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News release makes claims about ketamine for depression based on thin evidence

New Study Shows Ketamine May Regenerate Brain Cells, Relieving Depression with Lasting Benefit

Our Review Summary

KetamineThis news release cites findings from a physician’s “real world experience” in using the anesthesia drug ketamine for the treatment of depression, and promotes the Neuro-Luminence Ketamine Infusion Centers, which the study author  Dr. Theodore Henderson, co-founded. Acknowledged in the release as “controversial” and in direct opposition to the recommendations of the American Psychiatric Association, the use of ketamine can improve depression symptoms with six infusions or less, according to the release. The news release is thin on the kinds of facts we look for to support assertions about a drug’s safety and efficacy. It doesn’t address cost, benefit data or harms. It touts the putative benefits of a treatment that has not been approved by federal health authorities as either safe or effective, and it offers little evidence to support its use. It makes no mention of randomized trials in terms of real data–the only way one can tell if a treatment is really of benefit.

 

Why This Matters

Depression affects some 350 million people globally, according to the World Health Organization, and represents the leading cause of disability. Although effective treatments exist for depression, they do not always work. A new weapon in the armamentarium of health professionals might reduce the impact of depression, which can lead to suicide.

Standard anti-depressant medication and therapy generally take a month or more to help, and it would be great to have something with a quicker onset on action as ketamine purportedly has.

Criteria

Does the news release adequately discuss the costs of the intervention?

Not Satisfactory

The news release makes no mention of the cost of the infusions, nor does it say whether insurance pays for them. Given that they are not approved as safe and effective by the U.S. Food and Drug Administration (FDA), any cost would likely be borne by the patient.

The only person cited in the release, Dr. Theodore Henderson, is co-founder of Neuro-Luminance Ketamine Infusion Centers. The center’s website states that infusions start at $745 each, with discounted rates available for multiple-infusion packages.

Does the news release adequately quantify the benefits of the treatment/test/product/procedure?

Not Satisfactory

Claimed benefits are not quantified in the release. The only number we are provided comes from this statement: “Patients in the study complete the Quick Inventory of Depressive Symptoms (QIDS-SR), among other scales, and 80% showed persistent positive response to the ketamine infusions treatments.”

How many patients? The study says 100, but the news release says nothing. How long did the “persistent” response last? We never find out. The news release does say that the study included more than “three years of clinical experience,” but does not say how long the improvements were seen.

The release relies almost exclusively on the professional experience of the study author to make its case. Referring to Henderson, “his clinical experience shows ketamine can invoke long-lasting effects often with less than six infusions.”

The most intriguing possibility suggested is this: “Another conclusion Dr. Henderson highlights is ketamine infusions can relieve refractory depression symptoms persistently, perhaps for years.” Alas, that statement, too, is not followed by supporting data, nor are they apparent in the study itself.

We aren’t even told how depression is diagnosed. Without a randomized trial (and this study is a retrospective look at past studies, not a randomized controlled trial) no definitive conclusions can be drawn.

Does the news release adequately explain/quantify the harms of the intervention?

Not Satisfactory

No mention is made of possible side effects in the news release, other than to challenge the broader psychiatric community’s belief that ketamine is addictive. The author is quoted saying, “Our patients get better after a few infusions and from there treatments can be discontinued.”

In contrast to the release, the study did point out some side effects, which should have been included in the PR release. It states, “The most common side effects in doses used for depression treatment include: dizziness, nausea, and a slight sense of dissociation. The side effects clear generally within 15-30 minutes after the infusion.”

Does the news release seem to grasp the quality of the evidence?

Not Satisfactory

We found this release read more like an ad than a rigorous study synopsis. Retrospective studies combined with individual experiences are not considered among the most persuasive in terms of scientific evidence. Henderson himself appears to be aware of that. The news release states,”While controversial in academic settings, Dr. Henderson said his direct experience supports a different strategy for multiple infusion treatment regimens and his clinical experience shows ketamine can invoke long-lasting effects often with less than six infusions.” The study itself is largely anecdotal.

In a section on abuse potential, he writes, “Now, while the multiple of ‘anecdote’ is not ‘data,’ our clinical experience is that patients undergoing our protocols do not become addicted to ketamine and the ‘slippery slope’ from treating depression to creating a ketamine addiction is not so precipitous …”

In addition, one of the few numbers that is cited in the news release appears to be wrong: “Citing over 60 published scientific research studies, the new research article also reviews the molecular mechanisms by which ketamine invokes a robust activation of the brain’s own repair mechanisms.” The study contains 56 references.

Does the news release commit disease-mongering?

Not Applicable

The release doesn’t define depression or give any sense of its prevalence or impact. So while it doesn’t disease-monger, we’re hesitant to give the release credit here. We’ll call it Not Applicable.

Does the news release identify funding sources & disclose conflicts of interest?

Not Satisfactory

The news release notes that Henderson is co-founder of a center that uses the treatment but the release does not point out for readers the potential conflict of interest. The study even states “none” in regard to conflict-of-interest which seems implausible.

Does the news release compare the new approach with existing alternatives?

Not Satisfactory

The news release does not tell us about the treatments that are approved for depression, nor does it say what percentage of people suffering from depression fail to find relief from them.

Does the news release establish the availability of the treatment/test/product/procedure?

Not Satisfactory

Other than to note that the author of the study is co-founder of an unspecified number of ketamine infusion centers, the news release does not address where to access the treatment.

Does the news release establish the true novelty of the approach?

Satisfactory

The news release attempts to give readers a sense of what’s new here, even if we disagree with its characterization of the importance of that news. It suggests that the study provides useful new information about the clinical experience with ketamine. “The wealth of clinical experience from treating hundreds of patients with ketamine has supplanted the preliminary data that emerged from the initial open-label and small double-blinded studies,” says Henderson.

Does the news release include unjustifiable, sensational language, including in the quotes of researchers?

Satisfactory

The release does not engage in the use of unjustifiable language by calling the treatment a “cure” or “breakthrough.”

Total Score: 2 of 9 Satisfactory

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