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Bovaer to be added to cattle feed

During the covid vaccine rollout for example, there was no limit (as far as I can see) given on adverse events or deaths e.g the products were never halted,
Don't be silly! You mention one which was limited in its use (and got very little use in the EU).

Medicines are different to (say) teaspoons. There's no major cost in banning some specific kind of teaspoon. But medicines will generally do some good and some harm, so banning one will (while removing its harms) also remove its benefits. The Ox/AZ C19 vaccine continued in use in some countries because its known risks were more than balanced by the benefits it provided. In the UK we stopped use earlier because the mRNA vaccines were readily available, but they're harder to provide in some countries making the Ox/AZ vaccine still a win (while it risked causing deaths in a small proportion of people).

Similarly, there's an argument that OPV is still worth using in much of the world even though it's known to spread, potentially causing paralysis and death, but much less paralysis and death than without vaccination. (I'm not entirely persuaded: I think we should try harder to offer IPV. But I don't think it's a crazy argument to make, though it seems to me to be incompatible with the drive to eliminate the virus.)
Sometimes it can take 20 years before anyone acts and pulls the product.
Sometimes. Sometimes the evidence takes a while to emerge, sometimes it takes a while before there's a good alternative (and so even with the risks, the benefits make it worthwhile), and I'm sure sometimes regulators incorrectly fail to act.
 
Don't be silly! You mention one which was limited in its use (and got very little use in the EU).

Medicines are different to (say) teaspoons. There's no major cost in banning some specific kind of teaspoon. But medicines will generally do some good and some harm, so banning one will (while removing its harms) also remove its benefits. The Ox/AZ C19 vaccine continued in use in some countries because its known risks were more than balanced by the benefits it provided. In the UK we stopped use earlier because the mRNA vaccines were readily available, but they're harder to provide in some countries making the Ox/AZ vaccine still a win (while it risked causing deaths in a small proportion of people).

Similarly, there's an argument that OPV is still worth using in much of the world even though it's known to spread, potentially causing paralysis and death, but much less paralysis and death than without vaccination. (I'm not entirely persuaded: I think we should try harder to offer IPV. But I don't think it's a crazy argument to make, though it seems to me to be incompatible with the drive to eliminate the virus.)

Sometimes. Sometimes the evidence takes a while to emerge, sometimes it takes a while before there's a good alternative (and so even with the risks, the benefits make it worthwhile), and I'm sure sometimes regulators incorrectly fail to act.
Bruce,

It would be great if you could share with us all what these product limits/thresholds are on adverse events and deaths before they decide to recall and/or halt a product.

rsvp

 
It would be great if you could share with us all what these product limits/thresholds are on adverse events and deaths before they decide to recall and/or halt a product.
One might be does the medicine do more good than harm. That would need some qualification if there are other medicines in that category you'd want to compare them (maybe some don't need to be available). NICE also requires some kind of cost effectiveness, as does JCVI.

I don't think there's much value in just looking at adverse events and deaths without also looking at the benefits of whatever it is. In some cases, an extremely dangerous medicine or procedure might be quite acceptable.
 
One might be does the medicine do more good than harm. That would need some qualification if there are other medicines in that category you'd want to compare them (maybe some don't need to be available). NICE also requires some kind of cost effectiveness, as does JCVI.

I don't think there's much value in just looking at adverse events and deaths without also looking at the benefits of whatever it is. In some cases, an extremely dangerous medicine or procedure might be quite acceptable.
I agree, it depends whether there are substantial potential benefits like in the instance of treating cancer. But what about where the JCVI made clear to the government there was no cost benefit to vaccinating children against COVID? Or what about where natural immunity is ignored? Or pre-existing immunity is also ignored? Or you have had to take a novel drug against your wishes (no jab no job)?

Have you found that information on what their limit was on deaths and injuries before they would consider recalling and halting their vaccine products?

Furthermore, what benefit is there to cows taking 3nop?
 
But what about where the JCVI made clear to the government there was no cost benefit to vaccinating children against COVID?
I don't remember their decision as being as confident as that. I think it's plausible for JCVI (and NICE) to decide that a medication isn't cost effective without deciding that it's too dangerous. MHRA thought (and thinks) the vaccines are safe and effective for children. JCVI decided that, on balance, it wasn't clear that vaccination was generally desirable for children. Some other countries made quite different determinations. My guess is that in the future we'll decide that JCVI probably made a mistake on this one (as they probably did with the chicken pox vaccine).
Or what about where natural immunity is ignored? Or pre-existing immunity is also ignored? Or you have had to take a novel drug against your wishes (no jab no job)?
Those are more political judgements, I think. I think there are reasonable arguments on both sides of each, with the possible exception of "pre-existing immunity". I presume by that you're talking about a fairly small proportion of the population who have some unusual resistance to this novel virus, but that kind of thing isn't likely to be established quickly and is quite likely hard (and expensive) to test for, so I'm not sure how useful it could be practically.
Have you found that information on what their limit was on deaths and injuries before they would consider recalling and halting their vaccine products?
I presume they're looking at the balance of harms and benefits. While vaccines can have side effects they obviously need to be very safe since they're generally given to people who are healthy. (Statins fall into a similar category.) Some vaccines can be offered to those who are particularly likely to be infected and/or likely to suffer particularly from the infection, as statins are offered to people who seem likely to benefit particularly from them.

I still don't think you could use only deaths and injuries to decide to recall a vaccine. You need to consider the benefits of it. In some cases the decision's easier: we no longer use the Oxford/AstraZeneca C19 vaccine since we have safer (and more effective) alternatives. One Australian candidate C19 vaccine was never even released because some trial participants tested positive for HIV (not because they actually had HIV but because the vaccine caused a false positive).
 
Presumably none. Cows get less protection than humans, I'm afraid.
So if we use the favoured drug regulators definiton of safe (e.g benefits from taking a product outweigh the risk of injury or death from the product etc) which allows sales to continue for perhaps decades before any issues are recognised and action taken. At what point would the product be recalled or halted given there is no limit / threshold for adverse events?
The favoured drug regulators defintion of safe is clearly quite different from definitions of safe in other sectors, like the food industry, car manufacturing, construction, health and safety etc
 
At what point would the product be recalled or halted given there is no limit / threshold for adverse events?
When it causes more harm than benefit. Perhaps earlier, if there is some alternative that's safer (or more effective).
The favoured drug regulators defintion of safe is clearly quite different from definitions of safe in other sectors, like the food industry, car manufacturing, construction, health and safety etc
Is it? Cars still kill plenty of people. We try and make them safer, obviously, but plenty of people are very annoyed about reducing speed limits (the general reduction to 20mph where previously 30mph was the norm) even though there's good evidence that being hit by a car at 20mph is significantly less likely to be fatal than at 30mph.

For some things the choices are simple: if a cafe is very unhygienic (risking significant food poisoning), closing it until that's fixed is an easy decision since there are lots that are run more safely.

But for chemotherapy offered to people with late stage cancer? Well, danger is more acceptable since the person is likely to die without treatment.

And for COVID-19 vaccines, a vaccine offered to over-75 people in care homes can be riskier than one offered to "healthy" 18 year olds since the risks without the vaccine are quite different. (I think JCVI may well have underestimated the risks to 18 year olds, but that there's a significant difference between young and old seems undeniable.)
 
For some things the choices are simple: if a cafe is very unhygienic (risking significant food poisoning), closing it until that's fixed is an easy decision since there are lots that are run more safely.
Yes, because the food industry is properly inspected, regulated and enforced with customers being able to report incidents without fear of being told "correlation doesn't mean causation". Nor do incidents and reports just get added and added onto a list. Each is investigated on its own merits.
 
But there are no benefits.
No benefits to what?

Are you referring to Bovaer? In that case there aren't intended to be any benefits for the cows, the benefit is that they'll produce less methane (while leaving the milk unchanged, as far as they can tell). I think the regulatory information also mentioned that there didn't seem to be any harm to the cows; I presume if there were harms those would need to be considered (even if we have a lower standard of care for cows it's not no care at all, and there'd likely be economic issues then anyway).
 
The benefit is that we can reduce methane output from cows for (apparently) low cost and low risk. Low risk because it seems not to harm the cows and the milk seems unchanged.
There is no need for cows to consume 3nop.

This is similar to the covid vaccines which were effectively forced on people via no jab no job. Pfizer knew this even during their own trials that people who had recovered from COVID had equal protection from COVID 19, yet, this was never made clear (informed consent) to those taking the vaccine or all the companies, governments, organisations that were bribing, scaring, coercing and threatening people to have the jab.

 
There is no need for cows to consume 3nop.

This is similar to the covid vaccines which were effectively forced on people via no jab no job. Pfizer knew this even during their own trials that people who had recovered from COVID had equal protection from COVID 19, yet, this was never made clear (informed consent) to those taking the vaccine or all the companies, governments, organisations that were bribing, scaring, coercing and threatening people to have the jab.

Cows are what they are. 3nop is just a “sticking plaster.” (In the grand scheme of things. short sighted. Like “add blue in diesels. A quick buck.) lol, there was probably no issue since the human population explosion & Industrial Revolution to cater for it. the covid jab, just like any other vaccine, If I catch it? Lessens the impact. I have flu jabs shortens the recovery. My body, my choice. Where I work. If I get “something.” They have no problem sending me home. It’s just too dense a population. No one seems to have the balls to suggest a discussion & debate on human birth management on this spinning limited resourced rock.
 
There is no need for cows to consume 3nop.
Well obviously not. But there's some benefit (to the environment) if they do. We could instead do other things to reduce greenhouse gas emissions, but this particular intervention seems attractive: it's easy and cheap.
Pfizer knew this even during their own trials that people who had recovered from COVID had equal protection from COVID 19
"Equal"? Really, or did they think that was likely based on the evidence at the time? What about the risks of post-sequelae? What about the costs of treating some proportion of people so that they did survive, displacing care of other conditions?

There were also stories early on suggesting that hybrid immunity (some stories called it "super immunity") was better than both "natural" and vaccine produced immunity. If that's true, surely we'd like previously infected people also to be vaccinated? (I'm ignoring the obvious risks of encouraging people to get infected rather than to take a very safe vaccine.)
 
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