by Renata Hill, Moodfuel
Part One of the series about determined parents who worked the federal system to get their adult children an uninterrupted supply of medicine that restores their sanity
On Nov. 19, Kate Rawlinson, leader of Colorado Mad Moms, will join other very angry parents in Washington, D.C. testifying in front of a joint meeting of two U.S. Food and Drug Administration (FDA) committees. Accompanied by representatives from the American Psychiatric Association, parents are gathering in the nation's capital from around the country to speak about their adult children living with treat-resistant schizophrenia (TRS) and the challenges they face in obtaining what Rawlins said is a "godsend medication" for treating it.
The medication is clozapine, a second-generation anti-psychotic. A pivotal study showed it can reduce hallucinations and delusions, lower the risk of suicidal ideation and tardive dyskinesia (chronic, involuntary body movements) and improve the ability to think, all of which would enhance quality of life for about 1.02 million people with TRS. However, while researchers in another study agreed clozapine "is a very effective drug in everyday clinical practice," the potentially dangerous side effects they cited prompted the FDA to implement stringent safety protocols, called the Risk Evaluation and Mitigation Strategy (REMS) in 2015.
The most notable side effect is severe neutropenia, a condition in which the number of white blood cells – neutrophils – decreases drastically and the body becomes unable to fight infection. Yet, research as recent as June 2024 said that the risk for severe neutropenia was overstated in the original research 35 years ago and the risk drops steeply after the first year of use.
Over the last nine years, REMS has created significant access barriers to clozapine nationwide. Physicians and pharmacies must be REMS-certified, patients must be REMS-enrolled and they're on their own in finding the few doctors and pharmacies who will administer it and supervise lifetime blood tests and monitoring. Supply shortages, problems with incorrect prescriptions, lost lab results – all causing treatment interruptions – add to the quagmire.
Meanwhile, relatives, like Rawlinson, must watch loved ones deteriorate daily on the schizophrenia spectrum without effective treatment. Now, thousands of families have moved past frustration to outrage. They are focusing their ire and allying together through in-person meet-ups and social media to build a national REMS reform coalition called The Angry Moms. Colorado Mad Moms is a Centennial State chapter of this patient advocacy initiative.
During a phone interview on Nov. 13, Rawlinson felt confident and determined in her Western Slope home about the impact of the coalition's upcoming federal testimony. On Nov. 19, people living with the brain illness known as schizophrenia, their families, clinicians, legislators and the 80-member strong and growing Colorado Mad Moms will watch as the FDA's joint committee meeting streams live on YouTube. If their traction is any indication, these devoted, angry advocates may persuade the committees to update REMS policies so clozapine access gets easier.
Read Part Two of this series here.
Editor's Note: the committees are the Drug Safety and Risk Management Advisory Committee (DSaRM) and Psychopharmacologic Drugs Advisory Committee (PDAC).
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