I was doing a little research into the new depression screening guidelines issued by the United States Preventive Services Task Force (USPSTF) when I ran across an article about a newer, more expensive antidepressant called Brintellix (vortioxetine).
It costs about $300 for 30 tablets, and is apparently no better at treating depression than the plethora of other cheaper drugs already out there, so it hasn’t been a best seller for its manufacturer, Lundbeck, Inc.
But Lundbeck and its partner Takeda Pharmaceutical hope to change that by convincing the Food and Drug Administration (FDA) this week that Brintellix is better than its competitors at treating the negative cognitive effects of depression, aka cloudy thinking or mental fog.
If the FDA approves, Brintellix will be the first drug marketed for “muddled thinking.”
The demand could be huge, don’t you think?
Such a move would help Brintellix get around the problem that insurance companies don’t want to pay such a high price for an antidepressant when there are so many less expensive choices.
But if Brintellix is the only medication available to treat brain fog, the insurance companies will have no choice but to pay for it.
So does Brintellix really treat the cognitive side effects of depression better than other antidepressants?
Experts say it’s not clear that Brintellix is any more effective than its competitors in making a difference for reversing depression’s cognitive complications.
“Clinically, in talking to my colleagues, we don’t really see any major differences in terms of cognitive effects between Brintellix and other drugs,” said Dr. Norman Sussman, a psychiatrist at New York University’s Langone Medical Center. “We don’t know that Prozac doesn’t do it as well. Or Zoloft. Or any of the other drugs.”
Even if Brintellix is approved for this, we won’t know if it’s any more effective than the other antidepressants because no one is testing them side-by-side.
Brintellix appears to provide cognitive benefits, but anecdotal reports suggest that other antidepressants do, too.
But patients with depression and their doctors don’t have a good way to assess whether Brintellix is their best option because no trials — including the ones being used to support Brintellix’s application — have tested drugs head-to-head for their cognitive effects. And the makers of antidepressants that have gone generic have little incentive to invest in the kinds of rigorous clinical studies needed for FDA approval.
This new drug is out there just as the USPSTF has upgraded its recommendation that all adults, including pregnant and post-partum women, be screened routinely for depression.
They gave their recommendation a “B” rating, which means there appears to be a “moderate” benefit to the screening.
While I don’t want to play down the the very real problem of major depression, I’m concerned that increased screening could lead to the increased use of antidepressants, including Brintellix.
Related post: The overuse of antidepressants
Many individuals who are prescribed and use antidepressant medications may not have met criteria for mental disorders. Our data indicate that antidepressants are commonly used in the absence of clear evidence-based indications.
Among antidepressant users, 69% never met criteria for major depressive disorder (MDD); and 38% never met criteria for MDD, obsessive-compulsive disorder, panic disorder, social phobia, or generalized anxiety disorder in their lifetime.
Related post: The Age of Abilify
Will the Brintellix gambit pay off and see sales (and health care costs) skyrocket? Only time will tell.
But I would counsel anyone seeking treatment for depression to consider a few things:
- Counseling, specifically cognitive behavior therapy, is an effective non-drug treatment for mild to moderate depression. It takes longer, yes (6-8 weeks rather than 2 weeks), but the benefits also last much longer (hopefully a lifetime).
- Drugs that are new to the market, like Brintellix, have an unproven safety record. Start with an older, cheaper drug first. (Related post: The Seven Year Rule)
- Work with your physician so that any drug you take is in the smallest effective dose, for the shortest period of time possible.