## Coronavirus

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With the new Sanofi vaccine, there are also concerns that it will simply not be profitable for pharmaceutical companies to develop vaccines against a family of rapidly mutating viruses, such as the coronaviruses.

With Pfizer's technology they can make a new vaccine in a couple of weeks.

Unfortunately it has to be super frozen, so it's not ideal for protecting war torn regions, for instance.
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A couple random questions about the vaccines:

Would anyone put it past Donald Trump to pressure US pharmaceutical companies to cut corners and seek approval for a vaccine they weren't sure was safe and effective, and then to pressure federal agencies to approve and distribute such a vaccine? The President made much of Operation Warp Speed, and was probably looking forward to claiming victory again whether he had won or not. (In the fight against the virus, that is. No one would ever do that in a national election.)

That's an unlikely amount of paperwork to fake, and maybe there are limits to how self-centered he is, I dunno. Of course the vaccines arrive right as he's leaving, but if we was putting his thumb on the scales, the incoming administration would need time to figure that out and then what? "Sorry folks, it's going to be another year"? Yikes. More likely, they'd just hush it all up, even though it was really the outgoing administration's fault. But then they'd be getting the blowback when the thing turns out to be dangerous or ineffective, so maybe it's more of a risk not to clean up the mess you inherited.

Second question: pharmaceutical companies have been getting pretty bad press lately; would they be stupid enough to provide vaccines that were dangerous or ineffective, knowing that it would be rolled out to hundreds of millions of Americans, and probably that many more in less important places? Wouldn't they be scared of the inevitable blowback if this thing either didn't work or was actually harmful?

Again, a lot of paperwork hurdles to get through, and maybe there's enough greed to overcome what looks like a pretty big PR risk, I dunno.

These are sort of "skin in the game" questions. Obviously the makers of vaccines stand to make money. But what risks are they taking? Is there any risk from a PR nightmare, or do you just sit on your money and wait for it all to blow over? Do the feds claw back their money if you misrepresented your vaccine? What about the federal agencies involved? The CDC, once the most trusted institution in America, took a pretty big hit to its credibility. How many bureaucrats and government scientists worried about losing their jobs if they bungled this -- I'm not talking about political appointees, who have a whole different calculus. Maybe not many, but the loss of reputation could seriously hurt your options for jumping to the private sector. Who is so secure that they're not worried about sitting under the lights in the inevitable televised Congressional hearings, trying to explain how it's not personally their fault that somebody's family members died. (This isn't like climate change, where you're long gone by the time it'll be obvious how badly you fucked up.)

Just wondering.
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maybe there are limits to how self-centered he is

No.
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Some of this stuff would require a global government.

https://unu.edu/news/news/reaffirming-the-uns-role-in-global-governance.html#info
• 5.3k
if the effort had not been put in the death toll would likely have been much. much greater by now and into the near future.

You don't know how great the death toll could be in twenty years; it's pure conjecture.

So do you have knowledge I'm not privy to? Or is there some other reason why you can say that the death toll would likely have been much much more "into the future", yet I can't possible know what the death toll would be?

If there were no vaccination program much more virulent strains might have emerged. They might anyway.

Do you have any evidence at all of this? The prevailing scientific opinion is that the virus will become a flu-like endemic disease.

I am really struggling to see what your position actually is. Are you against the vaccination program? Do you think there is a viable alternative to it in the situation we find ourselves in?

It's not that complicated - vaccination is a small part of a much larger raft of measures which are needed to combat the crisis now and into the future, it's a useful tool, not a panacea. There's absolutely no need to pursue anyone who doesn't want to take the vaccine for any reason (it's just not that important a tool, so long as a good number want it); and focusing all the media attention on anti-vaxxers as being to blame for the continuation of the crisis draws attention away from the huge amount of other actions which are required to protect us now and in the future, but which governments are more reluctant to take given the expense an unpopularity of many of them.

Pressure needs to be substantial and consistent to force governments (and the population) to take the steps necessary in terms of health investment, inequality, and public health improvements. That pressure is currently being pissed away in favour of righteous tribalism.
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So do you have knowledge I'm not privy to? Or is there some other reason why you can say that the death toll would likely have been much much more "into the future", yet I can't possible know what the death toll would be?

Wait until the state begins really enforcing its Covid mandates, you will see the death toll rise immensely. . .as a result of Covid of course.
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I'm not sure what you're getting at here.

It think I do. Possibly, it's that clinging on to every second of life by our fingernails and "hang the expense" is pointless and undignified. People die when it's their time. The important thing is that they've had a good life. We too easily forget about giving people a good life and pour every expense into just extending it. We live in a world in which child labour is still part of the normal cycle of production, yet helping a 95 year old terminal cancer sufferer die is, mostly, illegal. It's a huge part of what's skewed our response to this crisis.
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So do you have knowledge I'm not privy to? Or is there some other reason why you can say that the death toll would likely have been much much more "into the future", yet I can't possible know what the death toll would be?

It was "now and into the near future". If no lockdowns and other measures had been in place and no vaccines, there would likely have been a much greater death toll. Are you seriously claiming that the vaccines haven't made a significant difference to the death toll?

And I said you couldn't possibly know what the death toll would have been or will be twenty years into the future. But you ignored those qualifications regarding the future.

Do you have any evidence at all of this? The prevailing scientific opinion is that the virus will become a flu-like endemic disease.

Do you have any papers to cite in support of that claim? That may indeed be the more likely scenario, but who knows? Even the experts can't predict the future with certainty.

It's not that complicated - vaccination is a small part of a much larger raft of measures which are needed to combat the crisis now and into the future, it's a useful tool, not a panacea. There's absolutely no need to pursue anyone who doesn't want to take the vaccine for any reason (it's just not that important a tool, so long as a good number want it); and focusing all the media attention on anti-vaxxers as being to blame for the continuation of the crisis draws attention away from the huge amount of other actions which are required to protect us now and in the future, but which governments are more reluctant to take given the expense an unpopularity of many of them.

I think you are going against the grain of expert opinion if you think that vaccination is a "small part". The consensus seems to be that without vaccines we might never get out of the next wave/ lockdown cycle, which is obviously unsustainable. Also the more people get vaccinated the better the outcome will be. I'm not in favour of blaming people as I've said, but I really can't understand why anyone intelligent who isn't given to irrational fears would be reluctant to do their bit for the effort to get the best outcome. Other social issues should be addressed of course, but the emergency now is the fight against covid. You still haven't given your reasons for not wanting the vaccine. Do you have a rational reason or are you simply afraid of it?
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As I'm sure you're aware, the pharmaceutical companies have a track record of lying about both safety and efficacy, so they wouldn't even need the pressure from Donald Trump, or anyone in government.

As the Cochrane Foundation recently concluded...

all aspects of most high impact, industry-sponsored clinical trials remain influenced by industry and systematically produce more favourable efficacy findings and conclusions than research supported by other sources — Lundh A, Lexchin J, Mintzes B, et al.Industry sponsorship and research outcome. Cochrane Database Syst Rev

85% of vaccine clinical trials are sponsored by vaccine manufacturers and non-industry trials are over four times more likely to report negative or mixed findings than industry-sponsored trials — Manzoli L, Flacco ME, D’Addario M, et al. Non-publication and delayed publication of randomized trials on vaccines: survey. BMJ

the majority of panel members producing clinical practice guidelines have disclosed or undisclosed financial CoI [Conflicts of Interest] — Neuman J, Korenstein D, Ross JS, et al.Prevalence of financial conflicts of interest among panel members producing clinical practice guidelines in Canada and United States: cross sectional study. BMJ

Perhaps more pertinent to our current situation is the handling of the HPV vaccine. In an investigation Researchers found that "the involvement of the vaccine manufacturer, Merck,was particularly damaging".
Merck’s intervention in the policy process, included the provision of funds to an organisation of female legislators that introduced many of the bills to mandate HPV vaccination.
Most damningly, a principal investigator of HPV vaccine trials for Merck and GlaxoSmithKline agreed that “It seemed very odd to be mandating something for which 95 percent of infections never amount to anything”
Later reviews showed that design problems in the HPV vaccine trials, most of which were led by academics but sponsored by industry, made it difficult to evaluate the extent to which the vaccine prevented cervical cancer.
The program was stopped.
(Rees CP, Brhlikova P, Pollock AM. Will HPV vaccination prevent cervical cancer? J R Soc Med)

The FDA are not much better unfortunately

On June 7, the FDA approved aducanumab for the treatment of Alzheimer's disease. The drug received accelerated approval because it showed it could reduce the rate of amyloid plaque on scans. What remains uncertain is whether this reduction in plaque means Alzheimer's patients live longer or better lives -- and notably, the totality of the clinical trial data do not show that. Moreover, the drug has various side effects and a whopping price tag: $56,000 a year. In response to the FDA's approval, three members of the Peripheral and Central Nervous System Drugs Advisory Committee who opposed approval of the drug, quit the panel in protest. Aaron Kesselheim, MD, JD, MPH, a Harvard professor called the drug "problematic," and argued that there was little evidence it would help patients. Writing in The Atlantic, Nicholas Bagley, JD, and Rachel Sacks, JD, MPH, estimate that if the drug is prescribed to just one-third of eligible patients, it would cost Medicare$112 billion a year -- a massive figure that dwarfs any other medication.

As to their current practices... From Pete Doshi, writing in the BMJ

On 28 July 2021, Pfizer and BioNTech posted updated results for their ongoing phase 3 covid-19 vaccine trial. The preprint came almost a year to the day after the historical trial commenced, and nearly four months since the companies announced vaccine efficacy estimates “up to six months.”

measuring vaccine efficacy two months after dosing says little about just how long vaccine-induced immunity will last. “We’re going to be looking very intently at the durability of protection,” Pfizer senior vice president William Gruber, an author on the recent preprint, told the FDA’s advisory committee last December.

But you won’t find 10 month follow-up data here. While the preprint is new, the results it contains aren’t particularly up to date. In fact, the paper is based on the same data cut-off date (13 March 2021) as the 1 April press release, and its topline efficacy result is identical: 91.3% (95% CI 89.0 to 93.2) vaccine efficacy against symptomatic covid-19 through “up to six months of follow-up.”

As an RCT reporting “up to six months of follow-up,” it is notable that evidence of waning immunity was already visible in the data by the 13 March 2021 data cut-off.

“From its peak post-dose 2,” the study authors write, “observed VE [vaccine efficacy] declined.” From 96% to 90% (from two months to <4 months), then to 84% (95% CI 75 to 90) “from four months to the data cut-off,” which, by my calculation (see footnote at the end of the piece), was about one month later.

But although this additional information was available to Pfizer in April, it was not published until the end of July.

The final efficacy timepoint reported in Pfizer’s preprint is “from four months to the data cut-off.” The confidence interval here is wider than earlier time points because only half of trial participants (53%) made it to the four month mark, and mean follow-up is around 4.4 months

Despite the reference to “six month safety and efficacy” in the preprint’s title, the paper only reports on vaccine efficacy “up to six months,” but not from six months. This is not semantics, as it turns out only 7% of trial participants actually reached six months of blinded follow-up (“8% of BNT162b2 recipients and 6% of placebo recipients had ≥6 months follow-up post-dose 2.”) So despite this preprint appearing a year after the trial began, it provides no data on vaccine efficacy past six months, which is the period Israel says vaccine efficacy has dropped to 39%.

Former FDA commissioner Scott Gottlieb, who is on Pfizer’s board [[b]says it all doesn't it? - my addition[/b]], said: “Remember, the original premise behind these vaccines were [sic] that they would substantially reduce the risk of death and severe disease and hospitalization. And that was the data that came out of the initial clinical trials.”

Yet, the trials were not designed to study severe disease. In the data that supported Pfizer’s EUA, the company itself characterized the “severe covid-19” endpoint results as “preliminary evidence.” Hospital admission numbers were not reported, and zero covid-19 deaths occurred.

In the preprint, high efficacy against “severe covid-19” is reported based on all follow-up time (one event in the vaccinated group vs 30 in placebo), but the number of hospital admissions is not reported so we don’t know which, if any, of these patients were ill enough to require hospital treatment. (In Moderna’s trial, data last year showed that 21 of 30 “severe covid-19” cases were not admitted to hospital; Table S14).

on preventing death from covid-19, there are too few data to draw conclusions—a total of three covid-19 related deaths (one on vaccine, two on placebo). There were 29 total deaths during blinded follow-up (15 in the vaccine arm; 14 in placebo).

Last year the FDA said it was “committed to use an advisory committee composed of independent experts to ensure deliberations about authorisation or licensure are transparent for the public.” But in a statement, the FDA told The BMJ that it did not believe a meeting was necessary ahead of the expected granting of full approval. Diana Zuckerman, president of the National Center for Health Research, who has also spoken at recent VRBPAC meetings, told The BMJ, “It’s obvious that the FDA has no intention of hearing anyone else’s opinion.

Same old, same old... fudging, deception, poor methodology...and this is the stuff they publish! With no requirement at all to publish null results, raw data sets nor statistical analysis methods.

A report from an analyst at Goldman Sachs came out a little while back about the Hep C treatment...
“GILD is a case in point, where the success of its hepatitis C franchise has gradually exhausted the available pool of treatable patients,” the analyst wrote. “In the case of infectious diseases such as hepatitis C, curing existing patients also decreases the number of carriers able to transmit the virus to new patients, thus the incident pool also declines … Where an incident pool remains stable (eg, in cancer) the potential for a cure poses less risk to the sustainability of a franchise.”

Or Ritalin as another example...

the number of children on medication for ADHD has grown to 3.5 million from 600,000 in 1990, according to the Centers for Disease Control and Prevention. A diagnosis is now found in 15 percent of high-school age children when, in fact, the true rate is closer to 5 percent, with only a small minority of that group truly needing to be medicated.

This gross over-diagnosis and prescription is a direct result of intense, multi-million dollar marketing campaigns by the drug makers, both through celebrity endorsements as well print and television ads that prompt patients and their families to ask doctors about those specific drugs. The result is to sway doctors to go for the easy, quick fix solution of a pill (when you have a hammer, everything you see is a nail). And the tactic has paid off, with a quintupling of stimulant sales since 2002, to over $8 billion in revenues. The practice has created a situation of widespread drug abuse, affecting the long-term health and well-being of millions of young people. This mess has prompted long-time ADHD advocate Dr. Keith Conners to call the rising diagnosis rates a “concoction to justify the giving out of medication at unprecedented and unjustifiable levels,” that has resulted in “a national disaster of dangerous proportions.” — New York Times - The Rise in Ritalin In 2012, GlaxoSmithKline was fined$3 billion fine and pled guilty to criminal charges of knowingly promoting anti-depressant drugs to children despite not being approved by the FDA to be used for off-label purposes in minors. In 2013 Johnson & Johnson were fined $2.2 billion for its promotion of off-label drugs. In 2009 Pfizer were fined$2.3 billion for illegally marketing Bextra, a painkiller. Note these were all illegal acts. Criminal activity.

Anyway, unlike the wisdom displayed in your previous deleting activities, I should have deleted all this but won't, it's not like all of this isn't common knowledge. If these deals were made with the arms industry or the tobacco industry, or some chemical giant there'd not be a soul just taking them at their word but medicines get a free ride I guess.
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And I said you couldn't possibly know what the death toll would have been or will be twenty years into the future. But you ignored those qualifications regarding the future.

I didn't ignore them, they are the entire point. I was refuting a response from ssu that we had made progress on the other causes of death - the drop in death rate after 20 years was cited in evidence. I was just saying that in 20 years the death rate from COVID would be that low too, the relevant comparison is the effort we're putting in right now.

Do you have any papers to cite in support of that claim? That may indeed be the more likely scenario, but who knows? Even the experts can't predict the future with certainty.

Of course - https://www.bmj.com/content/372/bmj.n494

Other social issues should be addressed of course, but the emergency now is the fight against covid.

The other issues are the fight against COVID - that's the point. And they come from the WHO's own agency responsible (as I've extensively quoted above).

I think you are going against the grain of expert opinion if you think that vaccination is a "small part". The consensus seems to be that without vaccines we might never get out of the next wave/ lockdown cycle

Yes, I'm aware of that. As I've argued extensively, there's no moral nor rational reason why one ought to adhere to the consensus opinion. Consensus among experts is not strongly predictive of the utility of a theory, membership of the set of theories considered by experts is.

You still haven't given your reasons for not wanting the vaccine. Do you have a rational reason or are you simply afraid of it?

I've discussed the matter extensively. I don't trust the pharmaceutical industry and I don't agree that giving vaccines to healthy people who have little chance of contracting the severe disease is a good use of limited resources. I don't see any moral imperative for me to take a vaccine since the outcome of my doing so is very unlikely to reduce harm relative to my not doing so. I'm very unlikely to need hospital treatment if I do get it, I'm very unlikely (given my hygiene measures) to pass the disease on (and the vaccine is only marginal in reducing transmission anyway), and there little to no evidence that mass vaccination will do any more to stop the virus's spread than naturally acquired immunity.
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