Can ketamine help people with depression and other psychiatric diagnoses? Unfortunately, this story doesn’t answer that question, beyond vague claims about one patient’s outcome. It skips any discussion of limitations of the studies or caveats about their conclusions. Importantly, it does not tell readers about the side effects reported in these and other studies. The only two experts quoted are advocates of expanded ketamine use. One of them has applied for a patent on a ketamine delivery device, which is not disclosed.
Following a developing story is a valuable journalistic practice, but there is little in this story that explains why it is news now. The lack of references to side effects or to published studies showing poor results deprive readers of vital background and context.
The pain, fear and frustration of psychiatric disorders can be overwhelming, and sufferers and their loved ones may be desperate to find effective help. A story like this one, painting a picture of a miracle cure, preys upon such desperation. Readers deserve a balanced report with appropriate cautions.
The story does not discuss cost, even though it presents a substantial barrier to people who might want to explore ketamine treatment, especially since it is unlikely to be covered by insurance. Although ketamine is not approved by the FDA specifically for treatment of psychiatric diagnoses, some physicians do prescribe it. Some online sources quote costs of $400-800 per treatment (here and here). Typical treatment regimens involve multiple treatments at first, then maintenance sessions every few weeks. Most clinics inject or infuse ketamine. A nasal spray form is offered by some clinics, including this one, which charges $395 for an initial assessment, then $250 to $350 per session.
The story relies largely on a single anecdote of a person who says ketamine “helped me get my life back”. The expert sources use only vague descriptions of ketamine as “transformational” and that patients in one trial “got dramatically better.” There are references to clinical trials, but none cites any specific results in quantified terms.
There is no discussion of harms in the story. The Johnson & Johnson news release cited in the story lists a number of side effects: “The most common treatment-emergent adverse events (>10%) reported in the esketamine group were metallic taste, nausea, vertigo, dizziness, headache, drowsiness, dissociation, blurred vision, paraesthesia (tingling sensation) and anxiety.”
A recent journal article that was not mentioned in this story reported side effects so severe that all the participants quit taking an inhaled form of ketamine.
The story does not give readers important details about the studies it cites.
One of the Johnson & Johnson trials reported that patients who received the experimental esketamine drug and an antidepressant improved more than patients given a placebo and antidepressant. But it is not clear how meaningful the improvement was. (Four points on the 60-point MADRS questionnaire, which is a smaller improvement than reported in many trials of approved antidepressants.) A second trial mentioned in that J&J release did not show any statistically significant difference. What’s more, one of the J&J researchers noted in a recent letter to a medical journal that, “Larger phase 3 studies are required before the patient population and the utility of esketamine can be fully evaluated in [Treatment Resistant Depression].”
The journal article cited in the story about a study in children with a fear disorder notes that it was merely a “[r]etrospective review from a single practice without placebo control with potential for response and recall bias”; that is, a low level of evidence.
In addition to using ketamine to treat depression, the story touts “growing evidence it can help people with anxiety, bipolar disorder, post-traumatic stress disorder, and perhaps even obsessive-compulsive disorder.” The story dangles unsubstantiated hopes in front of readers with a vast array of mental health diagnoses or concerns.
The only two experts quoted in the story are research collaborators who have long advocated for expanded use of ketamine treatment. One of them, Demitri Papolos, has applied for a patent on a ketamine delivery device. The story should have reported this potential financial interest.
The story makes numerous claims about ketamine helping people when other treatments did not, but it does not provide specific comparisons about the pros and cons of ketamine compared to approved treatments.
The story highlights a patient using a ketamine nasal spray without making it clear that this form of the drug has not been approved by the FDA.
The story does not appear to be based on a news release.