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 Gentleman_Jellyfish wrote:
This is why I get my news from Dakka.

This may be the most frightening thing I've ever read.

 Monster Rain wrote:

 Gentleman_Jellyfish wrote:
This is why I get my news from Dakka.

This may be the most frightening thing I've ever read.

Weirdly, I actually found myself notably more depressed while I was a daily reader of the Seattle Times

If you read the data sheet on the original product, the side effect that this patient suffered is included. Thus I don't see how she could sue the original pharmaceutical company for non-disclosure of side effects.

 Rented Tritium wrote:
So here's the thing. It's a good ruling because generic manufacturers are already set up to be allowed to just copy a drug without testing it, since the testing was already done, so there's no reason for them to be responsible for the actual drug itself unless they've done something different. So in that sense, this is fine with me.

But on the other hand, this ruling creates a weird situation where a drug could eventually be discontinued by the original maker, such that there are ONLY generics. In which case the drug could keep getting made forever and nobody can ever be sued. Ostensibly, that's what the FDA is for, they could step in and halt sale of the drug and investigate, etc etc, but what if they're slow?

So basically, on principle this is fine, but it creates a corner case that we will have to deal with. The good news is that the corner case could be solved by legislation adjusting the FDA's role in the situation.

That is actually a very good point that I hadn't considered. I was more concerned about a law suit with the Plaintiff suing the Original Manufacturer, and the Original Manufacturer trying to bring in the Generic Manufacturer into the proceedings trying to claim that they are liable based on their production methods.

 Kilkrazy wrote:
If you read the data sheet on the original product, the side effect that this patient suffered is included. Thus I don't see how she could sue the original pharmaceutical company for non-disclosure of side effects.

From the article:

Karen Bartlett sued Mutual Pharma in New Hampshire state court, arguing that the drug company included no warning about the possible side effect. A court agreed and awarded her $21 million. The FDA went on to force both Mutual, as well as the original drug manufacturer Merck & Co., to include the side effect on the two drugs’ warning labels going forward.

How do we go from it isn't on the label to it is on it? Or is it a case where it is on the data sheet but isn't listed on the drug? It seems odd that the courts would agree that it wasn't there if it was there.

 Ahtman wrote:

 Kilkrazy wrote:
If you read the data sheet on the original product, the side effect that this patient suffered is included. Thus I don't see how she could sue the original pharmaceutical company for non-disclosure of side effects.

From the article:

Karen Bartlett sued Mutual Pharma in New Hampshire state court, arguing that the drug company included no warning about the possible side effect. A court agreed and awarded her $21 million. The FDA went on to force both Mutual, as well as the original drug manufacturer Merck & Co., to include the side effect on the two drugs’ warning labels going forward.

How do we go from it isn't on the label to it is on it? Or is it a case where it is on the data sheet but isn't listed on the drug? It seems odd that the courts would agree that it wasn't there if it was there.

He could be referring to the Material Safety Data Sheet

http://www.sciencelab.com/msds.php?msdsId=9925155

Edit: Possibly misread your post Ahtman

It isn't a direct Hitchhiker's reference, but it is spoken in the same vein.

Beware of the Leopard.

Well, you woldn't really go by the MSDS.

When drugs are dispensed they usually include what we call a Monograph (the big long paper full of writing that everybody just throws out when they open a new bottle of drugs).

The Monograph for the drug includes the following side effects:

For the Consumer

Applies to sulindac: oral tablet

Get emergency medical help if you have any of these signs of an allergic reaction while taking sulindac: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Stop using sulindac and call your doctor at once if you have a serious side effect such as:

chest pain, weakness, shortness of breath, slurred speech, problems with vision or balance;
black, bloody, or tarry stools, coughing up blood or vomit that looks like coffee grounds;
urinating less than usual or not at all;
nausea, stomach pain, low fever, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes);
fever, sore throat, and headache with a severe blistering, peeling, and red skin rash; or
bruising, severe tingling, numbness, pain, muscle weakness.

Less serious side effects of sulindac may include:

upset stomach, mild heartburn or stomach pain, diarrhea, constipation; bloating, gas;
dizziness, headache, nervousness;
skin itching or rash;
dry mouth;
increased sweating, runny nose;
blurred vision; or
ringing in your ears.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects.

So even if somebody reads the big giant piece of paper included in the box, it doesn't really mention that particular side effect.

The Monograph does include the following:

For Healthcare Professionals
....
Stevens-Johnson syndrome and toxic epidermal necrolysis have been reported.
...

So while the insert, and the Physicians Desk Reference entry would mention Toxic Epiderman Necrolysis, it isn't really included as a warning or potentila side effect for patients. It makes a generic warming about "call your doctor if you get a rash. Which is a lot less severe than "call your doctor if your skin falls off".

Or at least that is how it appears to me (somebody trained in handing out pills for a living).

Although this doesn't change the fact that generic manufactures who follow the exact formulation and labeling as the brand name manufacturers shouldn't held liable for the testing done by the brand name manufacturer and the labeling approved by the FDA for that drug IMO.

 d-usa wrote:
Well, you woldn't really go by the MSDS.

When drugs are dispensed they usually include what we call a Monograph (the big long paper full of writing that everybody just throws out when they open a new bottle of drugs).

Ah, thanks! I don't think I've ever bought medicine!

 Gentleman_Jellyfish wrote:

 d-usa wrote:
Well, you woldn't really go by the MSDS.

When drugs are dispensed they usually include what we call a Monograph (the big long paper full of writing that everybody just throws out when they open a new bottle of drugs).

Ah, thanks! I don't think I've ever bought medicine!

Even if you did, 99% of the time it just gets thrown away with the packaging .

I truly wonder how many people actually read the papers they get with their drugs from the pharmacy.

 d-usa wrote:

 Easy E wrote:
So, if a Generic Drufg manufacturer puts a bunch of low-cost crap into their generic knock-off drug and you get sick/die from it; you are suppose to sue the person who made the original "Brand" version of the drug?

I'm not exactly a legal eagle, but how does that make any sense?

Let's try this again, shall we:

If the generic versions of the drugs are made from the exact same formula and labeled with the exact same warnings as their brand name counterparts, the generics and their manufacturers were not liable.

And of course we are talking about "side effects" in this case, not "manufacturing errors". The SCOTUS ruling didn't address somebody suing somebody because they made a crappy product.

But if a stupid website writes a stupid article there will be people who are confused by it.

Thanks for the clarification.

However, it seems like this will raise R&D costs even more as the Brand maker won't want to get sued once the drug goes Generic. I'm not sure this is better, considering how much Big Pharma all ready complains about R&D issues.

Edit: Again, I'm far from knowledgable about this subject.

Looking through the information for the drug, it does seem like that particular side effect was a known possibility, it just doesn't appear that it was included in the "for the consumer" side effect list. So it's an interesting issue for sure, but not really anything the generic manufacturer should be liable for.

If anyone is interested, this is a good summary.

 Ahtman wrote:

 Kilkrazy wrote:
If you read the data sheet on the original product, the side effect that this patient suffered is included. Thus I don't see how she could sue the original pharmaceutical company for non-disclosure of side effects.

From the article:

Karen Bartlett sued Mutual Pharma in New Hampshire state court, arguing that the drug company included no warning about the possible side effect. A court agreed and awarded her $21 million. The FDA went on to force both Mutual, as well as the original drug manufacturer Merck & Co., to include the side effect on the two drugs’ warning labels going forward.

How do we go from it isn't on the label to it is on it? Or is it a case where it is on the data sheet but isn't listed on the drug? It seems odd that the courts would agree that it wasn't there if it was there.

If you read the list of clinical indications, you will see it couldn't possibly fit on a label. As is true for practically any drug. That is why doctors rely on data sheets and books like the British National Formulary, not labels, for writing prescriptions.

 d-usa wrote:
Looking through the information for the drug, it does seem like that particular side effect was a known possibility, it just doesn't appear that it was included in the "for the consumer" side effect list. So it's an interesting issue for sure, but not really anything the generic manufacturer should be liable for.

Looks like she has a reasonable case against the original manufacturer then if they were negligent in passing that information on to the customer.

 d-usa wrote:


Even if you did, 99% of the time it just gets thrown away with the packaging .

I truly wonder how many people actually read the papers they get with their drugs from the pharmacy.

I drink often enough I usually scan the sheet for a big red "DO NOT DRINK ALCOHOL WITH THIS PRODUCT!", but I don't go through the entire thing unless I start having something strange happen to me and want to check for side effects.

I will admit to being boring and check side effects. I'd rather not take something that causes drowsiness if I have to drive

 Kilkrazy wrote:
If you read the list of clinical indications, you will see it couldn't possibly fit on a label. As is true for practically any drug. That is why doctors rely on data sheets and books like the British National Formulary, not labels, for writing prescriptions.

d-usa already covered it, but I also imagine there are a lot of things Doctors use that patients do not use. I don't think there was any confusion as to doctors being more versed in pharmacology and the texts relating to it.

 whembly wrote:
Yep... that's my read on this. This doesn't absolve the original patent holder from any liability if they were found fraudulent during the developement of their product.

To me, I see this as a function to keep the generic drug's cost lower.

It's also a basic issue of fairness. The generic manufacturer relied on the testing undertaken by the original company and the FDA, and put on the label all the warnings of the original. For them to be penalised because testing by other parties wasn't sufficient just seems really unfair, and would also introduce a lot of legal risk to generic manufacturers that they can't mitigate through any actions of their own.


Automatically Appended Next Post:

 KalashnikovMarine wrote:
I know you read selectively but I've been massively taking the piss this entire thread. You are tracking that right?

No, I hadn't. Because you recently claimed that tactical police units wear balaclavas out of shame, and in another thread you're arguing that you wouldn't let police in to your own home to aid in a hostage situation next door, just because.

At this point, I don't think it's possible to say 'oh that's just too crazy, KalashnikovMarine must be making a joke'.

That said, there is an argument that the European witch hunts, which mostly occurred under the Catholic Church through the 15th to 18th century were incredibly gender biased with traditional women's roles and tasks, which included traditional medicine being labeled as "witch craft". This is also right around the rise of so called "scientific" medicine. I put air quotes on that because medicine of the day was not much better then witchcraft considering leeches and stabbings were popular medical treatments. Any way an acquaintance of mine wrote her master's thesis on the concept of the witch hunts as gendercide, I'll see if I can dig a copy up some where if you're interested. When her paper was publicly discussed/critiqued on campus one of the odder counterpoints is that not enough people had died for it to qualify for a "cide" of any kind. The low number is approximately 60,000 deaths last I saw anything, so I suppose it depends on your own goal posts for that?

Hang on, so you weren't actually joking? Anyhow, it's weird that Catholic Church gets picked out in isolation for its oppressive activities, instead of being seen as it was - a single actor in a region that was full of oppression. I mean, go read about the reformation, and this idea of the Catholic Church alone being evil and nasty should disappear out of your head.

And yeah, the roughly 40,000 people killed as witches over roughly 400 years isn't actually that massive a number. A hundred people a year is, of course, a hundred too many, but if we lower the goal posts to the point where the deaths of roughly a hundred people a year across a region the size of Europe qualifies as a genocide, then basically everything was a genocide and the word has no meaning.

And finally, the idea that witches had this vast store of medicinal knowledge is pure imagination. The witches used the same half assed non-science as the leach doctors that replaced them. The assumption that their methods must have worked better is constructed from nothing other than your own assumption that witches were good and wise.


Automatically Appended Next Post:

 Rented Tritium wrote:
But on the other hand, this ruling creates a weird situation where a drug could eventually be discontinued by the original maker, such that there are ONLY generics. In which case the drug could keep getting made forever and nobody can ever be sued. Ostensibly, that's what the FDA is for, they could step in and halt sale of the drug and investigate, etc etc, but what if they're slow?

I think that's the point that you need to start considering a compensation scheme that isn't dependant on finding someone to blame.

A lot of the people killed as witches weren't actually witches, either. I wouldn't be surprised if the majority of them weren't.

 Hordini wrote:
A lot of the people killed as witches weren't actually witches, either. I wouldn't be surprised if the majority of them weren't.

It has been awhile but I recall a historical theory that the Salem Witch trials were essentially a land grab from women who had land. I'll have to see if I can find it.

I've definitely heard that before.

 sebster wrote:


Automatically Appended Next Post:

 KalashnikovMarine wrote:
I know you read selectively but I've been massively taking the piss this entire thread. You are tracking that right?

No, I hadn't. Because you recently claimed that tactical police units wear balaclavas out of shame, and in another thread you're arguing that you wouldn't let police in to your own home to aid in a hostage situation next door, just because.

At this point, I don't think it's possible to say 'oh that's just too crazy, KalashnikovMarine must be making a joke'.

That said, there is an argument that the European witch hunts, which mostly occurred under the Catholic Church through the 15th to 18th century were incredibly gender biased with traditional women's roles and tasks, which included traditional medicine being labeled as "witch craft". This is also right around the rise of so called "scientific" medicine. I put air quotes on that because medicine of the day was not much better then witchcraft considering leeches and stabbings were popular medical treatments. Any way an acquaintance of mine wrote her master's thesis on the concept of the witch hunts as gendercide, I'll see if I can dig a copy up some where if you're interested. When her paper was publicly discussed/critiqued on campus one of the odder counterpoints is that not enough people had died for it to qualify for a "cide" of any kind. The low number is approximately 60,000 deaths last I saw anything, so I suppose it depends on your own goal posts for that?

Hang on, so you weren't actually joking? Anyhow, it's weird that Catholic Church gets picked out in isolation for its oppressive activities, instead of being seen as it was - a single actor in a region that was full of oppression. I mean, go read about the reformation, and this idea of the Catholic Church alone being evil and nasty should disappear out of your head.

And yeah, the roughly 40,000 people killed as witches over roughly 400 years isn't actually that massive a number. A hundred people a year is, of course, a hundred too many, but if we lower the goal posts to the point where the deaths of roughly a hundred people a year across a region the size of Europe qualifies as a genocide, then basically everything was a genocide and the word has no meaning.

And finally, the idea that witches had this vast store of medicinal knowledge is pure imagination. The witches used the same half assed non-science as the leach doctors that replaced them. The assumption that their methods must have worked better is constructed from nothing other than your own assumption that witches were good and wise.

I don't assume any of that, the witch hunts with the possible gendercide theories are all valid historical arguments that have been made by many other people then myself, but since misinterpretation like what set off your hilarious little rant about the balacava and the need to force your ideals, morality and apparent hatred of both privacy and property rights while shoving your usually wrong interpretation of what others say down their throats, or didn't for that matter is par for the course I suppose I won't bother to get into it.

And yes, the Catholic church gets a lot of spot light considering there was religious motivation behind much of the witch hunts and the protestant reformation didn't kick off for a full two centuries or so after the witch hunts began in earnest. Going with the low numbers that's 20,000 people, hunted down and executed for funsies. Or more accurately to manipulate fear to control and sway the masses of the age, like the sudden changes that one Lucifer who you might recall from the Bible suddenly underwent. Like it or not it's just history.

 Ahtman wrote:

 Hordini wrote:
A lot of the people killed as witches weren't actually witches, either. I wouldn't be surprised if the majority of them weren't.

It has been awhile but I recall a historical theory that the Salem Witch trials were essentially a land grab from women who had land. I'll have to see if I can find it.

That's interesting. I hadn't heard the reasons behind it specifically, but I do recall hearing that many, if not all of the Salem "witches" weren't actually witches at all.


Automatically Appended Next Post:

 KalashnikovMarine wrote:
Or more accurately to manipulate fear to control and sway the masses of the age, like the sudden changes that one Lucifer who you might recall from the Bible suddenly underwent. Like it or not it's just history.

What sudden changes did Lucifer undergo in the Bible, and when did it happen? If I'm remember right, the name Lucifer is barely mentioned in the Bible. I think it pops up like once.

Most if not all witches rounded up in any of the major witch hunts weren't witches in any sense of the term. Hell Joan of Arc was burned for witchcraft (on the grounds that she wore pants, seriously) and she's a Catholic saint.

It's not in the Bible, except maybe some creative edits in the new testament here and there, but the Church (in the total christian sense of the term not just the Catholics) influence, especially culturally in the Middle Ages is near total. The modern concept of Satan, and the individual Lucifer as we now know him was mostly invented by the Church during and around the Black Black Death in the mid 1300s, can't have the flock blaming God for all their problems, you need a bad guy. If you dig into the bible, the only appearances of Lucifer ends up with him acting more like Heaven's prosecuting attorney.

Otherwise his existence is confined to Hell, Heaven's supermax level. To really get the "Lord of Hell" stuff you have to wait till a creative young Italian by the name of Dante Aligihieri wrote the most culturally influential piece of slam poetry ever sometime in the early 1300s*, his Divina Commedia. Of course of those most people have only read, or heard about just one part of it, Inferno. A lot of the modern Western conception of hell, and the imagery we associate with it, namely the circles/levels, hell as a place of eternal torment for sin ruled by Satan/Lucifer/The Morningstar, etc come from there and not any actual Christian dogma.

*The Divine Comedy would not be fully published and gain recognition as a "master piece" until the mid 1500s, but the work did the rounds through out the twelfth and thirteenth centuries.

 KalashnikovMarine wrote:
I don't assume any of that, the witch hunts with the possible gendercide theories are all valid historical arguments that have been made by many other people then myself, but since misinterpretation like what set off your hilarious little rant about the balacava

My little rant about the balaclava? Because you brought up out of the blue an idea that tactical police units wear balaclavas out of shame, and when I said that was nutty, you doubled down over and over again, insisting that it was true... that's become my little rant?

Dude, seriously, you're having problems with reality here. Not just in believing that tactical police wear balaclavas out of shame, but in your basic ability to remember recent events.

apparent hatred of both privacy and property rights

Apparent hatred of privacy and property rights? That's just not even a half plausible interpretation of that other thread. I mean, I said plain as day that if a person has no good reason to deny police access to their home, and it would help in resolving some situation, then they should. You disagreed, and now you think that means I hate privacy and property rights.

Real problems with reality.

And yes, the Catholic church gets a lot of spot light considering there was religious motivation behind much of the witch hunts and the protestant reformation didn't kick off for a full two centuries or so after the witch hunts began in earnest.

Yes, but when hundreds of thousands died in all kinds of religious persecution, worrying about the witches and looking at them without the context of the surrounding religious violence is inane.

Going with the low numbers that's 20,000 people, hunted down and executed for funsies. Or more accurately to manipulate fear to control and sway the masses of the age, like the sudden changes that one Lucifer who you might recall from the Bible suddenly underwent. Like it or not it's just history.

Of course its history. I already gave you a higher number. But guess what, 20,000 dead people over the course of 400 years is not major, shocking history, and sure as hell isn't a genocide.


Automatically Appended Next Post:

 KalashnikovMarine wrote:
It's not in the Bible, except maybe some creative edits in the new testament here and there, but the Church (in the total christian sense of the term not just the Catholics) influence, especially culturally in the Middle Ages is near total. The modern concept of Satan, and the individual Lucifer as we now know him was mostly invented by the Church during and around the Black Black Death in the mid 1300s, can't have the flock blaming God for all their problems, you need a bad guy. If you dig into the bible, the only appearances of Lucifer ends up with him acting more like Heaven's prosecuting attorney.

Sort of, but not really. You're right that many people's understanding of modern Christian lore is from stuff outside the bible, particularly when it comes to Satan and Hell (but also the nativity and many others), but it wasn't 'invented' by the Catholic Church as some conscious act.

Rather, the bible influences popular culture, it is used to tell exciting, imaginative tale. This is as true today as it was in the middle ages. These stories get quickly absorbed into the popular understanding of the bible, so that things like the three wise men unquestioned elements of the faith, despite being straight up fan fiction. Your point on Dante's Inferno is a classic example - it draws on the bible as a direct inspiration, but adds many imaginative elements, which rather quickly become a key part of how people come to understand their religion, those in the church included.

Fred Clark of the slacktivist, has been doing an epic analysis of the Left Behind books, and he made the point that despite the claims that Left Behind was directly inspired by the Bible and nothing else, he couldn't see how any of it would be possible if films like The Omen hadn't already been written.

 sebster wrote:

Going with the low numbers that's 20,000 people, hunted down and executed for funsies. Or more accurately to manipulate fear to control and sway the masses of the age, like the sudden changes that one Lucifer who you might recall from the Bible suddenly underwent. Like it or not it's just history.

Of course its history. I already gave you a higher number. But guess what, 20,000 dead people over the course of 400 years is not major, shocking history, and sure as hell isn't a genocide.

Nor did I say it was, I said the argument's been made in academic settings and without. Also I think the term used is "gendercide".

Are you sure you're not the one with a loose grip on reality?

 KalashnikovMarine wrote:
Nor did I say it was, I said the argument's been made in academic settings and without. Also I think the term used is "gendercide".

There's all kinds of nonsense put forward in academic debates. Being well informed on an issue does not necessarily mean forming a sensible conclusion. That's basically why academic debate exists, because not everything put forward is reasonable and well considered, and so the process works (for the most part) to sift out the weaker stuff. As such, the measure of an argument having merit isn't just that it's been made, but that it's survived debate and has achieved acceptance within that specific field.

And gendercide is just wordplay, meaning the same thing but with a twist to note the kind of victim. For it to be appropriate, it would still have to be on a scale that would justify regular use of genocide, and no, a hundred people a year across Europe doesn't qualify.

Are you sure you're not the one with a loose grip on reality?

I'm pretty confident I'm not the one who's claimed that saying a person, absent a good reason, should allow police in to their home must hate privacy and personal property.

Man. I'm amazed that this thread has provided the answer to a question historians have been unable to agree on for decades: namely, the number of 'witches' killed during the period when the inquisition was active.

I think it's really strange that a grown ass man can't tell the difference between using a number as a shorthand for the broad range of figures considerd by historians to the reasonably likely range, and thinking we have a specific answer.