FDA reviews new brain implant to treat depression

[Erik von Nein]

FDA Panel to Review Studies of Cyberonics Device
By JON KAMP
December 27, 2006 5:58 p.m.; Page D4

A Food and Drug Administration advisory panel on neurological devices will review post-approval studies for a depression-treatment device made by Cyberonics Inc., but isn't likely to make moves that could affect the regulatory status for that device, an FDA spokeswoman said.

The panel of outside experts won't vote on anything regarding Cyberonics following the Jan. 26 meeting, which is intended to follow up on the status of studies that were required when the FDA approved the Cyberonics device for depression treatment last year, agency spokeswoman Karen Riley said. The meeting "will basically just be a discussion," she said.

In a statement, Cyberonics said that it would brief the FDA panel on the company's progress on the two studies the agency required and that both studies are enrolling patients. "These reports are part of the FDA's commitment to monitor the progress of post-market studies required as a condition of approval," the company said.

The company has had trouble winning reimbursement coverage for the pacemaker-like device, which the FDA approved in 2005 for the treatment of severe depression via stimulation of a nerve in the neck. If the FDA panel of outside experts makes comments or recommendations that could lead to new restrictions on the device, "it doesn't make the case for reimbursement any easier," said Stephen G. Brozak, an analyst with WBB Securities LLC.

The same FDA panel didn't unanimously recommend approval for the device in 2004, Mr. Brozak said, and the agency's approval process has generated some controversy. The Senate Finance Committee probed the matter and concluded this year that the FDA's approval process for the device raised some questions.

According to Ms. Riley, the panelists are "basically just going to listen," suggesting the meeting won't lead to major changes for Cyberonics. The event "would not be anything of major consequence," she said.

The FDA doesn't yet know what data will be presented, as such details are typically announced a day or so before the meeting. The agency typically publishes the name of involved companies at that point, too. In fact, the Federal Register posting Tuesday showing the involvement of Cyberonics and other companies represents the first time the agency has made such information available so far in advance, Ms. Riley said.

The move is part of an effort to increase transparency, she said. The panel also will review studies for a device made by Confluent Surgical, which was purchased by Tyco International Ltd. this year, and will discuss and make recommendations regarding an application for a depression-treatment system made by Neuronetics Inc.

The Cyberonics device is approved for the treatment of epilepsy. The FDA's approval for depression treatment required two follow-up, or post-market, studies regarding device performance. It is typical in such instances to hold later panel meetings to discuss the progress of those studies, Ms. Riley said.

Write to Jon Kamp at jon.kamp@dowjones.com

[Broomstick]

Here's the crux of the issue:

While there's no question the device - a pacemaker device that stimulates the vagus nerve - is quite effective in treating certain types of epilepsy, all the studies done so far that hold up to rigourous examination show that it is no better than placebo when used for depression.

Sure, some folks with intractable epilepsy reported fewer depression symptoms when the device controlled their epilepsy - having uncontrolled epilepsy can be pretty fucking depressing. Having it gone or at least better controlled can be a huge relief. DUH!

It was worth trying as an experiment to help those with intractable, treatment-resistent depression because that's a condition with potentially fatal consequences. But it doesn't seem to work any better than placebo.

Where I work, in the Evil Insurance Empire, we don't pay for it because it hasn't been proven to work as advertised. It's that simple. It's an expense, it's an invasive operation with all the risks that entails (anesthesia, infection, etc.), surgery must be repeated every 10 years or so because these units don't last forever, there can be side effects such as changes in the voice and other symptoms that can be unpleasent, and frankly sending someone to a Voodoo doctor is cheaper, less likely to cause side effects, and is just as likely to work (and we don't cover Voodoo, either).

Cyberonics is fucking pushy about it, too - one of their hired guns started in with it over the phone with me one day - said I couldn't possibly understand what it was like, to have a family member with clinical depression, because if I did I'd have compassion and convince the decision makers at work to change their minds, my god, people die of depression, didn't I, heartless person that I was, know that?

At which point I had to hand the call off to someone else because, you know, my oldest sister died of her depression. Just really fucking pissed me off. But it's because I know just how desparate the patients and families can become, clutching at straws, that I feel an ineffective treatment should not be paid for or approved.

The FDA approval states basically that it's no worse that what's currently out there, and isn't likely to cause a lot of harm. Since we have very little, if anything, that works for long-term resistant depression that's not saying very much.

Cyberonics has not been able to prove the device actually reliably relieves depression. That's why insurance companies don't want to pay for it. End of story.

[Gil Hamilton]

Aside from the idea being fucking creepy, brain surgery to treat depression seems like an awfully big risk, particularly when there are plenty of effective (at least, as effective as anything else) chemical treatments that don't involve cutting open someone's head.

[Setesh]

Aside from the idea being fucking creepy, brain surgery to treat depression seems like an awfully big risk, particularly when there are plenty of effective (at least, as effective as anything else) chemical treatments that don't involve cutting open someone's head.

And even then it would require them correctly diagnosing the patient.

My wife was on several medications to control both her anxiety disorder and depression. All of which it turns out was worse than useless. (After she moved here she stopped taking them, her weekly depression induced crying fits and daily (sometimes 3 or 4 times a day) anxiety attacks became far rarer occurrences. (Crying fits now occur at most bi-monthly, and aniety attacks are now trigger responsive rather than random.)

Based on the ‘diagnoses’ she had (from a five minute talk where her mother basically told the doctor what she had) she went through 7 years of unnecessary meds she now has unreverseable damage to her thought process. Based on that same 'diagnoses' she would be elligable for this, and it would still have done nothing to help her.

[Superman]

First you're treating your depression, then the next thing you know you're part of an interconnected collective of emotionless cybernetic beings are programmed to assimilate more and collect their technology.... which is pretty depressing. Ironic when you think about it.

[darthdavid]

First you're treating your depression, then the next thing you know you're part of an interconnected collective of emotionless cybernetic beings are programmed to assimilate more and collect their technology.... which is pretty depressing. Ironic when you think about it.

Or you might become an attorney for the partnership collective.

[Broomstick]

Aside from the idea being fucking creepy, brain surgery to treat depression seems like an awfully big risk, particularly when there are plenty of effective (at least, as effective as anything else) chemical treatments that don't involve cutting open someone's head.

Strictly speaking, this is NOT brain surgery - it does involve the neck and upper chest, but no need to crack the skull.

This is targeted at a group of patients for whom medication does nothing to treat their underlying, long-term, severe depression. The death rate among this group is about 20% in any given year. This is NOT typical clinical depression, and there really is little, if anything, to help these people.

There are people at Cyberonics with their hearts in the right place, but they seem to have trouble coming to grips with the notion that maybe their wonder device isn't that effective after all.

Yes, some of the patients have gone into remission - a number go into spontaneous remission even if you do nothing.

[Chiaroscuro]

And even then it would require them correctly diagnosing the patient.

Yep... I got major depression in high school and they tested my blood for everything from anemia to mono, then pretty much gave up. It was my school nurse a year later who finally suggested to me that it might be depression; I certainly had no idea. I'm still amazed, though, that my real doctor never even once considered depression, even though my symptoms were pretty much dead on.
As Broomstick said, depression meds are hard to test because some of the patients will either go into remission on their own, or be so happy that someone actually recognizes their disease that they have a placebo effect.

[Gil Hamilton]

Strictly speaking, this is NOT brain surgery - it does involve the neck and upper chest, but no need to crack the skull.

I made an assumption from the title that they were actually sticking the implant, but even so, any surgeon carries no trivial risks.

This is targeted at a group of patients for whom medication does nothing to treat their underlying, long-term, severe depression. The death rate among this group is about 20% in any given year. This is NOT typical clinical depression, and there really is little, if anything, to help these people.

If no medication is capable of treating their condition and it is still, in fact, a physical medical condition, then I'd question whether any cybernetic implant would succeed where medication has failed, at least the sort of thing being talked about in the article.

[Broomstick]

This is targeted at a group of patients for whom medication does nothing to treat their underlying, long-term, severe depression. The death rate among this group is about 20% in any given year. This is NOT typical clinical depression, and there really is little, if anything, to help these people.

If no medication is capable of treating their condition and it is still, in fact, a physical medical condition, then I'd question whether any cybernetic implant would succeed where medication has failed, at least the sort of thing being talked about in the article.

Your skepticism is understandable.

However, the anecdotal accounts from the implant's use in epilepsy were common enough and strong enough that testing it in people who were depressed without epilepsy was warranted. It was no crazier an idea than, say, removing part of a hypertrophied heart to improve function (since proved not to work) or removing large parts of emphysemic lungs to allow for greater expansion of the remaining, functional tissue (since proven to provide great improvement for about 25% of patients, those meeting some rather specific criteria) or using small amounts of an explosive to treat angina (nitroglycerin) which has been a standard treatment for decades.

It's also an illustration of how a promising idea might not pan out in the long term. Rather than resist calls for more data, Cyberonics would better serve both their stockholders and mankind by either seeking other forms of treatment, or attempting to analyse the data in such a way as to attempt to identify a sub-set of patients who can benefit, even if all can't.

[Gil Hamilton]

In the grand scheme of weird medical ideas that involve surgery (combined with psychology for that matter, considering the medical procedures of the early to mid 20th century revolving around treating psychiatric problems), this barely rates on the Weird-Shit-O-Meter. In fact, it might not even be that bad an idea. But as you say, the company isn't willing to let go to one of its babies, since if it did work, it would be cutting edge futuristic medicine.

[Trytostaydead]

Aside from the idea being fucking creepy, brain surgery to treat depression seems like an awfully big risk, particularly when there are plenty of effective (at least, as effective as anything else) chemical treatments that don't involve cutting open someone's head.

There's brain surgery for everything these days. Oftentimes they're used as a last resort when conventional treatments have failed. This sounds like something along the lines of a deep brain stimulator, so I don't think there's anything too revolutionary about it. And it's better than going in there and frying a few neurons which are involved in things like Parkinsons and hell, even OCD treatment.

[Shannon]

I recall a TV news report from the UK sometime within the last couple of years regarding a woman with virtually incurable unipolar depression who'd volunteered for a deep-brain surgical implant. Essentially (IIRC), the idea was to insert a probe into her brain's 'mood centre' which would then be stimulated via electrical pulse. The battery for the device was implanted subdermally on the back of her shoulder, I think. Anyone else hear of this? It was a trial reserved only for the most treatment-resistant depressive disorders as I recall.
I was diagnosed by my GP with moderately severe clinical depression in 2000, upgraded to Major Depressive Disorder (Recurrent) in 2002 by a consultant psychiatrist. Through taking a shitload of meds (once they found the right ones of course), psychoanalysis and counselling, along with better diet and exercise I manage to live a reasonably happy, healthy life . . . most of the time, if I behave myself and stay within certain boundaries. But sometimes the wheels fall off the cart, and life becomes hellish for me and my family. Its certainly not so bad as the bad old days, but its sometimes bad enough that if someone offered me a device that could alleviate my condition, even if it required surgery every 10 or so years, I'd seriously consider it. And I'm far from being the worst case out there. I've got enough of a rational bent and a grip on reality now such that I'd thoroughly investigate said device, but I've met people who possibly wouldn't. They'd jump without looking, and I can understand why. Severe depression really does rob life of any joy whatsoever. You really do literally just want to die.

[Gil Hamilton]

There's brain surgery for everything these days. Oftentimes they're used as a last resort when conventional treatments have failed. This sounds like something along the lines of a deep brain stimulator, so I don't think there's anything too revolutionary about it. And it's better than going in there and frying a few neurons which are involved in things like Parkinsons and hell, even OCD treatment.

You said it in the second sentence. As a last resort. Brain surgery is inherently high risk, which is why doctors often exhaust every other option before they are willing to go through with it and why non-invasive surgery that can be performed on the brain, with focused radiation and soundwaves, is a major area of medical reserach.

I misunderstood where the implant was being stuck, I freely admit.