Who are The Angry Moms? What are we angry about?

It started, unintentionally, when I spoke with a senior officer of the National Alliance on Mental Illness (NAMI) at a conference in July 2022. He very kindly listened to my plea, “we need your help.”  He asked me what group I represented, I told him that I was just a mom that had been talking to other angry moms, and that we needed help. Bam. The Angry Moms received our name.

The most basic goal of the “Angry Moms” is to get their sons and daughters access to clozapine, for treatment-resistant psychosis. Clozapine has been called the “gold standard” medication and is the most effective antipsychotic medication that exists for treating psychosis. It is greatly underutilized, due to an unreasonable fear of side effects. In less than 1% of patients, there is a severe drop in white blood cell levels (agranulocytosis). In one study, Li et al. found the overall prevalence of agranulocytosis and death caused by agranulocytosis were 0.4% and 0.05%, respectively (1). At present the FDA requests monitoring weekly for six months, every other week for six months, and monthly afterwards.

However, since the FDA began regulating clozapine prescription, setting up a program called the REMS (Risk Evaluation Mitigation Strategy) many mistakes have been made, and patients have not been able to access clozapine. Because clozapine is highly effective for preventing suicidal ideation in some patients, access to clozapine can literally be a life-or-death matter. Lack of access to this medication can also bring on a full-blown relapse which is devastating to patients.

At minimum, 30% of patients with schizophrenia are treatment-resistant, and deserve a trial of clozapine, but due to ignorance and fear of clozapine, only about 5% begin the medication (2). Many without access to clozapine are totally disabled.

Weeks after speaking with the officer from the National Alliance on Mental illness, I received an email from him. He wanted to know: 1) if we had seen barriers to treatment with clozapine caused by REMS (Risk Evaluation and Mitigation Strategies), and 2) how widespread the problems were. NAMI was very interested in our “Impact Stories” and suggested that we have a “Listening Session.”

I immediately followed up with a survey of a large group of families with a loved one taking clozapine and found three major issues: 1) It is challenging to find well informed and trained doctors to prescribe clozapine and adjunct medication for predictable side effects; 2) Labs/pharmacies/hospitals often experience miscommunications, not understanding criticality of timeliness, and there are delays/inability to get clozapine. Bloodwork is mandatory for life, and psychiatric hospitals do not stock or administer clozapine because of the REMS; 3) Because of lack of access to clozapine, many patients experience years of unnecessary suffering due to sub-optimal treatment: near death disasters, incarceration, loss of quality of life, and families are traumatized and broken. There are financial hardships, homelessness, and even death.

Additionally, lack of insight into one’s mental illness, “anosognosia” is seldom understood or acknowledged. The difficulty that it adds to the care-taker’s burden of care is huge. One being that getting someone that is unable to recognize that they are ill to comply with weekly blood tests.

Ironically, while there are years (or even decades) of unnecessary suffering and loss of quality of life due to delay in use of clozapine, there is also the constant monthly fear of not getting clozapine.

In August 2022, I met some representatives of the Schizophrenia and Psychosis Action Alliance (S&PAA). They shared many of our concerns and joined in on the Listening Session with NAMI on September 20, 2022. I also networked with another organization, “Team Daniel running for recovery from mental illness” which shared my goals for making clozapine more accessible.

Three S&PAA Subject Matter Experts spoke. Facts mentioned included: The Division of Risk Management for REMS is not composed with experts in psychiatry; There is a large lack of providers that prescribe clozapine; When clozapine began to be used in the US, around 1990, prescribers were not equipped to deal with side effects and still are not; Work needs to be done with Medicaid and billing for complex levels of care; Pharmacies have problems accessing REMS at times; Prescribing/dispensing clozapine is very time consuming and expensive; There is discrimination and negligence on a large level toward the Seriously Mentally Ill (SMI) and their needs for treatment.

Four Team Daniel “experts” added important points which included: NAMI needs to support the Seriously Mental Ill (SMI); There is an urgent need to educate prescribers and decrease barriers to care; The American Psychiatric Association (APA) guidelines need change (Stop saying clozapine is the last resort when it’s the most effective and safest antipsychotic and lowers mortality); Doctors do not follow APA guidelines which state clozapine should be among the first three antipsychotics used (sooner with agitation, aggression, and suicidal risks.); Doctors are not held accountable for not following APA guidelines; REMS has increased Clozaphobia – puts fear into doctors and pharmacists.

March 2023 TheAngryMoms.com website “went live.” For a detailed summary of all of our efforts I refer you to this website: theangrymoms.com.

For now, The Angry Moms are focused on stopping the interruption or discontinuation of clozapine. In the future we may focus on: 1) Disconnecting pharmacies from REMS/stopping the blocking of refills; 2) “Fixing” the REMS by keeping the money designated for it to educate and train doctors; 3) Eliminating unnecessary blood tests; 4) Updating clozapine label to include rational ANC (absolute neutrophil count, or white blood cell) monitoring, titration schedule, and adjunct medications; 5) Increasing clozapine utilization (awareness campaigns, medical training, visibility); 6) Supporting a class action lawsuit; 7) Assisting in proposed legislation to “End Discrimination Against Treatment Resistant Schizophrenia.”

In short, we are angry because our loved ones deserve optimum care for Meaningful Recovery, and it seems that damage caused by REMS, and ignorance regarding clozapine, are standing in the way of what we need.

 

References

  1. Li et al. The prevalence of agranulocytosis and related death in clozapine-treated patients: A comprehensive meta-analysis of observational studies. Psychol Med. 2020 Mar;50(4):583-594.
  1. Rubio JM, Kane JM. How to Make an Effective Offer of Clozapine. J Clin Psychiatry. 2021 Nov 30;83(1):21.
  1. MDLinx. Clozapine blood tests can be reduced after two years, finds analysis. Retrieved February 8, 2024.
  1. Magistri C, Mellini, C. Clozapine-Associated Agranulocytosis: A Systematic Review. Is It Really so Frighteningly Common? J Clin Psychopharmacol. 2023 Nov-Dec; 43(6):527-533.
  1. Taylor D et al. Distinctive pattern of neutrophil count change in clozapine-associated, life-threatening agranulocytosis. Schizophrenia (Heidelb). 2022; 8(1): 21.
  1. Correll CU et al. A Guideline and Checklist for Initiating and Managing Clozapine Treatment in Patients with Treatment-Resistant Schizophrenia. CNS Drugs. 2022 Jul;36(7):659-679.