The Vaccine

[AZMark]

Personally I would not trust the FDA to tell me what flavor of Slurpee to buy at the local 7-Eleven but that’s just me.

please explain why the FDA just approved Adulhem for Alzheimer’s over the overwhelmingobjections of its own experts and advisers.

“
Statisticians at the Food and Drug Administration opposed this month's agency approval of a controversial Alzheimer’s drug, saying there was not enough evidence to prove the treatment works.

The objections by Office of Biostatistics Director Sylva Collins, reviewer Tristan Massie and other agency statisticians are detailed in documents that the FDA released Tuesday. The criticisms align with those from a panel of external FDA advisers who voted last fall that there was not enough evidence to prove the drug from Biogen, known as Aduhelm, is effective.”

All these experts who were just following the science were overruled by the top brass.

This treatment will cost 56,000 per year per patient. There is an estimated 6 million potential patients. Not enough numbers on my calculator to figure out the staggering amount of money to be made.

So follow the science unless Biogen can make billions upon billions of dollars using a drug that nobody but the bosses agree will have any benefit.

“Three FDA advisory committee membersresigned in protest over the drug approval. Other critics have warned that the high cost, coupled with the need for expensive diagnostic procedures and regular screening of patients who take the medication, could overwhelm the health care system. Nearly 6 million Americans have Alzheimer’s disease.”

This is just one example of how things work in the real world. It’s been said since the beginning of time FOLLOW THE MONEY.

FDA approved Alzheimer's drug over internal objections

FDA gave the drug conditional approval earlier this month, making it the first new Alzheimer’s therapy approved in nearly 20 years.

www.politico.com

So we want more government control and less individual choice to purchase a medicine of your choosing. Got it.

 

[AZMark]

Really??? Then I suggest you step away from this echo chamber and do some of your own digging.

Not sure if I offended you with my comment? Wasn’t the intent.
I know a number of people who are vaccinated and also those who refuse to get vaccinated and most have gone the opposite way of what you’re saying after exposure to the virus. I don’t know any that have sworn off vaccines. Doesn’t have anything to do with this thread.

 

[Jim_in_Delaware]

@BigN8, the 2007 Amendments do give me reassurance in the drug approval process, as I think there is a greater level of transparency and a greater emphasis of data, post-approval, of drug products.

I would encourage that if anyone is unsure about either getting the vaccine or the booster (or frankly any new drug), to have a discussion with your family physician. He/she would be in the best position to explain the pros/cons in doing so, especially taking into account one's personal health.

Personally, I do have faith in the FDA vaccine approval process. My wife and I will likely be getting the seasonal flu vaccine next week, and the Covid-19 booster shots when the time come (I have had the Moderna vaccine and she the Pfizer vaccine).

Jim

 

[MidnightRider]

You have no choice on Tuberculosis or Mental Illness for example. (treated or restrained against your will) Not the same for sure, but not that different. Vaccines are ALREADY mandatory for many jobs. I am unconvinced by your argument that all medical treatment is always voluntary.

I can understand an argument that says this is a sliding scale and the risk reward does not in your opinion reach the threshold to demand such an action (I would disagree, but at least it would be a reasonable position), but that's not what you are arguing, instead stating instead treatment is always voluntary, therefore, this is WRONG. That argument falls flat. Government does tell you already how to behave (no screaming in public or behaving like maniac, or they take your freedom away for disorderly conduct for example), how to dress, who can work, what taxes you owe, and what medical treatment is mandatory for many activities. Are all those also wrong? (Perhaps you think so and would prefer a more libertarian society, but it's not the one we live on right now., That would be a much bigger topic, good for another off topic thread)

The focus of my post was on NEW medications, medical innovations and the fact that the oversight of these rollouts is fallible - we don't know what we don't know. Sorry if that was unclear. Having millions take it does not make it 100% safe and having it out there for 1 year doesn't mean we won't learn something in 5 years. Again, the risk is fine and inevitable - the coercion is not. I'm not against it, I'm against mandating it.
To force someone to participate at the threat of their livelihood is wrong. Past government/corporation overreach does not justify current government/corporation overreach. Also, refusing to hire someone over an existing vaccine requirement is very different than terminating someone over a new vaccine requirement.

 

[Jim_in_Delaware]

Personally I would not trust the FDA to tell me what flavor of Slurpee to buy at the local 7-Eleven but that’s just me.

please explain why the FDA just approved Adulhem for Alzheimer’s over the overwhelmingobjections of its own experts and advisers.

“
Statisticians at the Food and Drug Administration opposed this month's agency approval of a controversial Alzheimer’s drug, saying there was not enough evidence to prove the treatment works.

The objections by Office of Biostatistics Director Sylva Collins, reviewer Tristan Massie and other agency statisticians are detailed in documents that the FDA released Tuesday. The criticisms align with those from a panel of external FDA advisers who voted last fall that there was not enough evidence to prove the drug from Biogen, known as Aduhelm, is effective.”

All these experts who were just following the science were overruled by the top brass.

This treatment will cost 56,000 (THIS IS NOT A TYPO) per year per patient. There is an estimated 6 million potential patients. Not enough numbers on my calculator to figure out the staggering amount of money to be made.

So follow the science unless Biogen can make billions upon billions of dollars using a drug that nobody but the bosses agree will have any benefit.

“Three FDA advisory committee membersresigned in protest over the drug approval. Other critics have warned that the high cost, coupled with the need for expensive diagnostic procedures and regular screening of patients who take the medication, could overwhelm the health care system. Nearly 6 million Americans have Alzheimer’s disease.”

This is just one example of how things work in the real world. It’s been said since the beginning of time FOLLOW THE MONEY.

FDA approved Alzheimer's drug over internal objections

FDA gave the drug conditional approval earlier this month, making it the first new Alzheimer’s therapy approved in nearly 20 years.

www.politico.com

The money has NOTHING to do with it. FDA review and approval does not take into account if a new drug cost $1 or $1,000,000. It is a review if the drug is safe and effective, looking at potential benefits and risks.

Again, speaking as a private citizen, my guess is that the approval is based on the fact that there are NO other treatments for Alzheimer's disease.

The article you posted is a very balanced article. I would encourage folks to read the entire article and not just cherry pick pieces of it.

Jim

 

[Julian]

I asked the pertinent question right there in my post, but not surprised you missed/ignored it. Regardless of my opinion of Covid and line of duty, it's spin to assume that every officer who died from Covid contracted it on-duty. The "facts", in this case, are not supported by data.

And I stated the facts right in my post and I'm not surprised you missed/ignored it too. Sorry the facts don't align with your desire to change them. Fact is, they've chosen to consider it a line of duty death. You can't change that.....unless you are involved in each Police Department's decision making process for this. Otherwise - the facts are what they are.

Personally I'm glad they've chosen to consider them line of duty deaths. The officers can't quarantine, and died because they couldn't. No question in my mind that they should get the benefits of a line of duty death. Are you anti cop and don't want want their families to get this benefit? Do you have some data source that says that no work was put into determining if they were exposed in the line of duty, and these departments shouldn't give them LOD death benefits? Frankly I don't think they should be forced to prove how they caught it. They exposed themselves day in and day out protecting us. Its disgusting that anyone would question that.

 

[crazy4life]

The money has NOTHING to do with it.
Jim

LMAO Gotta admit thats a pretty funny statement.


Scott Gottlieb Former commissioner of the FDA

Scott Gottlieb (born June 11, 1972) is an American physician and investor who served as the 23rd commissioner of the Food and Drug Administration (FDA) from 2017 until April 2019. He is presently a senior fellow at the conservative think tank the American Enterprise Institute (AEI), a partner at the venture capital firm New Enterprise Associates (NEA),[1][2] a member of the board of directors of drug maker Pfizer, Inc,[3] a member of the board of directors of Illumina, Inc.,[4] a contributor to the cable financial news network CNBC, and a frequent guest on the CBS News program Face the Nation. He is the author of the The New York Times best selling book Uncontrolled Spread[5] on the COVID-19 pandemic and the national security vulnerabilities that it revealed. Before becoming FDA commissioner, he was a clinical assistant professor at New York University School of Medicine, the FDA deputy commissioner for medical and scientific affairs, a venture partner with New Enterprise Associates, a member of the policy board of the Leukemia & Lymphoma Society, a senior official at the Centers for Medicare and Medicaid Services, and a member of the Federal Health Information Technology Policy Committee, which advises the United States Department of Health and Human Services on healthcare information technology. He was previously a resident fellow at AEI from 2007 to 2017 prior to joining the FDA as commissioner in May 2017.

 

[Crob83]

You’re one of the first I’ve heard go this way after already being vaccinated, that’s interesting.

The statement above obviously includes a big assumption that the roll of the dice with covid goes well for each person and that there aren’t unknown negative long term effects from a virus that we know as little about as we do the vaccine.

Add me to the list...lol. Already had covid and my 2 shots afterwards to keep my job. I'm done

 

[Lurch]

Do you have some data source that says that no work was put into determining if they were exposed in the line of duty, and these departments shouldn't give them LOD death benefits? Frankly I don't think they should be forced to prove how they caught it.

I'm not the one who posted click bait. Don't ask me to do the legwork to back up your argument.

"Frankly I don't think they should be forced to prove how they caught it". - Unfortunately, that small detail is relevant when classifying an on-duty event.

Good talk!

 

[crazy4life]

So we want more government control and less individual choice to purchase a medicine of your choosing. Got it.

So we want more government control and less individual choice to purchase a medicine of your choosing. Got it.

I see reading comprehension is not your thing. I said I would not trust the FDA to tell me what flavor of slurpee to get. You can do whatever you want and I would not tell you what to believe because last I checked it's a free country. Also you are really good at putting words in peoples mouths that were never uttered.

Please show me where I said this
"60,000 vioxx deaths is absolutely an outrage, but a few hundred thousand from covid isn’t anything to be concerned about, or a hoax, or overstated because “my friends cousins barber got in a motorcycle crash and they called it covid…”

Or this
"Should we have no FDA? No government? Just create our own medicine with our internet knowledge? Maybe let “God’s will” take us if we get diabetes or an infection or pneumonia?"

You make this satement
"Take what they say with a grain of salt and educate yourself to the extent possible"

Then you get all butthurt when people do just that and voice their opinion after they educate themselves.

Carry on

 

[AZMark]

I see reading comprehension is not your thing. I said I would not trust the FDA to tell me what flavor of slurpee to get. You can do whatever you want and I would not tell you what to believe because last I checked it's a free country. Also you are really good at putting words in peoples mouths that were never uttered.

Please show me where I said this
"60,000 vioxx deaths is absolutely an outrage, but a few hundred thousand from covid isn’t anything to be concerned about, or a hoax, or overstated because “my friends cousins barber got in a motorcycle crash and they called it covid…”

Or this
"Should we have no FDA? No government? Just create our own medicine with our internet knowledge? Maybe let “God’s will” take us if we get diabetes or an infection or pneumonia?"

You make this satement
"Take what they say with a grain of salt and educate yourself to the extent possible"

Then you get all butthurt when people do just that and voice their opinion after they educate themselves.

Carry on

Is there a point in here somewhere? I’m certainly not butthurt.

You have some pretty conflicted views on things, just an observation.

 

[Beachbummer]

The focus of my post was on NEW medications, medical innovations and the fact that the oversight of these rollouts is fallible - we don't know what we don't know. Sorry if that was unclear. Having millions take it does not make it 100% safe and having it out there for 1 year doesn't mean we won't learn something in 5 years.

You could say the same for year 5 and 10. How long before you are confident it is "Safe enough" to mandate, say as we demand Polio and Measles vaccines today?

Fear of the unknown is a reasonable position, and one of the struggles of increasing vaccination rates. (I'm afraid we don't know what we don't know - Hard to argue against, except for that the vaccines normally in the past wear out, so any BAD things in the past appears early and up front.... but how do I prove you will not turn into a pumpkin in 2030 after vaccination? It's impossible to prove a negative without a time machine, so you are entitled to your concern about the unknown.) - The challenge is that NOT vaccinating is also an active choice, and so far based on DEATH data I think it's the right choice to vaccinate.

Again, the risk is fine and inevitable - the coercion is not. I'm not against it, I'm against mandating it.
To force someone to participate at the threat of their livelihood is wrong. Past government/corporation overreach does not justify current government/corporation overreach. Also, refusing to hire someone over an existing vaccine requirement is very different than terminating someone over a new vaccine requirement.

So the private employers are unable to demand the employee vaccinate? That will be tough argument. In Texas you are employed at will. Even if you "BAN" mandates you can be fired for any or no reason. Not sure you can legislate that.

 

[Jim_in_Delaware]

LMAO Gotta admit thats a pretty funny statement.


Scott Gottlieb Former commissioner of the FDA

Scott Gottlieb (born June 11, 1972) is an American physician and investor who served as the 23rd commissioner of the Food and Drug Administration (FDA) from 2017 until April 2019. He is presently a senior fellow at the conservative think tank the American Enterprise Institute (AEI), a partner at the venture capital firm New Enterprise Associates (NEA),[1][2] a member of the board of directors of drug maker Pfizer, Inc,[3] a member of the board of directors of Illumina, Inc.,[4] a contributor to the cable financial news network CNBC, and a frequent guest on the CBS News program Face the Nation. He is the author of the The New York Times best selling book Uncontrolled Spread[5] on the COVID-19 pandemic and the national security vulnerabilities that it revealed. Before becoming FDA commissioner, he was a clinical assistant professor at New York University School of Medicine, the FDA deputy commissioner for medical and scientific affairs, a venture partner with New Enterprise Associates, a member of the policy board of the Leukemia & Lymphoma Society, a senior official at the Centers for Medicare and Medicaid Services, and a member of the Federal Health Information Technology Policy Committee, which advises the United States Department of Health and Human Services on healthcare information technology. He was previously a resident fellow at AEI from 2007 to 2017 prior to joining the FDA as commissioner in May 2017.

So, what is your point? Gottlieb was not a member of the board of directors when he worked for FDA. He was hired by Pfizer after he left the FDA.

Confuse conspiracy theories with facts much?

Jim

 

[AZMark]

So the private employers is unable to demand the employee vaccinate? That will be tough argument. In Texas you are employed at will. Even if you "BAN" mandates you can be fired for any or no reason. Not sure you can legislate that.

Same in AZ, can be fired for looking at your boss wrong. This freedom for corporations is the will of the people now furious about it.

 

[crazy4life]

Is there a point in here somewhere? I’m certainly not butthurt.

You have some pretty conflicted views on things, just an observation.

Sorry Bro I have not lived in a fantasy world since I got out of basic training in the 70's and wound up in Central America chasing Sandinista around with the contra's while our Government was selling arms to Ayatollah Khomein.

Called me whatever you like but I am pretty sure I have a grasp on how Government really works.

Carry on

 

[crazy4life]

So, what is your point? Gottlieb was not a member of the board of directors when he worked for FDA. He was hired by Pfizer after he left the FDA.

Confuse conspiracy theories with facts much?

Jim

That was exactly my point and thank you for making it for me.

 

[Julian]

I'm not the one who posted click bait. Don't ask me to do the legwork to back up your argument.

"Frankly I don't think they should be forced to prove how they caught it". - Unfortunately, that small detail is relevant when classifying an on-duty event.

Good talk!

Not asking you to do anything. I'm simply telling you that facts are facts. Sorry you don't like them. Calling it "click bait" doesn't change the facts.....its just a weak attempt to characterize facts as something else. You don't like the fact that they've determined to have died in the line of duty. Tough. Those are the facts. If YOU want to dispute them...feel free to do so. Whining about it being fake....isn't a debate worth continuing. Bring some facts, and I'll happily review them.

 

[Bruce]

Already had covid and my 2 shots

Thank you for getting vaccinated.

 

[mwalker4]

Got my booster on Friday. No issues except a sore arm for 24 hours. I have never even had a Covid test and plan on keeping it that way. I'm really concerned about everybody that has only had two shots and don't think they should be let into indoor public gathering places after 6 months from their second shot. JUST KIDDING, I really don't care much about anybody elses vaccination status, but I would recommend everyone get it.

 

[Lurch]

Not asking you to do anything. I'm simply telling you that facts are facts. Sorry you don't like them. Calling it "click bait" doesn't change the facts.....its just a weak attempt to characterize facts as something else. You don't like the fact that they've determined to have died in the line of duty. Tough. Those are the facts. If YOU want to dispute them...feel free to do so. Whining about it being fake....isn't a debate worth continuing. Bring some facts, and I'll happily review them.

Man, some of you people are emotionally invested in pushing a narrative. Have a super day!