Strange question but more people are asking it in the last few years especially with confusion, misinformation, and politicization around COVID. Now, I’m no expert about COVID and how to safely avoid and treat it, although plenty of my non-health care professional friends and family ask me questions all the time. But what I am an expert in is in treating mood and anxiety disorders. Mostly what I treat are people that have either failed or are intolerant to traditional, approved medication therapies. But there are many other treatment options that may not have undergone the scrutiny of the Food and Drug Administration (FDA) or other government agency but there are controlled and well conducted studies showing they are effective and safe as well as a good deal of clinical experience with the treatments. Do we offer these options to our patients or not? What is our threshold as health care providers for non-FDA approved therapies?
As someone that has done clinical research for over two decades with new psychiatric medications, often studies use participants that are cherry picked in such a way that they do not represent the real world patients that we would use the treatment for. They are more designed to get the FDA to approve the treatment rather than tell us who would really do well and for whom it may be safe to use. And just because a treatment was shown in a clinical trial to be safe, there are many examples of medications taken off the market because unsafe side effects appeared later.
Where this issue has presented itself prominently in psychiatry is in the use of ketamine for mood and anxiety disorders. The drug has been around for over 40 years and has been shown to be safe in children, adults, and seniors as an anesthetic agent. There are many studies showing it is safe and effective for many psychiatric conditions. While these studies may not meet the standard for FDA drug approval, they may be more real world and generalizable for the patients we see every day who are desperate for treatment alternatives.
With the proliferation of access to information and more well informed consumers, it seems that our society is evolving in a way that people want the freedom of choice for health care alternatives. And are willing to take the risks-known and unknown. This is evident in the increasing legalization of medical cannabis and interest in psychedelics such as psilocybin, MDMA, and LSD.
I personally believe that we need some science. I haven’t made a decision yet as to whether to advocate for medical cannabis or psychedelics for treatment of mental health disorders. But when it comes to ketamine, I’m a believer, even if the FDA hasn’t bought in yet. I have seen too many people’s lives changed for the better, too many people whose daily suicidal thoughts have disappeared, and too many smiles return to faces that haven’t smiled for many years. And while it doesn’t work for everyone, for everything, and indefinitely, it works enough.