By Renata Hill, Moodfuel
Activation warning: this article describes a suicide attempt.
Part Two 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
After listening to hours of explanations by medical experts and 25 compelling, personal stories on Nov. 19, a joint advisory committee of the Food and Drug Administration (FDA) recommended ending the restrictions on clozapine, an antipsychotic medication for treatment resistant schizophrenia (TRS). During a live stream on the FDA's YouTube channel, committee members voted 14-1 to dismiss a decades-old policy that requires an exclusive, exhaustive process for doctors, pharmacies and patients in order for patients to acquire a handful of pills before restarting the process month after month, for life.
Coloradan Kate Rawlinson, leader of the Colorado Mad Moms, had flown in for the eight-hour meeting and sat among the large group of patient advocates. Many wore black t-shirts proclaiming "Clozapine is the safest antipsychotic in the world."
Although the expert presentations about the policy, known officially as the Risk Evaluation and Mitigation Strategy (REMS), were essential to committee members' medical understanding, the content was bone-dry. In stark contrast, the stories of tragedy and tenacity voiced by the mothers of adult children living with this severely debilitating brain disease were gripping. These tough, organized women, who called themselves The Angry Moms, had gathered from around the country to express clear frustration with REMS. They testified about their loved ones' needless suffering due to multiple points of failure built into the process causing extreme access problems and interruptions. Many concluded their testimony with the same statement, which became somewhat of a mantra, "The greatest risk of clozapine is not getting clozapine."
Many Angry Moms opened with gutting stories of family members' suicide attempts and follow-throughs after doctors refused to prescribe clozapine because of the burdensome REMS. Others detailed the challenges of drawing blood from patients with schizophrenia and "no blood, no drug" pharmacy policies.
The Angry Moms brought with them two doctors, a pharmacist, two patients and the doctor director of the National Alliance on Mental Illness (NAMI), all of whom testified about the helpfulness of clozpine, the only FDA-approved treatment for TRS. Several reiterated the consequences of not receiving the medication once started, including a very high suicide risk.
Dr. Kathryn K. Erickson-Ridout, who arrived separately, testified for the American Psychiatric Association. She said, "The REMS program, while well-intentioned and -designed, does create a barrier to prescribers and patients using clozapine."
She noted that only four to five percent of schizophrenia patients receive clozapine, despite 22 to 37 percent having TRS. Since November 2021, she said, 66 percent of prescribers reported trouble obtaining the drug for their patients.
The livestream translated the committee members' rapt attention as complete stillness. It was obvious even through the camera. They didn't want to miss one word of these lived experiences, one image of a person on clozapine who could smile again versus one image of a car crashed into a tree, the latest suicide attempt of a person who couldn't get clozapine because of REMS.
The FDA implemented clozapine REMS in 2015 to educate stakeholders about the drug's potentially dangerous side effects. It can cause 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 this risk had been overstated in the original studies 35 years ago and drops steeply after the four months to one year of use.
The committee members spoke about their choices after the voting concluded. "I do not believe that the REMS' approach to documenting and enforcing is serving the health of the patients or the needs of the community," said member Sascha Dublin, M.D., Ph.D., an epidemiologist at Kaiser Permanente.
Rajesh Narendran, a psychiatrist at UPMC Western Psychiatric Hospital, stated, "I strongly feel that the REMS at this point is just a hindrance. I think you should get rid of the REMS."
Other members noted that clozapine's effectiveness outweighs the neutropenia risk for most patients, and argued prescribers should be trusted to follow labeling instructions without REMS requirements.
The lone dissenting vote came from Walter Dunn, M.D., Ph.D., director of the Mood Disorders Section at West Los Angeles Veterans Affairs Medical Center. He favored a streamlined REMS focused on the first 18 weeks of therapy when neutropenia risk is highest.
The FDA is not required to follow advisory committee recommendations, but often does. Dr. Tiffany R. Farchione, director of the FDA's Division of Psychiatry, assured the audience that their testimony would impact regulatory decision-making.
Back at her hotel after the hearing, Kate Rawlinson emailed about the committees' support of terminating the clozapine REMS. "We were gobsmacked! (I) did not expect that vote outcome at all ... we prepare ourselves for the worst in this world of disappointment, but the angels were with us today!"
Now, the FDA will consider the committees' recommendations as it evaluates potential changes to the clozapine REMS. Any modifications could significantly improve prescribing practices and patient access to this critical medication.
Editor's Note: the joint committees are the Drug Safety and Risk Management Advisory Committee (DSaRM) and Psychopharmacologic Drugs Advisory Committee (PDAC).
Read Part One of The Angry Moms series here.
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