Priority Update

Too Much Of A Good Thing? 

F. Scott Fitzgerald famously declared that “Too much of anything is bad, but too much champagne is just right.” That may be true, but it now appears that it may have been “Special K” that proved the undoing of beloved actor Matthew Perry – and we’re not talking about the breakfast cereal!

The loss of Perry was a tragedy at many levels. Not only did a talented and charming man seemingly lose his battle with addiction (the precise circumstances of his final hours may never be fully understood), but the substance abuse disorder and behavioral health community may see tighter controls imposed on an otherwise promising medication for treatment-resistant depression.

Though the exact details elude us, Perry’s death was ruled an accident brought on by a combination of coronary heart disease, Buprenorphine, and a toxic level of Ketamine. For providers at the forefront of behavioral health, the loss was particularly troubling. Although Buprenorphine is an established treatment for opioid use disorder, the administration of Ketamine in psychiatric care is still considered novel and is typically categorized as an off-label or unconventional treatment.

Much has already been written about Ketamine, a unique drug that was first approved for medical use in 1970 and has since proved to be a reliable choice within the anesthesiologist’s toolbox. More recently, however, as taboos around psychedelic compounds have begun to recede, the psychiatric community has been exploring Ketamine’s remarkable qualities in the area of treatment-resistant forms of depression, anxiety, and pain management as an alternative for those who have been failed by traditional, and oftentimes, more addicting prescription drugs. Notably, though the advancement of Ketamine has been a gradual and sometimes uneven journey, it has been characterized by a juxtaposition of hope and skepticism, especially in the face of this most recent link between the drug and the death of a major celebrity.

The historically conservative US Food and Drug Administration (FDA), constrained as it has been by the government’s “War on Drugs,” has been resistant to research on medical uses for marijuana (listed as a Schedule I drug with a high potential for abuse) but has, on the other hand, been reviewing and approving unique modalities of Ketamine to treat major depressive disorder and treatment-resistant depression. Currently, Ketamine is listed on the federal government’s list of Controlled Substances as a non-narcotic Schedule III pain reliever in the same category as Acetaminophen (Tylenol) with codeine and testosterone gels, indicating that even the federal government deems Ketamine safer than marijuana.

As recently as 2018, pharmaceutical giant Johnson & Johnson obtained FDA fast track approval for the drug and breakthrough therapy designations to treat major depressive disorder and treatment-resistant depression with its Spravato intranasal inhaler of the “esketamine” variant of Ketamine, the early clinical trial results of which showed a “statistically significant” effect as quickly as within two (2) days of use.  In addition, beyond this singular FDA-approved use of Ketamine outside of anesthesiology, there has been a growing trend toward “off-label” prescribing of Ketamine by psychiatrists hoping that this medicine, coupled with traditional therapeutic techniques, might prove effective where others have failed. A headlong rush into Ketamine-Assisted Therapy (KAT) has ensued, with providers of all stripes not wanting to be left out of the next gold rush.

At the same time, as the world of psychiatry explores the benefits of Ketamine as a medically supervised treatment modality, it is true that its use (whether exploratory or recreational) without adequate medical supervision and appropriate informed consent may result in unforeseen and often tragic consequences. Matthew Perry’s death is no exception. Although Perry’s untimely death may draw unwelcome scrutiny to the development of safe and effective uses for Ketamine, we hope that the medical community will continue to explore Ketamine’s potential as a therapeutic tool. Indeed, just as Michael Jackson’s death brought “Propofol” into the lexicon, and Prince’s death brought knowledge of Fentanyl, let us hope that Matthew Perry’s enduring legacy is not the dimming of Ketamine’s “dazzling promisebut rather the wit and charm that he brought to life as Chandler Bing.

Authored by

Jonathan Berger & Adella Katz

Nelson Hardiman LLP

Healthcare Law for Tomorrow

Nelson Hardiman regularly advises clients on new healthcare law and compliance. We offer legal services to businesses at every point in the commercial stream of medicine, healthcare, and the life sciences. For more information, please contact marketing@nelsonhardiman.com.