So your faith in the FDA comes from...? — Isaac

It's more that I have faith that neither Pfizer nor Moderna want to deal with the legal downside of giving false info about their testing.

And yes, the more I hear about the British healthcare system, the more horrified by it I get. But that's another story.

It's more that I have faith that neither Pfizer nor Moderna want to deal with the legal downside of giving false info about their testing. — frank

Well, it didn't stop them with Neurontin, Genotropin, Bextra, Detrol, Lipitor, or Rapamune...all of which were proven to have been based on false information and marketed illegally. So what makes you think they'd stop now?

Sigh. Who gave false info about their testing (to the FDA)?

Who gave false info about their testing? — frank

Pfizer. 2004 Cereblex, trials showed evidence of elevated risk of heart problems and they withheld them. $894 million in lawsuits. Didn't even break their stride.

Pfizer. — Isaac

Which drug?

Edited

I could list the full rap sheet, but it's common knowledge which has already been publicly written about at great length, there's little point in me reproducing it here. If you're not convinced already, just by being involved in healthcare, then you probably never will be.

At what point did I say that the level of investment would not produce a vaccine more quickly? — Isaac

At least you said so:

You think those billions now poured into various vaccine programs by major countries won't have an effect? — ssu

Yes, absolutely I think that — Isaac

At least you said so:

You think those billions now poured into various vaccine programs by major countries won't have an effect? — ssu


Yes, absolutely I think that — Isaac — ssu

The context of 'effect' was the global decease in deaths due to the pandemic and it's collateral damage. Obviously I didn't mean to claim that it would have no effect on the world whatsoever. The entire argument I've been presenting is about the negative effects it will have, for goodness' sake.

I could list the full rap sheet, but it's common knowledge which has already been publicly written about at great length, there's little point in me reproducing it here. If you're not convinced already, just by being involved in healthcare, then you probably never will be. — Isaac

Shouldn't be a big deal to identify who gave false info to the FDA about which drug.

Pfizer. 2004 Cereblex, trials showed evidence of elevated risk of heart problems and they withheld them. $894 million in lawsuits. Didn't even break their stride. — Isaac

Look closer. The heart scare came after the original trials and we now know that Celebrex is not more likely to cause adverse heart related outcomes than other NSAIDS.

Pfizer's lack of honesty was about Celebrex being easier on the stomach. And sure, that's bad, especially for all the people who ended up in the hospital with GI bleeds. It's terrible. I don't see what it has to do with the safety of Pfizer's vaccine though.

There aren't many medical interventions that carry no risk of adverse side effects. I'll no doubt have to sign something to acknowledge all the things that could go wrong when I get the vaccine (up to and including death). Shit happens.

Yes, drug companies are the scum of the earth. I see it all the time, mainly wrt opioid addiction. You're not really broadening my horizons about that.

Pfizer's lack of honesty was about Celebrex being easier on the stomach. And sure, that's bad, especially for all the people who ended up in the hospital with GI bleeds. It's terrible. I don't see what it has to do with the safety of Pfizer's vaccine though. — frank

No. According to the NYT who broke the story...

Pfizer said in October that no completed study had ever shown any increased heart risks related to Celebrex. ..

...the 1999 study, which was intended to examine whether Celebrex could treat Alzheimer’s disease, found that the number of Celebrex patients suffering heart attacks was almost four times that of those taking a placebo. Pfizer’s own analysis found the difference statistically significant.

But the study was never published and not submitted to the Food and Drug Administration until June 2001, four months after the F.D.A. conducted a major review of the safety of Vioxx and Celebrex.

They outright hid and lied about a negative trial to maintain sales, and it's absolutely not a one off.

And you ask what this has to do with the efficacy of the vaccine they stand to make billions from?

the 1999 study, which was intended to examine whether Celebrex could treat Alzheimer’s disease, found that the number of Celebrex patients suffering heart attacks was almost four times that of those taking a placebo. Pfizer’s own analysis found the difference statistically significant.

The issue was whether Celebrex is more likely than other NSAIDS to cause heart attacks. It's not.

”A 2013 meta-analysis of hundreds of clinical trials found that coxibs (the class of drugs that includes celecoxib) increase the risk of major cardiovascular problems by about 37% over placebo.[6] In 2016, a randomized trial provided strong evidence that treatment with celecoxib is not more likely to result in poor cardiovascular outcomes than treatment with naproxen or ibuprofen.[26] As a result, in 2018 an FDA advisory panel concluded that celecoxib poses no greater risk for causing heart attacks and strokes than the commonly-used NSAIDs ibuprofen or naproxen and recommended that the FDA consider changing its advice to physicians regarding celecoxib's safety.[9]”. -- wiki

Also note: the Celebrex fiasco was a big deal. There were repercussions for the stomach safety issue.

The entire argument I've been presenting is about the negative effects it will have, for goodness' sake. — Isaac

Well, good to weigh those negative effects. Yet do weigh then them on the fact that now the US has lost daily the equivalent of those lost in 9/11 to Covid-19 and the pandemic has killed more than heart disease kills annually. So what does 9 months compare to two years?

Moderna will soon begin testing its vaccine in 3,000 teens age 12-17. ...The study is set to finish in June 2022 ...it’s normal that studies are conducted first in adults, then older children and teens down to young kids....hopeful that by the school term of 2021 … we will certainly have a vaccine I think that we could administer to children over 12 ...Moderna is currently awaiting emergency use authorization from the Food and Drug Administration for its mRNA vaccine that could be distributed shortly. ...Moderna said it expects to have 20 million doses available in the U.S. by the end of 2020 and between 100 million and 125 million doses available globally in the first quarter of 2021. -- Boston Herald

I take it that Pfizer has claimed that they have already tested 12-17 year olds?

I understand that medical-pharmaceutical research is complex and problematic. Therefore, it would stand to reason that it cannot be held to the same rigorous statistical standards as most other sciences where the variables can be minimized before data is collected for statistical analysis. Then all pharmaceuticals developed and released to the public carry relatively high risk to be counterbalanced against vastly greater gain.

The real issue lies in the political pressure and interference coming from the President who treats watchdog agencies like the FDA as worthless bureaucrats. He may well be right about that, I don't know. But public confidence in the process of approvals is eroded if the FDA is threatened and berated.

Yet do weigh then them on the fact that now the US has lost daily the equivalent of those lost in 9/11 to Covid-19 and the pandemic has killed more than heart disease kills annually. — ssu

How does the number of Covid deaths impact on the likely efficacy of the vaccine as a means of reducing them (together with collateral deaths from pandemic-related impacts)? Is there some threshold of deaths at which a previously inefficient approach to reducing them suddenly becomes efficient?

It seems to me the number of deaths only serves to make it all the more urgent that we work out some effective course of action. So an argument about the negative effects of any strategy is not to be 'weighed against' the death rates, it's fully about the death rate.

Then all pharmaceuticals developed and released to the public carry relatively high risk to be counterbalanced against vastly greater gain. — magritte

Thus only works as an argument if you assume the only consequence of 'complexity', as you diplomatically put it, is negative side effects. It's not. Serious short-term negative side effects are, most of the time, very rare. More often if there's side effects they're mild and treatable. Long-term, of course, we can't really know, but there's no general correlation to worry about, so unlikely to be anything there.

The real concern is not side effects, it's ineffectiveness. Most of the cover-ups and pay-offs have been for drugs which simply don't work. That's the worry here. As Peter Doshi (Associate Editor of the British Medical Journal and assistant professor of pharmaceutical health services research at the University of Maryland) put it recently...

None of the trials currently under way are designed to detect a reduction in any serious outcome such as hospital admissions, use of intensive care, or deaths. Nor are the vaccines being studied to determine whether they can interrupt transmission of the virus.

The real concern is not side effects, it's ineffectiveness. — Isaac

I would have said adverse side effects are the bigger concern. 1 out of a million people vaccinated for small pox will die from the vaccine. So if we vaccinate everyone in the UK, we know we'll be killing a bunch of people. Approving a vaccine is a heavy decision because you could hurt people who would be fine otherwise.

Ineffectiveness should have shown up in the phase 3 testing of either Pfizer or Moderna.

I would have said adverse side effects are the bigger concern. 1 out of a million people vaccinated for small pox will die from the vaccine. So if we vaccinate everyone in the UK, we know we'll be killing a bunch of people. Approving a vaccine is a heavy decision because you could hurt people who would be fine otherwise. — frank

Possibly you're right there.

Ineffectiveness should have shown up in the phase 3 testing of either Pfizer or Moderna. — frank

Do you even read what I write?

Do you even read what I write? — Isaac

Yes. I mean, you could be right. It may be that this vaccine does nothing. The flu vaccine I get every year is only 70 % effective. I was kind of surprised they were saying 95% for the mRNA.

We'll see.

I was kind of surprised they were saying 95% for the mRNA. — frank

It may well be 95% effective at what it's been tested for, but that's the generation of a sufficient immune response to limit subsequent infection in healthy adults.

What we need, to escape this pandemic, is a way of minimising hospital admissions among the vulnerable and reducing transmission. Two things we have absolutely no idea if the vaccine will do because it's not been tested for either.

What we do know is that investment in critical care, general health improvements, community healthcare and poverty reduction all lower hospital admissions. We also know that contact tracing, social distancing and mask-wearing reduce transmission.

So I remain baffled as to why people have suddenly decided to intern themselves to provide free marketing to the largest industry on the planet when it can't even demonstrate that it's 'holy grail' is any more effective than measures that have been around (and woefully underfunded) for years.

What's going to happen next time (and there will be a next time)? Another million dead while we wait for the vaccine? Rather than just invest in the healthcare services that could have saved the overwhelming majority of those lives?

Not sure about TB deaths, but we could see some truely startling suicide rates from the lock down. As we have statistics for normal rates of overdose, suicide, etc, any marked increase in those from established baselines could be attributed as collateral damage from Covid lockdowns. That might get to half a million before it's all said and done.

no lives are ever "saved" eh. The end gets delayed, best case scenario. That's it. The finish line is moved back a bit, but the race always ends.

no lives are ever "saved" eh. The end gets delayed, best case scenario. That's it. The finish line is moved back a bit, but the race always ends. — Book273

It's just a colloquial term. We could talk about Quality Adjusted Life Years if we wanted to be more accurate, but generally a 'life saved' in this context just means a reversion to the risk spectrum they were exposed to prior to the threat under consideration.

How does the number of Covid deaths impact on the likely efficacy of the vaccine as a means of reducing them (together with collateral deaths from pandemic-related impacts)? Is there some threshold of deaths at which a previously inefficient approach to reducing them suddenly becomes efficient?

It seems to me the number of deaths only serves to make it all the more urgent that we work out some effective course of action. So an argument about the negative effects of any strategy is not to be 'weighed against' the death rates, it's fully about the death rate. — Isaac

First of all, Isaac.

Where the corners have been cut in the "race to a vaccine" is that before the approval was gotten, the large scale production of the vaccine was started. This is the multi-million dollar risk here, what was deemed OK. And I guess big Pharma was given a assurances that they wouldn't have to cover the risk all by themselves if the vaccine is a bummer. That's were the millions poured into this come out. In any other situation only now would large scale production of the vaccine would have started, not that the vaccine would be ready for shipping. Hence part reason was what said earlier.

Seriously. Would we trust a massive multinational business to act in the interests of the wider community under any other circumstances? Do we need to go through the track record of giant multinationals with social welfare? — Isaac

This is YOUR punchline. Multinationational corporations are evil.

Your point has been heard.

Dogs bark and the caravan goes on...

What we need, to escape this pandemic, is a way of minimising hospital admissions among the vulnerable and reducing transmission. Two things we have absolutely no idea if the vaccine will do because it's not been tested for either. — Isaac

Phase 1 just tests for baseline safety. Phase 2 optimizes dosing. Phase 3 checks again for safety, dosing, and effect.

Once it's approved for use, we can do multi-center randomized double blind what-not to see if it really improves outcomes.

Rather than just invest in the healthcare services that could have saved the overwhelming majority of those lives? — Isaac

This is simply not true. It eats holes in people's hearts, it destroys brain tissue, it turns lung into concrete.

Yes, Isaac, we need a vaccine.

Where the corners have been cut in the "race to a vaccine" is that before the approval was gotten, the large scale production of the vaccine was started. This is the multi-million dollar risk here, what was deemed OK. — ssu

Rather than just invest in the healthcare services that could have saved the overwhelming majority of those lives? — Isaac


This is simply not true. It eats holes in people's hearts, it destroys brain tissue, it turns lung into concrete. — frank

You'd both have some evidence to back up these claims I presume?

How are we determining that the only corners cut were in early production?

How are we determining that heath service and critical care improvements would only have saved an insignificant number of lives?

Yes, Isaac, we need a vaccine. — frank

Where have I suggested that we don't need a vaccine?

How are we determining that the only corners cut were in early production? — Isaac

Hmm. Peace out zombie. :cool:

We don't need a vaccine. We need an acceptance of mortality. end of story. way cheaper.

You'd both have some evidence to back up these claims I presume? — Isaac

Why don't you listen to Faucci?

Or you assume he is a corporate hack? Wearing your tinfoil hat are you, Isaac?



Oh but they didn't have pregnant mothers in the group and children! Do you know just who basically are killed by Covid-19? I think the worst group being killed by Covid-19 aren't actually children and pregnant women. I think that the way the US, the UK, the EU or heck, even Russia are handling this issue with starting the vaccinations is correct. Yes, get those vaccinations out there: you have a system of approving vaccinations so follow it... as has been done.

Sorry, but I'll leave now my tinfoil hat in the cupboard this time. Call me a sheeple or something if you want.

I’m standing looking out the kitchen window this afternoon when I see a double-trailer FedEx pull into the parking lot of the commercial garage/truck repair next door, stretching a great length across the wide lot. Now, I’ve seen a lot of unusual things be hauled or drive in there, but this was particularly unusual, so I called to my girlfriend, “hey, honey, come look at this.”

She approached the window and looked out: “what is it?” she asked.

“A double-trailer FedEx.”

“Oh!” she exclaimed with excitement, “maybe it’s full of vaccines!”

“What?” I asked.

“Maybe it’s hauling vaccine; I heard on tv that FedEx was gonna haul the vaccine.”

Now, I was just as surprised by her answer as I had been by seeing the truck, cause she usually doesn’t pay much attention to such tv news or comment on it: I realized she had been secretly watching stories about the imminent distribution of the vaccine, that she was highly anticipating it.

I put my head down b/w my hands and said, in a low voice, “this makes me mad.”

“What’s the matter?”

“You think this vaccine is gonna make you safe and solve all our problems, when you won’t even do the things now that you need to to stay safe until you can get vaccinated!” Cause you see, in 6 days, due to her and her family’s folly, and, frankly, selfishness, we’re gonna travel for Christmas to meet with them, who live in different parts of the state, and live in the same house with them for 2 days and nights.

A wise and benevolent govt would have kept this vaccine a secret until the very first day it was administered, in order to prevent a selfish foolish ppl from being even more of a harm to themselves.

But that’s not the way things work in this day of total transparency.