Who is this idiot wrote:
Welcome to Phase IV trials.
Oh really? Wow.
and ongoing pharmacovigilance ...
-
41
-
rojo wrote:
I saw this on the NY Times website.
Only three controlled studies of the drug’s efficacy have been published, and all three lasted for only five weeks...
And thought to myself. That's ridiculous. You need to test a drug longer than that. Then I read this.
BMS has set its wholesale cost at $1,850 a month, or around $22,500 a year, in line with other branded antipsychotics, said Adam Lenkowsky, chief commercialization officer for BMS.People talk about the damage the military-industrial complex does to this country. Is the medial-pharmaceutical complex even worse? It just seems that the FDA is a drug pusher.
If I was in charge of the FDA, I'd temporarily approve a drug like this after 5 weeks as sick people and their relatiaves are often desperate but I would keep the trials going for years. And I would have kept the Covid-19 trials going for years as well.
Careful, Rojo. One of your lefty volunteer mods might delete your thread.
In all seriousness, this is why the crimes committed by Fauci, the NIH, the FDA, Pfizer and Moderna, along with the media regarding the mRNA gene therapy treatments were so heinous. You could have an actually good medicine or treatment, but people will now understandably doubt it.
813 -
This quoted post has been removed.
Just like they did with OxyContin right
22 -
So let it play out. Those people are already f*d up so just give this a chance.
what could happen?
1) it works and their symptoms are decreased or even go away completely.
2) it really doesn't work that well and is about the same as the current drugs on the market.
3) it makes their problem worse, but they are already crazy so they'll just be crazier.
4) death- not likely and even so, we dont really need crazy people in society any way, so it would be a net gain.
16 -
This is way for drug companies to profit off of patents. They take two already existing drugs that have generic labels and are no longer making big bucks, combine them together...
and PRESTO! New product, new patent. Money gun go brrrrrrr.
Even though you could get the two already existing drugs as a generic and save big bucks.
They also do this by simply changing the dosage from 10 mg to something random like 11.5 mg, label it as a new product, and wham bam thank you maam.
54 -
Schizophrenia isnt even a real diagnosis if you know anything. The term was created to make an excuse to take "crazy" homeless people off the streets and torture them with electroshock and lobotomies.
Google it - Schizophrenia is a nonsense category - that nobody even knows what it holds. They throw some "aspergers autistics in there, and people doing too much meth". It should be labeled something like "psychosis prone individuals" and it has more to do with severe complex PTSD and Abuse than you realize.
lol because of propaganda from the gov and media - people think schizos actually "see and hear" things haha, its a lie. Schizos make that up, but its not exacltly fake to them - they have imploded and created their own language, so its like its a linguistic thing, they are actors who died in the act. it has to do more with society and language than the person labeled - they are the product of torture, abuse, and linguistic manipulation.
just discussing this with my parents this week, as I know im "schizophrenic" i have visions and stuff, but tis because of drugs, but I dont want to admit the drugs are because I was raped as a kid by a family member, and also have ADHD. After a while you start to split, as when I see my family member I get paranoid and have to treat them as family but then sometimes I still look at them and see a pedophile.....imagine doing this for 20 years - so yeah when I took LSD the first few times I went psychotic becuase I realized my family member was my biggest abuser and I cant tell anyone becuse it would ruin our family. Imagine all the girls out there that ffffed their dads and dont tell anyone - their dads later on tell them to go to the doctors and help "diagnose" them as schizos lmao its a joke, nah dad you were a pedophile and i've tried to not tell anyone and now when people ask me serious quetsions I dont answer serious anymore and just say i see demons....he is the demon. Do you guys get it? Its a category of idiots they created so they can hide the abuse of society on people - trust me back in the days when torture was more common place im sure schizos were more real. Torture doesnt make one tell the truth, it can make them tell lies - so sure the stories of people saying they spoke in tongues and saw God was real - because humans torture the hell out of other humans and then when they "break" aka stop taking language seriously - you call them schizophrenic - its the biggest evil of pyschology to treat the human being and life as something to be cured by definition.
I figured this all out myself as I have been addicted to weed, molly, lsd, dmt, and schrooms the last 10 years - and recently adderal sent me over the edge and now I am schizophrenic....lol nah im suffering fam and dont need to explian the human condition to you. its like basic humans torture other humans until they cant understand them and are like "oh this must be a mental disorder" what a joke. heres some links below if you are curious:
Schizophrenia in my mind is more related to "disembodiment of intersubjectivity" which can be caused by trying to ffffing grow up in a family where you are sexually abused and nobody knows -and you have to live WITH YOUR ABUSER AND PRETEND IT DIDNT HAPPEN!!!!!!! After a while you go ffing crazy. I can't even go home to a christmas party without seeing this MFs face.
Imagine being raped by someone and the rest of your life - this person trys to give you advice on dating, college, and your career. I'm pretty sure most people would then understand why I dissociate and can't find reality. I dont know what "reality" is. Does anyone else have massive incest in their family?? exactly....
https://theconversation.com/the-concept-of-schizophrenia-is-coming-to-an-end-heres-why-
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6999022/82775#:~:text=Arguments%20that%20schizophrenia%20is%20a,%2C%20%E2%80%9Cdoes%20not%20exist%E2%80%9D.
.Think about it. If you dont understand pysch - schizophrenia is like the pinnicle so you wont get it. But language is the issue - I also know a girlfriend who was just diagnosed but it was while she was tripping on LSD and METH! They diagnosed her in 1 visist. I met the girl, she is just a sad depressed abused girl who is acting and needs attention - he talks about seeing and talking to God is not different than what i say, and I'm not stupid. Also schizophrenia is related to genius - so I see many of them just as Genius who were abused - so yeah when you grow up you dont need to "communicate" as you are smarter than everyone - why give them what they want - society has been hurting you for years, so yeah I dont answer people honestly and I think I'm going to get diagnosed and then go back to school just to probe the category is not understood - its just Genius. or people who are aspergers who need to be put in their proper category.
315 -
rojo wrote:
I saw this on the NY Times website.
Only three controlled studies of the drug’s efficacy have been published, and all three lasted for only five weeks...
And thought to myself. That's ridiculous. You need to test a drug longer than that. Then I read this.
BMS has set its wholesale cost at $1,850 a month, or around $22,500 a year, in line with other branded antipsychotics, said Adam Lenkowsky, chief commercialization officer for BMS.People talk about the damage the military-industrial complex does to this country. Is the medial-pharmaceutical complex even worse? It just seems that the FDA is a drug pusher.
If I was in charge of the FDA, I'd temporarily approve a drug like this after 5 weeks as sick people and their relatiaves are often desperate but I would keep the trials going for years. And I would have kept the Covid-19 trials going for years as well.
the last sentence proves you are not democrat. Quit lying on here
21 -
and look at how many days vac's are tested. 5 days on 100's of kids only and no inert placebos. Only tested vs other vac's or adjuvants. maybe because pharma can't be sued if a v injures a kid or and adult. If you want to hear more Aaron Siri's testimony in the state houses of AZ and NH are compelling. Good to do our own RBA risk benefit assessments. IMO
12 -
rojo wrote:
If I was in charge of the FDA, I'd temporarily approve a drug like this after 5 weeks as sick people and their relatiaves are often desperate but I would keep the trials going for years.
That's literally exactly how it currently works. They've approved the drug, and there will be ongoing post-market analysis for years to come.
So if you were in charge, you'd do exactly what they're already doing. But you're also mad about how they're doing it? I don't understand.
93 -
Rojo didn’t even read the article. Dude is an embarrassment.
74 -
If you go to clinicaltrials.cov and search for trials involving the drug I see this:
https://clinicaltrials.gov/study/NCT04659174?intr=Xanomeline&rank=4
Where long term safety was measured for 52 weeks. Interim analysis were publicized already here: https://news.bms.com/news/details/2024/Bristol-Myers-Squibb-Presents-New-Interim-Long-Term-Efficacy-Data-from-the-EMERGENT-4-Trial-Evaluating-KarXT-in-Schizophrenia-at-the-2024-Annual-Congress-of-the-Schizophrenia-International-Research-Society/default.aspx
The application was submitted to the FDA after this trial completed, so I imagine these results were part of the application.
Also I will add both components of Cobenfy have been around for a while and been in multiple clinical trials/approved so the FDA has a very good idea of safety already.
The NYT generally hates that the pharma industry saves lives and makes money so their reporting is never amazing on these fronts.
77 -
Death of Expertise, Part 12422442 wrote:
Or, maybe, and hear me out, don't get on the internet and make a fool of yourself? You have zero idea what went into conceiving, developing, testing, or approving this or any medication.
Phase 3 trails are to determine if a drug works in a statistically meaningful population. While safety data is also analyzed, much of that work was done before the phase 3 study. This drug has been in development for years. You can't start a phase 3 trial without already showing that the potential drug is likely safe. BMS bought the company that did all the early heavy lifting with this drug. It was known as KarXT for years if you want to dig up the data.
You literally fucccking though they just decided 5 weeks ago to start dosing people with some random chemical mixture. And the EFFICACY for this drug apparently can be assessed over 5 weeks. Do you know some drugs are SINGLE DOSE? And can be evaluated in a very short time frame? Did you want to rerun trials of those where people take it (needlessly) for months on end?? What sense would that make?
Do yourself a favor and STOP TALKING.
Sounds like you could benefit from this drug, schizo.
28 -
Dr. Steven-Huy Han, a UCLA liver specialist, has prescribed Ocaliva to a handful of patients, although he’s not sure it helps.
As advertised, the drug is lowering levels of an enzyme called alkaline phosphatase in their blood, and that should be a sign of healing for their autoimmune disease, called primary biliary cholangitis. But "no one knows for sure," Han said, whether less enzyme means they won’t get liver cancer or cirrhosis in the long run.
"I have no idea if the drug will make them better," he said. "It could take 10, 20, or 30 years to know."
16 -
Harambe wrote:
If you go to clinicaltrials.cov and search for trials involving the drug I see this:
Where long term safety was measured for 52 weeks. Interim analysis were publicized already here:The application was submitted to the FDA after this trial completed, so I imagine these results were part of the application.
Also I will add both components of Cobenfy have been around for a while and been in multiple clinical trials/approved so the FDA has a very good idea of safety already.
The NYT generally hates that the pharma industry saves lives and makes money so their reporting is never amazing on these fronts.
Never let facts in the way of rojorage!
55 -
DanM wrote:
Dr. Steven-Huy Han, a UCLA liver specialist, has prescribed Ocaliva to a handful of patients, although he’s not sure it helps.
As advertised, the drug is lowering levels of an enzyme called alkaline phosphatase in their blood, and that should be a sign of healing for their autoimmune disease, called primary biliary cholangitis. But "no one knows for sure," Han said, whether less enzyme means they won’t get liver cancer or cirrhosis in the long run.
"I have no idea if the drug will make them better," he said. "It could take 10, 20, or 30 years to know."
There's no effective drugs from primary biliary cholangitis (PBC).
PBC leads to liver cancer or liver failure.
Studies have shown that levels of akaline phosphatase in the blood correlate well with progression of disease and there's a mechanistic reason for this. Thus, it stands that a drug that interacts with bile acid biochemical pathways that leads to akaline phosphatase reduction has a good shot at preventing serious illness (cancer/liver failure) from PBC.
However, it will take a long time to tell if any intervention affects things like cancer/liver failure because those illnesses take years to develop.
It was agreed that lowering levels of alkaline phosphatase in the short term is a reasonable stand-in for possible benefit down the road.
Because there's no drugs for this disease, the FDA approved Ocaliva because it reduces alkaline phosphatase levels. Again, there is good reason to believe lowering these levels will reduce the risk of cancer/liver failure.
Trials are being run to determine on the long-term benefits. The drug passed it's phase 1 safety evaluation.
The alternative: no treatments and these people die of cancer and liver failure.
I don't find the arguments above that absurd nor evidence of corruption. It seems like scientists and doctors are trying their best to treat a rare, slow moving disease.
Disappointing fear mongering from DanM, who seems to prefer that people just painfully of liver cancer. Charming.
82 -
The field might as well be witch trials.
Witch trials had a higher success rate.
It’s a way to abuse power to deprive people of justice.
100% of those involved are avoiding justice because it’s hard.
Authority without responsibility.
22 -
Harambe wrote:
DanM wrote:
Dr. Steven-Huy Han, a UCLA liver specialist, has prescribed Ocaliva to a handful of patients, although he’s not sure it helps.
As advertised, the drug is lowering levels of an enzyme called alkaline phosphatase in their blood, and that should be a sign of healing for their autoimmune disease, called primary biliary cholangitis. But "no one knows for sure," Han said, whether less enzyme means they won’t get liver cancer or cirrhosis in the long run.
"I have no idea if the drug will make them better," he said. "It could take 10, 20, or 30 years to know."
There's no effective drugs from primary biliary cholangitis (PBC).
PBC leads to liver cancer or liver failure.
Studies have shown that levels of akaline phosphatase in the blood correlate well with progression of disease and there's a mechanistic reason for this. Thus, it stands that a drug that interacts with bile acid biochemical pathways that leads to akaline phosphatase reduction has a good shot at preventing serious illness (cancer/liver failure) from PBC.
However, it will take a long time to tell if any intervention affects things like cancer/liver failure because those illnesses take years to develop.
It was agreed that lowering levels of alkaline phosphatase in the short term is a reasonable stand-in for possible benefit down the road.
Because there's no drugs for this disease, the FDA approved Ocaliva because it reduces alkaline phosphatase levels. Again, there is good reason to believe lowering these levels will reduce the risk of cancer/liver failure.
Trials are being run to determine on the long-term benefits. The drug passed it's phase 1 safety evaluation.
The alternative: no treatments and these people die of cancer and liver failure.
I don't find the arguments above that absurd nor evidence of corruption. It seems like scientists and doctors are trying their best to treat a rare, slow moving disease.
Disappointing fear mongering from DanM, who seems to prefer that people just painfully of liver cancer. Charming.
Forcing people to die a painful death to own the libs
54 -
rojo wrote:
I saw this on the NY Times website.
Only three controlled studies of the drug’s efficacy have been published, and all three lasted for only five weeks...
And thought to myself. That's ridiculous. You need to test a drug longer than that. Then I read this.
Drugs go thru 4 phases of testing. Phase III is the one you referenced, and even wrote in your post that they were testing “efficacy”. Phases I and II are much longer (preclinical and safety data) and are always done first before they’re even allowed to do a Phase III (testing it in a randomized trial to see if it works).
The two drugs have been around in testing since 1997, and in this combination together started preclinical safety testing in 2012. (You can find the references to those studies in the Wikipedia entry for Cobenfy).
And yes… the drug companies will suck the life out of our economy when they get approval for a new drug. That’s not the FDAs responsibility to regulate, though. That’s on congress (who passed prescription drug benefits literally saying “we won’t negotiate, we’ll just pay the bill). The primary sponsor of that bill left congress and became Pharmas top lobbyist.
70 -
Huwang2.0 wrote:
Death of Expertise, Part 12422442 wrote:
Or, maybe, and hear me out, don't get on the internet and make a fool of yourself? You have zero idea what went into conceiving, developing, testing, or approving this or any medication.
Phase 3 trails are to determine if a drug works in a statistically meaningful population. While safety data is also analyzed, much of that work was done before the phase 3 study. This drug has been in development for years. You can't start a phase 3 trial without already showing that the potential drug is likely safe. BMS bought the company that did all the early heavy lifting with this drug. It was known as KarXT for years if you want to dig up the data.
You literally fucccking though they just decided 5 weeks ago to start dosing people with some random chemical mixture. And the EFFICACY for this drug apparently can be assessed over 5 weeks. Do you know some drugs are SINGLE DOSE? And can be evaluated in a very short time frame? Did you want to rerun trials of those where people take it (needlessly) for months on end?? What sense would that make?
Do yourself a favor and STOP TALKING.
Sounds like you could benefit from this drug, schizo.
Sounds like my up/downvotes are crushing yours, rojo. Or Vladimir.
Pathetic that the OP can't respond and instead relies on his troll army.
20 -
Thanks for the additional links, Harambe. I think most people would interpret the NYT article as Rojo did, because most people would not make the distinction between *safety* and *efficacy* trials and would erroneously conclude that safety was only studied for 5 weeks.
20
What People Are Talking About On LetsRun
No top threads at the moment. Check back soon.