Wireheads in our midst.

The Outrage Starts
Let me start with the open letter to the FDA to reject the premarket approval (PMA) for Vagus Nerve Stimulation use in depression. This was dated May 11, 2005 and contained quite a bit of information that shows a severe and questionable lack of data on the device, in particular the safety and efficacy of the device has not been tested. In addition, the only randomized trial failed to demonstrate efficacy for treatment-resistant depression. It goes on to discuss the nonrandomized data submitted was called "highly questionable" by the FDA statistician reviewing the material. Again, in a massive lack of oversight, or coverup there was no subsequent investigations into possible VNS related suicides, or clinical worsening of depression. This kind of cover-up should be familiar with anyone loosely following SmithKline Beecham (Paxil), and other similar antidepressant drugs.

Now
Last Friday, the FDA has approved a vagus nerve stimulator in implant form. It was a turnaround decision, surprise on all sides, as the advisory board did not recommend approval. Success rates are not really quantified, or well known, the trial sizes were extremely small (less than 100), and some place benefit from the device at 30%, but other studies peg it at around 17%-20%. Lets call it even and say it helps 1 out of 4 people, for a retail cost of nearly $10,000, if your insurance does not cover it. Which in most cases it will not, unless repeated ECT treatments have not worked. By that time you are for all intents a wirehead with repeated and necessary bilateral brain shocks and induced seizures to continue to stay in remission. These are colloquially called maintenance treatments, and typically range from every month to every 3 months, depending on your need (or is that addiction?). One must not forget cognitive decline, memory loss, and possible fatal or permanent damage from repeated barbituate sedation; really is this any better than other methods of treatment? You're happily stupid, but yes, radical me, would advocate methadone treatment (regardless of need for opiates) to induce happiness and rehabilitation without risk of permanent and severe damage to yourself and the quality of your life.

What happened to ECT?
A little known fact in psychiatric and patient circles is that the the two most common manufactures of ECT devices (Mecta, Somatics) in use in hospitals areunlicensed by the FDA for safety concerns and lack of testing -- isn't that a comforting thought? Being shocked into seizures by a device that is not FDA approved?

Cybertronics VNS Device
For a rational look at what this device does and how it is thought to work, this NPR article is a good introduction. In sum, electrodes are implanted in an area of the brain known as Area 25, a device is also implanted near your heart which controls the electrical impulses sent to the electrodes. Area 25 is associated with feelings of sadness, and has been located with PET scanning when comparing depressed volunteers to healthy volunteers. In tests, scripted material with sad content was shown to activate this specific paralimbic-cortical area, along with the dorsula insula and deactivation of Area 9 in the right prefrontal cortex and Area 40/7 in the parietal cortex. Roughly, we get an idea that the device in question will continually send electrical impulses to one area that has been positively identified with feelings of sadness.


Will it work? Speculation and thoughts.
Feelings of sadness, such as seeing a movie or your favorite television does not correspond on a 1:1 basis with what we consider neurological depression -- a disease, not a malfunction of one or even multiple areas of the brain, but a multifaceted complex issue involving neurotransmitters, areas of the brain, the parasympathetic nervous system, the central nervous system, early childhood development, PTSD-like trauma, and situational difficulties. Could this device help? It has obviously helped a small minority of people, but again we are playing in the dark, targeting one thing at a time (like SSRIs and other related drugs), instead of looking at the overall problem of what is depression, why do people suffer from it, and why do people fail to respond to current treatment methods? Sadly, this device gives me even more faith in ECT, as with bilateral electrical stimulation, all areas of the brain are flooded with electrical impulses instead of a single area. Yes, there are many negative effects to this, but it is also treating a whole entity, your brain, instead of a single area associated with sadness. What wonderful choices the FDA has given us to treat ourselves. This idea of "recalibration" of our brains with electrical impulses is nothing novel, it has been the basic premise of ECT -- although it's now tied up in much fancier words. I still believe ECT works for this very barbaric reason, and indeed it does work well for those that choose to voluntarily undergo it. Unfortunately the new breed of electrical brain stimulators, such as the new vagus nerve stimulator is too limited in scope, and I fail to see any benefit to it being on the market. I'm waiting for the negative results to show up and it to be implied with suicide -- everything else is, so I'm sure this will be lumped in there too, whether it does or not. I'm morbidly curious if it will worsen depression in people and cause suicide. I hope it doesn't, but lets let time and a few years pass before finger-pointing like every other righteous senator or parent of a child who committed suicide is wanting to do with all psychotropic medications. We all know we can trust parents and our elected officials to protect the innocent and depressed -- experts that they are in the fields of neurology, psychology, psychiatry, and mood disorders.

Wireheads - a short survey
Is this small device the beginning of what cyberpunk tradition calls wireheads? Maybe it is. In the coming years, I think more and more devices that play with our brains in these direct ways will come onto the market. The first mention of the addict-type wirehead that I can remember was published in 1980, by Larry Niven in the book The Ringworld Engineers, chapter 1, "Under the Wire". I'm sure there are earlier references to the idea. It has become fairly commonplace, especially with the years, the wirehead addict is seen in many cyberpunk and cross-over genre novels. The concept is fairly simple, you "wire" your brain with electrical impulses, voltage to the pleasure centers of your brain, replacing the need for antiquated chemicals that don't quite push our buttons perfectly. Long-term users of the wire become apathetic and nearly comatose. Put your mind back a bit and recall opium dens in late 18th century England or 19th century China and you have the basic idea of the physical capacity of these people and their use (or uselessness) to society. Opium use has been mostly superseded in modernized cultures with synthesized narcotics, with an economic and social divide usually separating those that choose to fulfill their addictions with pills (Vicodin, Percocet, Oxycontin becoming American's new secret and dirty mother's little helper). What's more alarming is that most of these addictions are not acknowledged or counted, latest figures count prescription pain killer abuse at around 31 million. Those are the people who admit to it. Do you know anyone who takes opiates? I know I'm not trustworthy and I will lie, steal and cheat and backstab anyone to get my fix -- I wonder how high these numbers really are. On the other side of the railroad, are those opiate users that indulge in mostly heroin use. There are no concrete numbers for the amount of heroin users, as it isn't seen as Bush's idiotic war on drugs doesn't see it as a high-threat item, even if it out of all the illicit drugs of abuse are costing us more in rehabilitation other resources than all other drugs combined. The economic cost can be said for our secret addictions that many of us middle and upper class Americans harbor, our family doctors complicit and smiling.

Disgust
There are some choice quotes from this MedScape update on the device. How much money changed hands between the FDA and Cybertronics, and how many lives does that buy?

The device would carry the strongest warning possible -- a so-called black box -- cautioning patients that the device is permanent, Schultz said in an interview. Cybertronics will also have to create a registry to monitor some patients.

The FDA approval sparked renewed concern from patient advocates. The agency rejected the device in August 2004.

"It's a new low for FDA device approvals. If this device can get approved with data as unconvincing as these, it's hard to see what can't get approved," Peter Lurie of Public Citizen's Health Research Group said.

An FDA advisory panel last year supported the device but said muddled data made it hard to tell if the implant or other factors were at work. The advisers also worried about suicide risk seen in some study patients who received the device.

The Future
This is a sad start to the possible future of implanted devices for mood disorders and other illnesses. The device has only been out for a few days and yet the the Senate Finance Committee is looking into to the VNS device and how it received FDA approval. But we all have to start somewhere, and eventually technology will progress to the point where self-medicating to keep oneself alive and functional is no longer a viable or rational option.

Disclosure
I have experienced opiate addiction in almost every form, both illicit and prescribed medication. It's abhorringly sad at how easy it is to obtain a controlled substance from a doctor, any doctor, especially one I have never seen before. Say the right symptoms, say the right complaints, and most of all don't demand, just let them push the drugs on you. I've never had to ask for what I want, it's always volunteered like a candy store and I have the pick of the litter, so the saying goes, of whatever drug I want for my condition. I have treatment-resistant depression and have suffered since I was 17. It is complicated with other comorbid psychiatric illnesses and I have only achieved remission a few brief times. I have tried most psychiatric medication aimed at depression, both on and off-label, and in many combinations. I have self-medicated with opiates and benzodiazepines when depressed.

References
Background information on what the Vagus Nerve is and what it does in our body (that we know -- and we don't know as much as we'd like). Wikipedia article.
A scholarly look at "wireheading" from the past to future perspectives.