Rethinking Antidepressant Medications for Children and … — Transcript

I'm Dr. Roger McFillin, clinical psychologist and host of the Radically Genuine Podcast. If we followed science and safety, antidepressant drugs for youth under the age of 24 would never have been approved and should be banned. In 2004, the Lancet editors, in an article titled “Depressing Research,” bluntly stated that “The story of research into (SSRI) use in childhood depression is one of confusion, manipulation, and institutional failure.” It is now well-established that most pediatric antidepressant trials were industry-sponsored and had serious methodological limitations; many trials remained unpublished due to unfavorable results, and those published were mostly ghost-written. They selectively reported efficacy outcomes and misrepresented the true rate of treatment-emergent suicidal events. Conclusions often did not fit the actual data.

Drug regulators issued a suicidality warning for pediatric antidepressant use in 2003 and 2004. Are these drugs proven to be effective?

A 2016 review deemed 34 trials eligible, including 5,260 participants and 14 antidepressant treatments. The quality of evidence was rated as very low in most comparisons.

These antidepressant trials for youth are characterized by high dropout rates, and in order to create a statistically significant difference between the drug and placebo, many participants in the placebo group abruptly discontinued psychiatric drugs they were taking at the time, creating drug withdrawal. Without the evidence from these problematic antidepressant placebo substitution trials, the authors concluded there "is no acceptable support for the inclusion of antidepressant medication for the treatment of depression." Let me be clear… We have no evidence that antidepressant drugs for youth have an antidepressant effect. We have no strong evidence they outperform placebo.

No ethical or reasonable professional can examine the totality of this evidence and conclude these drugs are safe and effective. However, we have strong evidence of adverse reactions including aggression, suicide, and worsening depression. This is clear. Medical professionals proclaiming these drugs are safe and effective are dangerously naive and not aware of the totality of the scientific findings. Antidepressants offer little to no benefit in improving overall well-being among depressed children and adolescents.

It is now proven that the drug industry has under-reported antidepressant-related harms, including suicidality. The risk of suicidality and aggression in children and adolescents is at least doubled compared to placebo.

The black box is the most severe warning the FDA can place on a drug short of an outright ban. The boldfaced text appears at the beginning of the package insert accompanying each prescription, warning that antidepressant usage for children and adolescents may increase the risk of suicidality.

In May 2006, the FDA expanded the warning to include 36 antidepressants and raised the age of potentially vulnerable patients from 18 to 24. This is a serious warning. Yet, the American Academy of Pediatrics guidelines for adolescent depression in primary care clearly state the following:

“Overall, both individual clinical trial evidence and evidence from systematic reviews still support the use of antidepressants in adolescents.” They even go as far as to minimize the federal government’s black box warning. In my opinion, this is criminal negligence, and they are providing guidelines to physicians who are not adequately trained to assess nor treat mental health-related problems. They are not specialists, nor do they have adequate time to fully evaluate this complex condition. This is clear manipulation and biased reporting of the clinical data. The American Academy of Pediatrics receives funding from the pharmaceutical industry, and this conflict is clear when reading these distorted guidelines.

Please share this video and subscribe to the Radically Genuine YouTube channel. Given what we know, it could save lives. Informed consent is a legal and ethical right. Demand informed consent. More importantly, send this video to pediatricians, nurse practitioners, physician assistants, and all medical professionals prescribing drugs in primary care. Over 80% of psychiatric drugs are now prescribed in these settings. Subscribe to the Radically Genuine Podcast for this type of content and more. We can’t consent unless we are informed.

Thank you.

In May 2006, the FDA expanded the warning to include 36 antidepressants and raised the age of potentially vulnerable patients from 18 to 24 This is A SERIOUS WARNING Yet.. The American Academy of Pediatrics Guidelines for Adolescent Depression in Primary Care CLEARLY the following:

“Overall, both individual clinical trial evidence and evidence from systematic reviews still support the use of antidepressants in adolescents. They even go as far as to minimize the Federal Governments Black Box Warning. In my opinion, this is criminal negligence

and they are providing guidelines to physicians who are not adequately trained to assess nor treat mental health related problems. They are not specialists nor do they have adequate time to fully evaluate this complex condition. This is clear manipulation

and bias reporting of the clinical data. The American Academy of Pediatrics receives funding the pharmaceutical industry and this conflict is clear when reading these distorted guidelines.

PLEASE SHARE THIS VIDEO and Subscribe to the Radically Genuine Youtube channel. GIVEN WHAT WE KNOW IT COULD SAVE LIVES. INFORMED CONSENT IS A LEGAL AND ETHICAL RIGHT DEMAND INFORMED CONSENT. More importantly- send this video to pediatricians, nurse practitioners,

physician assistants and all medical professionals prescribing drugs in primary care. Over 80% of psychiatric drugs are now prescribed in these settings. Subscribe to the Radically Genuine Podcast for this type of content and more. We cant consent unless we are informed.

Thank you