[account deactivated]
cars
cars
UNUSUALY COOL
Post rating:
~
now thats getting high in the vampire's castle
tears
tears
Post rating:
+
big fan of SSRIrony
Backus
Backus
Post rating:
~
insane no feels guy
tears
tears
Post rating:
+
The_Boourns_Identity
The_Boourns_Identity
Post rating:
~
i've been saying this works with low doses of dxm
shriekingviolet
shriekingviolet
Post rating:
~
Gssh posted:shriekingviolet posted:
finally i went to another new guy who, right in front of me, looks up "cluster headache" on fucking wikipedia
Why had you not looked it up on the internet yourself?
i had but pain is a really poorly developed field and difficult to describe and define, especially if you're not familiar with medical jargon. my symptoms weren't exactly in line with typical cluster headaches because i have continuous chronic pain in addition to the attacks, so the first couple doctors said I couldn't possibly have cluster headaches. but yeah, i should have been more aggressive about advocating for myself.
palafox
palafox
Post rating:
~
http://ir.aurismedical.com/phoenix.zhtml?c=253572&p=irol-newsArticle&ID=2025513
one of three current trials for tinnitus (that I know of) involves shooting ketamine gel into your eardrums. the future is bright
one of three current trials for tinnitus (that I know of) involves shooting ketamine gel into your eardrums. the future is bright
Keven
Keven
Post rating:
+
Hypothesis: in a pack of m&ms there will be the most red ones
Methodology: injected ketamine into the m&ms
Conclusion: yeop
Methodology: injected ketamine into the m&ms
Conclusion: yeop
drwhat
drwhat
mt.real
Post rating:
~
i'm going to a fancy medical conference tomorrow and will probably have to listen to people who work for multinational pharma companies talk about how they are sent from heaven to save us. hope i blow up
[account deactivated]
Gssh
Gssh
Post rating:
~
groundservices posted:I don't know many cats who get invited to parties
You're obviously attending the wrong parties then.
Edited by Gssh ()
chickeon
chickeon
chickeon
Post rating:
~
blow them up instead tia
[account deactivated]
drwhat
drwhat
mt.real
Post rating:
+
groundservices posted:I don't know many cats who get invited to parties
this is an old picture
[account deactivated]
shriekingviolet
shriekingviolet
Post rating:
~
groundservices posted:We should say: timeless
Speaking of does anyone have that pic of the three people drinking, two are old ladies, one's puking in a trashcan, and the third figure is some well coifed dude that looks like Julian from tpb, and there's some Americana kitsch on the wall? I need it for a project thanks
Edit I mean Ricky
i do
shriekingviolet
shriekingviolet
Post rating:
+
[account deactivated]
Flappo
Flappo
Post rating:
~
just lol if you've never snorted a line of ketamine and felt weird as fuck
[account deactivated]
[account deactivated]
[account deactivated]
tears
tears
Post rating:
+
drwhat posted:
you will all be on catamine all the time
[account deactivated]
cars
cars
UNUSUALY COOL
Post rating:
~
Flappo posted:just lol if you've never snorted a line of ketamine and felt weird as fuck
keep ketamine weird as fuck
Belphegor
Belphegor
Post rating:
~
with a 10 day prescription to opioids, 1/5 become long term users
A relative of mine was in a car crash 2 years ago and is still addicted to fentanyl
A relative of mine was in a car crash 2 years ago and is still addicted to fentanyl
tears
tears
Post rating:
+
opiates are fine, don't let anyone tell you otherwise, jsut took some nice opiates, listening to fleetwood mac, cooking a risotto, posting on the internet
Flying_horse_in_saudi_arabia
Flying_horse_in_saudi_arabia
Post rating:
~
you can do and enjoy all of those things without opiates, tears. Just say no
tears
tears
Post rating:
+
ive actually been pretty successfull recently in cutting lots of drugs out my life. I no longer take any benzos, which is the biggest thing, although its also ment ive had to give up weed. im not drinking as much either... as for opiates, well, sometimes its just nice to feel completly numb to the world. i try and stick to a rule of no more than once every 14 days.
anyway thats the update on the drugs im taking, thank you for your concern
anyway thats the update on the drugs im taking, thank you for your concern
herbsaint
herbsaint
ive gender
Post rating:
~
tears posted:ive actually been pretty successfull recently in cutting lots of drugs out my life. I no longer take any benzos, which is the biggest thing, although its also ment ive had to give up weed. im not drinking as much either... as for opiates, well, sometimes its just nice to feel completly numb to the world. i try and stick to a rule of no more than once every 14 days.
anyway thats the update on the drugs im taking, thank you for your concern
u ever try kratom. that shit's tite
Flying_horse_in_saudi_arabia
Flying_horse_in_saudi_arabia
Post rating:
~
well done on giving up benzos. evil shit. do take care with the opiates. by comparison, coming off benzos is worse for the people around you, kicking a proper opiate habit is a fucking nightmare for the user. not telling you anything you don't know i'm sure but just saying.
cars
cars
UNUSUALY COOL
Post rating:
+
Ruzbihan
Ruzbihan
Post rating:
+
Something weird is going on, other than EMS shooting people with huge dissociative doses for no reason. Ketamine doesn’t suppress your breathing (a major part of its medical usefulness), and it raises your heart rate+BP. Source: i took too many drugs as a teen
cars
cars
UNUSUALY COOL
Post rating:
~
https://www.cnn.com/2018/08/03/health/ketamine-suicide-depression/index.html
Whatever you call it, the treatment doesn't come cheap. Infusions at Ketamine Milwaukee cost $495 each, and Kane typically recommends an initial series of five to six infusions, after which patients generally return every four to six weeks for booster infusions.
Because treating depression with ketamine is an "off-label" use of the drug, it is not covered by health insurance, even when it is recommended by a doctor. Ferguson was able to scrape together enough cash for his first infusion. A good friend gave him the money for his second. And his church rallied around him and paid for his third treatment.
these quacks now have people literally begging for ketamine money from their communities, $3000 right off the bat then $500 every month
cars
cars
UNUSUALY COOL
Post rating:
+
drwhat change name of DYTD forum to Infusions at Ketamine Milwaukee
Cuntessa_Markievicz
Cuntessa_Markievicz
sOmEwHeRe OvEr ThE rAiNbOw
Post rating:
+
i did ketamine for the first time in like 2 years this weekend and kept on rubbing my hands apparently suggestively. weird thing was i kept on thinking in irish but could only respond in english and it was so confusing
BOFAnshen
BOFAnshen
Post rating:
~
MarxUltor
MarxUltor
Post rating:
+
Everyone loves Ketamine, the miracle drug that makes life worth living without actually changing a single material condition!
*five months later*
We regret to inform you that ketamine is now bullshit.
The problem, critics say, is that the drug’s manufacturer, Janssen, provided the FDA at best modest evidence it worked and then only in limited trials. It presented no information about the safety of Spravato for long-term use beyond 60 weeks. And three patients who received the drug died by suicide during clinical trials, compared with none in the control group, raising red flags Janssen and the FDA dismissed.
The FDA, under political pressure to rapidly greenlight drugs that treat life-threatening conditions, approved it anyway. And, though Spravato’s appearance on the market was greeted with public applause, some deep misgivings were expressed at its day-long review meeting and in the agency’s own briefing materials, according to public recordings, documents and interviews with participants, KHN found.
Dr. Jess Fiedorowicz, director of the Mood Disorders Center at the University of Iowa and a member of the FDA advisory committee that reviewed the drug, described its benefit as “almost certainly exaggerated” after hearing the evidence.
Fiedorowicz said he expected at least a split decision by the committee. “And then it went strongly in favor, which surprised me,” he said in an interview.
Esketamine’s trajectory to approval shows — step by step — how drugmakers can take advantage of shortcuts in the FDA process with the agency’s blessing and maneuver through safety and efficacy reviews to bring a lucrative drug to market.
Step 1: In late 2013, Janssen got the FDA to designate esketamine a “breakthrough therapy” because it showed the potential to reverse depression rapidly — a holy grail for suicidal patients, such as those in an emergency room. That potential was based on a two-day study during which 30 patients were given esketamine intravenously.
“Breakthrough therapy” status puts drugs on a fast track to approval, with more frequent input from the FDA.
Step 2: But discussions between regulators and drug manufacturers can affect the amount and quality of evidence required by the agency. In the case of Spravato, they involved questions like, how many drugs must fail before a patient’s depression is considered intractable or “treatment-resistant”? And how many successful clinical trials are necessary for FDA approval?
Step 3: Any prior agreements can leave the FDA’s expert advisory committees hamstrung in reaching a verdict. Fiedorowicz abstained on Spravato because, though he considered Janssen’s study design flawed, the FDA had approved it.
The expert panel cleared the drug according to the evidence that the agency and Janssen had determined was sufficient. Dr. Matthew Rudorfer, an associate director at the National Institute of Mental Health, concluded that the “benefits outweighed the risks.” Explaining his “yes” vote, he said: “I think we’re all agreeing on the very important, and sometimes life-or-death, risk of inadequately treated depression that factored into my equation.”
But others who also voted “yes” were more explicit in their qualms. “I don’t think that we really understand what happens when you take this week after week for weeks and months and years,” said Steven Meisel, the system director of medication safety for Fairview Health Services based in Minneapolis.
A nasal spray offers a path to a patent
Spravato is available only under supervision at a certified facility, like a doctor’s office, where patients must be monitored for at least two hours after taking the drug to watch for side effects like dizziness, detachment from reality and increased blood pressure, as well as to reduce the risk of abuse. Patients must take it with an oral antidepressant.
Despite those requirements, Janssen, part of Johnson & Johnson, defended its new offering. “Until the recent FDA approval of Spravato, health care providers haven’t had any new medication options,” Kristina Chang, a Janssen spokeswoman, wrote in an emailed statement.
Esketamine is the first new type of drug approved to treat severe depression in about three decades.
Although ketamine has been used off-label for years to treat depression and post-traumatic stress disorder, drugmakers saw little profit in doing the studies to prove to the FDA that it worked for that purpose. But a nasal spray of esketamine, which is derived from ketamine and (in some studies) more potent, could be patented as a new drug.
Although Spravato costs more than $4,700 for the first month of treatment (not including the cost of monitoring or the oral antidepressant), insurers are more likely to reimburse for Spravato than for ketamine, since the latter is not approved for depression.
Shortly before the committee began voting, a study participant identifying herself only as “Patient 20015525” said: “I am offering real-world proof of efficacy, and that is I am both alive and here today.”
The drug did not work “for the majority of people who took it,” Meisel, the medication safety expert, said in an interview. “But for a subset of those for whom it did work, it was dramatic.”
Concerns about testing precedents
Those considerations apparently helped outweigh several scientific red flags that committee members called out at the hearing.
Although the drug had gotten breakthrough status because of its potential for results within 24 hours, the trials were not persuasive enough for the FDA to label it “rapid-acting.”
The FDA typically requires that applicants provide at least two clinical trials demonstrating the drug’s efficacy, “each convincing on its own.” Janssen provided just one successful short-term, double-blind trial of esketamine. Two other trials it ran to test efficacy fell short.
To reach the two-trial threshold, the FDA broke its precedent for psychiatric drugs and allowed the company to count a trial conducted to study a different topic: relapse and remission trends. But, by definition, every patient in the trial had already taken and seen improvement from esketamine.
What’s more, that single positive efficacy trial showed just a 4-point improvement in depression symptoms compared with the placebo treatment on a 60-point scale some clinicians use to measure depression severity. Some committee members noted the trial wasn’t really blind since participants could recognize they were getting the drug from side effects like a temporary out-of-body sensation.
Finally, the FDA lowered the bar for “treatment-resistant depression.” Initially, for inclusion, trial participants would have had to have failed two classes of oral antidepressants.
Less than two years later, the FDA loosened that definition, saying a patient needed only to have taken two different pills, no matter the class.
Forty-nine of the 227 people who participated in Janssen’s only successful efficacy trial had failed just one class of oral antidepressants. “They weeded out the true treatment-resistant patients,” said Dr. Erick Turner, a former FDA reviewer who serves on the committee but did not attend the meeting.
Six participants died during the studies, three by suicide. Janssen and the FDA dismissed the deaths as unrelated to the drug, noting the low number and lack of a pattern among hundreds of participants. They also pointed out that suicidal behavior is associated with severe depression — even though those who had suicidal ideation with some intent to act in the previous six months, or a history of suicidal behavior in the previous year, were excluded from the studies.
In a recent commentary in the American Journal of Psychiatry, Dr. Alan Schatzberg, a Stanford University researcher who has studied ketamine, suggested there might be a link due to “a protracted withdrawal reaction, as has been reported with opioids,” since ketamine appears to interact with the brain’s opioid receptors.
Kim Witczak, the committee’s consumer representative, found Janssen’s conclusion about the suicides unsatisfying. “I just feel like it was kind of a quick brush-over,” Witczak said in an interview. She voted against the drug.
*five months later*
We regret to inform you that ketamine is now bullshit.
The problem, critics say, is that the drug’s manufacturer, Janssen, provided the FDA at best modest evidence it worked and then only in limited trials. It presented no information about the safety of Spravato for long-term use beyond 60 weeks. And three patients who received the drug died by suicide during clinical trials, compared with none in the control group, raising red flags Janssen and the FDA dismissed.
The FDA, under political pressure to rapidly greenlight drugs that treat life-threatening conditions, approved it anyway. And, though Spravato’s appearance on the market was greeted with public applause, some deep misgivings were expressed at its day-long review meeting and in the agency’s own briefing materials, according to public recordings, documents and interviews with participants, KHN found.
Dr. Jess Fiedorowicz, director of the Mood Disorders Center at the University of Iowa and a member of the FDA advisory committee that reviewed the drug, described its benefit as “almost certainly exaggerated” after hearing the evidence.
Fiedorowicz said he expected at least a split decision by the committee. “And then it went strongly in favor, which surprised me,” he said in an interview.
Esketamine’s trajectory to approval shows — step by step — how drugmakers can take advantage of shortcuts in the FDA process with the agency’s blessing and maneuver through safety and efficacy reviews to bring a lucrative drug to market.
Step 1: In late 2013, Janssen got the FDA to designate esketamine a “breakthrough therapy” because it showed the potential to reverse depression rapidly — a holy grail for suicidal patients, such as those in an emergency room. That potential was based on a two-day study during which 30 patients were given esketamine intravenously.
“Breakthrough therapy” status puts drugs on a fast track to approval, with more frequent input from the FDA.
Step 2: But discussions between regulators and drug manufacturers can affect the amount and quality of evidence required by the agency. In the case of Spravato, they involved questions like, how many drugs must fail before a patient’s depression is considered intractable or “treatment-resistant”? And how many successful clinical trials are necessary for FDA approval?
Step 3: Any prior agreements can leave the FDA’s expert advisory committees hamstrung in reaching a verdict. Fiedorowicz abstained on Spravato because, though he considered Janssen’s study design flawed, the FDA had approved it.
The expert panel cleared the drug according to the evidence that the agency and Janssen had determined was sufficient. Dr. Matthew Rudorfer, an associate director at the National Institute of Mental Health, concluded that the “benefits outweighed the risks.” Explaining his “yes” vote, he said: “I think we’re all agreeing on the very important, and sometimes life-or-death, risk of inadequately treated depression that factored into my equation.”
But others who also voted “yes” were more explicit in their qualms. “I don’t think that we really understand what happens when you take this week after week for weeks and months and years,” said Steven Meisel, the system director of medication safety for Fairview Health Services based in Minneapolis.
A nasal spray offers a path to a patent
Spravato is available only under supervision at a certified facility, like a doctor’s office, where patients must be monitored for at least two hours after taking the drug to watch for side effects like dizziness, detachment from reality and increased blood pressure, as well as to reduce the risk of abuse. Patients must take it with an oral antidepressant.
Despite those requirements, Janssen, part of Johnson & Johnson, defended its new offering. “Until the recent FDA approval of Spravato, health care providers haven’t had any new medication options,” Kristina Chang, a Janssen spokeswoman, wrote in an emailed statement.
Esketamine is the first new type of drug approved to treat severe depression in about three decades.
Although ketamine has been used off-label for years to treat depression and post-traumatic stress disorder, drugmakers saw little profit in doing the studies to prove to the FDA that it worked for that purpose. But a nasal spray of esketamine, which is derived from ketamine and (in some studies) more potent, could be patented as a new drug.
Although Spravato costs more than $4,700 for the first month of treatment (not including the cost of monitoring or the oral antidepressant), insurers are more likely to reimburse for Spravato than for ketamine, since the latter is not approved for depression.
Shortly before the committee began voting, a study participant identifying herself only as “Patient 20015525” said: “I am offering real-world proof of efficacy, and that is I am both alive and here today.”
The drug did not work “for the majority of people who took it,” Meisel, the medication safety expert, said in an interview. “But for a subset of those for whom it did work, it was dramatic.”
Concerns about testing precedents
Those considerations apparently helped outweigh several scientific red flags that committee members called out at the hearing.
Although the drug had gotten breakthrough status because of its potential for results within 24 hours, the trials were not persuasive enough for the FDA to label it “rapid-acting.”
The FDA typically requires that applicants provide at least two clinical trials demonstrating the drug’s efficacy, “each convincing on its own.” Janssen provided just one successful short-term, double-blind trial of esketamine. Two other trials it ran to test efficacy fell short.
To reach the two-trial threshold, the FDA broke its precedent for psychiatric drugs and allowed the company to count a trial conducted to study a different topic: relapse and remission trends. But, by definition, every patient in the trial had already taken and seen improvement from esketamine.
What’s more, that single positive efficacy trial showed just a 4-point improvement in depression symptoms compared with the placebo treatment on a 60-point scale some clinicians use to measure depression severity. Some committee members noted the trial wasn’t really blind since participants could recognize they were getting the drug from side effects like a temporary out-of-body sensation.
Finally, the FDA lowered the bar for “treatment-resistant depression.” Initially, for inclusion, trial participants would have had to have failed two classes of oral antidepressants.
Less than two years later, the FDA loosened that definition, saying a patient needed only to have taken two different pills, no matter the class.
Forty-nine of the 227 people who participated in Janssen’s only successful efficacy trial had failed just one class of oral antidepressants. “They weeded out the true treatment-resistant patients,” said Dr. Erick Turner, a former FDA reviewer who serves on the committee but did not attend the meeting.
Six participants died during the studies, three by suicide. Janssen and the FDA dismissed the deaths as unrelated to the drug, noting the low number and lack of a pattern among hundreds of participants. They also pointed out that suicidal behavior is associated with severe depression — even though those who had suicidal ideation with some intent to act in the previous six months, or a history of suicidal behavior in the previous year, were excluded from the studies.
In a recent commentary in the American Journal of Psychiatry, Dr. Alan Schatzberg, a Stanford University researcher who has studied ketamine, suggested there might be a link due to “a protracted withdrawal reaction, as has been reported with opioids,” since ketamine appears to interact with the brain’s opioid receptors.
Kim Witczak, the committee’s consumer representative, found Janssen’s conclusion about the suicides unsatisfying. “I just feel like it was kind of a quick brush-over,” Witczak said in an interview. She voted against the drug.
lenochodek
lenochodek
Post rating:
+
it's also ridiculous they put s ketamine in a sniffing bottle and use this as an excuse to patent the extremely novel idea that ketamine can be taken intranasally. so they can charge the bulk price of 20 kg of racemic ketamine for 8 doses of 84 mg of s ketamine
check the fda doc here: https://www.fda.gov/media/121376/download
according to table 2 the ratio of placebo vs s ketamine was approx: 374 to 507. if 6 people die in the trial, the chance that they will all be in the s ket group purely randomly is (507/(507+374))^6 = 3.6%
check the fda doc here: https://www.fda.gov/media/121376/download
according to table 2 the ratio of placebo vs s ketamine was approx: 374 to 507. if 6 people die in the trial, the chance that they will all be in the s ket group purely randomly is (507/(507+374))^6 = 3.6%