Hello and welcome back to the Psychiatry and Psychotherapy podcast.

I am joined today with Michael Cummings, expert psychopharmacologist was the head consultant in Patent State Hospital for a number of years now semi-retired

How's retirement going?

Pretty well pretty well actually. I came back as they retired and knew it and

So I'm still working part time, but the important feature there is part time. So yeah, that's good

That's good. Well, okay, so I wanted to jump in. We're gonna,

we're gonna get through a lot of questions hopefully today, but I wanted to start with Closepine.

And there's a new law that the Closepine REMS is scrapped. Yes. And it happened two days ago,

so that's February 25th, 2025. Yes. And so we no longer need to report to Elizabeth Rims, which was something I did on a weekly basis

for some of my clients.

So walk me through what happened and what this means for us.

Basically, a number of us have been lobbying the FDA for a number of years now to do away with the rims program in large for because it's become clear based on research data that the

primary risk for severe neutropenia occurs fairly early in close-up treatment and then declines to a level

of about

somewhere between one and 6 per 10,000 after a year of treatment, which are levels

comparable to other drugs that can affect the bone marrow.

And we don't have REMS programs for those.

So the FDA finally reconsidered the issue, and two days days ago they basically abolished the REMS program for

Chlozapine and simply noted that people should exercise good judgment and follow the recommendations

in the package insert.

In part what prompted this was the Europeans dropped all requirements for monitoring after

one year.

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