Originally Posted by Conductor71
Still, for me, at least, this is yet another reason why I would rather have a tube in my gut than a mini electrical parade in my head.
The alarming part is that the business press (and no one else is talking about it except the business press) is reporting this as being a Class 1 FDA urgency, which is the most severe level, involving “permanent damage or death”, both of which we prefer to avoid at this time.
Was that the sound of a click I just heard?
The actual letter from Medtronic, was sent in February to “health professionals”, a category that does not seem to include anyone we know.
I mean, they did not tell Kate Kelsall, who, in Colorado and beyond, is the very first person you would think of, especially for bringing patients through DBS.
The Medtronic letter is not as alarming as the FDA’s choice of category: Class 1 Urgency is when you hide in the nearest bomb shelter and emerge 30 years later to see who won, and what Keith Richards looks like.
The letter contains some interesting examples of “bafflegab” – speech designed to obscure rather than enlighten, such as:
… “There is no action required for existing patients in the absence of concern over potential lead damage.”
…in the absence of concern, do not be concerned… take no action if there is no concern, but if there is concern, well, then, that would be different, but no action is required when there is no concern. The FDA’ s Class 1 concerns contradict the absence of concern. For existing patients no action is required (what other kinds of patients are there, other than existing patients?) “no action required in the absence of concern over potential lead damage” inside your brain.
Probable translation to English: “If the patient is in lousy shape and not responding to treatment, then there’s a good chance we got a few wires crossed; maybe blew a fuse; so call those patients in to be re-wired, this time with a handiman-electrician on duty. But if the patient is okay, ignore this whole schtick and go play golf.”
This part of the letter is re-assuring to the extent that it’s hard to see it as a Class 1:
…”To date, (meaning February 2013), there have been NO REPORTS of permanent patient impairment, life-threatening injury, or death as a result of this issue…”
(Some patients, however, turned bright green).
The letter says that only one-quarter of one percent of operations damage the lead (which is about as good as it gets with any surgery).
…”however, this incidence is lower than the expected actual rate of occurrence since every event is not likely to have been reported…”
Ummmm, with a radical procedure such as wiring up human brains, “events” SHOULD be reported. (“Event” is a medical euphemism for “collosal blunder”.) (3 months have gone by--- is the rate of “events” still “lower than the expected actual rate of occurrence…” and what is that expected rate of occurrences and WHO is expecting it?)
… “and the actual number of uses of lead caps is unknown….”
Now that SHOULD be known. Surely the doctor scribbles down whether or not he stuck a lead cap in your brain, or dropped his wristwatch in, or whatever.
It is disconcerting to pick up the Wall Street Journal and be told that three months ago the FDA declared your brain to be a Category 1 Catastrophe Zone, so buy on rumour; sell on news.
But the letter is from 3 months ago. What happened since? Affected patients called in and re-wired? Or FDA has put MDT on the Abb fast track, and it will only take 6 months? Are both treatments now waiting in the FDA laundry room, and so right now we have no alternatives at all?
Did our collective Parkinson’s awareness just conclude that we should go with AbbVie and Duodopa? Mistake in intestine; sounds okay; mistake in the brain – it’s a Class One, baby.
May is starting to look like a better Parkinson’s Awareness month than April, now that AbbVie and Medtronic are putting on this dog and pony show for the Great Unwashed.
It’s a lot like Reality TV. You put these people together; the ONLY thing they all have in common is an incurable disease of unknown origin; and then you bombard them with promises and threats, none of which you can actually deliver, and then you time them to see how fast they go bonkers. It’s the only socially acceptable way to laugh at the antics of the spastics.
NOW they say listen for a click?
That’s the click after the one-quarter turn. They show it in bright red. Sometimes they don’t hear the click so they keep on screwing.
I’ve met people like that.