http://www.businessweek.com/news/201...-fda-for-flaws

And this:

http://online.wsj.com/article/HUG1698919.djm.html

let's get really drunk and laugh and cry, just for today

In February, 2013,
Medtronic notified "Health Care Professionals". (letter attached)
Medtronic told the FDA at about the same time.

April is Parkinson's Awareness Month; AbbVie and Medronics were both sponsors, and had information kiosks at the Unity Walk; but the topic did not come up.

On May 2, Businessweek and Wall Street Journal informed investors(Attached in posts above, by LindaL.) Shares in AbbVie reach new high.

On May 3, LindyLanka told PeopleWithParkinson's. The last to know.

Technical specs:
The letter to the health care professionals, in Feb. 2013:

http://professional.medtronic.com/wc...p-advisory.pdf

DX needed. Is there a stock broker in the house?

Wall Street is currently voting for Abbvie’s Duodopa over Medtronic’s DBS, but, there is no rush for the exit. After a flicker of fear in February, investors are voting “Steady as she goes” for Medtronic and “Full speed ahead” for AbbVie.

When investment analysts were informed in February that Medtronic was about to issue an “Urgent recall” for their Deep Brain Stimulation system; and that the FDA would declare it to be of “Class 1 urgency” (danger of death), there was a modest run on Medtronic shares, dropping from $47.12 on February 15, 2013, to $43.13 on Feb. 22. When nothing further happened, despite the FDA “Class 1” alert, this loss was slowly recovered over March and April, with Medtronic at $47.72 at the end of April.

During the same period, AbbVie shares were at $35.42 at the beginning of February, before their competitor’s product recall. By the end of April, AbbVie shares increased to $43.99, a solid performance for the three-month period.

DX:

Medtronic rates “hold”. The market sees the recall as a drag on earnings, but that the problem causing the “urgent recall” is not disastrous or widespread, and will be resolved.

AbbVie rates “strong buy”. The market sees duodopa taking market share from DBS, primarily because of Parkinson’s Patients choosing surgery to reach the intestines instead of the brain.

You may want a second opinion, from a doctor instead of a stock market analyst, but Wall Street is always better informed.

I'll bet you could have made a buck or two with this information. Hmmm.

Is there a den mother in the house?
A den mother specialized in DBS, preferably with extensive experience in chorus-line music-hall dancing.
I can only think of one, just off-hand. Kate Kolorado; Denver that is.

kate,

Lots of PwP think about the "crossroads" when they have to choose between staying on medication only, but the drugs work less and less, OR having DBS, which we are afraid of because it is a brain operation and we don't like to think about that; OR waiting for the ever-promised, never delivered Duodopa from AbbVie.

Now comes this bombshell, that we find out about 3 months late: the FDA has sent out a Class 1 recall (class 1 is danger of death; the worst level of urgency,) for some, not all, DBS wiring.

I get the impression the problem is under control, as the stock market is not running away from Medtronics. And the stock market analysts usually have the best inside information. They are not in a panic or dumping Medtronic stocks, so it can't be terribly serious. Or not?

But we get no information from the medical world - those of us who are considering DBS. And so in May we found out about the URGENT recall sent in February.

From where you stand, Kate, as den mother to us all, with your years and years of DBS experience, guiding many patients through what you yourself went through, have the doctors been calling the DBS patients in? Does it require a new operation? Is everybody freaking out, or is that just me?

Any commentary or stories from you and your extensive gang would be much appreciated, especially reactions to this scarey warning.

All we have so far is this URGENT letter from Medtronics three months ago, and the notice from the FDA saying "DEFCON ONE ALERT..... danger of immediate death... drop, roll, cover, NOW!"

Kate, is this the time to panic or should I still wait a bit?
Bob Dawson
solving the world's problems, one at a time

Hi Bob and Everyone,

I have been attempting to find answers to this scary report, but ibeing the weekend, I've been unsuccessful. Until I get answers from reputable sources, I will not offer my opinion. In the meantime, I'd recommend that you hold off on the panic and instead celebrate Cinco de Mayo. Seriously, I'll let you know as soon as I know.

Warm regards,
Kate Kelsall

I don't think we need to panic just yet. In reading the letter it says no death or impairment has occurred but treatment may be impeded, so it looks like Medtronic is doing the right thing.

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.”

Say what?
…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.