CoVID-19 / SARS-CoV-2 Information and Questions

[Jim_in_Delaware]

My responses will be limited as I am helping my daughter move this weekend and am on my phone.

I see several posts about drug approval, corporate profits, and government officials. Let’s be crystal clear on this no one working at any federal public health agency (including FDA, NIH, CDC, and the others) is making a dime off these COVID treatments. Ethic laws are very much enforced for government employees. As a matter of fact, even though I work in the regulation of pharmaceutical manufacturing, I can’t own stock in ANY FDA regulated industries, including food, biological, drugs, medical devices and others). Congress and the President have their own ethics rules, which I do agree are quite lax.

Well, back to moving! ?

Jim

 

[Farny]

My responses will be limited as I am helping my daughter move this weekend and am on my phone.

I see several posts about drug approval, corporate profits, and government officials. Let’s be crystal clear on this no one working at any federal public health agency (including FDA, NIH, CDC, and the others) is making a dime off these COVID treatments. Ethic laws are very much enforced for government employees. As a matter of fact, even though I work in the regulation of pharmaceutical manufacturing, I can’t own stock in ANY FDA regulated industries, including food, biological, drugs, medical devices and others). Congress and the President have their own ethics rules, which I do agree are quite lax.

Well, back to moving! ?

Jim

Former FDA Commissioner Scott Gottlieb joins Pfizer's board of directors

Scott Gottlieb, who stepped down as Food and Drug Administration Commissioner in April, will join Pfizer's board of directors, the company announced Thursday.

www.cnbc.com

Congress invests big in pharmaceutical, tech stocks

Congress continued to invest big in stocks of pharmaceutical and tech companies as it debated how to deal with rising drug prices.

www.opensecrets.org

 

[crazy4life]

Former FDA Commissioner Scott Gottlieb joins Pfizer's board of directors

Scott Gottlieb, who stepped down as Food and Drug Administration Commissioner in April, will join Pfizer's board of directors, the company announced Thursday.

www.cnbc.com

Congress invests big in pharmaceutical, tech stocks

Congress continued to invest big in stocks of pharmaceutical and tech companies as it debated how to deal with rising drug prices.

www.opensecrets.org

Check out this former gem of a FDA Commissioner. OXY’s for 11 year olds. WTF Gotta say that again WTF

Janet Woodcock

On January 27, 2021 a coalition of 28 public health groups and opioid crisis organizations sent a letter to the Biden Administration regarding Woodcock's position as Acting Commissioner of the FDA. The letter said in part that "as the Director of the FDA’s Center for Drug Evaluation and Research (CDER) for more than 25 years, Dr. Woodcock presided over one of the worst regulatory agency failures in U.S. history."[35] Examples of improper opioid decisions mentioned in the letter include "approving Opana without adequate evidence of safety or long-term efficacy, approving Zohydro despite a vote of 11-2 against approval by a scientific advisory committee, and approving promotion of OxyContin for children as young as 11 years olds.

Hook ‘‘em at 11 and you got customers for life. What scumbags.

 

[Julian]

Check out this former gem of a FDA Commissioner. OXY’s for 11 year olds. WTF Gotta say that again WTF

Janet Woodcock

On January 27, 2021 a coalition of 28 public health groups and opioid crisis organizations sent a letter to the Biden Administration regarding Woodcock's position as Acting Commissioner of the FDA. The letter said in part that "as the Director of the FDA’s Center for Drug Evaluation and Research (CDER) for more than 25 years, Dr. Woodcock presided over one of the worst regulatory agency failures in U.S. history."[35] Examples of improper opioid decisions mentioned in the letter include "approving Opana without adequate evidence of safety or long-term efficacy, approving Zohydro despite a vote of 11-2 against approval by a scientific advisory committee, and approving promotion of OxyContin for children as young as 11 years olds.

Hook ‘‘em at 11 and you got customers for life. What scumbags.

I don't know anything about this woman, my it is interesting how my reaction to the approval of Oxy for 11 year Olds differs diametrically from yours.

My reaction....man it must have sucked to be the parents of these 11 year olds with such terrible conditions that they likely begged the FDA to approve such strong pain killers for their terribly sick and possibly dying children.

 

[crazy4life]

I don't know anything about this woman, my it is interesting how my reaction to the approval of Oxy for 11 year Olds differs diametrically from yours.

My reaction....man it must have sucked to be the parents of these 11 year olds with such terrible conditions that they likely begged the FDA to approve such strong pain killers for their terribly sick and possibly dying children.

Why do you find it necessary to keep posting on my responses to other members. I was talking to Farny and I am pretty sure you are not him. It's entirely possible that you could be him.....are you Fany? Come to think of it you are always answering for Tabbius also..........are you also Tabbius? Not really sure you are even Julian so you could be Sybil. Think she had 6 different personalities. Is this you Sybil?

"My reaction....man it must have sucked to be the parents of these 11 year olds with such terrible conditions that they likely begged the FDA to approve such strong pain killers for their terribly sick and possibly dying children."

Hmmm...pretty sure there are other drugs for that. Wonder how much it would suck if you were the parents of a daughter who is sucking d*#k for her next round of Oxy's. But in your thinking at least she is all good if she gets cancer. GTFOH with that noise.

Anyway your beef is with the coalition of 28 public health groups and opioid crisis organizations that sent a letter to the Biden Administration opposing her appointment and not with me. Maybe send all them letters explaining the poor 11 year old dying of cancer who needs Oxy-Cotton. I can help you find there addresses if you would like some help. If you would like I can take you on some tours of Kensington Philadelphia and see what is happening in the real world, an entire generation of our youth that will never experience the joys of marriage, or the exhilaration of watching their child being born. Never to see their own children growing up to be productive citizens or having families of their own. I will introduce you to mothers with the look of shear terror in their eyes as they look for their drug addicted children. How about I show you hardcore tattoo'd dads crying like babies at the sight of there dead children in a drug den passed over like trash in a dumpster. That is if you had the balls to get out of the car when your getting bum rushed by 10 crackheads. It would suck for you but I would find it wildly entertaining. So please and I mean this in the nicest way possible but spare me your make believe bullshit while I get ready to head to Sodom and Gomorrah because it's Saturday night and the weather is warmer so the streets will be crowded tonight.

Carry on

 

[Bruce]

Reuters has a nice summary of recently published research.

Vaccination after COVID improves immunity; ivermectin fails in major trial

The following is a summary of some recent studies on COVID-19. They include research that warrants further study to corroborate the findings and that has yet to be certified by peer review.

www.reuters.com

 

[Bruce]

@crazy4life, if you wish to participate in this thread I expect your comments to be on topic and frankly less hateful.

 

[tabbibus]

Why do you find it necessary to keep posting on my responses to other members. I was talking to Farny and I am pretty sure you are not him. It's entirely possible that you could be him.....are you Fany? Come to think of it you are always answering for Tabbius also..........are you also Tabbius? Not really sure you are even Julian so you could be Sybil. Think she had 6 different personalities. Is this you Sybil?

"My reaction....man it must have sucked to be the parents of these 11 year olds with such terrible conditions that they likely begged the FDA to approve such strong pain killers for their terribly sick and possibly dying children."

Hmmm...pretty sure there are other drugs for that. Wonder how much it would suck if you were the parents of a daughter who is sucking d*#k for her next round of Oxy's. But in your thinking at least she is all good if she gets cancer. GTFOH with that noise.

Anyway your beef is with the coalition of 28 public health groups and opioid crisis organizations that sent a letter to the Biden Administration opposing her appointment and not with me. Maybe send all them letters explaining the poor 11 year old dying of cancer who needs Oxy-Cotton. I can help you find there addresses if you would like some help. If you would like I can take you on some tours of Kensington Philadelphia and see what is happening in the real world, an entire generation of our youth that will never experience the joys of marriage, or the exhilaration of watching their child being born. Never to see their own children growing up to be productive citizens or having families of their own. I will introduce you to mothers with the look of shear terror in their eyes as they look for their drug addicted children. How about I show you hardcore tattoo'd dads crying like babies at the sight of there dead children in a drug den passed over like trash in a dumpster. That is if you had the balls to get out of the car when your getting bum rushed by 10 crackheads. It would suck for you but I would find it wildly entertaining. But you are probably to busy yelling at your neighbors or helping that dipstick kid figure out what a muffler is. So please and I mean this in the nicest way possible but spare me your make believe bullshit while I get ready to head to Sodom and Gomorrah because it's Saturday night and the weather is warmer so the streets will be crowded tonight.

Carry on

Narcotics are extremely helpful in cancer pain. I agree with you that opiate abuse is a terrible problem. But they are also valuable in the right context.

 

[Jim_in_Delaware]

Check out this former gem of a FDA Commissioner. OXY’s for 11 year olds. WTF Gotta say that again WTF

Janet Woodcock

On January 27, 2021 a coalition of 28 public health groups and opioid crisis organizations sent a letter to the Biden Administration regarding Woodcock's position as Acting Commissioner of the FDA. The letter said in part that "as the Director of the FDA’s Center for Drug Evaluation and Research (CDER) for more than 25 years, Dr. Woodcock presided over one of the worst regulatory agency failures in U.S. history."[35] Examples of improper opioid decisions mentioned in the letter include "approving Opana without adequate evidence of safety or long-term efficacy, approving Zohydro despite a vote of 11-2 against approval by a scientific advisory committee, and approving promotion of OxyContin for children as young as 11 years olds.

Hook ‘‘em at 11 and you got customers for life. What scumbags.

I respect your opinion on opioid addiction, and agree with many of the things you have posted.

I would, however, disagree with your assessment that Woodcock is a "scumbag" as this just is not true. I have not agreed with all of the decisions that she had made over the years, but she has been an effective leader in FDA's CDER. (I would also like to make it clear that I do not work for CDER).

Jim

 

[Jim_in_Delaware]

Narcotics are extremely helpful in cancer pain. I agree with you that opiate abuse is a terrible problem. But they are also valuable in the right context.

I agree with this post.

Opiate abuse is a terrible problem.

I do, however, have close family members who benefited from opioids to treat severe pain when other medications did not work.

Jim

 

[Farny]

Reuters has a nice summary of recently published research.

Vaccination after COVID improves immunity; ivermectin fails in major trial

The following is a summary of some recent studies on COVID-19. They include research that warrants further study to corroborate the findings and that has yet to be certified by peer review.

www.reuters.com

We’re the Ivm trial subjects c19 vaxxed or not?

 

[Julian]

Why do you find it necessary to keep posting on my responses to other members. I was talking to Farny and I am pretty sure you are not him. It's entirely possible that you could be him.....are you Fany? Come to think of it you are always answering for Tabbius also..........are you also Tabbius? Not really sure you are even Julian so you could be Sybil. Think she had 6 different personalities. Is this you Sybil?

"My reaction....man it must have sucked to be the parents of these 11 year olds with such terrible conditions that they likely begged the FDA to approve such strong pain killers for their terribly sick and possibly dying children."

Hmmm...pretty sure there are other drugs for that. Wonder how much it would suck if you were the parents of a daughter who is sucking d*#k for her next round of Oxy's. But in your thinking at least she is all good if she gets cancer. GTFOH with that noise.

Anyway your beef is with the coalition of 28 public health groups and opioid crisis organizations that sent a letter to the Biden Administration opposing her appointment and not with me. Maybe send all them letters explaining the poor 11 year old dying of cancer who needs Oxy-Cotton. I can help you find there addresses if you would like some help. If you would like I can take you on some tours of Kensington Philadelphia and see what is happening in the real world, an entire generation of our youth that will never experience the joys of marriage, or the exhilaration of watching their child being born. Never to see their own children growing up to be productive citizens or having families of their own. I will introduce you to mothers with the look of shear terror in their eyes as they look for their drug addicted children. How about I show you hardcore tattoo'd dads crying like babies at the sight of there dead children in a drug den passed over like trash in a dumpster. That is if you had the balls to get out of the car when your getting bum rushed by 10 crackheads. It would suck for you but I would find it wildly entertaining. So please and I mean this in the nicest way possible but spare me your make believe bullshit while I get ready to head to Sodom and Gomorrah because it's Saturday night and the weather is warmer so the streets will be crowded tonight.

Carry on

If you want to talk privately with a member please click on the envelope at the top of the screen. It's called a "Conversation" and it is private between one or multiple members. Otherwise, every forum post is public and open for comments.

 

[Bluewater272]

Holy crap, basically every word crazy4life utters is a complete farce. Almost impressive. We're really still thinking that HCQ is some secret miracle cure that 'the man' is keeping down? That the FDA has a vested interested in the profit margins of pharma? LOLOLOLOL.


Regarding the questions about EUA expiration, its generally when the emergency has ended or there is ample real-world evidence that the product is no longer effective. You saw it happen with several different mAbs when the Delta variant faded away. EUAs for vaccines have already started to be converted to 'full approvals', and anything left with an EUA that is still viable will be given the requirements to secure a full marketing approval.

 

[Jim_in_Delaware]

As a matter of fact the FDA approved it for outpatient treatment just 2 months ago.

FDA authorizes remdesivir as outpatient COVID-19 treatment

The FDA on Jan. 21 expanded its emergency use authorization for remdesivir to include the drug's use in nonhospitalized patients with mild to moderate COVID-19 who have a high risk of their case becoming severe.

www.beckershospitalreview.com

From the FDA website linked in the Becker article:

"The approval of Veklury for use in non-hospitalized patients is supported by a randomized, placebo-controlled clinical trial that included 562 non-hospitalized patients with mild-to-moderate COVID-19 who were at high risk for progression to severe COVID-19, including hospitalization or death. The main outcome measured in the trial was whether a patient was hospitalized for any COVID-19 related reason or died from any reason within 28 days of treatment. Overall, 2 of 279 patients who received Veklury (0.7%) required COVID-19 related hospitalization compared to 15 of 283 patients who received a placebo (5.3%). There were no deaths in either group. "

Jim

 

[Bluewater272]

If you want we can meet up today let’s say the Bristol dock and we could discuss this mano a mano, what say you? Or I could make it easier and take a spin over Medford since it’s only 20 minutes away. My guess is you are a keyboard warrior and would shit your pants before spewing that garbage out of your pie hole. See you on the water this summer and we can discuss how full of shit I am.

Oh good lord .

PS, the good doctor and I are two different people.

On a serious note:

1. If we were discussing this in person, I would absolutely tell you that you're wrong. I'd also tell you that its awful fucking weird to come at a stranger with thinly veiled physical threats, but you do you.
2. Since you've joined this forum, you basically only post in two places, and only post in a manner so as to cause conflict. Those two places? This thread, and the Vaccine thread. Why do you do it? Don't you have anything better to do? You don't even seem interested to talk about your boat.
3. Don't ever attempt to threaten me again.

 

[crazy4life]

From the FDA website linked in the Becker article:

"The approval of Veklury for use in non-hospitalized patients is supported by a randomized, placebo-controlled clinical trial that included 562 non-hospitalized patients with mild-to-moderate COVID-19 who were at high risk for progression to severe COVID-19, including hospitalization or death. The main outcome measured in the trial was whether a patient was hospitalized for any COVID-19 related reason or died from any reason within 28 days of treatment. Overall, 2 of 279 patients who received Veklury (0.7%) required COVID-19 related hospitalization compared to 15 of 283 patients who received a placebo (5.3%). There were no deaths in either group. "

Jim

1 trial with 562 patients. If that's all it takes to approve something for covid with potential for serious proven side effects. This sentence says a lot. There were no deaths in either group

I raise your one study with these studies.

Remdesivir and Acute Renal Failure: A Potential Safety Signal From Disproportionality Analysis of the WHO Safety Database - PubMed

Remdesivir is approved for emergency use by the US Food and Drug Administration (FDA) and authorized conditionally by the European Medicines Agency (EMA) for patients with coronavirus disease 2019 (COVID-19). Its benefit-risk ratio is still being explored because data in the field are rather...

pubmed.ncbi.nlm.nih.gov

Kidney disorders as serious adverse drug reactions of remdesivir in coronavirus disease 2019: a retrospective case–noncase study - PMC

www.ncbi.nlm.nih.gov

Remdesivir, Survival, Length of Hospital Stay in Veterans With COVID-19 - American College of Cardiology

Debabrata Mukherjee, MD, FACC

www.acc.org

Conclusions:
The authors concluded that remdesivir treatment was not associated with improved survival but was associated with longer hospital stays in this cohort study of US veterans hospitalized with COVID-19.

There are to many studies showing the potential for serious injuries when using remdesivir to list here but by all means keep touting it.

 

[crazy4life]

Oh good lord .

PS, the good doctor and I are two different people.

On a serious note:

1. If we were discussing this in person, I would absolutely tell you that you're wrong. I'd also tell you that its awful fucking weird to come at a stranger with thinly veiled physical threats, but you do you.
2. Since you've joined this forum, you basically only post in two places, and only post in a manner so as to cause conflict. Those two places? This thread, and the Vaccine thread. Why do you do it? Don't you have anything better to do? You don't even seem interested to talk about your boat.
3. Don't ever attempt to threaten me again.

Triggered much? Where did I threaten you. I stated that we would be better off discussing this topic in person. This is not a threat. You would most assuredly come at this discussion with less bravado that I am sure of. Why don't we meet in kensington this Friday night and I can show you what unscrupulous Doctors and the Pharmaceutical Industry has done to an entire generation. You probably could not care less. I pray to the good lord that your children never become drug addicts. You can see for yourself that every word I utter is not a complete farce. I will even pick you up at the time and place of your desire. There will be no imaginary threats. We will just go on a fact finding mission. You in?

I could post comment after comment of yours where you are belittling people and calling them stupid or dumb or my personal favorite "you don't know what you don't know." I'd also tell you that its awful fucking weird to come at a stranger with thinly veiled comments about there intelligence. That make you feel superior or is that just some weird character trait.


As far as posting in this forum. I know which way to turn the oil fill cap. I do all my own work on my boat. I ask questions when I need answers. What do you care what I do on this forum.

 

[Bluewater272]

Triggered much? Where did I threaten you. I stated that we would be better off discussing this topic in person. This is not a threat. You would most assuredly come at this discussion with less bravado that I am sure of. Why don't we meet in kensington this Friday night and I can show you what unscrupulous Doctors and the Pharmaceutical Industry has done to an entire generation. You probably could not care less. I pray to the good lord that your children never become drug addicts. You can see for yourself that every word I utter is not a complete farce. I will even pick you up at the time and place of your desire. There will be no imaginary threats. We will just go on a fact finding mission. You in.

I could post comment after comment of yours where you are belittling people and calling them stupid or dumb or my personal favorite "you don't know what you don't know." I'd also tell you that its awful fucking weird to come at a stranger with thinly veiled comments about there intelligence. That make you feel superior or is that just some weird character trait.


As far as posting in this thread. I know which way to turn the oil fill cap. I do all my own work on my boat. I ask questions when I need answers. What do you care what I do on this forum.

?

 

[Jim_in_Delaware]

1 trial with 562 patients. If that's all it takes to approve something for covid with potential for serious proven side effects. This sentence says a lot. There were no deaths in either group

I raise your one study with these studies.

Remdesivir and Acute Renal Failure: A Potential Safety Signal From Disproportionality Analysis of the WHO Safety Database - PubMed

Remdesivir is approved for emergency use by the US Food and Drug Administration (FDA) and authorized conditionally by the European Medicines Agency (EMA) for patients with coronavirus disease 2019 (COVID-19). Its benefit-risk ratio is still being explored because data in the field are rather...

pubmed.ncbi.nlm.nih.gov

Kidney disorders as serious adverse drug reactions of remdesivir in coronavirus disease 2019: a retrospective case–noncase study - PMC

www.ncbi.nlm.nih.gov

Remdesivir, Survival, Length of Hospital Stay in Veterans With COVID-19 - American College of Cardiology

Debabrata Mukherjee, MD, FACC

www.acc.org

Conclusions:
The authors concluded that remdesivir treatment was not associated with improved survival but was associated with longer hospital stays in this cohort study of US veterans hospitalized with COVID-19.

There are to many studies showing the potential for serious injuries when using remdesivir to list here but by all means keep touting it.

LOL, you are a bit combative today.

All I did was post a link connected to an article that you put in a post. I admit I do not know enough from a medical standpoint if this drug should have/should still be used, while you obviously are the medical expert on this drug.

You seem to have cherry-picked what I posted, by only focusing on deaths. The paragraph also notes, "Overall, 2 of 279 patients who received Veklury (0.7%) required COVID-19 related hospitalization compared to 15 of 283 patients who received a placebo (5.3%)." This would suggest that there is some data that shows the drug has some value.

Covid hospitalization are quite expensive and no joy for the patients. Where the overall cost/benefit falls for this drug, ?‍

Jim

 

[GTBRMC]

MEDCRAM instructor Roger Seheult MD addresses topic of masks on planes (now that mandate is gone and air travelers must make individual choices on masks usage on airliners). He uses study data and describes the mechanics of how masks and aircraft air filtration and circulation systems impact airborne virus transmission. In his typical style, he methodically builds his discussion from start to finish using study data to back up key points as he makes them. At the end, he discusses his recommendations.

Dr John Campbell latest video on topic of now very high and building rates of natural immunity (proportion of people in the UK that national health PCR testing data indicates have had or have been exposed to COVID causing virus) and the implications of this now-endemic condition in the UK. In his typical style, Campbell summarizes the data and his interpretation of its meaning to public health in the first several minutes (about 4.5 mins in this case) then goes into detail about the data, including references to studies and/or public health data, etc, for the remainder of the video.