FDA committee votes 14-1 to dismiss clozapine REMS

[Stagg737]

Exactly. This is pomp, and show. On one hand they say sure, our bad, we screwed up, but they stopped short of making real world change.

Just like they did with circling back to ECT because it predated FDA, and now ECT docs have to talk about "brain damage" ... Thanks FDA.

And of course there is the joke of celexa and QTc... Thanks FDA.

Oh, and then recently the reduction of SSRI and Suicide risk black box being only downgraded to warning or whatever... another failed attempt, only to virtue signal to us rank and file docs in the trenches but missing the mark... thanks FDA.

I'm sure there's more.

Idk, I’d call dismantling the REMS program more than just pomp and show. The fact that a patient or their family would go after a doc vs the DEA is a pretty massive difference…

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[mistafab]

I am just grateful for this move in general.

It is very frustrating for bureaucracy to interfere in the care of a patient. I counsel patients frequently about severe risks from medications. The fact that they had been imposing required testing on patients who already were informed and consented was red tape between myself and my patient.

SMI patients already get the worst providers in the worst settings. Removing the red tape is a great leap forward.

FDA pretended they cared about agranulocytosis. But america turns a blind eye to our revolving door admissions for indigent populations with SMI. Many of whom had treatment resistant illness and perhaps could have their life changed with clozapine. I recall several patients of mine with SMI who's life was changed with clozapine. Years of providers saying "it won't make a difference" and never even trialed it. People getting back on their feet, even getting jobs. It is incredible. They would take a 1-15 in 10,000 chance of a dangerous side effect vs their daily dangerous lifestyle and unrelenting, distressing psychosis any day, a million times over.

 

[Merovinge]

I am just grateful for this move in general.

It is very frustrating for bureaucracy to interfere in the care of a patient. I counsel patients frequently about severe risks from medications. The fact that they had been imposing required testing on patients who already were informed and consented was red tape between myself and my patient.

SMI patients already get the worst providers in the worst settings. Removing the red tape is a great leap forward.

FDA pretended they cared about agranulocytosis. But america turns a blind eye to our revolving door admissions for indigent populations with SMI. Many of whom had treatment resistant illness and perhaps could have their life changed with clozapine. I recall several patients of mine with SMI who's life was changed with clozapine. Years of providers saying "it won't make a difference" and never even trialed it. People getting back on their feet, even getting jobs. It is incredible. They would take a 1-15 in 10,000 chance of a dangerous side effect vs their daily dangerous lifestyle and unrelenting, distressing psychosis any day, a million times over.

That's a gross culture to be witness to. It's one thing to bemoan a trial where pt is not able to keep at it due to REMS, it's another thing entirely to not try as it "won't make a difference". People as a whole get so uncomfortable by those who suffer from psychosis, it might be the single easiest population to pick on in modern era, not directly to someone's face, but certainly by action/policy.

 

[calvnandhobbs68]

Relapse is the norm, but relapse =/= failure.

I can't get the full article, but how did they determine "continuous D2 blockade"?

Past studies show a relapse rate of about 20% in treated schizophrenia, so 40-50% relapse quoted in this study is much higher. And do we even know the dosages these patients received? Given the higher relapse rate, I suspect a significant portion of patients did not receive maximum therapeutic doses or even treated with polyantipsychotics, which has been shown to much more effective.

By continuous administration of LAIs during the study period.

Which is, ya know, in the abstract. Methods sections are helpful to read sometimes.
Come on now, it's not a professional look to feign ignorance when the information is staring you in the face.
Making up information about a study you didn't even read is also just as unprofessional.
Also why do you just keep making up information? Where are you getting the consistent information that multiple antipsychotics are "much more effective" than one antipsychotic and why is this somehow preferable over clozapine?

 

[Merovinge]

Which is, ya know, in the abstract. Methods sections are helpful to read sometimes.
Come on now, it's not a professional look to feign ignorance when the information is staring you in the face.
Making up information about a study you didn't even read is also just as unprofessional.
Also why do you just keep making up information? Where are you getting the consistent information that multiple antipsychotics are "much more effective" than one antipsychotic and why is this somehow preferable over clozapine?

I'm very worried AI is only going to make the tendency to "read a headline and pretend to have read the article" tendency even worse. Not exactly sure what can be done to combat this cognitive bias, but it needs a snazzier name and a good psychologist to research it further.

 

[clausewitz2]

I'm very worried AI is only going to make the tendency to "read a headline and pretend to have read the article" tendency even worse. Not exactly sure what can be done to combat this cognitive bias, but it needs a snazzier name and a good psychologist to research it further.

An AI is much more likely to actually read the entirety of an article than the average person on the Internet. Current actual existing models are fairly good at putting together research summaries. Might want to take a look at Perplexity's Deep Research mode.

I trust an LLM, especially a current-gen (Claude 3.7/GPT4.5) reasoning model to read an article and give me the gist far more usefully than a headline or the average educated layperson's description of the study.

 

[ObsequiousAplomb]

The pharmacy I use still requires me to upload into the REMS, even though when I log into the REMS it reminds me I don't have to. Lol.

Are other people still experiencing this?

 

[Stagg737]

Are other people still experiencing this?

I am not, but I'm also prescribing on an inpatient basis, so getting the labs anyway.

 

[clausewitz2]

Are other people still experiencing this?

I had one pharmacy that I was dealing with that kept insisting that I was supposed to fax them lab results and kept having to have the REMS explained to them slowly and with small words. they've stopped hassling me like clockwork every few weeks asking for faxed results so apparently the message has gotten through.

 

[ObsequiousAplomb]

I am not, but I'm also prescribing on an inpatient basis, so getting the labs anyway.

I'm getting the labs, it's just that the pharmacy refuses to prescribe unless the rems itself is updated. Sending them the results or just assuring them that I did the labs doesn't satisfy them.

 

[Stagg737]

I'm getting the labs, it's just that the pharmacy refuses to prescribe unless the rems itself is updated. Sending them the results or just assuring them that I did the labs doesn't satisfy them.

Oh, well that’s stupid. Not an issue for me since the inpatient pharmacy just checks the chart themselves.