Hacker Newsnew | past | comments | ask | show | jobs | submitlogin

> This is a completely novel molecule...

Then do we understand the risk profile of this thing? That sounds like the sort of innovation that people would want to be at the back of the queue for.

Side effects don't have to happen in the next 6 months.



Pretty sure we don't understand the long term risk of getting COVID either right? I mean it has not even been around for 2 years. Plus we do know it is possible only 1 infection would kill you.


That’s a straw man argument, when you take this drug you already have 100% covid19. Presumably that means you’ll have that risk, plus additional unknown risk. Perhaps the drug works like advertised, but we’ve seen better and more successful studies for things like ivermectin and anti-body treatments. Which have a known risk profile.

It’s the same for the vaccine. You still have the risk of what ever the vaccine risk is, PLUS covid19. Supposedly it reduces the covid19 symptoms, but doesn’t reduce risk of infection (or at least unclear), it just improves the immune response.


The long term risks for either is not knowable.

Hospitalisation is an acute scenario that can lead to death, negating any concerns about the long-term in the first place. The short term risk of hospitalisation in the unvaccinated versus the vaccinated is well-known. Given what we know, it still makes sense to get vaccinated, and it may make sense for those at risk of hospitalisation (vaccinated or otherwise) to take an antiviral proven to cut the risk of hospitalisation.


Actually the long term risk of the covid-19 vaccines is well understood. You will not get a side effect from the vaccines in a year from now. For all of the vaccines created for any disease, the longest recorded period between taking the vaccine and side effects presenting is 6 weeks. 3.1 billion people are fully vaccinated for covid-19, many of them have been for longer than 6 weeks.


In Norway, some children developed narcolepsy after being vaccinated with Pandemrix. The average time from vaccine (or influensa) until developing narcolepsy was 8 months.

https://www.fhi.no/nyheter/2017/pandemi/ (in norwegian)


> You will not get a side effect from the vaccines in a year from now

There are possible severe negative effects due to vaccination, even if there are zero medical side effects. Herd vulnerability could cause widespread harm - there is a monoculture of immune responses and monocultures have vulnerabilities. I agree it's unlikely to have severe long term downsides, and the short-term gains are very significant. Note that I'm mostly pro vaccination.


I understand what well understood means but typically that also involves long term human clinical trials, and for a good reason.


[flagged]


The technology is not brand new. It has been used in labs for decades. This is just the first time it has been used in a drug for humans. All traces of the vaccine leave your body within days of receiving the shot.


This is a strange additive error to make: proactive or reactive treatments for COVID-19 don't produce additive unknowns in the presence of a COVID-19 infection, since their entire purpose is to improve healthcare outcomes (whether by reducing infection severity or incidence altogether).


Data shows that being vaccinated divides your odds of dying and being hospitalized from covid by about 10. There's no evidence I'm aware of showing that the vaccines create additional risk anywhere close to outweighing that benefit.


There is. Because kids (basically) don’t die from COVID. The side effect risk, while small, is material in a risk calculation for them, since their entire risk from the disease is small. At a minimum, mandating it for kids (as is openly stated to be the plan in CA) is unethical.


This argument makes no sense.

Even if we completely ignore that some children do in fact die (being rare doesn't stop it being terrible when it happens and worth avoiding), and that even if they don't, suffering while ill is bad: when we are talking about risks of completely unknown side effects, the side effect risk of the vaccine is obviously lower than the side effect risk of COVID itself.

The vaccine is relatively simple thing specifically designed to do one task. While there is always a chance there is something we didn't understand or see coming, the chance of a virus, a hugely complex and mutating thing with broad and varied effects, having some long-term side-effect is far, far higher.


> Even if we completely ignore that some children do in fact die ... the side effect risk of the vaccine is obviously lower than the side effect risk of COVID itself.

Why COVID-19 Vaccines Should Not Be Required for All Americans https://www.usnews.com/news/national-news/why-covid-19-vacci...

> Dr. Marty Makary, a professor at Johns Hopkins University School of Medicine and editor in chief of MedPage Today, argues that mandating vaccines for "every living, walking American" is, as of now, not well-supported by science. ... The risk of hospitalization from COVID-19 in kids ages 5 to 17 is 0.3 per million for the week ending July 24, 2021, according to the Centers for Disease Control and Prevention. We also know that the risk of hospitalization after the second vaccine dose due to myocarditis, or inflammation of the heart muscle, is about 50 per million in that same age group.


You elided my qualifier from your quote: "when we are talking about risks of completely unknown side effects"—the argument being made was that we can't possibly know the risks of the vaccine because we can't ever know with certainty until we've tested it for a long time, and therefore we should avoid it. My point is that the virus has far more "unknowns" to it, so that argument sucks.

As to vaccinating children more generally and assessing known risks, there is no simple answer. What are the risk levels for different age groups? What is the damage to kids if they pass COVID onto their parents or grandparents and they die? I'm not saying that we should just blanket give it to everyone, but I don't think that one stat is enough to say don't give it to any child, or that no mandate could be justified.


It's obvious to you because you are following a logical train of thought. These antivax people always do the same nonsense argument. It goes, COVID has risks and vaccines have risks, therefore it's impossible to know which is worse. It's literally the dril drunk driving tweet[1].

[1] https://twitter.com/dril/status/464802196060917762?lang=en


I'm not anti-vax, the logical train of thought you are incapable of yourself is based on the very factual reality that COVID presents highly variable risk to people based on their age. This, in combination with the known risks of the vaccine, in combination with the extremely early stage of wide-scale deployment of the vaccine in children, in combination with Hippocratic principles, in combination with risk-adjusted thinking, leads to the conclusions that no, it is not completely obvious if a parent should make an appointment for their 5 year old to get a medicine EUA authorized a week ago.

Besides, if you're so smart, and it's so obvious, why do you think you're smart enough to state that Sweden, a modern country, is objectively wrong for banning mRNA vaccines for children?

In any case, my primary point was that it should be up to parents if they give their kids this vaccine, and when. Not the government mandating it.


I mostly agree with you. I think the nuance that is missing here is that the degree of risk is different.

We know the degree of risk from vaccines is low, both in the short and long term. The side effects harm few people, and are not catastrophic.

With viruses, we know that side effects in the long term are real, and can be catastrophic. It is the reason that girl are vaccinated against HPV - HPV is the leading cause of cervical cancer. This is a very big problem down the line, even though HPV itself is mostly asymptomatic.

So, it does not follow that avoiding Covid vaccine for children because the immediate likelihood of death from acute covid is the only issue. We are aware that the long term risk of viral infection can be very great with viruses. Avoiding infection is much better if the alternative is the possibility of cancer.


> So, it does not follow that avoiding Covid vaccine for children because the immediate likelihood of death from acute covid is the only issue.

I never said it was the only issue. But neither is the only choice to give your kids the current approved vaccines ASAP or never give the vaccine to them ever.

Avoiding infection is much better if the alternative is the possibility of cancer. But of course, we don't know or plausibly think something like cancer is a long term risk of a COVID infection in children. Maybe one day we will realize such outcomes happen and then it would become much more sane to rush your kids to get the vaccine that day.

I think it's important to stick to what we know, about this virus, and these vaccines: we know that it is extremely rare for children to be hospitalized from COVID, and we know that it is extremely rare for diagnosed myocarditis. But what we also know is that as time goes on, we learn more. And especially for things where are very new, like using these vaccines have on children, we stand to learn a lot, quickly. So I think it's a bad frame to presume parents are pro- or anti- vax. Hesitancy is sane on this specific issue, and that's not to mean that other positions are insane, but what is insane is to impose this on parents who are hesitant at this present time, until we understand what, exactly, is going on with heart tissue.


Can you point me in the direction of studies comparing side effect risks for young children against COVID-19 risks for children? Presumably there's such a thing that you're basing your opinion on. I would find that useful, given that I have an 8 y/o who is now vaccine-eligible and her mother and I are discussing.


CDC admits that there has been severe cardiac damage to young people from the mRNA vaccines.

This leads to an obvious series of questions: just how dangerous is COVID for children? What mechanism is causing this heart damage? Could heart damage be happening without diagnosis, and manifest later? In a year, will we be able to fix this problem with the vaccines, or have protocols to prevent it? Are the vaccines more likely to cause permanent damage in children, than COVID, as opposed to temporary health problems? Are the non-mRNA vaccines completely de-risked from the proposition from causing permanent harm to children? Will CDC guidance in a year guide parents away from mRNA vaccines and towards different ones? Is there a correlating variable we will discover so we know which specific population of children would get heart damage from this? Etc.

https://twitter.com/cdcgov/status/1306689138612203520

More recent paper I found: https://www.ahajournals.org/doi/10.1161/CIRCULATIONAHA.121.0...

More questions: given this known to manifest in younger people, could it imply that age is inversely correlated with frequency? Will young children be less likely to report or articulate symptoms, even if they have increased risk? Given it seems sex coupled, is there an underlying variable correlated with sex that is a root cause we will soon understand, resulting in a vast risk reduction for parents who will be able to know if their children apply?

People claiming you can know if vaccination is a good idea or not for your kids have primitive mental models: the choice isn't to vaccinate or not vaccinate, but vaccinate now or (maybe) vaccinate later. When something is risk laden on both sides and is a dynamic system, the smart choice may be to wait if the marginal de-risking per unit time is high.

My personal view is that wrt children taking mRNA vaccines, there's basically close to free "money on the table" - wait a few months. If you've avoided COVID until now, its pretty unlikely your kids will catch it, nevermind be unlucky enough to get a severe case, which is extremely unlikely. On the other hand, it could turn out in a few months we identify the root cause of the heart issues of the vaccines, or alternative vaccines become available that de-risk it entirely. In any case, personal views aside, it's incredibly immoral to mandate this for schools, and it wouldn't surprise me if CA does this before we fully understand what is going on.


So that link you sent says there is 12.6 instances per million doses. So that is 0.00126% chance of happening. This article from March mentions around 22 per 100,000 chance from getting COVID. Much larger incidence rate. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7988375/ Now obviously might not be the same age ranges or such, but I do know last year the Big-10 almost cancelled it's football season due to myocarditis risk from COVID so clearly it has been an issue for a while. Might need to weigh that in the decision you make for your children. Too many people look for one side and use that to prove their point otherwise know as confirmation bias. I would study the incidence of both sides of this before making the decision. Although my children are less than 5 so they can't get it yet anyway.


Here's the problem with those stats.

First, if this has a mechanism which is damaging heart tissue, the diagnosed cases may just be the ones which are manifesting severely enough to the point of getting to through the entire funnel of a diagnosis. The actual blast radius may be much larger, and only result in problems later in life. Especially for children whose hearts are developing, it is extremely risky to administer a drug which we know has the capacity to damage heart muscle and we do not yet understand why and have a handle on the expected distribution of that damage across the whole population.

Second, the stat you mention on COVID is misleading, because a) it is a broad age group, my concern is primarily in the very young, many of whom are now being vaccinated in the US, and b) it is conditional on a positive COVID test. Many, many young children are contracting COVID and not developing symptoms or are not getting severe enough infections to get through the funnel of being determined to be a positive case. So the incidence rate you mention is effectively a meaningless number if you account for these two elements.

Based on our current understanding, it could very well turn out that the data we have now is consistent with a situation where eg, the vaccine administered to 5-6 year olds is in fact damaging their hearts with a sizable % liklihood, and their risk of having such kinds of permanent damage to their bodies from COVID (across the entire funnel, beginning at a non-infection) is much lower. I'm not sure of the liklihood of this reality, but it's not zero. We just don't know yet.


The abstract from your linked paper seems to indicate the risk is minimal.

>According to the US Centers for Disease Control and Prevention, myocarditis/pericarditis rates are ≈12.6 cases per million doses of second-dose mRNA vaccine among individuals 12 to 39 years of age

That's a 0.0013% chance of getting something that "almost all" patients had resolution of with or without treatment:

>Almost all patients had resolution of symptoms and signs and improvement in diagnostic markers and imaging with or without treatment. Despite rare cases of myocarditis, the benefit-risk assessment for COVID-19 vaccination shows a favorable balance for all age and sex groups; therefore, COVID-19 vaccination is recommended for everyone ≥12 years of age.


There is one in the Pfizer application for FDA authorization in 5-11 age group, see Table 14, page 34. It is not a direct study, it's an extrapolation based on antigen titers in a 2000 kid 2 months clinical trial, but it's the only one I am aware of.

https://www.fda.gov/media/153447/download


Considering they then become the primary host and spreader to all others there definitely is ethics involved in giving it to them.


Don’t mistake relative risk for absolute risk. Not everyone who is vaccinated gets Covid, but everyone vaccinated is at risk of vaccine side effects.

If a 30 year old has a 0.08% chance of hospitalization, the risk drops to 0.008%. But they might stand a 1 in 5 chance of getting infected so now it’s 0.016% to 0.0016%.

But if they get injected with a vaccine, the risk of a rare side effect might be 1 in 100,000 or 0.001% which is pretty similar to Covid.

It’s the same analysis the UK did that caused them to recommend against the AZ vaccine for certain age groups.


Your numbers are way off. The CDC estimated the hospitalization rate in the 18-49 age group at 3%.

https://www.cdc.gov/coronavirus/2019-ncov/cases-updates/burd...


Super skewed by the cohort they cobbled together. Look at the COVIDNet data for the decile age bands of hospitalization at peak waves: [0]

>18-29: 5/100000 = 0.05%

>30-39: 10/100000 = 0.1%

>40-49: 14/100000 = 0.14%

I would ask why our agencies keep doing things like this and burning trust, but it's rhetorical.

[0] https://gis.cdc.gov/grasp/COVIDNet/COVID19_3.html


You're comparing completely different statistics. The 3% is the infection hospitalization rate; in other words, the odds of being hospitalized once infected. The rates from your source are the total number of people per 100k who are hospitalized for covid in a given week; it does not mean they only have a .05% chance of being hospitalized once infected, it means .05% of the entire age cohort are hospitalized from covid that week.


edit2: actually, I see the denominator there is total population not cases but I still don't follow.

There have been 19,850,744 cases in 18-49 year olds [0] and 63,207 hospitalizations [1] which suggests at 0.3% infection hospitalization rate..

[0] https://covid.cdc.gov/covid-data-tracker/#demographics

[1] https://gis.cdc.gov/grasp/COVIDNet/COVID19_5.html#virusTypeD...


18-49...could that age gap be any wider. A 20 year old is going to deal with Covid quite a bit differently than a 40 year old.


Dying, not hospitalization.


Nope. Look at the data again. The risk of dying from an infection in the 18-49 age group is 0.06%. The risk of hospitalization from an infection in that age group is 3%; you claimed 0.08% which is wrong by two orders of magnitude.


Huh? 0.06% and 0.08% are 2 orders of magnitude different?


Are you being intentionally dense? Your original comment claimed a 0.08% hospitalization rate. The actual hospitalization rate is closer to 3%.


Typo. Meant death.


I think 1 in 5 is very optimistic. Unless you intend to remove yourself from society, you are very likely to catch Sars-Cov-2 in the upcoming years. Probably more than once. It's endemic and easily transmittable.


In the long run, everyone will get Covid (though many may be asymptomatic). It's not going away.


> Presumably that means you’ll have that risk,

But greatly improves the odds of not dying, which is pretty important for a lot of people.


> Presumably that means you’ll have that risk, plus additional unknown risk.

That's a bad argument. This makes COVID less severe, which in turn makes the long-term affects less severe. Things in medicine are rarely binary.


We don’t actually know if it makes the long term risk less severe or more severe. We don’t have the data.


Sure. We also don't know if it will give you superpowers. I mean, we have logic and the history of similar things that gives us good ideas. And the fact that the risks grow because the immune response means a shorter immune response is likely to be less severe long term. But yeah, technically there is no study there yet.


We have not seen better and more successful studies for ivermectin, we have seen a lot of studies that find it does next to nothing, and a few deeply fraudulent studies that finds that it solves world hunger.

It's a strange day when people argue against evaluating a new medicine, in favour of snake oil that doesn't work.

Given that you think that it's unclear that vaccines reduce the rate and seriousness of COVID, I am not sure that your have a good enough understanding of the ground facts to have an informed opinion on this subject.


Wow. I always wonder when I hear comments this.

Check out https://c19early.com (specifically, https://c19ivermectin.com/).


This drug might actually save the patient from the risk of dying from covid. It would be the same for the vaccine: the vaccines reduce the risk from dying.


> Side effects don't have to happen in the next 6 months.

If this is a molecule with a short half-life that is broken down and expelled by the body, it isn't going to have random side effects that show up months in the future.


As someone who worked in toxicology, this is absolutely a false statement. This molecule is a covalent binder - it basically attaches itself permanently to proteins. It absolutely could have effects long after the free molecule is metabolized and excreted. The molecule is designed to be selective for the Covid protease but off-target effects are inevitable.

Do I think that is likely? No, because the FDA isn’t stupid and screens for obvious toxicity in cell cultures and lab animals and only then is testing humans allowed. Then those are screened before approval.

Of course the risk isn’t 0%, but it’s pretty low and if you’re at chance of dying or Covid it’s a pretty small risk relatively speaking.


> this is absolutely a false statement. This molecule is a covalent binder

That's why I said if, I know nothing about the molecule.


But you're giving statements out like you know everything about it, and the fact you said if has no relation with the fact it binds to proteins


Unless it were to change something in the body while it was still active, and those changes didn't show any signs for a long time.

I'm just playing devil's advocate, but it doesn't seem impossible.


I guess my question is what is probable rather than possible or is that a risk that's even addressable to any reasonable degree


Well, nothing's impossible really.


Prions are "just" proteins that should get broken down by the body. But they don't, and they cause ‎Creutzfeldt-Jakob in over 10 years after ingesting.


It's a good thing we're all here on HN to question the safety of novel pharmaceuticals. If we weren't, maybe nobody would, and we'd all just be putting prions into ourselves.

If you have something specific about this particular molecule to talk about vis a vis safety, that's an interesting comment to make. But "aspirin is a molecule but so is Mad Cow Disease so we had better be careful about new drugs" is just about the most boring, banal comment you can make. Drugs: can they be unsafe??? We'll have more at 11!

We need more Derek Lowe-type drug safety discussion here, and a lot less of whatever this is.


Are you suggesting that every new molecule should be treated as if it were a prion?


I'm suggesting that sometimes a very small amount of a substance can cause catastrophic effects a decade later. That's why we do testing before we release drugs.

And Pfizer isn't the hero here, they never have been.

https://corporatewatch.org/pfizer-six-scandals-to-remember/

This list doesn't even include Celebrex.

1986: Pfizer had to withdraw an artificial heart valve from the market after defects led to it being implicated in over 300 deaths. The US Food and Drug Administration (FDA) withdrew its approval for the product in 1986 and Pfizer agreed to pay hundreds of millions of dollars in compensation after multiple lawsuits were brought against it.

2003: Pfizer has long been condemned for profiteering from AIDS drugs. In 2003 for example, it walked away from a licencing deal for its Rescriptor drug that would have made it cheaper for poorer countries.

2011: Pfizer was forced to pay compensation to families of children killed in the controversial Trovan drug trial. During the worst meningitis epidemic seen in Africa, in 1996, Pfizer ran a trial in Nigeria their new drug Trovan. Five of the 100 children who took Trovan died and it caused liver damage, while it caused lifelong disabilities in those who survived. But another group of 100 children were given the conventional “gold standard” meningitis antibiotic as a “control” group for comparison. Six of them also tragically died because, the families said, Pfizer had given them less than the recommended level of the conventional antibiotic in order to make Trovan look more effective.

2012: Pfizer had to pay around $1billion to settle lawsuits claiming its Prempro drug caused breast cancer. Prempro was used in hormone replacement therapy, usually for women going through the menopause. The settlements came after six years of trials and hardship for the women affected.

2013: Pfizer paid out $273 million to settle over 2,000 cases in the US that accused its smoking treatment drug Chantix of provoking suicidal and homicidal thoughts, self harm and severe psychological disorders. Pfizer was also accused of improperly excluding patients with a history of depression or other mental disturbances from trials for the drug. Later, in 2017, a coroner in Australia ruled that the drug had contributed to a man’s suicide. The man’s mother campaigned to change the label on the drug.

2020: Pfizer reached an agreement with thousands of customers of its depo-testosterone drug in 2018 after they sued it for increasing the likelihood of numerous issues, including heart attacks.


There is nothing here that suggests that:

>very small amount of a substance can cause catastrophic effects a decade later.

Medication failure modes are either short-term acute and found in test quickly, like Trovan example; or where long-term ingestion causes problems.

All of your examples are one of those two.


Are there any authorized or approved drugs that are taken over a short-term (say less than a month) that have been shown to cause long-term death?


This immediately jumped to mind (Contergan):

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

    The total number of people affected by the use of thalidomide during the mother's pregnancy is estimated at more than 10,000, of whom approximately 40 percent died at or shortly after the time of birth. Those who survived had limb, eye, urinary tract, and heart defects [...] The severity and location of the deformities depended on how many days into the pregnancy the mother was before beginning treatment; thalidomide taken on the 20th day of pregnancy caused central brain damage, day 21 would damage the eyes, day 22 the ears and face, day 24 the arms, and leg damage would occur if taken up to day 28. Thalidomide did not damage the fetus if taken after 42 days' gestation.
So ~280 days for a pregnancy, minu 21-41 still leaves way more than half a year after taking the drug for when death occurred. And I wouldn't say the non-lethal effects are to be dismissed. If you ask me they're way up there for making sure something like that doesn't happen again. The system today (hopefully) is better than back then. And yes, personally I think it's a good thing when the approval process for drugs assumes that "every new molecule should be treated as if it were a prion".


It is perhaps worth mentioning that our ability to detect compounds that are mutagenic or teratogenic, or are likely to cause developmental abnormalities, has improved dramatically in the past 60 years, as has the stringency of drug testing. I'm not an expert, but I can certainly imagine that some of the animal testing that goes on today before a drug is approved is designed to identify problems in offspring. (The problem with thalidomide was not that its problems could not have been identified even 60 years ago; the problem was that the testing was not done or was suppressed.)

So the previous poster's question about drugs given for a short time causing long delayed effects and approved in the last 20 years stands. If a drug is not a mutagen, it is harder to imagine how it could have a long-term effect.


No idea how I missed this for three days, I'm sorry.

I absolutely agree that they could have tested for certain things but didn't. It's a product of its time in that sense:

    One reason for the initially unobserved side effects of the drug and the subsequent approval in West Germany was that at that time drugs did not have to be tested for teratogenic effects. They were tested on rodents only, as was usual at the time
(side note, not to start a flame war on that, but this is a prime example of what happens thanks to regulation but not market forces) While a lot has improved in that regard through regulation, one thing that sticks out is how similar some of this is to how things are still happening in much more recent times:

    While initially considered safe, the drug was responsible for teratogenic deformities in children born after their mothers used it during pregnancies, prior to the third trimester. In November 1961, thalidomide was taken off the market due to massive pressure from the press and public
Purdue pharma and Oxycontin come to mind. I wasn't even aware of this one until I just tried to find something else I vaguely remembered for you via a quick Google: https://www.reuters.com/investigates/special-report/usa-cour...

I doubly apply to medications that can potentially eff your one body/mind you have up for good what I practice in software development and try to teach my teams: assumptions make an ass out of you and me.

     If a drug is not a mutagen, it is harder to imagine how it could have a long-term effect. 
Harder, sure. I'm not a doctor, pharmacologist or anything like that. But I doubt that somehow doctors, pharmacologists, chemists et al are somehow immune to making assumptions. Test the hell out of this stuff. Check the "impossible" things and sometimes you will find that the "impossible" really just wasn't impossible, we just didn't think of something or didn't know about it yet. It's why general regression testing in an area can very easily find bugs. "But that's impossible, how's that related?" Well, I also can't tell you, it doesn't make immediate sense to me either but you will surely find out once you start debugging this and figure out how you broke that other downstream system, two steps removed from your change.


The OP suggested that one-off drugs rarely had long-term side effects. Thalidomide was raised as a counter example (an expectant mother might take it only once). Oxycontin is not a counter-example; the long term side effects (as opposed to short-term overdose) require dosing over an extended period.


If I’m reading this correctly, Thalidomide caused damage to fetal tissue, but didn’t actually kill the parent? This is still an awful burden for the parent, but there’s lots of drugs that are known to cause tissue damage during pregnancy. I believe this is why pregnant people are often excluded from clinical trials.


Yes, it didn't kill the parent. You might have missed the part where it killed 40% of the children at or shortly after birth.

And yes, that's (one reason) why the recommendations for the Covid vaccine were not given for pregnant women at first.

The point wasn't that there are drugs known to be dangerous to pregnant women (mainly the unborn child). The ask was for an approved drug that caused delayed death.

There were definitely so many things going wrong w/ that specific drug but it serves as a really good example for why all these precautions are taken and should be taken and any new drug should not be presumed safe but presumed dangerous and proven to not be harmful. The specific time frames and measures can of course be debated to find a good spot on the spectrum and an active pandemic can influence the choices. The discussion was going in the direction of some posters saying we should assume safe first and the Contergan case very clearly shows why assuming safety is the wrong choice.


I think the ask was actually for an approved drug, taken briefly, that caused a delayed death in the person who was taking it. If we’re going to count prenatal effects, we can come up with thousands of examples. This is why pregnant women are always studied separately.


Let's take that apart:

    Are there any authorized or approved drugs that are taken over a short-term (say less than a month) that have been shown to cause long-term death?


    authorized or approved.
Check. Contergan was approved and used in 46 countries. Notably in East Germany there are no known cases of this, because "thalidomide was rejected by the Central Committee of Experts for the Drug Traffic in the GDR, and was never approved for use."

    taken over a short-term (say less than a month)
Check. As quoted before, taking Contergan past day 42 didn't harm the fetus and deformities seem to have started on day 21. Less than a month.

    cause long-term death
Check. Over the long term (>6 months) it caused death in 40% of the babies born.

Nowhere in there does it say to exclude any drugs than only cause direct death to the taker. Nor do I think should that matter. I do agree that pregnant women are studied separately precisely because the risks there are higher. To quote from the wikipedia article again:

    The Society of Toxicology of Canada was formed after the effects of thalidomide were made public, focusing on toxicology as a discipline separate from pharmacology. The need for the testing and approval of the toxins in certain pharmaceutical drugs became more important after the disaster.


Sure. But that’s not what they meant. Can you name any drug that, when taken over a short course, has had long term detrimental effects to the person taking it?


It's debatable what someone meant or didn't mean, if they don't say it. I tend to go by what someone actually said. Especially on the internet (or writing in general) i.e. people you don't know, whose background you don't know, without intonation etc. There's very little to no information for interpretation.

Now you asked a new question. Fair enough. Unlike the previous question, where Contergan immediately jumped to my mind, for your question nothing jumps to mind. But google helped. I think you wanted to ask a different question, more like what I originally answered to, e.g.:

    Can you name any approved drug that, that when taken over a short course, can over the long term cause the death of the person taking it?
You did ask though:

    Can you name any drug that, when taken over a short course, has had long term detrimental effects to the person taking it?
Yes I can, for example: Heroin. https://en.wikipedia.org/wiki/Heroin

Let's take that apart:

    name any drug
Check. Heroin is a drug. It's even been prescribed as a pain killing opioid.

        The UK Department of Health's Rolleston Committee Report in 1926 established the British approach to diamorphine prescription to users, which was maintained for the next 40 years: dealers were prosecuted, but doctors could prescribe diamorphine to users when withdrawing. In 1964, the Brain Committee recommended that only selected approved doctors working at approved specialized centres be allowed to prescribe diamorphine and cocaine to users. The law was made more restrictive in 1968. Beginning in the 1970s, the emphasis shifted to abstinence and the use of methadone; currently, only a small number of users in the UK are prescribed diamorphine.

    taken over a short term
Check. Heroin is apparently way up there in addictiveness. After a very short period of time, you will be addicted (even if not like some people claim, after the very first use and regardless of dose or your own addiction susceptibility.

    However, contrary to Bayer's advertising as a "non-addictive morphine substitute," heroin would soon have one of the highest rates of addiction among its users.
Also https://web.archive.org/web/20100213101818/http://www.drugre... which curiously notes that nicotine is even more addictive than heroin. I'll not mention nicotine further here though, because the detrimental effect come from the other substances usually taken with it when ingested via tobacco as far as I am aware (tar).

    long term detrimental effects to the person taking it
Check. Detrimental effects of heroin are numerous. And given it's addictive very fast, even side effects that only turn up later, I would definitely include.

    Common side effects include respiratory depression (decreased breathing), dry mouth, drowsiness, impaired mental function, constipation, and addiction.[12] Side effects of use by injection can include abscesses, infected heart valves, blood-borne infections, and pneumonia.[12] After a history of long-term use, opioid withdrawal symptoms can begin within hours of the last use.
Not to mention the constant possibility of overdosing. Meaning death. The ultimate detrimental effect.


I commend your ability to think outside the box, bringing up pregnancy and addiction as answers to the asked question.

So I’ll ask a third time, hoping that perhaps finally I can get you to the original asker’s intention:

Can you name any drug that when taken for only a short period of time, like this Covid drug surely would be, and is non addictive like this Covid drug surely is not, is harmful in the long term to the person who took it (assuming they are not pregnant as all of the people who would be allowed to take it would not be)?


While I do like this discussion I also wonder why addictive substances have to be excluded. I understand that you would like have the answer to the question be "no I don't". We can find all sorts exclusions and find a narrow path to an answer that says "no no, all drugs are always safe, see, if you only take them for a month you won't mysteriously die from exactly this 20 years from now". And while that is most probably true (and if it were true, probably hard to prove), the real answer to the question is: Yes, there medications that even if taken for a short period of time will be detrimental and harmful to you over the long term and heroin or morphine are perfect examples of this.

Remember all those war movies? I remember watching Vietnam war movies as a kid and one of the things I remember best is the use of morphine as _the_ field medicine.

Now we can argue that, especially in those times, it might be better to give a soldier that just lost a limb in the battlefield morphine than not to. It doesn't change the fact that

https://www.onceasoldier.org/veteran-ptsd-and-opioid-addicti...

    The VA and other reports acknowledge that physicians need better training to manage opioid treatment for veterans. Between 2001 and 2009, for example, the percentage of veterans receiving pain management with prescription narcotics increased from 17 percent to 24 percent. The number of opioid prescriptions written by military physicians more than quadrupled during that time.


Full credit to you for this. My only quibble is that "narrow" should be "wide". But all of the rest of your points have been enjoyable to think about and hold a lot of important truth. I believe at the heart of it you have a concern for humans and their welfare that is to be rejoiced and encouraged. I hope you have a good weekend!


[flagged]


This "how did the vaccines get approved so quickly" thing has to be one of the most asked- and- answered questions of the entire pandemic. The basic delivery platform for the vaccines had already been in human trials before the pandemic. We've also been doing rapid development of vaccines for many, many years to combat things like influenza. Coronaviruses had already been well studied, and we had dry-runs for vaccine design with SARS and MERS.

You can just do a Google search to read about 1,000 articles about how the vaccines got approved as quickly as they did. You don't need to ask your friend who works at Gilead. Not for nothing: their clinical trials would probably go a lot faster with a global pandemic lighting a fire under them.

We've administered these vaccines to almost four billion people. "COVID vaccines are dangerous" has become an extraordinary claim, demanding extraordinary evidence. There are people who sincerely believe that aspirin is dangerous, and yeast, and "mycotoxins" on coffee beans, and on and on. We're not required to take these arguments seriously on faith.


[flagged]


You broke the site guidelines badly with this, and we ban accounts that do that. Please don't do this again.

If you'd please review https://news.ycombinator.com/newsguidelines.html and stick to the rules when posting here, we'd appreciate it.


Dan, you're protecting tptacek from criticism which is absolute bullshit. I very fairly criticized his lack of reading comprehension, and the fact he's not an expert in anything except for security. What he accused me of in his comments was worse and protecting him is bullshit.

He came in attacking me twice and you do nothing to his account? He didn't even read my post and then started his rant about the vaccine when I wasn't even talking about the vaccine.

If you're going to threaten with banning, I suggest you do it to everyone fairly, even if he's one of your "favorites". You should be flagging his posts, not mine.

Plus, you flagged my perfectly accurate post on how thalidomide is safe, it's the chiral version of it that causes deformities?


That wasn't a neutral post about thalidomide, it was obviously flamewar fodder, and therefore rightly flagged.

Would you please stop posting like this now? If you keep up this flamewarry/offtopic stuff, we're going to have to ban you. Also, please stop hounding any particular user. That's not in the spirit of the site at all.

https://news.ycombinator.com/newsguidelines.html


There really isn't (on HN, at least) such a thing as 'very fairly criticizing [anyone's] lack of reading comprehension' in those exact terms, it's just a slightly wordier version of 'did you read the article/comment/etc'.


Dan doesn't flag posts, users do.


So 6 out of how many other studies and drugs they've released without scandal?

If we're applying the COVID standard to Pfizer, would their failure rate be greater than or less than COVID's death rate?

If we use the 2% number I've seen around here for COVID's death rate, that means if Pfizer has over 300 drugs, these six scandals are a non-issue because they happen so rarely.


I’m perplexed why you are defending a corporation after such an excellent reply from the above poster ( and I’ve taken the vax).

But l add the death rate according the administration is around 0.5% from the latest stats due to lack of testing.


It's less defending Pfizer and questioning the poster's true motives.

Some people seem determined to do anything except take precautions laid out by infectious disease experts and take medicine specifically for this virus. And they're looking for any excuse to do so.


A diversity of people will have a diversity of risk registers, this is actually healthy for long term stability because mono cultures have associated risks.


No it's about one third of drugs according to a Yale study and it took a median of 4.2 years after the drugs were approved for safety concerns to be apparent.


Again, as someone who worked with toxicology, yeah. The default is every new molecule might be highly toxic and needs to be proven otherwise.

It’s why we don’t look at a molecule and say “oh, that’s not a carcinogen! No need to test”. And the same reason we run hERG tests to make sure drugs don’t give you a fatal arrhythmia (a surprising number of drugs do this and some are still on the market).


So over what time period do you believe we should wait to release a drug to the public? 10 - 25 years after discovery?


Straw man. I never said don’t release the drug or delay it decades, I said “the risk is always there”.

And funny you should say 10-25 years. 10 years is pretty typical from initial molecule discovery to FDA approval.


Sorry to offend.

I was referencing your assertion that all molecules are prions until proven otherwise.

Also, I asked two questions. Next time try answering them before jumping to being an ass.


The post to which you are (nominally) responding was not obnoxious in the least. Your name-calling most definitely is obnoxious. I thought this was an adult forum. Eternal November?

And please show us the words where where the poster claimed that “all molecules are prions”…as you claimed. I can point to your exact words here…look forward to you doing the same.


I'm not an expert, but I think if a molecule is isolated, it is possible to determine whether or not it is a prion. IIRC, prions are basically misfolded protiens that cause other protiens to misfold, like a corrupted file that passes the corruption on to every copy or derived file until the system crashes. But you can examine them before systemic problems show up. And I believe a prion has to be a protien-like molecule. Again, not an expert.


Actually: Yes.


> Prions are "just" proteins

According to whom? You make it sound as if at some point scientists thought that prions were "just proteins", which I'm sure is not true.

I'm not saying new medicine can't have side effects a long time after ingestion.


So we shouldn't introduce any new drugs unless it's been tested for more than 10 years? Seems like a great way to put a complete halt on drug development and have more people die / suffer from preventable diseases.


A recent HN posting would like to remind you that this logic doesn’t work:

https://rxisk.org/post-ssri-sexual-dysfunction-pssd/

There are plenty of drugs with long term effects despite not remaining in the body. Every addictive substance comes to mind, but so do chemotherapies and many other things.


And you're going to take the drug for only about 7-10 days. It's unlikely that such a short exposure will introduce lasting toxicity.


What’s good about this pill is that it’s only given to people who have tested positive and likely it’ll only be prescribed to people with risk factors. In the trial, the placebo group saw a 7% hospitalization rate. That is very high, and many of the other 93% surely had a bad time as well. The risk of possible long-term side effects when weighed against a very real risk of hospitalization is an easy choice. It’s different from vaccines in that way. Vaccines are given to healthy people, so there is basically zero risk tolerance.


This isn't a chronic exposure kind of drug where you really care about those things. This is a horse pill where safety is pretty directly measurable in a short time.


If the consequence of not taking it is death, I think people would run to the front of the queue, though.


Soo, kinda like for a vaccine?

(And to clarify what I am saying, even though the vaccine does prevent death, there is still considerable push back. Not sure why it will be different for this drug)


Oh I think it will be gladly accepted by unvaccinated folk. The reason being is most unvaccinated people don’t believe it isn’t effective, they don’t like being forced to protect themselves by a bunch of moral busybodies.

I just accepted as soon as we saw that covid was spreading so quickly, welp I’m gonna get that. I figured I wouldn’t be that affected by it and wasn’t.

Our parents said, well if I get it I get it, and if I die, I die, now let me see my grandkids. When the vaccine came out they were like sweet I’ll get it, can we stop these stupid mask wearing and social distancing crap. No, we can’t. So now us younger folk who aren’t afraid of covid aren’t getting vaccinated because we’re being forced to, and they’re going to keep up all the stupid rules like wearing masks everywhere anyways.

An anti viral drug that is this effective gives even less reason to have any mandates around vaccines, so unvaccinated people will cheer this.


>The reason being is most unvaccinated people don’t believe it isn’t effective, they don’t like being forced to protect themselves by a bunch of moral busybodies.

I think this is something that's very understated in public discussion around COVID-19, I got vaccinated because I weighed up the odds and thought it made sense from both a social and a personal cost/benefit perspective. I didn't get vaccinated because I was gaslit into it by the government's "nudges", nor did I get it because I was nagged or shamed into it by those who can't keep their noses out of other people's business. There's few things I dislike more in a person than a Puritan wagging finger, yet all the messaging around the pandemic was nothing but wagging fingers.

People don't like being manipulated, even if it's "for their own good" or even "for the greater good". People aren't stupid either, they know when authority figures aren't being entirely upfront with them. As well-intentioned as the measures were, the institutions who imposed them have burned up a lot of public trust in the process with the use of fear and coercion as a tool to manage the pandemic as well as being a bit economical with the truth instead of just saying "we don't know" where appropriate. I think the unfortunate persistence of the anti-vax movement is partially down to this instinct for authoritarianism and shaming people rather than extending an olive branch.

I do wonder if "vaccines mean we can permanently rid ourselves of masks, distancing, and other authoritarian restrictions" would have been more effective as a campaign than "get the vaccine or you're a horrible selfish piece of crap who probably wants to bump off grandma for her inheritence". Maybe it wouldn't have made a difference, but I think it would.


> vaccines mean we can permanently rid ourselves of masks, distancing, and other authoritarian restrictions

They said that, and it turned out to also be a lie. I got the vaccine because I was threatened with loss of employment if I didn't, and enticed by a promise that frequent testing, social distancing, and mask-wearing would not be required for the vaccinated. They pretty quickly reneged on that. To say that I am infuriated is putting it mildly. I obviously cannot undo the vaccine that I didn't want and was forced/coerced into taking.

They have destroyed any faith I had in their promises. I will most certainly now refuse any further demands along these lines, whether for flu shots, boosters, or whatever. Fool me once, shame on you.


They didn't mean that the restrictions would go away if YOU personally got vaxxed, only if a respectable number in the US did. And that still hasn't happened because people are stubborn and selfish.


No, my employer specifically stated that the vaccinated would not need to mask or distance at work. Then they walked it back.


The parent comment was talking about public discussion of how vax would allow a faster return to normal life. Your employer is perfectly entitled to tell you to mask or distance, or where a pink jumpsuit.

With people getting fake vax cards, etc, I can see some employers deciding to err on the side of caution. Especially since some workers can't get vaxxed at all due to medical conditions.


Except they made a big deal about the no mask, no distancing promise. It was a central theme of their "get the vaccine" campaign. Oh and also you won't get fired.

Then they reneged.

Thus, they have destroyed any credibility they may have had for future similar promises.


People are stupid. As a species, we've survived despite this, but as Carlin used to say; "“Think of how stupid the average person is, and realize half of them are stupider than that.”

People hold irrational beliefs (JFK Jr. is still alive), the earth is flat, on and on.

And America in many respects can be incredibly anti-intellectual. Being smart is often a negative in a lot of environments.


That quote never sit well with me. How about "Think of how stupid the average person is, and realize there is a 50/50 chance you are stupider than that."


Your version is less accurate in reasonable contexts. People at a Carlin show or on HN are not the average person.


Nice story.

Meanwhile at least 5 million are dead - 750,000 in the US alone.

How does your story help their families?


I don’t think it helps their families. You know what does though, vaccines and this new anti-viral.

So can I live my life and worry about own family and not someone’s I don’t know?


> So can I live my life and worry about own family and not someone’s I don’t know?

Unfortunately, no. We live in a society where sometimes we have to take collective action to prevent collective harm. Taking personally inconvenient measures to help fight an epidemic is a prime example.


Oh so you’re the one who insists we keep taking shoes off at the airport, and throw our toothpaste that might be a bomb into the trash receptacle next to the crowd of people.

Yes there are collective actions we take, and the first two weeks of covid response might’ve been justified. But nothing since then. Maybe having to get tested to get on a plane.

Natural immunity does lower your chances, but you’re saying nope for the collective good (the good you’ve decided on) you must do xyz.

Bull crap. The emperor has no clothes.


And when you give a central authority permission to dictate these "inconvenient measures" to the population, what is the recourse when those authorities act in a contradictory, dishonest, or incompetent manner?


In a democracy, voting.


In the two party system in the US, this isn't really a viable option. It's a strange place where you're not allowed to be both pro-choice and against intrusive government. It makes an even stronger case for reigning in the centralized power of federal and state bureaucrats because they're even less accountable.


Help me understand the limiting principle in that logic. What prevents particularly egregious abuses of personal liberty using this as a pretext?

For example, people might get struck by lightning walking by your house, so we must force you to install a lightening rod on your house to protect the collective.

Where does it stop, and how do you make that determination?


The lightning example isn't really analogous. Sure, one or two people might get struck by lightning, but they're not then going to continue spreading lightning strikes once they leave my house. Moreso, those (non-existent) spreadable lightning strikes aren't going to mutate to get worse as they propagate.

There isn't an easy or obvious answer to where it stops and how to determine that, but that goes both ways. We can't just have zero laws for fear that the laws might overextend themselves.

Unfortunately, we have to deal with nuance either way.


Except, no.

Two important considerations:

1. The vaccine is extraordinarily effective at mitigating risk of hospitalization and death.

2. No current COVID vaccines are sterilizing. Vaccination confers only marginal reduction in ability to carry and transmit the virus (and even this, mainly due to duration, not due to viral load).

Taken together, the "get vaccinated to protect me" canard is insane. I don't care if other people are vaccinated or not, because I am. Any other position is political, not scientific.

There is a minor argument to be had over the (tiny) immunocompromised population, but it's important to bear in mind that this population already does conduct their lives with isolation, antiviral, antibacterial, and other safety protocols regardless of COVID. They did it before the pandemic, and they will after. Nothing changes for them regardless of vaccine uptake rates.


Important question:

Did they die from COVID-19 or did they with COVID-19?

Italy just revised their numbers and it’s quite a significant difference.


It's better to look at excess deaths since testing is so haphazard in much of the world. Current estimates are between 10-15m excess deaths world wide.


Excess deaths are not an anomaly to begin with. Year 2000 saw excess deaths, so did 2014.

Also, when you have deliberatly forced an additional 150 million people into extreme poverty to keep them healthy ( as it were ), you are bound to see a spike in deaths.

Frankly I am surprised the death toll of the brutal restrictions toward marginalized populations is not higher.

I suspect we will soon reap the dubious benefits of undoing 35 years of 3rd world progress in 22 months.

6 months ago I still cared. Now I am just numb.

Reduced from human being with rights, to a piece of diseased flesh that must be muffled, silenced, tested, regularily injected with one experimental drug after the other and preferably locked up for eternity.

To add to it, I must feel a sende of pride in partaking in this. Because it is the holy science.

My very existence is inconvenient to the experts.


Must be hard keeping your head up when you're swimming in such deep drama. You don't appear to understand what excess deaths mean; it means deaths over what previous trends would predict.

Here are some links to challenge your statements:

https://www.bmj.com/content/375/bmj-2021-066768

https://www.economist.com/graphic-detail/coronavirus-excess-...

I would post more, but I'm sure that you're capable of using Google.

150m pushed into extreme poverty? If you mean the US, your facts are wrong. And then you pivot to the "death toll of brutal restrictions"? What is this nonsense?

You've been muffled - Oh wow, wearing a mask is just torture.

You've been silenced - Hmm, not sure what this nonsense is about.

Tested - Yup. As part of an ongoing pandemic, yup. If you can't live in civil society and agree to give up some small freedoms, buy land in Alaska and live in a cabin.

"regularily injected" - A) the drug wasn't experimental, and B) it was primarily two doses. That's not regularly...

"preferably locked up for eternity" - wow, that's exactly what my daughter said when I grounded her last week.

Do you realize how ridiculous this sounds to people? How absolutely childish and selfish? This is why a huge portion of the US is just fed up with anti-vaxxers.


From what I understand it's taken once an infection is already established. Maybe it's easier to convince the "skeptics" under those circumstances to take potentially life-saving medicine.


Sure, those same skeptics, once they're sick, happily line up for an hourlong infusion of experimental monoclonal antibodies, which have similarly unknown "long-term side effects" or whatever they're worried about.

It turns out that long-term side effects (which are a possibility with every livesaving medical intervention- what are the long-term side effects of CPR?) are a lot less scary compared to short-term death.


this drug (and all covid medicine) at this point is no longer about people hesitant to take the vaccine. this is about going back to a pre covid life. the vaccine does not protect you fully from covid 19. states in the u. s. and some eu countries have very high vaccination rates and still saw a wave of covid go through them, examples: vt, nh, de, nl. in all these places roughly 70% vaccination rate and many vaccinated people testing positive, some vaccinated dying.

when this happens governments get scared. they start doing mask and vaccine mandates. things shut down. what if you could still have these waves but nearly eliminate the chance of anyone dying? then we could start treating this like an endemic cold or flu. i think these waves in high vaccine areas show convincing “vaccine skeptics” is not the gate to get there. we could be 100% vaccinated in areas and still see covid waves. the question is can we make it less risky to the point where we can go back to where we were


Away from the debate about who will or won't take the vaccines and why, isn't this is a huge positive for the small (but not tiny) number of people for whom vaccines don't provoke immune response (severely immunocompromised, etc)? That group are also more vulnerable to bad outcomes from Covid.


That's one of my hopes. I don't know if this would have an adverse reaction for immunocompromised patients, but if not that would be fantastic.


It’s not really like a vaccine. A vaccine is almost more abstract. You’re not sick, and to continue not being sick, take these shots.

With this treatment, you ARE sick. To become well, take these pills.


There are a lot of hospital bed requests for the vaccine(1) from people who thought COVID wasn't a big deal. I'm fairly sure they'll take this drug once they experience the alternative.

1) Obviously, it's too late then. So it's only the most ignorant of people who changed their minds we have anecdotes of.


Sounds like the consequence of not taking it is a 0.5% chance of death, so probably not a lot of running for those who understand COVID death rates.


It seems to me that you're one of those not understanding COVID death rates, though.

Firstly, even though I doubt your number a bit, even a 1/200 chance of death is mighty high enough for most people to seek treatment for something.

Secondly, if you're already infected, the pill is probably less risky than those 1/200.

Thirdly, the chance of death isn't equal for everyone. A healthy young person might have a 10x reduced risk, while an older person with an existing condition a 10x increased risk. So at least for one of them the new medicine is clearly worth trying.


> A healthy young person might have a 10x reduced risk

The risk doubles every 7 years so it's going to be ~18x between generations, and much greater beyond that. Those who are old and have existing co-morbidities are really pushing the difference as severity of disease is strongly correlated with number and severity of co-morbidities.

Edit: ~18x, not ~30x. It's late here, I can't calculate 2 to the power of 4 without a calculator until I sleep, wake up, and have a strong coffee.


People think 0.5% is low, but e.g. JFK airport has about 500 takeoffs a day, if on average every day 2 or 3 planes that flew out of JFK crashed, how would they feel about air travel?


I think part of the problem is people see getting covid as something that will only happen to them once. So it is easy for them to think "well, if JFK had that many crashes, but I only had to fly once in my life, that's not so bad."

Realistically, re-infection is going to become more and more of a thing. Especially as it mutates.


GP stated that "the consequence of not taking it is death", which is demonstrably false, and specifically what I was referring to.

Also, the current mortality rate overall in the USA for Covid is less than 0.1% - in fact it's less than 0.02%. 46M confirmed cases, and 751k deaths (not all confirmed to be caused by COVID)...


A 1/200 chance of death is gigantic.


Right!

It floors me to see so many not internalizing what that means.


So are the people who land in that numerator - a correlation that's not permitted in the public discourse apparently.


The study was for patients “who were at high risk of progressing to severe illness”, where the hospitalization/death rate was 6.7% without it and 1% with. You probably wouldn’t give it out to everyone but that’s the kind of risk decision doctors make routinely.


The actual death rate for the trial cohort is close to 2%:

Pfizer said 0.8 percent of patients who got the drug combination within three days were hospitalized within four weeks — three out of 389 patients — compared to 7 percent of patients who got placebos, or 27 out of 385. And seven of those who got placebos died, Pfizer said. No one who got the treatment died within a month.

https://nymag.com/intelligencer/2021/11/pfizers-new-covid-pi...


If the drug has got this far into testing, there is no chance in hell that it has >0.5% chance of death (or other awful side-effects) on ingestion. So it's an upgrade either way.


If this drug is administered in the hospital, you already have a severe case and are far more likely to die.


If you watch the mass media, that's the impression they love to give, yup. :)


But that's just it, there's less than a 2% chance of dying even if you get COVID.


If you die of Covid, your loved ones will not care if the chance of that happening was low. You won't care either, you'll be dead. All it really takes is that one previously-undiagnosed comorbidity to put you in the front of a the line for a casket-fitting even if you're young(-ish).

If you survive but get permanent damage e.g. due to the blood clots that a lot of COVID patients develop, or due to the side effects of medications and treatment e.g. (partial) blindness from high-dose steroids or reduced mobility up to no use in your limbs especially your legs due to ECMO, then I am pretty sure you won't be running around (in the latter example because you physically cannot anymore) telling people how COVID only kills so-and-so tiny percent of the population.

Even if you escape realtively unscathed, spending a month or two in the hospital followed by some weeks of recovery or in a rehab facility (e.g. to learn how to walk again after a few weeks of coma and maybe some ECMO hoses in your legs), then that probably still would be an experience you'd like to avoid.

And that isn't even yet considering what effects you may experience in the future, "long covid" and all that.


My teenage athlete nephew mysteriously developed heart problems right around after he got vaccinated, and now he can barely walk up a flight of stairs. No one is going to say the vaccine caused it, but the timing seems pretty damning. Meanwhile, if you look at the CDC stats, the risk of injury from covid for his demographic is at least an order of magnitude lower than his risk from riding in a car.

Personally I don't believe that we are living in a rational society right now. For the fun of it, maybe I'll figure out one of those browser plugins to replace the word "science" with "propaganda".


> Meanwhile, if you look at the CDC stats, the risk of injury from covid for his demographic is at least an order of magnitude lower than his risk from riding in a car

You have to look at the CDC stats and the vehicle fatalities to make this claim. "Risk from riding in a car" is extremely low. 0.008% of teens die annually (2400 out of 30 million, age 13-19) in car accidents.

Case fatality rates from COVID are an order of magnitude higher for that age group -- 0.04-0.06%, depending on your source -- so you'd have to believe case underreporting by 100x (impossible, since cases are > 1% of population everywhere) in order for risk from "riding in a car" to be "at least an order of magnitude" higher.


Okay. I already did that in recent memory, which is why I felt confident stating what I did.

Since you gave a statistic for car accidents, I'll do the same for the covid side: https://www.cdc.gov/nchs/nvss/vsrr/covid_weekly/index.htm

Since the start of 2020, there have been 576 "All Deaths involving COVID-19" among people under 18 in the US. Compared to 60,811 deaths from all causes, that's slightly less than 1% of all child deaths.

The 576 covers almost two years, so let's call it 300 deaths/year. Not accounting for the slight difference in age ranges, that's 1/8 your number of 2400 deaths/year from car accidents. I'd call that roughly one order of magnitude lower. If you clump in children under 13 in your car accident statistic, I suspect it would fall below 1/10.

Is my math wrong or is your math wrong? If my math is wrong I would love to understand why.


I think your math doesn't distinguish between rates and amounts: indeed, if every kid in the US got COVID and only 600 died, then sure, you could make the claim that it's less risky than driving. (Also, the pandemic would be over, rendering this whole conversation moot.)

The truth is we don't know how many kids in the US have had COVID, but I'm pretty sure it's not 100% of them -- which is why the number I cite is the estimated case fatality rate and not just the total number of cases.


If you throw in an unknown scaler and fudge it, then yes you can make the statistic do whatever you want. I'd argue it's not a relevant or useful statistic, though. It's analogous to you telling me my risk of dying from a bullet to the head is near 100%. It's technically true, but I'm not going to super glue a kevlar helmet to my head.


What’s the unknown scalar? We know the case fatality rate.


Oh, my apologies, I originally misinterpreted one of your earlier messages when you brought up underreporting.

I understand where the 0.05% case rate number comes from (reported deaths divided by reported cases). I do personally think the reported deaths number is probably slightly over-reported and the reported cases is significantly underreported.

Even if the case fatality rate is accurate, I just don't think it's useful when assessing personal risk unless you routinely go out of your way to catch covid. If you start getting into that level of detail, you at least need to correct for comorbidities as well.

Specifically, when I say that it's an order of magnitude less likely for a teenager to die from covid than a car accident, I don't mean a teenager that caught covid or a teenager that was in a car accident. I mean a randomly sampled teenager out of the 60 million or so in the US.


I was thinking about it a bit more. Apparently the fatality rate of car accidents is 0.7%, so comparing that to a covid case rate of 0.06%, it seems like it's still an order of magnitude less fatal for a teenager to get into a car accident than to catch covid. It's been an interesting discussion, and I've enjoyed diving into the numbers more. Thanks!


Perhaps he got the vaccine in the bloodstream as opposed to muscle tissue as intended.

There are reports now of injections done without pulling back to see whether the injection site is a blood vessel. How the drug performs is seriously different in blood stream vs muscle tissue.

The primary impact of blood stream doses appears to be heart related problems.

https://pubmed.ncbi.nlm.nih.gov/34406358/

TL;DR: The vaccine probably did not cause it. How it was administered could be the cause.


I mean come on, if the administration of the vaccine caused it, the vaccine caused it. If he hadn't gotten the vaccine, it would not have been (as conjectured) injected into his bloodstream.


Fact is, how it gets injected appears to have a very significant influence on it's impact to the patient.

There is a clear distinction here; namely, whether the vaccine was improperly used.

Taking too much Tylonol can cause liver failure. Too much Ibuprofen can cause renal failure...

In those cases, the drug was improperly used, but the cause analysis centers on improper use, because doing that multiplies the risk and symptom severity.

See how that all works?

Saying the "vaccine caused it" simply is not enough information, which is why I linked what I did.

It is important that we get these discussions right.

Edit:

In the interest of accuracy, note I did not say the vaccine did not cause the trouble. I said it probably did not cause it, and I said improper injection probably did.

Neither is an absolute. I did not intend, nor mean to imply otherwise. What I did intend was to improve on the clarity, scope and accuracy of the discussion.

Why bother?

Better discussion means more informed people taking fewer risks and or making more good choices, all of which will improve law, costs, outcomes.

Getting back to the matter at hand, when we factor the elements down, we see one thing we can do right away, and that is we make damn sure we are administering vaccines properly.

There are risks with the vaccine. They are small by percentage, but they are there. No argument from me.

Those risks go up dramatically with improper injection; namely, it being delivered directly to the blood stream, which is entirely avoidable.


That's a fair point. It seems to me like the government is pressuring people into taking a vaccine that isn't being properly administered en masse, and all the parties involved are both protected from liability and aren't being transparent about it, all to mitigate a trivial amount of risk.

I just saw an article yesterday talking about Pfizer making $36 billion on vaccines this year.


I see it that way too.

We do not have absolutes to work with here.

The damn Covid is novel, meaning we get our education together, the hard way and that sucks.

And that means being smart about probabilities and potential cost and risk outcomes matters a lot! Doing that is harder than necessary too.

A small investment in proper injection can seriously reduce vaccine risks, for example. That is real news as far as I am concerned and that should be acted on STAT. And you just gotta know the optics on all that complicate and likely bias action away from optimal too.

My own first injection was not done properly. (By that I mean the person doing it did not do a blood vessel check.)

I made sure the second one was done properly.

I very seriously oppose the blanket immunity myself for similar reasons.

The profit drive on this is pretty ugly too, and it is a complicated discussion. Very generally, I must say the problem is global and allowing profit to drive policy is not doing humanity any favors.

There is a whole lot to be said... but, maybe another day.


Frankly, our current body politic is very seriously ill.

Trust is low.

Because of all that, I personally am paying close attention to how I handle my part in it and am reluctant to judge anyone else.

I am usually reluctant anyway, because what I feel should be obvious reasons! But yeah, extra care is indicated right now.

Best move, in my view as a normie out there wanting to be a good human, is to try and understand one another better, avoid judgement and the usual fear, blame and shame, talk more and hopefully more of us make smarter choices and see lower risks and better outcomes more of the time as this all plays out.

Pretty sure that is as good as it all gets right now.


Really sorry about what happened too.

Sucks :(

Sure hope he improves and can get past it.


That's actually the theory I developed the first time myocarditis in skinny teenagers was reported many months ago. It just makes sense that spike protein mRNA is getting shotgunned into their heart muscle cells. So, I was rather disillusioned when I saw that theory finally pop up in the news in the last month.

Saying the vaccine didn't cause the myocarditis because it was "injected wrong" isn't a compelling argument to me, or likely to anyone that's thinking rationally.


I hear that. You are not wrong, in my view.

The discussion is complex and difficult enough as it is.

People struggling with it should be expected and handled with tact and candor far more than it is right now.


A 2% chance of death is actually very high risk for most people. Obviously with a name like dontcare007 I'm sure you've a huge appetite for risk that others don't.


There's a 40% chance Mr. Bond here would have died before his latest film "No Time To Die", if he had a 2% chance of death in each movie ;)


If 2% of domestic flights in the US crashed, that would be about 100 plane crashes. Per day.

An accident rate of less than 1% grounded the Boeing 737 MAX. In a study of the aircraft, the FAA estimated there would have been 15 crashes over 30 years. This was seen as unacceptable.


It's much higher than that for easily identifiable subgroups -- elderly people and obese people being trivial examples.

The control arm of this study had a rate of "hospitalization or death" of 7% because they selected for subgroups at high risk.

It's fine to acknowledge that aggregate risk of Covid is low (and indeed, more people should acknowledge that fact), but we must also acknowledge that it is a serious risk for a large group of people.


Especially when we note that the clinic definition of obesity is much smaller than people think of, and 42% of Americans qualify.


That may be true, but it doesn't automatically mean that 42% of Americans are high risk. This is reflected in the aggregate statistics. Mild obesity is probably not a significant risk factor, whereas severe obesity is a big problem.

The BMI-based definition of "obesity" is a crude qualifier, and the vast majority of the affected will be in the smaller group that is both elderly and obese (esp. considering that age is, by far, the more important factor for serious outcomes.)


There is a much higher chance of dying when you're in the ICU with Covid and a doctor thinks it's appropriate to prescribe this new medication.


The trouble is that the new medications probably don't work by the time you're in the ICU with Covid. I'm not sure it was tested with this one specifically, but at least one of the recently-approved medications was previously trialled on ICU patients and showed no benefit - they had to do another study giving it to people who hadn't been hospitalized yet to get any useful reduction in deaths, and there's some reason to think this is an inherent limitation of drugs that try and reduce viral replication. This study only seems to cover patients who haven't been hospitalized at the point when they start the treatment.


You're ok with a 1 in 50 chance of dying?

I know that people can have difficulty interpreting probabilities, but given the outcome, you don't think those are really terrible odds? Of course the medicine also has a risk profile but it's clearly much, much lower.

Also it should noted that even when covid doesn't kill you it can have debilitating effects that linger or are permanent.


According to the CDC, the actual infection fatality ratio is 0.6%. Fortunately vaccination cuts that pretty close to zero.

https://www.cdc.gov/coronavirus/2019-ncov/cases-updates/burd...


> Fortunately vaccination cuts that pretty close to zero.

Unfortunately as can be seen in table 5 from the link below, vaccination does not bring the fatality rate close to zero. It brings it closer to zero depending on your age. Bearing in mind this applies to hospitalized patients only(therefore not exactly IFR), the rate of death was reduced by vaccination in people over the age of 50, but not in people under the age of 50. Vaccination helps in certain cohorts.

https://assets.publishing.service.gov.uk/government/uploads/...


Statistically you won't die from Covid but that statistic may not apply to you.


I don't think you realize just how shitty those chances are.


The same people who take their chances with COVID have the same energy as those who play the lottery.


That's the problem - "even if you get COVID".

At the start of pandemic we could have hoped that it will pass in half a year, in a year or so. Now we know that it is probably here to stay.

So eventually you will get COVID.

Depending on how long has passed after your vaccine, what variation of virus you will get, how old you are and etc will depend if it is more like 5% or 1% or so.

In my office I have 200 or so colleagues. Imagine having 4-5 funerals at the company because of this illness.


> Depending on how long has passed after your vaccine, what variation of virus you will get, how old you are and etc will depend if it is more like 5% or 1% or so.

This is fear-mongering. There is no example of a risk of death post-vaccination that gets this high. The few studies that document a decline in efficacy show a modest decline, against symptomatic illness. The vaccines remain highly effective against severe disease and death.



Those statistics say nothing about the chances of going to hospital if you are vaccinated.

Currently, the deaths-per-100k of the unvaccinated vs vaccinated population is twelve times higher.

https://www.nytimes.com/interactive/2021/10/28/us/covid-brea...


The article also shows that deaths-per-100k is highly dependent on age. "“Age is our top risk factor for vaccine breakthrough deaths,” said Theresa Sokol, the state epidemiologist in Louisiana, one of the jurisdictions that contributed to the C.D.C. data.". In 12-17 and 18-29, deaths-per-100k are essentially 0 for both vaccinated and unvaccinated. This is fantastic news for kids of grade school age: they can live their lives for the next 20 years without having to worry about covid medical risks.


The even better news is that by the time they're older, they'll probably have substantial immunity to it anyway.


This is meaningless without context. What percentage of the population is vaccinated? How old are the patients? What percentage of the hospitalized are extremely old/frail/comprosmised?

Remember: if 100% of your population is vaccinated, then 100% of your hospitalizations and deaths will be in vaccinated people.

https://www.covid-datascience.com/post/israeli-data-how-can-...


When both the risks and vaccination rates are significantly different across demographic groups statistics for the whole population are often nearly useless due to Simpson's paradox.

Depending on how we define severe COVID you link is showing between 36% and 44% of the severe COVID patients at the hospital are vaccinated.

That's similar to what they have seen in Israel. As of about a month ago they were seeing about 60% of their severe cases were in vaccinated people.

Sounds pretty bad for vaccines, right? It does until you remember Simpson's paradox and take a finer look at the data [1]. It turns out that the Israel data showed in each age group efficacy against severe COVID ranging from 81.1% to 100%, with above 92% in all the 10 year age groups under 60 and still above 88% is the 10 years groups through 80.

It is very likely a similar thing is going on at the hospital whose data you linked to. That's been the case for every place I've come across in the US that published breakdowns of the stats by age group.

[1] https://www.covid-datascience.com/post/israeli-data-how-can-...


It could also show age of patients.

There is no doubt about vaccine efficacy. However it all depends. On your age, on your illnesses, on strains of virus. Who knows what you will get in 2 years.

So people who say that "pfft it is only 2% chance and only if you get" are just denying it.

You will get COVID. Hopefully you get it after a few years when there are not only vaccines but drugs widely available.


A death rate of 4-5 per 200 workers is highly unlikely. According to CDC data the infection fatality rate in a mostly unvaccinated population was 0.06% for the 18-49 age group and 0.6% for the 50-64 age group. The majority of deaths have been among older age groups, who are mostly not working at companies.

https://www.cdc.gov/coronavirus/2019-ncov/cases-updates/burd...

Fortunately vaccination provides good protection against death.


Unless you have a significant number of people working in your office over 70 years old, or if half of your colleagues are at least 60, it's more likely that nobody will die than 4-5.


The hospitalization rate of the control was over 6 percent. Most people want to avoid hospitalization.


Would you get on a plane if there was a 1.5% chance of it crashing every time?


There is free trial of World of Warcraft, download the game and make a warrior character.

You start with 5% critical strike chance, see how often that happens.

You will be seriously surprised.


2% is pretty damn high. Only 2.4% of allied troop that landed in France on D-Day died also.


I don’t think this is nearly as easy a question to answer as the other replies suggest. Pfizer will be required to make the case for safety whenever they apply for approval. It is premature to discuss this without reviewing the actual evidence they put forth.

That being said, one of the reasons that protease inhibitors are considered the way to go is that “no human proteases with a similar cleavage specificity are known, such inhibitors are unlikely to be toxic.” [1]

[1] https://www.science.org/doi/10.1126/science.abb3405


"Please don't talk about risk with so much at stake. Just push that code you wrote this morning to our mission-critical production system."

"We can do proper code review, unit testing, integration testing and full test cycle later on, when the pressure fades away."

We engineers all understand the risk of pushing untested code to production, but when it comes to medicine and other fields, we forget everything and rush it out. We basically act based on fear and hope.


This already went through Phase III trials. It's closer in analogy to having the entire QA team on standby at their desks to do a full test as soon as you submit a PR at 1:38am for a feature that has to go live ASAP.


Lol did you not see the revelations about what was going on inside of Ventavia, the contractor that did the trial research for pfizer?

They broke all sorts of protocols, covered it up, had it reported to the FDA, who in turn just sat on it.


The contractor that did a small percentage of the research, yes. Failures and fraud occur, and thankfully this one was small enough that it didn't matter.


During an incident you break glass if you have to. Because the risks of inaction outweigh action.


We detached this subthread from https://news.ycombinator.com/item?id=29119057.


> Side effects don't have to happen in the next 6 months.

If you're willing to go that route, the same could be said for COVID itself.


Yes, this makes sense. Innovative, but it will alert some people because of this.


Why do I feel like this will be the new mouthpiece for antivaxxers?


[flagged]


Interesting. From a quick google search: Pfizer brands include Advil, Bextra, Celebrex, Diflucan, Lyrica, Robitussin and Viagra

You never take an advil?


Pfizer also made Celebrex, the anti-inflammatory that they knew caused health issues but they buried them and claimed it was safe.

We are living in an upside down world now. All of a sudden the drug companies are the "good" guys. Since when did the drug companies suddenly become the heroes?

https://corporatewatch.org/pfizer-six-scandals-to-remember/

1986: Pfizer had to withdraw an artificial heart valve from the market after defects led to it being implicated in over 300 deaths. The US Food and Drug Administration (FDA) withdrew its approval for the product in 1986 and Pfizer agreed to pay hundreds of millions of dollars in compensation after multiple lawsuits were brought against it.

2003: Pfizer has long been condemned for profiteering from AIDS drugs. In 2003 for example, it walked away from a licencing deal for its Rescriptor drug that would have made it cheaper for poorer countries.

2011: Pfizer was forced to pay compensation to families of children killed in the controversial Trovan drug trial. During the worst meningitis epidemic seen in Africa, in 1996, Pfizer ran a trial in Nigeria their new drug Trovan. Five of the 100 children who took Trovan died and it caused liver damage, while it caused lifelong disabilities in those who survived. But another group of 100 children were given the conventional “gold standard” meningitis antibiotic as a “control” group for comparison. Six of them also tragically died because, the families said, Pfizer had given them less than the recommended level of the conventional antibiotic in order to make Trovan look more effective.

2012: Pfizer had to pay around $1billion to settle lawsuits claiming its Prempro drug caused breast cancer. Prempro was used in hormone replacement therapy, usually for women going through the menopause. The settlements came after six years of trials and hardship for the women affected.

2013: Pfizer paid out $273 million to settle over 2,000 cases in the US that accused its smoking treatment drug Chantix of provoking suicidal and homicidal thoughts, self harm and severe psychological disorders. Pfizer was also accused of improperly excluding patients with a history of depression or other mental disturbances from trials for the drug. Later, in 2017, a coroner in Australia ruled that the drug had contributed to a man’s suicide. The man’s mother campaigned to change the label on the drug.

2020: Pfizer reached an agreement with thousands of customers of its depo-testosterone drug in 2018 after they sued it for increasing the likelihood of numerous issues, including heart attacks.


And if Pfizer fucked up the covid-19 vaccine, one of 20 other alternatives would gladly inform the public and remove a competitor from the market. That's the great thing about having so many alternatives for the covid-19 vaccine, all of them can gain an advantage by pointing out that a competitor's vaccine does not work.


So if you get strep throat you are going to turn down the Z-pack?


The first line treatment for strep throat is penicillin or amoxicillin. Z-pack (Azithromycin) would typically only be used in case of a penicillin allergy, or maybe resistant bacteria.

https://www.goodrx.com/blog/z-packs-still-good-for-infection...


There is selection pressure against your type of actually wise human.




Guidelines | FAQ | Lists | API | Security | Legal | Apply to YC | Contact

Search: