The FDA’s Duty to Children’s Mental Health

Advocacy
Written By Len Lantz, MD
 

Synopsis: 50% of lifetime mental illness starts by age 14 and 75% of lifetime mental illness starts by age 24. It has been conclusively proven that mental illness is a disease of youth, yet the FDA has done little to approve mental health treatments for youth. This article addresses some of the enormous missteps by the FDA and what they – and you – can do today to improve the mental health of children.

BY LEN LANTZ, MD / 5.15.20; No. 24 / 9 min read

Disclaimer: Yes, I am a physician, but I’m not your doctor, and this article does not create a doctor-patient relationship. This article is for educational purposes and should not be seen as medical advice. You should consult with your physician before you rely on this information. This post might also contain affiliate links. Please click this LINK for the full disclaimer.

What is the job of the FDA?

The US Food & Drug Administration (FDA or USFDA) was formed in 1906 to protect public health by examining food and drugs in the US for "adulteration" or "misbranding." The FDA has grown over time to regulate many areas:

  • Prescription medications

  • Over-the-counter medications

  • Veterinary drugs

  • Medical devices

  • Nation’s food supply

  • Cosmetics

  • Products that emit radiation

  • Tobacco products

  • Dietary supplements

  • Vaccines

  • Blood transfusions

The FDA does important work to ensure the health and safety of our food supply, medications and medical equipment. As I am a psychiatrist, I most often think about the FDA in terms of mental health, as it approves psychiatric medications and other treatments, such as Electroconvulsive Therapy and Transcranial Magnetic Stimulation devices, for kids and adults.

If the developing brain is vulnerable, we should be careful about giving kids medication, right?

It is probably true that the developing brain is more vulnerable to short-term (and possibly long-term) side effects of psychiatric medications. However, untreated mental illness can be far more dangerous to the brain than psychiatric medication. Why? Untreated mental illness can become chronic and recurrent and puts people at increased risk of other illnesses and death by suicide.

Consider this statistic for a moment. 50% of lifetime mental illness starts by age 14 and 75% of lifetime mental illness starts by age 24 (Archives of General Psychiatry. 2005 Jul;62(7):768). These statistics came from the National Comorbidity Survey (NCS-A and NCS-R), which was carried out by the Survey Research Center of the Institute for Social Research at the University of Michigan in conjunction with the World Health Organization World Mental Health (WMH) Survey Initiative. The study was funded by:

  • National Institute of Mental Health (NIMH)

  • National Institute on Drug Abuse (NIDA)

  • Substance Abuse and Mental Health Services Administration (SAMHSA)

Mental illness usually starts in youth but often affects people throughout their lifetimes. Effective treatment for youth can have a tremendous impact and positively change the life trajectory of those who are affected. Effective mental health treatment also results in tremendous cost savings to our government and improved productivity of our workforce in our communities, states and nation.

According to the Centers for Disease Control and Prevention (CDC) data from 2018, the second leading cause of death in youth age 10 to 24 is suicide. Here is another statistic from the CDC: among all high school students in the United States, 7.4% had attempted suicide during the 12 months before the National Youth Risk Behavior Survey, 2017. Across Montana in 2019, 10% of high schoolers attempted suicide. Among American Indian Montana high school students in 2019, 15.4% attempted suicide in the previous 12 months. We should be appalled that so many of our children are attempting suicide and work for positive changes in our communities, states and nation.

What does it take to get a psychiatric medication approved by the FDA?

It is a massive, expensive undertaking for a pharmaceutical company to get a psychiatric medication approved by the FDA for adults. The cost increases when getting that same medication approved for children and adolescents. It is a common occurrence that most psychiatric medications are first approved in adults. Later, those same medications may or may not be approved by the FDA for the treatment of children. As a subspecialist in pediatric psychiatry, I frequently am frustrated that the FDA has not required pharmaceutical companies to submit data and research to approve medications for children at the same time as adults.

One study showed that the average cost to get a psychiatric medication approved by the FDA was $25.7 million (JAMA Internal Medicine. 2018;178(11):1451-1457). The authors of the study acknowledged costs could be higher or lower and likely did not include the full cost of developing the medications. Pharmaceutical companies have argued that the cost of getting a medication approved through the FDA is only a fraction of their total research and development (R&D) costs.

Members of the Pharmaceutical Research and Manufacturers of America (PhRMA) argue that its costs are $1.4-2.9 billion per medication (Journal of Health Economics 47 (2016) 20–33) and that these high costs justify their high pricing of newly-approved medications. Essentially, PhRMA members argue that a big risk should result in a big reward. And they are being rewarded as many new psychiatric medications are earning pharmaceutical companies billions per year for each new psychiatric medication.

If the cost of getting a medication approved through the FDA is around 1% of the total cost of R&D, then the cost of requiring that all psychiatric medications approved by the FDA include testing in children is negligible. The FDA can require through its approval process that all psychiatric treatments include children. Mental illness is a disease of youth and the cost of adding youth trials to research studies would be minimal, according to the financial information provided by PhRMA itself.

Another major misstep by the FDA in youth mental health

Antidepressants used to treat childhood depression were associated with a decline in the youth suicide rate for over a decade until about 20 years ago when something critical was found. It was discovered that about 1 in 140 youth who was placed on an antidepressant for major depression had worsened mood or the emergence of suicidal ideation. This is an incredibly important finding as we do not want to increase the risk of suicide for any patient, child or adult. In 2004, the FDA decided to put a “black box warning,” the most serious type of warning in prescription drug labeling, on antidepressant medications for children due to this risk. Unfortunately, how the FDA went about the warning scared parents and doctors away from antidepressants. As antidepressant prescriptions went down after 2004 due to the FDA warning, the suicide rate for youth went up.

You can come to whatever conclusion you desire, but it appears to me that the increase in the suicide rate among children occurred because of the FDA’s black box warning. The FDA did not intend to increase the youth suicide rate, but they implemented a warning without accurately predicting its potential negative impacts. It was like shouting, “Fire!” in a crowded theater.

Following the FDA’s warning, the vast majority of medical research has shown that the risk of skipping an antidepressant medication in the treatment of youth depression appears far greater than the risk of using an antidepressant.

Most research shows that antidepressants work faster than psychotherapy, such as cognitive behavioral therapy (CBT), but given enough time (6-12 months), the efficacy of CBT matches that of antidepressants. Therapy also appears to reduce the risk of suicide by directly addressing suicidal thoughts and teaching coping skills for emotional regulation. Therapy and medication (combination treatment) are better than either treatment alone.

There is also a substantial body of research that shows that the faster you get a child’s major depression to remission (i.e., fully free of depression), the better the outcome, so the use of antidepressant medication appears to be a rational approach in the treatment of childhood depression. Unfortunately, parents remain unnecessarily wary of antidepressant medications and often are freaked out about the black box warning.

The FDA must make better policy decisions. They are responsible for the negative consequences of their newly applied warnings and hopefully have learned from their mistake with their black box warning for antidepressants in children so as not to make similar errors in the future.

A patient story on antidepressant medication

“Emma’s” parents, Joe and Tina, were stressed out and scared. Their daughter had become increasingly anxious and depressed in middle school. Joe and Tina would never forget the day that they were called to the school by Emma’s eighth-grade school counselor and told to take her to the Emergency Room of their local hospital for a medical and safety evaluation. Emma had disclosed to her school counselor that she had overdosed on Sunday night, and it was now Wednesday. She had missed school Monday because she was vomiting, which her parents thought was due to food poisoning or a stomach virus. They were in the ER on Wednesday for 4 hours. The ER physician cleared her medically and requested an evaluation by the local crisis response team. The team determined that she was dealing with major depression and anxiety and they gave the family the names and phone numbers of some local therapists and psychiatrists.

Tina and Joe were concerned about using an antidepressant medication for their daughter. They were able to get in with a therapist about 3 weeks after the ER visit. Emma’s therapist, Susan, was fantastic. Emma formed a great connection with Susan and learned skills for coping with anxiety and depressed mood. Together, they developed a safety plan for Emma to follow for those times when her suicidal thoughts returned. Emma gradually improved over the next 6 months until she had a major life event – starting high school.

Emma’s life turned upside down as her friend group changed and she felt lost in a new school with different expectations. Nothing Emma, her parents, or her therapist Susan tried seemed to help and her mood spiraled down. Soon, she was missing classes and sleeping most of the day and the night. Susan recommended scheduling Emma to see her pediatrician for a possible antidepressant trial. Emma met with Dr. Green, who agreed that her depression was back and worse than ever. She started Emma on fluoxetine (Prozac). Emma needed some medication adjustments over time and she continued to meet in therapy with Susan. Over the next 3-4 months, her major depression finally went into full remission. Her pediatrician recommended that she stay on her antidepressant for 12-18 months and, if she stayed in remission, then consider tapering off the medication the summer after her sophomore year of high school.

The imbalance of “on-label” versus “off-label” in pediatric mental health

Here is something astonishing to mull over. There are over 2 dozen antidepressant medications approved for adult major depression. Only 2 antidepressants, fluoxetine (Prozac) and escitalopram (Lexapro), are FDA-approved for the treatment of pediatric depression. There are many more than 2 antidepressants that help depression in children, but all of those other medications are considered to be “off-label,” meaning doctors are allowed to prescribe them for a condition other than the original FDA approval. In this case, the antidepressants are off-label due to the age of the patient. While off-label prescriptions are allowed, they can leave parents and children uncertain and doctors uneasy.

It is estimated that over 20% of prescriptions in the US are off-label. It is common for certain medications in pediatric psychiatry. It may be even more common in other medical specialties, such as cardiac and cancer treatment, in which approximately half of the prescriptions are off-label.

What can the FDA do today to improve children’s mental health?

  • The FDA must be cautious in its warnings for pediatric mental health medications.

    • Before the FDA hands out future black box warnings, it must be more careful in crafting its messaging so as not to make the problem of youth suicide worse.

  • The FDA must require all new approval for adult mental health treatments to include data for kids.

    • Mental illness is a disease of youth, therefore, the only logical conclusion is that all medication trials for FDA approval in the treatment of mental illness must include youth.

  • The FDA must remedy its failure in the medication (and device) approval process for children with mental illness.

    • The FDA must create a process to review and retroactively approve psychiatric medications for pediatric mental illness, providing the safety data are available and efficacy data are convincing.

    • This will reduce the need for and potential risk of off-label prescribing.

What you can do today to promote children’s mental health

  • Support your local chapter of National Alliance on Mental Illness (NAMI), which

    • Supports anti-stigma campaigns

    • Advocates for legislation and funding to support community mental health treatments and suicide prevention

    • Offers support groups for family members and individuals affected by mental illness

  • Connect with your local chapter of the American Foundation for Suicide Prevention (AFSP), which

    • Supports research on suicide prevention

    • Leads community awareness campaigns on suicide prevention

    • Promotes legislation aimed at reducing suicide

  • Work with other mental health advocates in your community or county who care about:

    • Reducing access to lethal means in suicide attempts

    • Implementing depression screening and safety plans (such as the CAST-S) in schools

    • Supporting programs that reduce and respond to child abuse

    • Telling your story on social media or traditional media channels to advocate for change

  • Use what influence you have at a federal level to hold the FDA accountable for their duty to children’s mental health

    • Tell your story to your US Senator and/or Representative and ask them to pressure the FDA to fulfill their duty to children’s mental health

    • You can provide feedback to the FDA through this LINK.

  • Pay attention to kids at risk for suicide by using the acronym IS PATH WARM and taking action when you are concerned

    • Ideation—Threatened or communicated

    • Substance abuse—Excessive or increased

    • Purposeless—No reasons for living

    • Anxiety—Agitation/Insomnia

    • Trapped—Feeling there is no way out

    • Hopelessness

    • Withdrawing—From friends, family, society

    • Anger (uncontrolled)—Rage, seeking revenge

    • Recklessness—Risky acts, unthinking

    • Mood changes (dramatic)

We can make a difference

The FDA has to make some serious changes to fulfill its duty to children’s mental health. You can reach out to the FDA, your US Senators and US Representatives with your story and ask them to make changes at the FDA to meet the needs of our children. There are other areas in your circles of influence and your community where you can directly support children’s mental health. It does not take a fancy education or professional title to make a positive difference. As we improve the knowledge of our communities and work to reduce stigma, we can help kids and families and save lives!

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Len Lantz, MD
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