This CBS news story describes a possible mechanism by which botox (onabotulinumtoxinA) treatments could be an effective treatment for major depression. It cites a dermatologist who explains the possibility of a feedback loop between the facial muscles that express emotion and the amygdala in the brain. It suggests that botox may offer hope for treating not only depression, but also social anxiety and bipolar disorder.
However, the only evidence this story provides is a single anecdote by an army veteran. The only expert it cites is a dermatologist who stands to gain financially if the treatment receives FDA approval, and who has been a paid consultant for the company manufacturing the drug.
Like Allergan’s news release on a recently completed phase 2 trial of botox for depression (which the CBS story doesn’t mention) the article also omitted any specific description of the benefit, harms, alternative treatments for major depression and how botox might compare with them. The CBS story does, however, provide readers with a cost reference, something the release didn’t do.
It should also be noted that this single anecdote story ended with a quote from that one patient. Coincidentally, today, at the Association of Health Care Journalists annual conference, this advice was given by a veteran journalist and academic Jacqui Banaszynski: “Be careful if you end a story with a quote because whoever you give the last quote to you give the story to.” Be careful, because this tends to bias the reader’s perception, as this story may have done.
The National Institute of Mental Health estimates more than 20 million Americans suffer from major depression, and current treatments for depression help only about two-thirds of those with significant depression symptoms. A treatment with a different mechanism of action such as botox could be important news for those treatment-resistant patients and the clinicians who work with them. However, readers should know that botox has been marketed heavily as an off-label treatment for depression for the past several years. In this recent post, HealthNewsReview.org explored some eyebrow raising aspects of that marketing campaign.
Citing the American Society for Aesthetic Plastic Surgery, the article says that the average cost for a botox treatment was $376 in 2016. We also learn from the article that a typical treatment should confer benefits for about three months. This is important information considering that botox is not currently FDA approved for treatment of depression. Unless a patient is enrolled in a clinical trial, he or she will have to pay the approximately $1300 per year out of pocket.
The article gives next to no information about the size of the benefit. A single statement by Eric Finzi, a cosmetic dermatologist, explains that 50 to 60 percent of patients may benefit from botox as treatment for depression. (CBS reported those estimates came from past studies, but provided no details about nor links to those studies.) How big are those benefits? Are they sufficient to make a notable difference in daily life? Are they a slight improvement that is useful only when combined with other treatments? The article doesn’t address those questions.
No mention is made of possible negative side effects. According to MayoClinic.com, possible side effects include “pain, swelling or bruising at the injection site, headache or flu-like symptoms, droopy eyelid or cockeyed eyebrows, crooked smile or drooling, eye dryness or excessive tearing.” In rare cases, the effect of botulinum toxin can spread to other parts of the body and cause botulism-like signs and symptoms.
There’s another issue relating to potential harms that should have been mentioned here. Using botox to treat depression is still an off-label use, meaning that its safety and efficacy as a treatment for depression have not been established by the FDA.
Consumers of this piece have no way to make any kind of judgment about the quality of evidence because not a shred of evidence is provided. An opening anecdote from a patient contrasts her past difficulties finding effective treatment for her depression with botox, which gave her almost immediate improvement in her depressive symptoms. Narratives like this are fine for grabbing attention at the beginning of a story, but they should be followed up with hard facts demonstrating how typical the individual’s experience is, and quantifying the benefits of botox across a large sample. The introductory human interest story here is the sum total of evidence presented.
As it happens, several studies have addressed this issue. Although some of them suggest possible benefits of botox as treatment for major depressive disorder, many of those studies have been small, confounded by patients already on antidepressants, and limited to short follow-up periods. The larger and more definitive study findings by Allergan (manufacturer of botox) have been described by experts as mixed at best, unimpressive at worst. In that study, at the predetermined endpoint of six weeks, there was no statistically significant difference between either of two dosage levels of botox and the placebo groups.
This story does give us an explanation by Dr. Finzi that facial muscles are part of a brain circuit related to mood such that “Botox basically inhibits the muscle and calms it down, so it becomes more difficult to feel those negative emotions.” It’s hard to give much credence to that statement, though, when the story provides no effects of the treatment in the first place, much less any support for the mechanism it proposes.
We also have concerns about the headline which announces “Botox tested to help treat depression and anxiety.” The headline is technically true–botox is being tested as an intervention for those issues. The implication, however, is that botox is showing promise in those areas, and that isn’t at all clear yet.
The article does not engage in disease mongering. It does provide some background on how botox is believed to work on depression and other approved clinical uses for botox. The story would have been better had it given us some idea of how many people are affected by major depressive disorder.
The story cites no experts other than Dr. Finzi, author of a published study about the effects of Botox as a treatment for depression. This omission is made worse when you learn that Finzi’s 2014 study was funded by the Chevy Chase Cosmetic Center, where Finzi is medical director and president, that he has received a US patent for the treatment of depression with botox and was a paid consultant for Allergan in the past. In other words, the sole interviewee for this story holds an approved patent for the treatment in question, stands to gain financially if the treatment receives FDA approval, and has been a paid consultant for the company manufacturing the drug. Not telling readers about these major conflicts of interest is irresponsible.
The article makes no comparison between botox and current treatments for depression so we’re left wondering: what does botox bring to the table? How do its benefits compare with medication? Does botox have fewer side effects? Does it cost less than other therapies? All we get is anecdotal evidence from the one patient who had unsuccessfully “tried alternative therapies and medication to cope with her symptoms.”
No statement is made about the availability of botox, but readers can reasonably assume that it will continue to be widely available.
Botox has already been promoted for “off label” use to treat depression for some time. HealthNewsReview.org has previously explored the marketing of botox for depression and other conditions. Not only is evidence not presented well, but the news isn’t novel, either.
The story doesn’t appear to rely on a news release. It includes comments from Dr. Finzi.