I hope I'm not the only person who sees what is totally messed up about this.
What I want to know is how it's come to this point. First off, why is depression such a bad thing to suffer from? Okay, so, your depressed, perhaps there's a reason for it? The diet can effect your moods, believe it or not. So can upbringing and the world around you.
That's the problem here. Doctors are trying to force the person to change, rather than looking at what might be causing the clinical depression in the first place. Sure, they say there are simply chemical imbalances in the brain - but what causes them?
Have we become so blind to the flaws of our own society and culture that we feel that there is nothing in them that could be causing those members of our society more prone to depression to fall prey to it completely? Is our society that perfect?
Is our culture so perfect that rather than finding other, more humane, methods to induce a positive mood, we must develop a machine that will deliver electric shocks to parts of the brain 24 hours a day, even when people sleep? Because that's what this device does.
I remember watching a episode of Ren & Stimpy where Stimpy is sad to see Ren depressed, so he builds Ren an invention - The Happy Helmet. Ren doesn't want to wear it at first, but Stimpy forces him. Ren is then forced into "happiness" by the helmet, and eventually resorts to singing the "HAPPY! HAPPY! JOY! JOY!" song.
Now, for those of us who remember that episode of Ren and Stimpy, don't we all remember just how absurd that helmet was?
How is this new implant any different?
According to a press release from Cyberonics, the company that produces the implant, the implant sends "mild, intermittent electrical pulses" to a nerve in the neck. But here's how a Washington Post article describes it:
The implant involves connecting a wire to the left vagus nerve in the side of the neck; a battery is implanted high in the left chest or under the armpit, and the amount of current can be regulated externally. Typically, the implant sends a 30-second pulse of current followed by a five-minute pause, 24 hours a day.That's a little different from "intermittent," wouldn't you say?
If we start allowing this type of treatment to be performed on people who want it, how long will it be before someone who doesn't want it is forced to go through it? There are many cases throughout the 20th century of people going through electro-shock therapy against their will. And even if this form of electro-shock therapy is "mild," it's still zapping your brain into submission with electric shocks.
Is this really the way we want people to live? I don't know what clinical depression is like, but I've got to think electric shocks are not the way to go to avoid it. I suppose if you try it and it works for you, then fine. But shouldn't we try to find other solutions? Solutions aside from even drugs?
Just a thought...
Read about this new implant at the Washington Post website.
Read more about the implant and it's company from a business perspective at the CBS Marketwatch website.
Check out the Citizens Commission on Human Rights web page for the "Psychiatry Kills" exhibit at the CCHR building in Hollywood, California.
From WashingtonPost.Com:
FDA Panel Backs Implant To Counter Depression
But Questions Linger About Manufacturer Data
By Shankar Vedantam
Washington Post Staff Writer
Wednesday, June 16, 2004; Page A03
A surgical implant that stimulates the brain should get government approval to treat chronic depression, an expert panel of federal experts said yesterday -- marking the first time an implanted device has been recommended for the treatment of a psychiatric disorder.
Using a technique known as vagus nerve stimulation, the device uses electrodes implanted in the neck to activate brain regions that are believed to regulate mood.
The decision by an expert advisory panel of the Food and Drug Administration came after a day of clashing scientific opinions about whether the data submitted by the manufacturer were adequate for approval. Proponents of the device prevailed, citing the desperate need of patients with chronic depression that does not respond to existing treatments.
"We lost four of these individuals in the last 2 1/2 hours," said A. John Rush, a psychiatrist at the University of Texas Southwestern Medical Center at Dallas, basing that figure on the high suicide rate among patients with resistant depression.
The verdict by the advisory panel came after FDA scientists and some panel members argued the data presented by the manufacturer to show the device works were not convincing.
The agency is not required to follow the guidance of its advisory committee but usually does.
The device has been used in the United States since 1997 to control epileptic seizures. The manufacturer, Cyberonics Inc. of Houston, hopes to expand its market: Fifteen to 25 percent of the 19 million Americans with depression may not respond to available treatments, Rush said.
The implant involves connecting a wire to the left vagus nerve in the side of the neck; a battery is implanted high in the left chest or under the armpit, and the amount of current can be regulated externally. Typically, the implant sends a 30-second pulse of current followed by a five-minute pause, 24 hours a day.
Karmen McGuffee of Garland, Tex., told the panel she had tried virtually every antidepressant drug on the market before getting the device. Improvement came within weeks, she said.
"My mother said she wasn't looking into the eyes of a dead person anymore," she said. When people asked why she was willing to get an implant, she replied, "I had nothing to lose."
McGuffee was paid by Cyberonics to testify. Rush, who was paid to conduct some of the clinical trials, said there are 30,000 suicides a year in America, about 80 percent of them attributable to depression. Half of those are among patients with treatment-resistant depression who had tried multiple therapies and were still not better, he said.
In response to suggestions by some panel members that the company conduct another trial, Rush warned, "In the time to do another trial, we will lose another 1,000 patients a month, 36,000 if the trial takes three years."
Still, at least two members of the eight-member panel said the company had not provided sufficient evidence.
"It's possible this is a viable treatment; it is also possible it is not a treatment," said Richard P. Malone, a psychiatrist at Philadelphia's MCP Hahnemann University. "I'm not sure it is ethical to give a treatment for which there is not substantial evidence."
Malone and another panel member, statistician Jonas Ellenberg, nearly convinced other panelists that the company should conduct another trial, but the proposal was shot down after a tense vote, with one panelist changing her mind. The chairwoman of the panel, Kyra Becker, a neurologist at the University of Washington School of Medicine in Seattle, cast the deciding vote.
The panelists mostly agreed that the data presented by Cyberonics had problems but were swayed by the lack of alternative treatments and the evidence that the device is generally safe, based on its widespread use to reduce epileptic seizures.
Cyberonics' central study was a randomized trial involving 221 patients. All received implants, but the power was turned on for only half the group.
Of 111 patients getting stimulation, 17 showed an improvement of at least 50 percent on a psychiatric scale of depression after 12 weeks. Of 110 patients getting "sham" treatment, only 10 showed similar improvement. The difference between the groups was not statistically significant, however.
The company conducted a separate analysis with patients in another study. This group involved 124 patients who were similarly ill but were not getting vagus nerve stimulation. The company showed trend data that over 12 months, patients with the device were significantly better compared with those getting drugs or electro-convulsive therapy.
Malone, Ellenberg and the FDA's statisticians expressed worry that the two groups of patients were not comparable and the apparent benefit might be statistically spurious. Cyberonics officials argued that conducting a new trial would be problematic because of the special needs of this patient group.
© 2004 The Washington Post Company
From the CBS MarketWatch website:
Depression device wins panel nod
By CBS MarketWatch
Last Update: 8:04 PM ET June 15, 2004
SAN FRANCISCO (CBS.MW) -- Cyberonics said an FDA panel recommended approval of its VNS system for patients suffering from treatment-resistant depression.
The company said the panel voted 5-2 to approve the device, which is similar to a pacemaker and is already used to treat patients with epilepsy.
While the recommendation is not binding, the Food and Drug Administration typically follows the lead of its advisory panels.
"It's a giant step forward toward approval," said Skip Cummins, chairman and CEO of Cyberonics. Assuming the FDA does approve use of the device, Cyberonics will be "the market leader in what's considered by many to be the next frontier in medical devices," Cummins said.
Approximately 4.4 million Americans suffer from treatment-resistant depression, according to Cummins. That's more than 10 times the size of the company's current potential market for treatment-resistant epilepsy, he said.
The company believes the device may eventually be able to be used to treat other conditions as well, including Alzheimer's disease, anxiety and chronic pain.
The VNS system applies "mild, intermittent electrical pulses" to a nerve in the neck, according to a company press release.
While the devices run about $15,000, and the surgical implant procedure can cost $20,000, insurers see it as cost effective, Cummins said. He noted that Medicare had recently raised the amount it reimburses hospitals for the procedure by 23 percent.
Patients in the company's studies had suffered depressive illness for an average of more than 25 years, Cummins said. Victims of treatment-resistant depression currently "have no safe tolerable and effective long-term treatment for their terrible life-long and life-threatening illness," he said.
Shares of Cyberonics rallied Monday to close at $19.59, up 6.6 percent, ahead of the vote. The stock was halted Tuesday.
Piper Jaffray issued a research note ahead of the meeting, advising investors without a position in the stock to "get up to speed" with Cyberonics's (CYBX: news, chart, profile) story because "we strongly believe that regardless of the outcome, the day after the panel meeting will be an advantageous investment period."
The firm said it believed the stock could run as high as $30 with approval of the device.
© 1997-2004 MarketWatch.com, Inc.
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