The FDA recently convened an expert panel which debated whether there should be stronger warnings about potential adverse effects of Selective Serotonin Reuptake Inhibitors (SSRI) use during pregnancy. This comes after much previous debate around the current antidepressant black box warning related to increased suicidal thoughts and behaviors in young people aged 24 and younger. In observing these debates, it’s easy to see two things that are overlooked – first, that medical interventions should be assessed at an individual patient level. Secondly, we also ignore a much bigger issue – the woeful inadequacy of access to treatment in general.
In today’s online discourse, bold statements get attention while nuance and context can get lost. While I agree with the many medical organizations and medical professionals whose responses highlight that some of the information presented by the panel was taken out of context or potentially misleading, it’s also true that all medical interventions require a careful risk-benefit analysis on an individual patient level.
When making decisions about medical interventions, each patient’s unique situation should be considered. The potential risks of any intervention must be weighed against the risk of foregoing the intervention. In the case of the most recent FDA expert panel, the risks of not treating moderate to severe depression and anxiety were not fully addressed or considered. The conversation also included little mention of research-supported, evidence-based treatments for different levels of depression.
The back-and-forth debate over whether antidepressants such as SSRIs should be used in pregnancy, and previous debates over their use in children and adolescents, detracts from a much larger and potentially even more important issue, which is access to treatment in general.
According to Mental Health America, in 2024 nearly 60 million adults experienced a mental illness and nearly 13 million reported serious thoughts of suicide. Our youth fared no better, with 1 in 5 people between the ages of 12 and 17 experiencing at least one major depressive episode in the past year, and more than 3.4 million youth having serious thoughts of suicide. Despite this, 56% of youth and 54% of adults do not receive any mental health treatment.
Based on these numbers, it’s clear that there are many people in the U.S. who are suffering needlessly from what are treatable mental health issues. Barriers such as the growing mental health professional shortage (in the U.S. there is one mental health professional for approximately every 340 people who need mental health treatment) and lack of insurance coverage only serve to further compound this issue. I’m not suggesting that conversations about potential risks and benefits of utilizing SSRIs, and risks of not utilizing them, to treat moderate to severe depression or anxiety aren’t important. What I am suggesting is that such conversations deflect the focus from an underlying and equally important critical conversation, which is around improving access to mental health treatment for everyone.
Any discussions about the different modalities of treatment, including medication, must also foster conversations around ensuring that everyone who needs mental health treatment has access to it. As passionate as the discussion around use of SSRIs has been, we need to be equally passionate about improving access. We need to talk about the inclusion of innovative treatment options, including those for patients who express hesitation about taking antidepressant medication for a variety of legitimate personal reasons.
While the FDA expert panel led by Commissioner Dr. Martin Makary highlighted that medications such as SSRIs are not the only viable treatment option, the Commissioner did not speak to the fact that most people who experience a mental illness are unable to access other treatment options, like therapy.
Dr. Makary did not address the fact that there are often long wait lists to get in to see a mental health professional, or that patients often must go out of network for mental health treatment. He did not talk about the need for insurance companies to embrace innovative and effective mental health treatments like digital therapeutics, rather than simply labeling them “experimental” or “investigational” and declining to cover them.
These conversations are just as critical, as you cannot have a discussion around alternatives to medication without acknowledging that alternative treatment options are not readily accessible. It’s great to highlight that therapy can be effective for mild depression and anxiety, but how can we recommend therapy as a viable alternative without talking about the reality of the situation – most patients who need therapy are unable to access it because of provider shortages. Clinically validated tools backed by myriad research studies, such as Freespira, an at-home medical device indicated for PTSD and Panic Disorder in adults and adolescents with anxiety and trauma symptoms, need to be brought into the conversation.
As we consider the next era of treatment for these conditions, we need to inject just as much energy and passion into improving access and coverage into new – and desperately needed – mental health treatments as we do into debating whether additional labeling needs to be placed on SSRIs.
Malika Closson, MD, is a double-board-certified psychiatrist in adult, child, and adolescent psychiatry, and is a consulting clinician to Freespira.
