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HealthDay provides needed details on side effects of THC-based drug studied for Alzheimer’s agitation

Rating

4 Star

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Could Pot-Linked Drug Help Ease Agitation in Alzheimer's?

Our Review Summary

This story summarizes the findings of a small Canadian study investigating whether a synthetic form of THC (the psychoactive ingredient in marijuana) helps calm agitation in people with Alzheimer’s disease. It’s unpublished work that was presented this week at the Alzheimer’s Association meeting in Chicago, and we were pleased to see the story make it clear that this means the results should be considered preliminary.

We also appreciated the overall cautious tone of this story, the clinical context of why agitation in Alzheimer’s disease is difficult to treat, and numbers that explain the frequency of the worrisome side effect of sedation. However, the story didn’t provide any supporting numbers for the touted benefits.

 

Why This Matters

As lucidly communicated in this story, treating Alzheimer’s patients for agitation is a common challenge. Existing approaches aren’t very effective and can lead to significant side effects.

As this story makes clear new approaches, even when helpful, carry a significant risk of creating new problems. This places a premium on reporting that makes it clear to readers what the trade-offs are in balancing the harms and benefits of emerging treatments.

Criteria

Does the story adequately discuss the costs of the intervention?

Not Satisfactory

The cost of nabilone is not mentioned.

According to drugs.com:

The cost for Cesamet (nabilone) 1 mg capsules is around $2,054 for a supply of 50 capsules, depending on the pharmacy you visit.

GoodRx.com quotes a similar price point with a 60-count bottle of 1 mg capsules costing $2,300-2,400.

Cost per tablet, therefore, would be roughly $40. Of note, the dosage used in this study wasn’t mentioned.

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

Not Satisfactory

The story says 36 patients were treated for 6 weeks with nabilone, followed by 6 weeks with placebo. While taking nabilone, the patients experienced a “significant decrease in agitation … the decrease was larger than is seen in currently used medications.”

How this was measured, the dosage used, and what the quantitative changes were, are not provided.

Does the story adequately explain/quantify the harms of the intervention?

Satisfactory

A major strength of this news release is that it favors cautious, rather than hyped language.

It’s clearly stated:

About 45 percent of patients experienced sedation with nabilone, compared with 16 percent for placebo.

We very much appreciated how the story also anticipated that some readers might take the study findings as justification for self medicating with marijuana, and why that might be risky.

Does the story seem to grasp the quality of the evidence?

Satisfactory

The story was clear about the preliminary nature of this trial, and how many patients were enrolled. A source urges the need for a larger trial.  We are also glad that HealthDay repeatedly used this sentence, which it often does when reporting from medical meetings:

The study was (to be) presented Tuesday at the Alzheimer’s Association meeting in Chicago … research presented at medical meetings is considered preliminary until published in a peer-reviewed journal.

Does the story commit disease-mongering?

Satisfactory

The story does an admirable job of not only explaining how common agitation is in Alzheimer’s, but also why it’s so difficult to treat.

Does the story use independent sources and identify conflicts of interest?

Not Satisfactory

A lead researcher and a source from the Alzheimer’s Association were quoted. Since this research was presented at the Alzheimer’s Association meeting, this does not meet the bar for an independent source.

Does the story compare the new approach with existing alternatives?

Satisfactory

It’s clearly explained that a major rationale for this study is that the existing pharmaceutical approaches in treating agitated Alzheimer’s patients – mainly off label use of antipsychotics and anti-seizure meds — don’t work very well and have significant side effects.

There are behavioral approaches to agitation but, given the topic of this article, not including them seems reasonable.

Does the story establish the availability of the treatment/test/product/procedure?

Satisfactory

It’s mentioned that a form of synthetic THC (dronabinol; trade name ‘Marinol’) also is available in the U.S. (The story makes it sound like Nabilone is only available in Canada, but it does appear to be FDA approved in the US for cancer treatment as side effects, known as Cesamet.)

Given the fact that this a Canadian study (where medical marijuana has been legal since 2001), and that the legality of medical marijuana in the US varies by state, it might have helped readers to clarify if a synthetic like nabilone is considered legal, experimental, and/or requires a prescription.

Does the story establish the true novelty of the approach?

Satisfactory

An independent source cited in the story says:

Marinol is now being tested for its usefulness in treating Alzheimer’s symptoms. People interested in trying it should reach out to one of the big clinical trials; Johns Hopkins is one of the centers testing Marinol.

Does the story appear to rely solely or largely on a news release?

Satisfactory

The story doesn’t not rely on the news release issued by the Alzheimer’s Association.

Total Score: 7 of 10 Satisfactory

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