to, and probably their family doctor, the latter of whom might be referring more than the odd second opinion. In many cases, they might only trust their pastor, their mother, their wife, their husband or their buddy.

4. The FDA has little control over what Trump says or what he might promise. Public Health officials have been repeatedly hamstrung in there messaging, and the ‘promise’ of a vaccine, whether you like it or not, has an obvious capacity to undermine the acceptance and uptake of the only current weapons we have against COVID-social distancing, masks, limiting crowds. I’d say yesterday’s multi 1000 person indoor maskless rally in Nevada, once again brought this disgusting refrain into sharp relief.

On the inherent political nature of your question, I guess we should also agree to disagree. 

Here was Dr Birx back in April pleading w people to not expect a magic bullet despite her boss cheerleading for chloroquine. Just one of so many examples of inter agency-executive strife.

...President Donald Trump has been a consistent cheerleader for the drugs, tweeting last month that hydroxychloroquine and the antibiotic azithromycin could be “one of the biggest game-changers in the history of medicine.” Still, experts on the U.S. coronavirus task force cautioned about early, anecdotal evidence. This week, Dr. Deborah Birx, a health expert in the group, said there’s no “magic bullet" in the nation's fight against the pandemic.

“There’s no magic vaccine or therapy,” she said, noting that the current U.S. battle will be won by social distancing measures...

https://www.fiercepharma.com/pharma/europe-locks-down-chloroquine-scripts-as-researchers-china-report-positive-controlled-covid

 

 

Link to post
Share on other sites
3 hours ago, EYESAILOR said:

 I wont be drawn into politics. I realize you think he can influence the approval process. I simply do not think that he can.  

On #1 while you might not be drawn into politics, the sad reality now is everything in society now is viewed through that lens first.  And since you clearly have a preconceived notion of both the answer and what should be done, and keep misrepresenting folk's position, and you are going to be linked to and viewed through a political lens.  To be fair, you have a doc's lens which may be worse and more dangerous for multiple reasons.

On #2, clearly yes they do.  And they are wrong (and you are right re #3) and its provably and factually incorrect but you are not going to change their mind. In many ways people like Clean are the most dangerous thing on this site in terms of people's health. People who do things based on the political lens are Darwin candidates and what will be, will be. But to set himself as (and wholly unqualified IMHO) arbitrator of truth and thereby stifle debate, and promote a flawed POV that would stop people who need to get vaccinated for their own health to not get vaccinated is ethically questionable if not immoral IMHO

Link to post
Share on other sites

April 23, 2020 — The U.S. Food and Drug Administration (FDA) issued a Drug Safety Communication today reminding doctors there are serious side effects when using hydroxychloroquine and chloroquine in the off-label use to treat COVID-19 patients. This includes potentially life-threatening heart rhythm problems. 

The FDA said case reports from the FDA Adverse Event Reporting System database, published medical literature and the American Association of Poison Control Centers National Poison Data System are reporting serious heart-related adverse events and death in patients. 

These COVID-19 patients were receiving hydroxychloroquine and chloroquine, either alone or combined with azithromycin or other QT-prolonging medicines. These adverse events included QT interval prolongation, ventricular tachycardia and ventricular fibrillation, and in some cases, death, the FDA said in its safety report. The FDA also said patients who have other health issues, such as heart and kidney disease, are at increased risk of these heart problems when receiving these medicines.

Link to post
Share on other sites
2 hours ago, IStream said:

The Justice Department has been influenced. 

DHS has been influenced. 

EPA has been influenced.

NOAA has been influenced.

CDC has been influenced.

FDA has been influenced.

This is just a partial list and the fact that an agency is ostensibly science-based has not protected them.

I will think about taking a vaccine while tRump is *resident IF

He and his whole family are given doses under 3rd party supervision.

They are all exposed to Covid-19

3 months pass and none are hospitalized

tRump himself can then speak in coherent sentences about a single subject for 1 minute.

 

 

 

Link to post
Share on other sites

The deputy director for public communication Caputo told a facebook gathering that there is a seditious* cabal of scientists with CDC working to undermine our Fearful Leader.

Yeah, I'll believe in a vaccine promoted by tRump.  Oh sure.

 

* His word.

Link to post
Share on other sites
44 minutes ago, MR.CLEAN said:

April 23, 2020 — The U.S. Food and Drug Administration (FDA) issued a Drug Safety Communication today reminding doctors there are serious side effects when using hydroxychloroquine and chloroquine in the off-label use to treat COVID-19 patients. This includes potentially life-threatening heart rhythm problems. 

The FDA said case reports from the FDA Adverse Event Reporting System database, published medical literature and the American Association of Poison Control Centers National Poison Data System are reporting serious heart-related adverse events and death in patients. 

These COVID-19 patients were receiving hydroxychloroquine and chloroquine, either alone or combined with azithromycin or other QT-prolonging medicines. These adverse events included QT interval prolongation, ventricular tachycardia and ventricular fibrillation, and in some cases, death, the FDA said in its safety report. The FDA also said patients who have other health issues, such as heart and kidney disease, are at increased risk of these heart problems when receiving these medicines.

Is this an example of the FDA contradicting Trump by issuing a DSC based on factual data?

Anyway......Some suggest that I am naive and dont understand that the OVRR and FDA vaccine review process has been compromised by political influence. We have to simply agree to disagree. Pointless discussing it any further. I have explained the checks and balances in how a vaccine is approved and specifically named the people involved and something about their personal history. Above all, how even the commissioner of the FDA cannot approve a drug or vaccine that has not  been recommended by the review team. We know who the review team is. We know they are not political appointees   I trust them and the [rocess. Others dont.  Fine. 

 

  • Like 1
Link to post
Share on other sites

For those of you who think it is safe to rely on the FDA, see below.  Would it have been immoral to caution those folks against taking hydrochloroquine even though the FDA was all about it?

 

.

In the first six months of 293 people died after taking hydroxychloroquine, according to the Milwaukee Journal Sentinel's review of the Food and Drug Administration's (FDA) adverse events reporting system. 

That's compared to just 75 in the first half of 2019. 

 

 

Link to post
Share on other sites
37 minutes ago, EYESAILOR said:

  I trust them and the [rocess. Others dont.  Fine. 

 

According to the administration, there is now a sleeper cell of some sort inside the CDC which is practicing sedition against the country.  

Link to post
Share on other sites
9 hours ago, MR.CLEAN said:

For those of you who think it is safe to rely on the FDA, see below.  Would it have been immoral to caution those folks against taking hydrochloroquine even though the FDA was all about it?

 

.

In the first six months of 293 people died after taking hydroxychloroquine, according to the Milwaukee Journal Sentinel's review of the Food and Drug Administration's (FDA) adverse events reporting system. 

That's compared to just 75 in the first half of 2019. 

 

 

The FDA never approved it for CV19 and went even further to issue a notice saying it was unsafe.

i think it was French doctors and POTUS who advocated it as a remedial

My answer to Eye is “yes” provided the vaccine is fully approved and the trial results are published   
 

 

  • Like 1
Link to post
Share on other sites

Bill Gates laments how much the reputation of the best regulatory agency in the world has been tarnished by Trumps pressure on his recently appointed commissioner to say "positive things".

Please dont we realize that if we allow Trump to tarnish the FDA then we are the losers.

Dont let Trump destroy the efficacy and trust of one of the good things that we have. I honestly believe that despite the blunders of a commissioner subject to political pressure, that the vaccine approval process has not been affected.

Yes Trump might make exaggerated claims when the phase 3 trials are announced. You will have to tune them out and look at the actual trial results. 

I really and truly hope we find a good vaccine because the US economy is a service economy. The employment of millions of people in hospitality and retail depends on a return to normal and although masks and distancing helps, a successful vaccine gets us back on track....and we need that.

I sit here on my way to my office.  Its real for me. I believe that dozens of patients delay visits and delay surgery because either they are not comfortable going to a hospital or because they lost their job and are worried about how to pay for stuff. My heart goes out to the economic suffering caused by CV1`9. So yes, I earnestly hope for a safe and reliable vaccine and I earnestly hope that the approval process is credible so that those of you worried or skeptical about vaccines feel comfortable enough to have you and your families vaccinated. 

It is an added stress on everyone that it is an election year in a bitterly partisan landscape.  I think many former presidents from either party would have made the fight vs CV19 a non-partisan issue.....it is  damn shame that the current political landscape is hindering a health challenge that is so important to our society. 

 

Link to post
Share on other sites
1 hour ago, IPLore said:

The FDA never approved it for CV19 and went even further to issue a notice saying it was unsafe.

i think it was French doctors and POTUS who advocated it as a remedial

My answer to Eye is “yes” provided the vaccine is fully approved and the trial results are published   
 

 

There was in fact an Emergency Use Authorization which was later revoked. 

https://www.fda.gov/media/138946/download

Link to post
Share on other sites
1 hour ago, IPLore said:

The FDA never approved it for CV19 and went even further to issue a notice saying it was unsafe.

i think it was French doctors and POTUS who advocated it as a remedial

My answer to Eye is “yes” provided the vaccine is fully approved and the trial results are published   
 

 

 

6 minutes ago, Matagi said:

There was in fact an Emergency Use Authorization which was later revoked. 

https://www.fda.gov/media/138946/download

You are both (also IPL) correct Matagi.  And what you, or Clean with his especially comical post re AEs above demonstrating just how little he understand what he is posting about (or how blinded by hate he might be), fail to understand that you are actually making Eye's case (and mine... on this point I agree w Eye) on behalf the FDA.

Link to post
Share on other sites
1 hour ago, IPLore said:

The FDA never approved it for CV19 and went even further to issue a notice saying it was unsafe.

i think it was French doctors and POTUS who advocated it as a remedial

My answer to Eye is “yes” provided the vaccine is fully approved and the trial results are published   
 

 

IPL:  To be strictly accurate.  At the request of BARDA, the FDA granted an emergency use approval in March when we were struggling to have any treatment protocols. Less than a month later they issued a safety warning and then withdrew EUA.   Withdrawing the EUA was the right thing to do based on the data.  

To be fair, the hospitals were using these compounds off label anyway, because of results from Europe, and sending data to FDA.   The data did not support the reports from Europe and the FDA quickly advised accordingly. Other protocols have been more successful but ultimately it would be much safer to have a vaccine. Nothing has been truly successful at remediation yet.  

Link to post
Share on other sites
1 hour ago, EYESAILOR said:

Bill Gates laments how much the reputation of the best regulatory agency in the world has been tarnished by Trumps pressure on his recently appointed commissioner to say "positive things".

 

Does Bill Gates know a thing or two about the FDA?  Does he know more than you? Is he an intelligent person?

Quote

Please dont we realize that if we allow Trump to tarnish the FDA then we are the losers.

You write this as though you 'we' have some special anti-trump spray that we can somehow use to prevent his political appointees from doing what they are already doing.  Are you smarter than Gates?  

The story Eye is referencing is here. https://www.bloomberg.com/news/articles/2020-09-15/bill-gates-wonders-whether-fda-can-be-trusted-on-a-covid-vaccine

 

Link to post
Share on other sites

Let's not forget that even later on, a person very (very!) high up the administration publicly suggested Sex on the Bleach or shining a UV light up your a**, just to try out, you know, because... why not? 

I mean, come on, early this year, every one with a medical degree and many others were basically plundering the cupboard just to find something -anything- that would quickly produce promising data.

Some still do.

I for one would love to see further studies on the Univerity of Cordoba's Vit D trials, that was a correlation that surprised me a lot. But that is just me and I would never shove that down someone's throat.

Sadly, we tend to forget that science means to stand on the shoulder of giants: you add up your knowledge, piece by piece. And you argue. But with data and facts. And you state, where you cannot explain the data. you don't take it an prove a point that may be wrong just as well.

Being the hobby-historian that I am, this all reminds me of the days when religious zealots came in the way of Galilei and others. I sometimes wonder where we would be as humans, had we had our enlightenment much earlier or -for that matter- had we been able to capture the innovations of the old Asian and Oriental societies. Why are we still behaving as if the holy inquisition was still around?

Link to post
Share on other sites
31 minutes ago, Wess said:

 

You are both (also IPL) correct Matagi.  And what you, or Clean with his especially comical post re AEs above demonstrating just how little he understand what he is posting about (or how blinded by hate he might be), fail to understand that you are actually making Eye's case (and mine... on this point I agree w Eye) on behalf the FDA.

ah and you are also smarter than gates.  What branch of infectious disease study is your degree in again, Wess?

Link to post
Share on other sites
49 minutes ago, Matagi said:

There was in fact an Emergency Use Authorization which was later revoked. 

https://www.fda.gov/media/138946/download

And there are still gullible idiots dying right now from taking hydrochloroquine thanks to their demon sperm docs and the fact that they can order this shit online.  

Link to post
Share on other sites

:blink:  Wow; just wow.  Do you interview your docs to know how they voted before getting a medical exam or taking their counsel?

But anyway I think I can fairly say I am closer to the facts, don't have a political motive (he does), and have greater insight on this issue.

But what is both scary and interesting (to me) is that more than anything else political hatred and irrational fear is driving some (and maybe even many or most) people's health care decisions on both sides.

The real funny thing here Clean is there is actually an interesting legal argument and even a precedent that you could be leveraging to spread your message.  But instead you post facts you don't understand and actually support the other side. 

Link to post
Share on other sites
38 minutes ago, Wess said:

:blink:  Wow; just wow.  Do you interview your docs to know how they voted before getting a medical exam or taking their counsel?

But anyway I think I can fairly say I am closer to the facts, don't have a political motive (he does), and have greater insight on this issue.

But what is both scary and interesting (to me) is that more than anything else political hatred and irrational fear is driving some (and maybe even many or most) people's health care decisions on both sides.

The real funny thing here Clean is there is actually an interesting legal argument and even a precedent that you could be leveraging to spread your message.  But instead you post facts you don't understand and actually support the other side. 

Wess, your perceptions are clouded by your habit of invalidating people to portray yourself as neutral and wise above all others.

I don't buy it.  Gaslighting doesn't work on me, I'm immune.

Link to post
Share on other sites
2 hours ago, Wess said:

political hatred and irrational fear is driving some (and maybe even many or most) people's health care decisions on both sides.

Is Bill Gates full of political hatred and irrational fear?  Do you know more about vaccines or governmental agencies than he does?  Or maybe you are a better businessman?

Link to post
Share on other sites
On 9/10/2020 at 5:37 PM, Wess said:

Look I can’t get into any great detail and you are going to believe whatever you want to believe but in terms of the Agencies relevant to this discussion you are so far off base you can’t begin to imagine.  The money grubbing nuts on TV are a different story but at a working level nothing has changed. Literally nothing. Given your (and your wife and kid’s) age and health it likely don’t matter what you do. And that is likely true for most folks. But for somebody older or in poor health what you are saying matters and while it maybe makes great internet fodder it’s absolutely totally 100% bunk. Just sayin...

I don't agree.  Clean is doing the right thing for other people.  No need to be sheep, call em all out, get an independent lab to approve it, be transparent and do it independently of the election dates... and get on with it...  Basically do what the govt should have done 5 months ago.  If you Blindly take what the FDA and other govt agencies say(even with them fudging the #'s at every turn) with this administration, you are insane and deserve what you get...  I personally put a vaccine prior to the election in the same bucket as the Russian one until there are other studies...  (My dad worked for Abbott and I am a stockholder, so I do  trust big Pharma to an extent.)  Not the ones in bed with this administration tho...  

Link to post
Share on other sites
18 hours ago, EYESAILOR said:

I realize the sample size is meaning less.  According to reports, distrust of vaccine is much higher which is a negative for economy.

Me?  I will trust a vaccine approved by OVRR and FDA and when my number comes up, I will take it.  It is that simple.

If you think that means I trust Trump , (a guy who wishes a know pedophile "I wish her well"), then you are very much mistaken.  You have deduced something from my medical position on the process for approving vaccines to my position on politics...and for me....unlike some, they are not connected. That is the nub of our disagreements.  I wont be drawn into politics. I realize you think he can influence the approval process. I simply do not think that he can. Lets just agree to disagree.   

IMHO, My life, or that of my loved ones is not going to rest on a any agency that has trumps fingers in it until full (To a reasonable extent) trials are complete....  I have spent the better part of 5 months within 5 mi of my house, IN THE SUMMER....  I can certainly make it another couple until the vaccine is deemed not to kill people...    YMMV

Link to post
Share on other sites
13 hours ago, EYESAILOR said:

Is this an example of the FDA contradicting Trump by issuing a DSC based on factual data?

Anyway......Some suggest that I am naive and dont understand that the OVRR and FDA vaccine review process has been compromised by political influence. We have to simply agree to disagree. Pointless discussing it any further. I have explained the checks and balances in how a vaccine is approved and specifically named the people involved and something about their personal history. Above all, how even the commissioner of the FDA cannot approve a drug or vaccine that has not  been recommended by the review team. We know who the review team is. We know they are not political appointees   I trust them and the [rocess. Others dont.  Fine. 

 

Eye, 

You are the voice I have been listening to as you are a doc and I am not.  I am using your info.  Please keep posting.  We agree on mostly everything except the orange ones influence and your arguments are persuasive and rational.  

 

Thank you for your input...  

Link to post
Share on other sites

Eye, I'd like to express my gratitude for your presence here as well. We may disagree on the degree to which the FDA has, can, and will maintain its independence from the Trump administration's influences, but I do appreciate the medical information you provide.

Link to post
Share on other sites

As long as the discussion is about science and medicine, Eye is an unimpeachable and trusted source.  As soon as it is about the hierarchy and power of criminally minded political appointees in administrative agencies,  she is no longer in an area in which she has any expertise.  And of course, final approval of a vaccine is a call made directly by Trump through his lying cheating scamming douchebag FDA director.

Wess says things like "I can't go into any great detail" and "literally nothing has changed" to suggest he is or has some authority on the issue, but i guarantee you that he is just another trumpy pretending to be something else. 

Link to post
Share on other sites
14 hours ago, EYESAILOR said:

Is this an example of the FDA contradicting Trump by issuing a DSC based on factual data?

Anyway......Some suggest that I am naive and dont understand that the OVRR and FDA vaccine review process has been compromised by political influence. 

You might be interested in the corruption standing of the USA by the International community.  In 2019 the USA is ranked #23, behind the UAE at #21.

https://en.wikipedia.org/wiki/Corruption_Perceptions_Index

Link to post
Share on other sites
11 minutes ago, Terry Hollis said:

You might be interested in the corruption standing of the USA by the International community.  In 2019 the USA is ranked #23, behind the UAE at #21.

https://en.wikipedia.org/wiki/Corruption_Perceptions_Index

In 2020 the US is likely to drop another ten points or so, around botswana/israel/brunei level. #winning

 

Link to post
Share on other sites
4 hours ago, shaggy said:

  No need to be sheep, call em all out, get an independent lab to approve it, be transparent and do it independently of the election dates... and get on with it...

The way a trial works is that it is farmed out to lots of independent research organizations. They have to be certified. Many are teaching institutions.  Some are just research and testing clinics. The data is then pooled by the research group who analyze and decide whether to proceed with a submission to the FDA,The FDA does not conduct the trials themselves, Their role is to review the data and the submission.  When you read about a vaccine or drug that failed phase 3 trials,  9 times out of 10, it didnt even go to the FDA.

 

  • Like 1
Link to post
Share on other sites
7 hours ago, MR.CLEAN said:

Does Bill Gates know a thing or two about the FDA?  Does he know more than you? Is he an intelligent person?    Yes.  But in this case we agree. Trump is tarnishing the reputation of the FDA.  Gates point is the same as mine.  He is saying that Trump meddling in announcements by his commissioner is tainting the reputation of one of the best regulatory agencies in the world....which might cause people (and he could well point to you) to distrust the work of the good people at the FDA and negatively effect the roll out of the vaccines.

You write this as though you 'we' have some special anti-trump spray that we can somehow use to prevent his political appointees from doing what they are already doing.  Are you smarter than Gates?  I spay it on myself so that I can look at the vaccine trials objectively without paranoia.    Of course I am not an expert in lobbying or politics but I am good at looking at new drug approvals to understand possible side effects etc.

The story Eye is referencing is here. https://www.bloomberg.com/news/articles/2020-09-15/bill-gates-wonders-whether-fda-can-be-trusted-on-a-covid-vaccine

 

 

Link to post
Share on other sites
4 hours ago, MR.CLEAN said:

As long as the discussion is about science and medicine, Eye is an unimpeachable and trusted source.  As soon as it is about the hierarchy

True about most administrative agencies but I have provided some factual information about the process for approving a vaccine and actually named the team members who will be responsible for approving a CV19 vaccine.

Going back to my post which specifically names who will be responsible for sending a recommendation to accept or decline a vaccine, you havent identified one of them as "criminally minded".......so although no expertise in any other agency, I can at least name the key people and their role.  ....so perhaps a bit less of a non-expert than you?

Just as a reminder.....the commissioner of the FDA does not approce a vaccine unless the OVRR has approved it first. He can decline an approval they recommend approving, but he cannot approve a vaccine they have declined because it doesnt get to his desk. I guess he could storm over to her office and deamnd that a rejected vaccine is looked at again.....but I think the staff would politely agree to look at the data again and come to the same result. He could fire them all, and hire a whole new OVRR but they wont be ready before the election.

 

 

and power of criminally minded political appointees in administrative agencies,  she is no longer in an area in which she has any expertise.  And of course, final approval of a vaccine is a call made directly by Trump through his lying cheating scamming douchebag FDA director.

Wess says things like "I can't go into any great detail" and "literally nothing has changed" to suggest he is or has some authority on the issue, but i guarantee you that he is just another trumpy pretending to be something else. 

 

Link to post
Share on other sites

Changing topic.....but hopefully sharing something interesting to all of you.

By way of background CT is a Democrat state with a Democrat Governor called Ned Lamont, The state epidemiologist is a good guy called Matt Cartter and the person who will be in charge of any vaccine program is Kathy Kudish. Both are employees of CT Dept Public Health. 

The State is already planning how it would administer CV19 vaccines if one is approved. That is sensible because planning is everything in a mass vaccination program. I imagine all of your states are doing the same. Nobody in our DPH is beholden to Trump.

Here is an extract from the first step. The full memo is longer but I think you get the gist:

  2120747096_1Vaccine.thumb.JPG.75ee4e266d6d46633201a553f3d8d42d.JPG

Link to post
Share on other sites

Democrats Fear Trump Will Rush Unsafe Vaccine To Help His Reelection Bid, by Igor Bobic, 09/15/2020
Republicans respond by calling Democrats “the party of anti-vaxxers.”
https://www.huffpost.com/entry/coronavirus-vaccine-trump-2020-election_n_5f60cc29c5b65fd7b8550ef9

I hate to quote an entire article but every line of this one is good.

Quote

Democrats are very suspicious of President Donald Trump’s big promises to develop and bring to market a vaccine for the coronavirus before the end of the year.

They fear the president and his political appointees at the Department of Health and Human Services will pressure scientists, regulators and drugmakers into releasing an insufficiently safe or effective vaccine in order to help bolster Trump’s reelection chances in November. 

Republicans, meanwhile, say Democrats are guilty of sowing doubt about a potential vaccine by engaging in what they’ve called unfounded and irresponsible conspiracy theories driven primarily by Democrats’ opposition to Trump.

The heated fight over a vaccine marks yet another way in which the COVID-19 pandemic is dominating the campaign ― in both the presidential race and down-ballot contests ― during the final weeks before Election Day.

“I would be hesitant, but I’m going to ask a lot of questions. I think that is incumbent on all of us right now, in this environment, with the way we’ve seen politics intervening in Washington,” said Democratic Senate candidate Cal Cunningham during a Monday debate against Sen. Thom Tillis (R-N.C.) when asked if he would take a vaccine if one were available before the end of the year.

“That statement puts lives at risk,” shot back Tillis, who is considered vulnerable in this year’s election. Tillis’ campaign later clipped the exchange for a digital ad. Some North Carolina political commentators called the moment a “gaffe” by Cunningham.

Sen. Tom Cotton (R-Ark.) soon weighed in on Twitter, calling Democrats “the party of anti-vaxxers.”

Polls show that most Americans don’t trust what Trump has said about a vaccine and that they have concerns about political pressure by the Trump administration and whether it might lead to an unsafe and rushed product. One recent poll found as few as 50% of people in the U.S. are committed to taking a coronavirus vaccine.

It’s not hard to see why there’s so much mistrust.
[...]
“I’m not doing it for political reasons. I want the vaccine fast,” Trump said Tuesday in an interview on “Fox & Friends.” “You wouldn’t have a vaccine for years. ... I speeded up the process with the FDA. ... We’re going to have a vaccine in a matter of weeks ― it could be four weeks, it could be eight weeks.

The rollout of a vaccine ― or even merely the announcement of a vaccine ― before November would plainly aid Trump’s reelection bid. The president has shown no qualms about marshaling the powers of the federal government to help his campaign, including staging pardon and naturalization ceremonies as part of the GOP’s official nominating convention last month, so it’s not entirely far-fetched that he might do so again.
[...]
But Democrats remain skeptical about promises from Trump’s political appointees and their meddling in health agencies like the FDA and the CDC.

”It has become abundantly clear that the leadership at the Department of Health and Human Services has allowed perhaps the most important federal agency right now to become subservient to the president’s daily whims,” Senate Minority Leader Chuck Schumer (D-N.Y.) said Tuesday, calling on HHS Secretary Alex Azar to resign.

Sen. Elizabeth Warren (D-Mass.) joined over a dozen other Senate Democrats in asking the FDA to commit to a transparent review process for potential vaccines. 

“We are concerned that the accelerated timeline and intense political pressure around the vaccine development process could have the unintended consequence of undermining public confidence in the safety and quality of an eventual vaccine,” the senators wrote in a letter on Monday.

 

Link to post
Share on other sites

Trump Administration Has Yet To Pay USPS For COVID-19 Postcard Issued In March, 09/15/2020
The postcard featured “PRESIDENT TRUMP’S CORONAVIRUS GUIDELINES FOR AMERICA” — despite the president downplaying COVID-19 at the time.
https://www.huffpost.com/entry/trump-usps-covid-19-postcar_n_5f60d34cc5b68d1b09c81473

Quote

Donald Trump’s administration has yet to repay the U.S. Postal Service for a postcard it sent out in March prominently displaying the president’s name alongside a series of guidelines for combating COVID-19, according to a report from USA Today.  

The cost of producing and sending the postcards to an estimated 138 million addresses across the U.S. was $28 million, USA Today reported, with $4.6 million spent on printing alone.
[...]
A letter sent in early April by Kyle Herrig, president of watchdog group Accountable.US, to the inspector general of the U.S. Department of Health and Human Services called the postcard a case of “electioneering.”  

In terms of design, the main feature of the mailing is Trump’s name rather than the actual guidelines,” the letter stated. “In fact, the message including the President’s name takes up more real estate on the postcard — one full side — than any other item.”

 

Link to post
Share on other sites

Scientific American Makes First Political Endorsement In 175 Years, 09/15/2020
“[Trump’s] administration has been even worse for science than we feared,” Scientific American Editor-in-Chief Laura Helmuth told HuffPost.
https://www.huffpost.com/entry/scientific-american-endorses-joe-biden_n_5f60e701c5b6e27db133a902

Quote

Scientific American has dipped a toe into political waters for the first time in its 175-year history and is endorsing Joe Biden for president.

The science and research publication is publishing the endorsement in a two-page statement in its upcoming October issue.

“Scientific American has never endorsed a presidential candidate in its 175-year history,” the editors wrote. “This year we are compelled to do so. We do not do this lightly.”

 

Link to post
Share on other sites

Patagonia’s New Clothing Tag Has A Punchy Political Message: ‘Vote The Assholes Out’, 09/15/2020
The brand said the tag on their shorts “refers to politicians from any party who deny or disregard the climate crisis and ignore science.”
https://www.huffpost.com/entry/patagonia-clothing-tag-trump-election_n_5f60d61dc5b65fd7b8553e06

patagonia_tag.jpg.84ddf8a85af95d3bbedaf235407d793d.jpg

  • Like 1
Link to post
Share on other sites
2 hours ago, EYESAILOR said:

 

Thank you for the additional information.  Can you say, beyond any doubt, that Dr. Gruber would never, ever approve a vaccine unless she was sure it was safe and effective, and would resign immediately and go to the press if she found that somehow the FDA decided to approve a vaccine that the OVRR rejected?

Link to post
Share on other sites
11 minutes ago, ProaSailor said:

Democrats Fear Trump Will Rush Unsafe Vaccine To Help His Reelection Bid, by Igor Bobic, 09/15/2020
Republicans respond by calling Democrats “the party of anti-vaxxers.”
https://www.huffpost.com/entry/coronavirus-vaccine-trump-2020-election_n_5f60cc29c5b65fd7b8550ef9

I hate to quote an entire article but every line of this one is good.

 

It is so damn sad ........I dislike what both sides are saying. I dislike politicians. All they care about is the election. This is a health crisis and an economic crisis. 

I am tired and exhausted tonight. I have been up since 4 am. I have not left my office yet.  I have been understaffed since March.  I have patients who layer on stress to their underlying medical condition. 

I look forward to a vaccine because I see it as a realistic light at the end of the tunnel but we have to have an approval process that we trust, Now both sides are saying this that cause distrust. All for now.

Link to post
Share on other sites
Just now, MR.CLEAN said:

Thank you for the additional information.  Would you say Dr. Gruber would never, ever approve a vaccine unless she was sure it was safe and effective, and would resign immediately and go to the press if she found that somehow the FDA decided to approve a vaccine that the OVRR rejected?

Would you say Dr. Gruber would never, ever approve a vaccine unless she was sure it was safe and effective?   Yes.

If the FDA Commissioner approved a vaccine that the OVRR rejected I am confident that that information would be made public.    I cannot say whether she would be best advised to resign or not. She might choose to be terminated...or just to stay in place. Only her legal advisers can advise on that. Im not a lawyer.

It is quite hard to see how the FDA commissioner can approve something that is not submitted to him for approval but I guess in that scenario then the OVRR can deny they approved it.

In addition they are certainly obliged to tell the company that it was not approved. As a lawyer, can you imagine the liability risk of say Pfizer going to market with a vaccine that has been deemed unsafe by OVRR....I dont know, you are a lawyer, I imagine that if Bayer is paying, what $10 bn for round up which has been deemed safe by all the regulatory bodies and research until one case and is used in bulk by agricultural workes and landscapers...what would a vaccine liability be for something that was unsafe and used to dose tens of millions..,,,$20bn? more?   $50bn?

Link to post
Share on other sites
14 minutes ago, EYESAILOR said:

It is so damn sad ........I dislike what both sides are saying. I dislike politicians. All they care about is the election.

There is only one side to blame for this very sad state of affairs.  And it goes way beyond the pandemic.

3 minutes ago, EYESAILOR said:

I imagine that if Bayer is paying, what $10 bn for round up which has been deemed safe by all the regulatory bodies and research until one case and is used in bulk by agricultural workes and landscapers...

Glad you brought that up.  How did Roundup weed killer ever get approved as safe when one look at the black death along the roads on Kauai, where the stuff runs directly into the rivers and ocean, tells anyone with common sense otherwise?  The sad fact is that a lot of people don't have common sense and believe what they are told.

Link to post
Share on other sites
1 hour ago, EYESAILOR said:

Would you say Dr. Gruber would never, ever approve a vaccine unless she was sure it was safe and effective?   Yes.

If the FDA Commissioner approved a vaccine that the OVRR rejected I am confident that that information would be made public.    I cannot say whether she would be best advised to resign or not. She might choose to be terminated...or just to stay in place. Only her legal advisers can advise on that. Im not a lawyer.

It is quite hard to see how the FDA commissioner can approve something that is not submitted to him for approval but I guess in that scenario then the OVRR can deny they approved it.

In addition they are certainly obliged to tell the company that it was not approved. As a lawyer, can you imagine the liability risk of say Pfizer going to market with a vaccine that has been deemed unsafe by OVRR....I dont know, you are a lawyer, I imagine that if Bayer is paying, what $10 bn for round up which has been deemed safe by all the regulatory bodies and research until one case and is used in bulk by agricultural workes and landscapers...what would a vaccine liability be for something that was unsafe and used to dose tens of millions..,,,$20bn? more?   $50bn?

Do you actually think that the OWS agreements do not indemnify Pfizer and every other vaccine developer and manufacturer from exactly that claim????? Do you not remember who negotiated those agreements? Never mind that no one would be able to prove negligence if one agency rejects and another approves.  

 https://scholarship.shu.edu/cgi/viewcontent.cgi?article=1279&context=student_scholarship

 

 

 

Link to post
Share on other sites
1 hour ago, ProaSailor said:

The sad fact is that a lot of people don't have common sense and believe what they are told.

By the way, a medical degree does not guarantee common sense.  A doctor friend of mine with an encyclopedic memory for facts and trivia had some of the craziest notions I ever heard about healthy foods, including GMOs.   Smart, well educated people can be very weird (and wrong) about many things - with absolute confidence and authority.

Link to post
Share on other sites
On 9/8/2020 at 5:31 PM, Kent H said:

However I follow a couple of guys who seem to know what to do well before most people.   Scott Gottlieb and Jim Cramer.   Everything I am reading is to stay clear of Moderna.   I am waiting to see what shot Jim Cramer gets.  He seems to have access to a tremendous amount of insider information.

This sounds like complete bullshit from crazy Jim Cramer:

 

Link to post
Share on other sites

I think Mr. Cramer has called her Crazy Nancy so many times in private that he slipped up. Good for her for calling him on it and she demonstrated real grace after he started flailing by jumping in to drop the subject and talk about Trump. 

Link to post
Share on other sites
2 hours ago, IStream said:

I think Mr. Cramer has called her Crazy Nancy so many times in private that he slipped up.

I don't believe Cramer's remark was a slip up at all.  "I have such reference for the office I would never use that term." is complete horseshit!  Respect for the office maybe but clearly none for Pelosi.  Cramer is a dishonest deplorable dick.

Link to post
Share on other sites

Most of this story is behind a pay wall.

The Global Rush to Approve a COVID-19 Vaccine Keeps Getting Creepier, by David Axe, Sep. 16, 2020
https://www.thedailybeast.com/the-global-rush-to-approve-a-covid-19-vaccine-keeps-getting-worse

Quote

The United Arab Emirates has approved a largely untested Chinese vaccine for emergency use, making the vaccine available to health-care workers as the country experiences a surge in COVID-19 cases.

It’s a reckless move, experts told The Daily Beast, one they described as just the latest sign of the global race for a coronavirus vaccine going off the rails. Pushing a vaccine before the completion of large-scale Phase 3 trials risks exposing people to dangerous complications—and, of course, it might not even protect anyone.

 

Different story, quoted in full:

CDC Director: Face Masks Are Better COVID-19 Safeguard Than Potential Vaccine, Sep. 16, 2020
https://www.thedailybeast.com/cdc-director-robert-redfield-says-face-masks-are-better-coronavirus-safeguard-than-potential-vaccine

Quote

Robert Redfield, director of the Centers for Disease Control and Prevention, told a Senate committee Wednesday that he believes face masks are “the most important, powerful public health tool we have” to fight COVID-19—and even better than a potential vaccine. “This face mask is more guaranteed to protect me against COVID than when I take a COVID vaccine because the immunogenicity may be 70 percent and if I don’t get an immune response the vaccine’s not going to protect me,” Redfield said. He strongly recommended all Americans wear face masks, especially young people who continue to spike the curve of infections. Redfield also told the committee most Americans probably wouldn’t be vaccinated against COVID-19 until summer or early autumn 2021.

 

Link to post
Share on other sites

Trump Health Official Taking Leave Of Absence After CDC, Election Conspiracies Rant, 09/16/2020
https://www.huffpost.com/entry/michael-caputo-apology-facebook-rant_n_5f620d85c5b68d1b09ca6b34

Quote

Michael Caputo, the politically appointed assistant secretary for public affairs at the nation’s health department, is taking a leave of absence [for 60 days], the agency announced Wednesday. This follows his posting a video of himself accusing the government scientists fighting the coronavirus pandemic of having a “resistance unit” and of plotting to undermine President Donald Trump.

Caputo’s science adviser, Dr. Paul Alexander, will also leave the Department of Health and Human Services entirely, the agency said in a statement.

 

Link to post
Share on other sites

I'm sure this will shock you but I thought I would let you know, that yesterday I volunteered for the vaccine trials for Covid-19, held here in the Charlotte  area. The vaccine is one that was created in Russia.
I received my first shot yesterday at 4:00 pm, and I wanted to let you know that it’s completely safe, with иo side effects whatsoeveя, and that I feelshκι χoρoshό я чувствую себя немного странно и я думаю, что вытащил ослиные уши.

Link to post
Share on other sites

I read this yesterday but didn't post it because it sounds speculative and uncertain.  Still, the issue of how long immunity lasts is an important consideration since:

  1. Annual shots might be necessary. (for the rest of our lives!?)
  2. Some people may lose immunity in less than 12 months.

Coupled with the suggestion by the CDC director that immunogenicity of a COVID vaccine may be only 70% (meaning it has no effect on 30% of recipients), there appear to be some weak spots in the assertion that a vaccine is our best and only hope?

 

Coronavirus immunity may not last more than 12 months, study finds, SEPTEMBER 16, 2020
A group of scientists studied protective immunity to similar coronaviruses and reached troubling conclusions
https://www.salon.com/2020/09/16/coronavirus-immunity-may-not-last-more-than-12-months-study-finds/

Quote

Having previous knowledge of the behavior of other coronaviruses has been a boon to scientists, as it allows for some predictions as to SARS-CoV-2's likely behavior. 

On this premise, a study published on Monday in the scientific journal Nature Medicine reached a troubling conclusion about SARS-CoV-2 — namely, that people who contract the virus and then become immune to it may not stay that way for long. The scientists reached their conclusion by studying whether those infected with previous seasonal coronaviruses retained their immunity. Unfortunately, they didn't.

"A key unsolved question in the current coronavirus disease 2019 (COVID-19) pandemic is the duration of acquired immunity," the scientists — who hailed from Belgium, the Netherlands and Spain — wrote in their abstract. "Insights from infections with the four seasonal human coronaviruses might reveal common characteristics applicable to all human coronaviruses. We monitored healthy individuals for more than 35 years and determined that reinfection with the same seasonal coronavirus occurred frequently at 12 months after infection."
[...]
Unfortunately, the scientists learned through their research that "in a few cases, reinfections occurred as early as 6 months (twice with HCoV-229E and once with HCoV-OC43) and 9 months (once with HCoV-NL63), but reinfections were frequently observed at 12 months."
[...]
The findings have huge repercussions for public health globally, as well as for the application and distribution of vaccines. 

 

Link to post
Share on other sites

I'm not a doctor but...  this approach ("Treating") sounds much better to me than a vaccine.

Pitt Scientists Discover Tiny Antibody Component That is Highly Effective in Preventing and Treating SARS-CoV-2 Infection in Animal Models, September 14, 2020
https://www.pittwire.pitt.edu/news/pitt-scientists-discover-tiny-antibody-component-highly-effective-preventing-and-treating-sars

Quote

University of Pittsburgh School of Medicine scientists have isolated the smallest biological molecule to date that completely and specifically neutralizes the SARS-CoV-2 virus, which is the cause of COVID-19. This antibody component, which is 10 times smaller than a full-sized antibody, has been used to construct a drug—known as Ab8—for potential use as a therapeutic and prophylactic against SARS-CoV-2.

The researchers report today in the journal Cell that Ab8 is highly effective in preventing and treating SARS-CoV-2 infection in mice and hamsters. Its tiny size not only increases its potential for diffusion in tissues to better neutralize the virus, but also makes it possible to administer the drug by alternative routes, including inhalation. Importantly, it does not bind to human cells—a good sign that it won’t have negative side-effects in people.

Ab8 was evaluated in conjunction with scientists from the University of North Carolina at Chapel Hill (UNC) and University of Texas Medical Branch (UTMB) at Galveston, as well as the University of British Columbia and University of Saskatchewan.

 

More here:

Human testing for new COVID-19 treatment developed by Pitt researchers planned for 2021, SEP 15, 2020
https://www.post-gazette.com/business/healthcare-business/2020/09/15/human-testing-Ab8-COVID-19-UPMC-Pitt-research-antibody-vaccine/stories/202009150155

Quote

A Pittsburgh-created medicine to prevent and treat COVID-19 could begin testing in humans in 2021, University of Pittsburgh doctors said Tuesday.

Safety trials of the medicine, dubbed Ab8, will start next year with the hope of getting Food and Drug Administration approval to begin clinical trials, said Dr. John Mellors, chief of the Division of Infectious Diseases at UPMC and Pitt, the hospital giant’s academic partner.

The medicine — which is not a vaccine — is meant to help protect people who are already infected with COVID-19 from having it spread further in their bodies. It should last “weeks to months,” Dr. Mellors said during a briefing, but added that it was too early to speculate about the cost of the treatment. 

 

Link to post
Share on other sites

https://investors.pfizer.com/investor-news/press-release-details/2020/Pfizer-and-BioNTech-Propose-Expansion-of-Pivotal-COVID-19-Vaccine-Trial/default.aspx

NEW YORK & MAINZ, Germany--(BUSINESS WIRE)-- Pfizer Inc. (NYSE: PFE) and BioNTech SE (NASDAQ: BNTX) announced today that they have submitted an amended protocol to the U.S. Food and Drug Administration to expand the enrollment of their Phase 3 pivotal COVID-19 vaccine trial to up to approximately 44,000 participants which also allows for the enrollment of new populations.

This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20200912005013/en/

Enrollment in the trial has been proceeding as planned and the company expects to reach its initial target of up to 30,000 participants next week. The proposed expansion would allow the companies to further increase trial population diversity, and include adolescents as young as 16 years of age and people with chronic, stable HIV (human immunodeficiency viruses), Hepatitis C, or Hepatitis B infection, as well as provide additional safety and efficacy data.

The pivotal trial is event-based and there are many variables that will ultimately impact read-out timing. As stated previously, based on current infection rates, the companies continue to expect that a conclusive readout on efficacy is likely by the end of October.

 

Link to post
Share on other sites

Here is the Moderna Phase 3 trial protocol

https://www.modernatx.com/sites/default/files/mRNA-1273-P301-Protocol.pdf

This is unusual. The results of a trial for a submitted treatment are public but its unusual and very transparent to publish the protocol ahead of time. From this we get to see what they are doing and to compare the submitted results vs the items they said they would review.

Pfizer has done or will shortly do the same.

The folks supervising the trials are going above and beyond to provide transparency so that we.get some sense of trust in the process.

Please note my post up thread where I forecast that Tak Zal would be in overall charge of the Moderna trial....I guess I got one thing right.

 

For anyone still worried about political interference, Page 124 paragraph (b) describes the strict controls on how Trump gets to edit the final recommendation and how his edits are subject to independent review by Rudy Giuliani,  Mikhail Murashko and Jared Kushner.

  • Like 1
Link to post
Share on other sites
1 hour ago, EYESAILOR said:

For anyone still worried about political interference, Page 124 paragraph (b) describes the strict controls on how Trump gets to edit the final recommendation and how his edits are subject to independent review by Rudy Giuliani,  Mikhail Murashko and Jared Kushner.

Very funny.  Cavalier jokes about political influence won't be so funny if Trump gets an electoral boost related to an early COVID-19 vaccine.

1 hour ago, EYESAILOR said:

As stated previously, based on current infection rates, the companies continue to expect that a conclusive readout on efficacy is likely by the end of October.

In other words, by November 1st, just as Trump claimed in early August.  Good for him?  Oh yeah it is.

Link to post
Share on other sites
On 9/17/2020 at 6:14 PM, EYESAILOR said:

 

 

For anyone still worried about political interference, Page 124 paragraph (b) describes the strict controls on how Trump gets to edit the final recommendation and how his edits are subject to independent review by Rudy Giuliani,  Mikhail Murashko and Jared Kushner.

Well this sure seems like transparency?

 

The White House has blocked FDA Commissioner Stephen Hahn from testifying to a House committee about his agency’s pandemic response, angering the panel's top Democrats who said they have pressing questions about political interference at the agency.

“The American people deserve to hear Commissioner Hahn’s response to those concerns during a public hearing and what actions he is taking to ensure that the agency’s COVID-19 decisions remain science-based,” said Frank Pallone (D-N.J.), chair of the Energy and Commerce Committee, and Anna Eshoo (D-Calif.), who heads its health subcommittee.

A White House spokesperson confirmed that Hahn was blocked from testifying, calling the decision "part of the administration’s existing protocol to make sure health officials can keep their time and energy focused on responding to the coronavirus." The spokesperson noted Hahn has testified to Congress four times in the past six months, including before Pallone's committee in June.

Link to post
Share on other sites
4 minutes ago, MR.CLEAN said:

Well this sure seems like transparency?

 

The White House has blocked FDA Commissioner Stephen Hahn from testifying to a House committee about his agency’s pandemic response, angering the panel's top Democrats who said they have pressing questions about political interference at the agency.

“The American people deserve to hear Commissioner Hahn’s response to those concerns during a public hearing and what actions he is taking to ensure that the agency’s COVID-19 decisions remain science-based,” said Frank Pallone (D-N.J.), chair of the Energy and Commerce Committee, and Anna Eshoo (D-Calif.), who heads its health subcommittee.

 

A White House spokesperson confirmed that Hahn was blocked from testifying, calling the decision "part of the administration’s existing protocol to make sure health officials can keep their time and energy focused on responding to the coronavirus." The spokesperson noted Hahn has testified to Congress four times in the past six months, including before Pallone's committee in June.

The fact: Trump doesnt want Hahn to testify before a house committee.

The Possible Interpretations :

1. The White House doesnt want Hahn to testify because they are afraid he will not stick to their script. After apologizing to staff for the plasma incident, he has vowed to be more independent and the White House is scared of that,

2. The White House know he will happily lie on their behalf but they dont want to risk him lying under oath whereas making misleading statements in public is less likley to lead to court.

3. Hahn doesnt want to testify , he is too busy and asked the white house to say no

4. White House just did it to piss off the democrats.

Who knows?

On with the real world away from the political circus where vaccine trials are being worked on by real people trying to do real good..

Link to post
Share on other sites
15 minutes ago, EYESAILOR said:

On with the real world away from the political circus where vaccine trials are being worked on by real people trying to do real good..

Politics is definitely a real world that often consists of undue influence toward goals that benefit a few, not the majority.

Denial of that reality is your BIG blind spot.

Link to post
Share on other sites

This is transparency:

 

The study will utilize an IRC, an internal Pfizer committee that will review data to allow dose escalation or changes to continuation of specific groups. An external data monitoring committee (DMC) will be formed and will review cumulative unblinded data throughout the study.

All other study and site personnel, including the investigator, investigator staff, and participants,will be blinded to study intervention assignments. In particular, the individuals who evaluate participant safety will be blinded. Because the BNT162 RNA-based COVID-19 vaccine candidates and placebo are different in physical appearance, the study intervention syringes will be administered in a manner that prevents the study participants from identifying the study intervention type based on its appearance.The responsibility of the unblinded dispenser and administrator must be assigned to an individual or individuals who will not participate in the evaluation of any study participants. Contact between the unblinded dispenser and study participants and unblinded administrator and study participants should be kept to a minimum. The remaining site personnel must not know study intervention assignments.6.3.3.Blinding of the Sponsor.The majority of sponsor staff will be blinded to study intervention allocation in Phase 2/3. All laboratory testing personnel performing serology assays will remain blinded to study intervention assigned/received throughout the study.

Link to post
Share on other sites
1 minute ago, ProaSailor said:

Politics is definitely a real world that often consists of undue influence toward goals that benefit a few, not the majority.

Denial of that reality is your BIG blind spot.

Does Politics sometimes also benefit the majority at the expense of a minority?

Proa. It might be your real world. I certainly care who is elected and I have voted in every election since I was 18 but it is not my everyday life. I'm sorry, it just does not consume my day. I have a life that revolves around healthcare and a recreational life that used to revolve around my family and sailing.  I live in a democracy. I will vote.  I do not talk politics while at work and I have never tried to influence a patient or a colleague with my political views. I consider that inappropriate.

My sister (also a doctor) and I vehemently disagree about politics. It used to matter to us.  We would have fierce debate. But this year that debate has grown more muted, not least because I stand in such admiration of her contribution during the Cv19 peak. I think she also feels that there are some things that are more clearly precious to us now than they were before.

 

Link to post
Share on other sites

I don't need it right now. like the sudden puerto rico hand out, most of all this is being sped through as an 'merikan 'reich-wing' campaign ploy; patronizing, half-assed, glaringly transparent bullshit, eh. but when it's refined and proven safe from unacceptable side effects, you betcha'.

and btw, fuck tRump and the 'gop', all day long.

Link to post
Share on other sites
28 minutes ago, EYESAILOR said:

Does Politics sometimes also benefit the majority at the expense of a minority?

You mean "majority rules"?  That's the ideal of democracy, yes.  Sometimes things go that way but too often they do not.

P.S.  If the majority ruled we would have Hillary instead of Trump.  I can find fault with both Clintons and Obama but Hillary was by far the most qualified candidate from either party in 2016.  She won the popular vote decisively and yet we have suffered four years of despotic political chaos, in no small part the fault of the corrupt Republican senate which would have opposed Hillary every single day. Trump is a useful idiot for a select few, most of his devotees are clueless victims.

Link to post
Share on other sites

HHS lawyer pushed to gut testing safety rules to help “special interest friends": Watchdog group, SEPTEMBER 18, 2020
HHS general counsel Robert Charrow represented more than a dozen clients in the medical device and diagnostic space
https://www.salon.com/2020/09/18/hhs-lawyer-pushed-to-gut-testing-safety-rules-to-help-special-interest-friends-watchdog-group/

Quote

A watchdog group has accused Robert Charrow, the general counsel at the Department of Health and Human Services, of pushing to ease testing rules to help his former clients in the medical device and diagnostic industry.

Charrow, who was appointed by President Trump in 2017, led the administration's push to ease rules ensuring the safety of coronavirus diagnostic tests developed by individual labs before HHS Secretary Alex Azar "overruled" Food and Drug Administration (FDA) officials to revoke their ability to regulate the tests, according to Politico.

 

HHS chief overrode FDA officials to ease testing rules, 09/15/2020
Alex Azar took matters into his own hands, overriding objections from FDA chief Stephen Hahn.
https://www.politico.com/news/2020/09/15/hhs-alex-azar-overrode-fda-testing-rules-415400

 

NOTE: Justice Ruth Bader Ginsburg has died.  With only 46 days before the election, what will dastardly Mitch McConnell do about it?

Link to post
Share on other sites
1 hour ago, ProaSailor said:

NOTE: Justice Ruth Bader Ginsburg has died.  With only 46 days before the election, what will dastardly Mitch McConnell do about it?

Well that didn't take long.  No surprise, the man is rotten to his core.  That's political power in action.  Three Supreme Court justices!

Mitch McConnell Promises Trump’s Ruth Bader Ginsburg Replacement Will Get A Vote, 09/18/2020
He clearly does not care about being called a hypocrite about the Supreme Court.
https://www.huffpost.com/entry/mitch-mcconnell-trump-rbg-scotus-replacement-vote_n_5f6557b4c5b6480e896ed943

Quote

Nine months out from the 2016 election, Senate Majority Leader Mitch McConnell (R-Ky.) made the unprecedented decision not to let President Barack Obama fill a Supreme Court opening because, he argued, the next president should get to pick the nominee.

He left the seat vacant, handing Donald Trump the political gift. 

On Friday, less than two months out from the election, Supreme Court Justice Ruth Bader Ginsburg passed away. 

This time, McConnell is not waiting around.
[...]
The opportunity to replace one of the court’s most liberal justices with a conservative is a dream come true for many in the Republican Party. If Trump’s nominee is confirmed, the court would be tilted 6-3 toward conservatives.  

 

https://en.wikipedia.org/wiki/List_of_federal_judges_appointed_by_Donald_Trump

"As of September 17, 2020, the United States Senate has confirmed 216 Article III judges nominated by President Trump, including two associate justices of the Supreme Court of the United States, 53 judges for the United States courts of appeals, 159 judges for the United States district courts, and two judges for the United States Court of International Trade."

That's in four years.  By contrast, in eight years 329 judges were confirmed under Obama
https://en.wikipedia.org/wiki/List_of_federal_judges_appointed_by_Barack_Obama

"The total number of Obama Article III judgeship nominees to be confirmed by the United States Senate is 329, including two justices to the Supreme Court of the United States, 55 judges to the United States Courts of Appeals, 268 judges to the United States district courts, and four judges to the United States Court of International Trade.[2][3] Obama did not make any recess appointments to the federal courts."

Link to post
Share on other sites

This thread has veered to much into politics. I think there is interest in a thread which provides updates and discussion on vaccines which tries as much as possible to stay newsworthy and analytical on vaccine progress and how we feel about vaccines without digressing into politics.

i am not naive. I realize the Trump would like to announce a successful vaccine before the election for purely political reasons. I acknowledge that the Democrats know this and will be very skeptical and critical of any White House announcements regarding vaccines .One of the platforms of  Biden's campaign is the Trump administration's failings during the CV19 crisis.

There will almost certainly be a politically motivated vaccine announcement, with or without formal FDA/OVRR approval of a vaccine. It is not hard to do. Factually we know that there will at a minimum be a progress report on vaccines prior to November and we know factually that stockpiles are being built of the trial vaccines.  I think it is safe to assume that a positive spin will come out of the White House whatever the news flow. Biden's response is going to be more nuanced.  If the vaccine news is exaggerated and misleading, they will obviously jump on that. If vaccine progress is genuinely and significantly positive, then Biden needs to be careful not to be too skeptical . When and if he comes into the presidency he will want to be supporting vaccination.  

But putting aside the politics ......where we can forecast the roles of the players .....I think we need a thread where we talk about the vaccines , the science, the news, the pros and cons, and analysis of updates without the political angle. 

Take pure politics about judicial appointments etc to PA

I will start a new thread.

Link to post
Share on other sites
30 minutes ago, EYESAILOR said:

This thread has veered to much into politics.
[...]
Take pure politics about judicial appointments etc to PA

With all due respect doctor, and I mean that sincerely, I've had it with your "politics doesn't matter (or belong here)" bullshit.  I mentioned RBG's death and the political consequences of it in this thread precisely because it matters very much, to healthcare and life in general in the USA.  You keep bringing up politics in a disparaging manner, as if the ivory tower world of dedicated pharma professionals is all that matters and politics can be dismissed.  BULLSHIT!  Your arguments will carry more weight when you stop saying that.

Link to post
Share on other sites
50 minutes ago, ProaSailor said:

With all due respect doctor, and I mean that sincerely, I've had it with your "politics doesn't matter (or belong here)" bullshit.  I mentioned RBG's death and the political consequences of it in this thread precisely because it matters very much, to healthcare and life in general in the USA.  You keep bringing up politics in a disparaging manner, as if the ivory tower world of dedicated pharma professionals is all that matters and politics can be dismissed.  BULLSHIT!  Your arguments will carry more weight when you stop saying that.

RBG opened doors for me that you cannot begin to imagine. I think her achievements and the implications of her passing deserve several threads of their own.

One thing I admired about RBG is that she had a deep friendship and respect for the leading conservative on the bench. It made her rulings all the more meaningful because you knew is wasn't personal distrust of the other side that guided her judgement but the facts and the "rightness" of the matter in hand. 

"Don't be distracted by emotions like anger, envy, resentment. These just zap energy and waste time."  RBG

Link to post
Share on other sites

The success that China has had in curtailing the virus is incredible.  As America and Europe enter 2nd and even possibly 3rd waves China has snuffed out the virus even though they had the disadvantage of going first when the disease was the least understood.

Either

1.  Unhampered by democracy and personal freedoms and the conflict between states rights vs Federal rights, their short and total lockdown and domestic travel ban ..worked

2. They adopted masks as a culture more readily than we did.

3. They adopted faster test and trace.  They have supposedly conducted 160 million tests.

4. Their numbers are completely fabricated and there are thousands of deaths daily. This is unlikely because our satellites and economic activity indicators would have picked this up

5. They have a vaccine and have vaccinated many more than the hundreds of thousands they refer to.

Link to post
Share on other sites