Off-label use & aggressive public relations • Treating depression with botox

Michael Joyce is a writer and multimedia producer for HealthNewsReview.org. He tweets as @mlmjoyce.

A magazine cover like this can raise three things:

eyebrows …

questions …

hope.

How can one drug do all this cover claims?

Botox injections (usually botulinum toxin type A) are currently FDA-approved for overactive bladders, chronic migraine headaches, repetitive neck spasms (cervical dystonia), spastic arm muscles, overactive sweat glands in the armpits (axillary hyperhidrosis), and two eye conditions: painful contraction of the muscles encircling the eye (blepharospasm) and misaligned eyes (strabismus).

You’ll notice all these (except the sweaty armpits and perhaps migraines) have to do with muscles, which makes sense, because that is how botox works — it stops muscle contraction by blocking signals at the neuromuscular junction.

But since the FDA approval of the use of botox in treating chronic migraine headaches (2010) there has been an avalanche of off-label uses that raises eyebrows. Maybe because the problems being treated don’t seem to have anything to do with muscles. As last week’s Time magazine cover suggests, this can range from problems with your penis to problems with your mood.

How can a drug that blocks muscle contraction improve your mood?

“Your facial expressions of emotion — including fear, anger, and sadness — all use the corrugator muscle,” says Dr. Eric Finzi, a cosmetic dermatologist in Maryland who treats an estimated one to two depressed patients a day with injections of botox between the eyebrows (the so-called glabella region, which includes the corrugator muscle).

Finzi believes there is a feedback loop he calls “emotional proprioception” between the amygdala region deep in the brain (which, among other things, is involved with emotions) and the blocked muscle.

“When people are depressed their corrugator muscle is activated. When you quiet the muscle you quiet the amygdala,” says Finzi, who in 2014 published a double-blind, randomized, placebo-controlled study showing significant improvement in depressive symptoms in 52 percent of botox injected subjects compared with 15 percent injected with placebo. Other studies following subjects as far out as 6 months have found similar response rates, usually in the 45 to 60-percent range.

But there are several things going on here which warrant scrutiny …

First, using botox to treat depression remains an off-label use. Using a drug off-label means using it for a condition other than what the FDA approved it for – like using the stimulant adderall for weight loss. That means the safety and efficacy have not been fully established by the FDA. Of note, about 1-in-5 prescriptions written in the US are off-label, and several studies suggest anywhere from 50 to 75 percent of these off-label uses have poor to no evidence of effectiveness. It’s a topic we have covered many times. Allergan, the company that manufactures Botox, is currently in Phase II trials gathering preliminary data on the effectiveness of botox in treating depression. To date, many of the studies looking at botox in the treatment of depression have been small, confounded by patients already on antidepressants, and limited to short follow-up periods.

Secondly, with regard to Dr. Eric Finzi, when you google his name, or ‘botox and depression’, you will eventually find this page: Botox For Depression.com. It walks a fine line between information and promotion. The NBC video embedded on the website certainly seems more promotional with terms like “groundbreaking” and “breakthrough.” There is also the glowing anecdotal testimony of two patients, one who says “with botox there was a real positive side effect that it would make my skin look smoother, and what woman doesn’t want that?” What does that have to do with depression? The video does well to remind viewers that more research is needed, and does employ an outside psychiatrist who brings up of the possibility that botox recipients may simply feel better because they like the way they look.

Finally, nowhere on the website, or in the embedded videos, does it mention that Finzi’s 2014 study was funded by the Chevy Chase Cosmetic Center, where Dr. Finzi is Medical Director and President. Likewise, it does not mention that Finzi has received a US patent for the treatment of depression with botox. When I asked him to tell me more about that he replied, “I’m not at liberty to discuss that.” He does admit that he was a paid consultant for Allergan in the past “but not for a couple of years now.” To exclude potential conflicts of interest is irresponsible; especially considering the vulnerabilities of interested consumers with depression who are often desperate for any kind of help.

What you will find on the website is the following:

  • Recruitment for two ongoing (off-label) studies looking at treating Social Anxiety Disorder and Bipolar Depression with botox.
  • A link to amazon.com to buy a copy of Dr. Finzi’s 2013 book, The Face of Emotion: How Botox Affects Our Moods and Relationships.
  • A Botox for Depression Blog maintained by a paid publicist.
  • Links to over two dozen examples of media coverage focusing on Dr. Finzi’s work with depression and botox.

Whether or not botox injections ever become FDA-approved as a safe and effective treatment for depression is beside the point. The point is: this is an off-label use of a drug being promoted for a psychiatric illness by a cosmetic dermatologist. Someone with an approved patent for the treatment in question who stands to gain financially by its widespread adoption, and who has been a paid consultant for the company manufacturing the drug.

And we journalists have a responsibility here as well. We need to remain wary of jumping on “breakthrough” bandwagons too often driven by preliminary results or, as in this case, hyped by public relations, or popularized by those with conflicts of interest. Off-label usages touted as “ground-breaking” should be a red flag for all of us.

I do not question Dr. Finzi’s sincerity in wanting to help people who suffer from depression. But I do think it’s important to raise potential conflicts of interest that could affect how this information is being presented to the public; many of whom suffer from a debilitating and stigmatizing illness in which any ray of hope is often seized upon without much scrutiny.

The numbers aren’t small here. The National Institute of Mental Health (NIMH) estimates that 7-percent of US adults suffer from major depression. That is over 20-million people. As for botox, Allergan estimates global revenue for the drug in 1998 was $125 million. In 2015, it was $2.5 billion.

 

 

 

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