Do you suffer from depression? Well buck up little camper, because the FDA has just approved a cure for it! I bet you want to know more, don’t you?
It’s a device that is surgically implanted into your upper chest, and then wires are threaded into your neck. Add a couple of AAs, and the device stimulates a nerve in your brain, curing your depression. See? Easy! It’s neat, like you’re a cyborg! Who doesn’t want that?
Of course there are some drawbacks — there’s the possibility of voice alteration, increased cough, shortness of breath, neck pain and difficulty swallowing. And rarely, there might have been a few reports of death, heart problems and vocal cord paralysis. But that’s rare!
Oh, and there’s one other thing. There’s only been one clinical trial. And it failed. Miserably. Also, the entire FDA committee of scientists rejected the device, but Dr. Daniel G. Schultz, director of the Center for Devices and Radiological Health, singlehandedly overruled them.
The device was originally used to control epilepsy. The company that makes the device got reports back from patients claiming that their moods had been altered. Maybe, just maybe (I AM NOT A DOCTOR) this had something to do with the patients being HAPPY that they weren’t so damn epileptic anymore. That’s just a stab in the dark. Here’s how I see the conversation happening at Cyberonics, the company that makes the device:
YOUNG EXECUTIVE #1: Hey Tad, I just got this letter from one of our epileptic patients. He says the device works great, and he’s much happier now.
YOUNG EXECUTIVE #2: Eureeka Chad, our device enhanced the mood of that patient! Let’s implant our devices in hundreds of depressed people and CHANGE THE WORLD!
Thank god they don’t make anal suppositories.
According to the New York Times, the company implanted the devices in
235 depressed patients and turned the machines on in half of them. After three months, the two groups were equally depressed. The trial had failed.
It’s not made clear how they managed to turn on exactly half of 235 machines, but let’s set that aside for a second because it gets better. I mean worse.
Cyberonics then turned the devices on in all 235 patients and determined that 30 percent showed significant improvement after six months or more.
YOUNG EXECUTIVE #1: You know what went wrong, Tad?
YOUNG EXECUTIVE #2: Yes, Chad. That pesky control group! Let’s be rid of it at once!
FATHERLY CEO TYPE: Good job boys, million dollar bonuses for everyone! Let’s go dig up the corpse of Sir Isaac Newton and perform horrible acts upon it!
Gah, now I’m all depressed.
Ah, I found this transcript of the FDA meeting on the subject, if you want a little light reading:
They approved that but they won't approve the sale of Plan B over the counter? Oy.
You know, I used to deal with the FDA for work and generally found the career bureaucrats to be pretty decent folk. For the most part they were competent and dedicated to serving the public.
But, man, all bets are off when it comes to the political appointees. From what I can tel,l things have only gotten worse.
From the NYT story:
“A top federal medical official overruled the unanimous opinion of his scientific staff when he decided last year to approve a pacemaker-like device to treat persistent depression…
…not proved effective against depression in its only clinical trial for treatment of that illness. As a result, scientists at the Food and Drug Administration repeatedly and unanimously recommended rejecting the application of its maker, Cyberonics Inc….
… the Senate committee, which for two years has been investigating the decision-making processes at the F.D.A., could find no previous instance in which the director of the center had approved a device in the face of unanimous opposition from staff scientists and administrators beneath him, the report said.”
I find this incredibly disturbing. As a provider it means I can no longer rely on FDA approval as meaning anything. It smells like an Abramoff like deal. Someone in that office is clearly connected to Cybertronics. This needs more attending to. It is a very important issue with all sorts of ramifications.
Its all a secret cybrog conspiracy run by the masons to implant devices in our brains to make us by more Cream of Wheat. You see, inside Cream of Wheat are millions of Thetans that will control our minds for the evil overlord xenu. The masons are, of course, controlled by scientologists and have been since the Roswell Crash, which is real… unlike that damn faked moon landing.
Pardon my poor typing skills, but "by" should have been "buy"…
Adrian, I appreciate your careful attention to detail and willingness to correct inconsistencies in your reply . . . heh . . .
Skeptigirl, if I had to guess who the person with the connection is, the money would probably go on Dr. Schultz. What’s amazing to me is that one person has such control over these things.
I also have the geeky urge to edit my entries when I make an error. Probably goes with my compulsive obsessive disorder. ;)
I might try to find out just where the FDA connection is. Dr Schultz is definitely the logical choice. Bush has appointed several people that gave out no bid contracts or wrote particular pieces of legislation then went to work for the companies that got the bids or benefited from the legislation. And while Cheney claims to be divorced from Haliburton, there were connections to Haliburton at that ranch where the shooting took place. For an Evangelical, Bush sure is dripping in corruption schemes.
While I do not wish to excuse that which is inexcusable, depression is a treatable illness which often goes untreated. However, around 15 to 20 percent of depressed patients do not respond to medication. ECT (shock treatments) are still indicated as a last resort. And research continues on brain "pacemakers," which show promise in the therapy of severe depression.
Thomas Jones, himself subject to bouts of depression
Thomas, I don’t discount the possibility of a device like this curing or easing depression. I don’t think it’s asking too much that we have at least a single double-blind study showing that it works before it is given the stamp of approval and surgically implanted into patients.
The scientists at the FDA all voted to reject the approval. The only actual trial of the device failed. The FDA director pushed the device along the path to approval anyway.
That's the issue, not the hypothesis or the research.
Given the Bush administration's history of corruption and croneyism, I have little doubt what the problem is.