medtronic
 

And this:

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

1st step
 

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

Technical letter from Med
 

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

Is there a stock broker in the house?
 

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.

Just follow the money.
 

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

Is there a den mother in the house?
 

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

Is There a Den Mother in the House?
 

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.

“You may or may not hear the sound of a click.”
 

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.

National Parkinson Foundation Statement on Recall of Medtronic DBS Component
 

edited in by Chemar Please go here to read the statement http://www.parkinson.org/getdoc/59a6...36f411/default

http://www.startribune.com/business/...1.html?refer=y
Star Tribune

A deep brain stimulation device used to treat conditions like Parkinson’s disease was classified Thursday by the U.S. Food and Drug Administration as a Class I recall — meaning the FDA believes there is a “reasonable probability” that a device will cause “serious adverse health consequences or death.”

But on Friday, Medtronic and two doctors said that patients are not in imminent danger. “No one’s going to die,”said Dr. Bryan Klassen, a Mayo Clinic neurologist who specializes in movement disorders and Parkinson’s.
Said Dr. Ali Rezai, a neurosurgeon and director of neuromodulation at Ohio State University: “It’s definitely not life-threatening. That is really incorrect. … I was very surprised by this.”

FDA officials on Friday did not respond to a request for an explanation about the recall classification.
Ihle said Medtronic has proposed a manufacturing change to fix the problem. That is under FDA review…

No one, Ihle said, has been reported to be harmed as a result of the problem.

Why, then, did the FDA *classify this as a Class I recall? “We certainly can’t speak on behalf of the FDA, or their reasoning behind the classification,” he said.

QUOTE: National Parkinson's Foundation Statement on Recall of Medtronic DBS Component
Release date: May 6, 2013

..."The manufacturer of deep brain stimulation (DBS) devices used in the USA and internationally, Medtronic, Inc., of Minneapolis, Minnesota, announced on May 2nd a risk of damage to DBS devices associated with the use of a component used in DBS surgery. The FDA classified this as a Class I Recall indicating high risk to patients. Medtronic had notified physicians of this issue in February." QUOTE...

"High risk to patients" is a watered-down definition of what the FDA said.
Class One is the most severe recall warning in the FDA's arsenal.

This is what the FDA means by Class 1:
..."A deep brain stimulation device used to treat conditions like Parkinson’s disease was classified Thursday by the U.S. Food and Drug Administration as a Class I recall — meaning the FDA believes there is a “reasonable probability” that a device will cause “serious adverse health consequences or death.”

How y'all like that with your breakfast coffee?

That FDA evaluation is still the official FDA evaluation.

Today is May 7. Medtronic sent out the letter to doctors - and to the FDA, - in February. What happened in those three months, from February to May?

The very first mention of the "recall" (has anyone been called?) was on this forum, on May 3, posted by Lindy Lanka, a patient.

Not the doctors, not Medtronic, not the FDA, and not the Parkinson's organizations. The first information made public and addressed to Parkies was from a patient. Three months after the doctors and the FDA were notified by the manufacturer.

What went on during those three months? Obviously nothing involving PwP awareness during their Awareness Month.

How did this go on for 3 months in secret and then out-of-the-blue the FDA tells us about the "reasonable probabilty" that something might happen, such as "death" and so there is a recall... but no one is being called.

Just ask Alice when she is two feet tall.

Hi Bob, would like to say that the first time I heard of this issue was from this forums' Violet Green, on the day I posted it. I believe that she read about it through a listserve. Perhaps she will be able to clarify which one. So I was more the messenger than the origin of this information. It was the result of a chain of PwP connections.......

As often, it is through the Pwp/patient network that such issues rise to the surface; without it most of us would be singularly ill-informed on just about everything we need to know, about managing and living with PD.

The fact that this arrived via the financial news media and not the medical/healthcare route just highlights our place in the scheme of things. For us the 'tiny' amount of people who could be affected are not negligible. They ARE us, regardless of whether we have had DBS or not. For all of us with PD, our disease could have gone wherever it needed to warrant the decision, never taken lightly, to have DBS surgery. In this respect as a person who is unlikely to ever be the recipient of such surgery, I still stand in solidarity with those who have done. In this case, even if the eventual numbers are found to be few, I believe that there is a right to be informed and that Medtronics' obligation should be greater to patients than to shareholders.

Lindylanka

https://www.michaeljfox.org/foundati...lation-surgery

“Medtronic tells The Michael J. Fox Foundation (MJFF) that the reported adverse event occurs at a rate of 0.25 percent when a lead cap is used during surgery.”
Medtronic is thereby telling the MJF Foundation substantially less than they told the doctors and stock analysts in their letter of Feb. 2013. Here is the same sentence 3 months ago:
“… has been reported with 0.25% of the DBS leads distributed, however, this incidence is lower than the expected actual rate of occurrence since every event is not likely to have been reported and the actual number of uses of lead caps is unknown.”

So the number is higher than a quarter of one percent, but they don’t know how much. They’ve done 114,000 of these, so how many patients are getting hit? 300? 1,000? Not many, everybody is saying.
But we OWE these people. Medtronic is now marketing the device around the world, for more diseases than just PD. But it was PwP who were the guinea pigs for this process.

ALL surgery is a risk?
Agreed.
The number of patients suffering a hardware and software upgrade will not be enormous.
Agreed.
It is a technology that probably will do things in the future that we can scarcely imagine today.
Agreed.
The FDA has jumped the shark.
Agreed.
This issue is being well-handled by the Parkinson’s Empire.
Disagree.
Just simple things, like sending one letter to the medical industry in February and then a truncated version 3 months later, to patient advocates, feeding them pabulum.
Just the whole sequence of events.
It is a desolate charade. For shame.
For shame.

Does the FDA get to see evidence like this?
 

I am so thankful for your kind help.

My disability made me very self-conscious and quite depressed at times. I had got to the stage where I was finding it too difficult to even write and this is my first letter in ten years.

I feel that you and the professor and the doctor have given me a new lease of life.

I watched my father, who I inherited the disease from, go through his life progressively getting worse, incapable of doing the simplest of daily chores like eating and drinking without aid and could only see myself going the same way.

I am only 52 years old but I had been noticing my shakes getting worse, so for me to have my operation regardless of what it involved has been a real life saver and no words can express my absolute gratitude.
Thank you
Rita Carlisle

Hey, doc! You just saved another life.

Gooooood-mooorning Medtronic!!!
 

Gooooood-mooorning Medtronic!!!
(soundtrack: Ride of the Valkyries, helicopters approaching at tree height)

Deep Brain Stimulation is one of the truly great accomplishments in the history of medical science. And PwP were substantially involved, as volunteers, for clinical trials, and as the first patients to dare to have it done to them.

People with Parkinson’s were there when it happened. They helped make it happen. They should be proud of themselves, and you should be proud of them. They should be treated with the utmost respect by the industry that grew up around their illness.

This absurd and surreal FDA “Class 1 recall”, fumbled from start to finish, is a perfect opportunity for Medtronic to defend its people, and its product.
And “its people”? Yes, the scientists and doctors… and the patients.

A small number of people, we are told, have been affected by caps designed to protect the lead inserted in their brains.

It was the luck, or bad luck, of the draw; it could have been any of us; many do not even know if their treatment involved use of the cap or not.

It is obscene the way these patients have been left dangling by this mini-farce operetta being played by the FDA. What has happened there should be thoroughly explained, and understood, instead of being belittled, feeding us bromides and pabulum, and forgotten about.

If you ignore the ”recall” and wait for it to be forgotten, it would most certainly tarnish the reputation of your whole futuristic project. Nobody gets away with anything, ever. That's a law of the universe: every grain of sand is numbered.

Track down the patients who suffered damage; guide them through a retro-fit; if needed; at no additional cost to them, and give them a thank-you gift and high praise.

One of the aspects of the Parkinson’s personality: when they get treated like cattle, they participate less. Treat them as equals, and they will emerge from their lonely sentry posts. And that’s not the Mirapex talking.

They are heroes, and should be treated as such. It would be a wise investment for Medtronic to make a grand gesture of justice; to cut the quibbling and the P.R. crap and be utterly transparent about the history of DBS, from its earliest days to now; because it is a glorious history, and it is a technology still in its infancy; a technology with a great future; and PwP are very much part of that history. And now, a small number have to go through the damn operation a second time, because of a minor glitch that no one could have foreseen. MDT, join us in saying, as say the Marines, we will not retreat from the battlefield and leave our wounded people behind.

The history of electronic brain stimulation has only just begun; don’t mess it up now, because history is hard to take back once it is done.

PwP offered up their living bodies and their living minds to make this history happen. One by one, the patients said, “Doc, let’s do it.”

Now, Medtronic, DO THE RIGHT THING. And then some.

And as for the FDA, it may take more time, as they seem to have morphed into some sort of doomsday cult of refuseniks. Their Import Refusal of Duodopa; their “Class 1 Recall” of DBS ; the only two alternatives PwP were examining, are stuck at the FDA.

Has the FDA started testing all the drugs on themselves? Has testing agonists made them irrational and dangerously compulsive – obsessive? After spending too long in the suntan machine?

I knew a guy like that. Then one day his urine sample exploded.

Some people just don’t know when to quit. Or what to quit. Or why.

But this case is very simple.

Fifty thousand years ago, we painted on the walls of the cave.
Twelve thousand years ago, we invented agriculture.
Ten years ago, we started wiring up our brains.

Those who accomplished this unimaginable medical revolution; those on both sides of the scalpel, are heroes.

A small number of the heroes were hurt by a small piece of plastic. That can be fixed. In a victory parade, not a funeral march.

Don’t show the FDA how fast you can bully your way past a “Class One Urgent Recall”. Instead, demonstrate to the FDA how a Class One medical team treats their Class One patients: be a Class Act.

Be transparent and be generous and be true, and you will, over time, notice that you are getting more volunteers, and more support, than the Pharma firms who simply hand every question over to their lawyers, to lay down a thick fog of deception and delay.

Say, by taking action: “We ain’t like them other folks. We take care of our people.” You will find it rewarding, in every way.
Show us your colours, MDT. Make it shine.
Bob Dawson

The FDA has discovered the internet
 

The FDA Patient Network Blog:
Bringing Your Voice
to Drug and Device Approval and Safety

Enter key words:

Search: Duodopa - Your search yielded no results

Search: Duopa - Your search yielded no results

Search: AbbVie - Your search yielded no results

Search: Medtronic - Your search yielded no results

Search: DBS - Your search yielded no results

Search: Deep Brain Stimulation - Your search yielded no results

Search: Parkinson’s - Your search yielded no results

Search: patient –
Become a Patient Representative We are committed to making more opportunities for patients to participate in FDA decision-making. Our Patient Representative Program brings your voice to discussions about new and already approved drugs and devices and policy questions.

http://www.patientnetwork.fda.gov/

May I ask?
 

Bob, I hope you know that I applaude your tenacity. As I understand this recall is because the leads may have been damaged during the surgery. I ask whether a patient may have been given these caps but the leads were not damaged. They have been successfully treated and are having good results. I don't understand how they are going to do anything beyond assist those who may be having problems. If it ain't broke they aren't going to do anything for you.
I think this recall action should be focused on the physicians and to inform them of this and then to replace these caps with something else. Recall the DBS caps. I got the impression it was technique and not necessarily device related.
GO GET 'EM

May I ask? Yes, Caveman Jim, ask away

Bob, I hope you know that I applaud your tenacity.
It’s the Mirapex, Jim.

As I understand
As YOU understand, Jim? Now we are in another dimension. I am the walrus.

this recall is because the leads may have been damaged during the surgery. I ask whether a patient may have been given these caps but the leads were not damaged.
From conversations; statistics not official:

80 % of the surgeons never used the protective caps.
20 % did, but not always.

Usually the cap did no damage and the treatment went as well as expected.

Why are they bringing in a better and safer design of caps from Europe? Why not stop using the caps altogether? I don’t know.

It seems likely that some PwP will require a second operation. It will be MUCH easier than the first, because drilling, implanting brain zapper, etc., are all done. Just gotta replace the wires, which is why I advised them to just bring in a handiman electrician, non-union.

I have heard from one source that 80,000 of these operations have been done; another source says it was 114,000 operations. The company states problems with one-quarter of one percent of the operations; in another document they say that number is too low, because of “events” not being reported, and because they don’t seem to know how many times the surgeons used the caps. That sounds like sloppy record keeping, surely they must have written down what they did in each operation.

They have been successfully treated and are having good results.

Yes, most PwP for whom the caps were used, had good results, as good as no caps. The caps are also used in other countries, with success.

I don't understand how they are going to do anything beyond assist those who may be having problems. If it ain't broke they aren't going to do anything for you.

That is correct. Most people suffered no damage. They will not get a second operation, because they don’t need one.

Any help given will be to those who had the cap used, but who are showing no benefit from the treatment…different levels of intervention will be required. We want MDT to err on the side of generosity to the patient if there are disputes about just how “Off” you get or how much benefit you are getting from the treatment. But I doubt that patients will demand a new operation frivolously. It’s not that much fun.

The craziness of Parkinson’s is a problem. For them, not for us. The FDA assumes everyone fits a category. Some of the Parkies have been horsing around with things like changing the signal strength and changing the frequency of zaps to your brain…

Don’t forget, these are PwP’s. There’s always somebody like Rick using it with starter cables and a truck battery… or somebody like me trying to get the electrical pulses lined up with the Stones singing Street Fightin’ Man.

The FDA panics because this is worse than Cataclysm Code One, at least within their life experience, and they scream: What category are you in?
PWP: The category of who wants to free you from your own prison, baby. Drink some of this. It’s home brew dyn-o-mite. Cure all aches and pains.
FDA: who are these strange people?
PWP: we are the future honey. We use our brains to control our brains. Now zap my brain onto over-drive and let’s get down.
FDA : Am I here all alone? Weren't these people all recalled?

The civil servants at the FDA all believe that Ralph Nader was talking about life itself – not just Chevrolet Corvairs – life itself is unsafe at any speed. When they meet some of these Parkies, and especially the self-created civilian scientists, the cultural dissonance is deafening.

You are the patient, so act sick when the inspector comes around. They are confused when you turn on and off. When they ask you how you are doing, burst into laughter. Practice vomiting on command. Speak in tongues.

I think this recall action should be focused on the physicians

Yes. But MDT should take charge. And I resent that they all brush us aside by saying Go See Your Doctor and leave us out of it. No way. Of course we have to see the doc. But there was a team, remember? Doc is just one of my players.]

I got the impression it was technique and not necessarily device related.
Funny, that’s what women always tell me.

The plot thickens as the mystery deepens
 

You want to know all about the relationship between the Parkinson’s community and the community at large, in particular, the medical industrial complex?

Here is all you ever need to know; just this one sentence; engrave this in your memory:

“In making this risk-based assessment, the agency may consider factors about which local practitioners are unaware.”


And of course they refuse to say what those factors might be.
Orwellian to perfection.

To Be Continued, but right now I have got to pick myself up off the floor.

Scheduled for DBS?
 

I've been following this topic with great interest as I am scheduled for DBS. So I started asking questions and was referred to the Medtronic rep. I was told that it was up to me and that I could tell my surgeon whether or not I wanted him to use that cap or not!!!!????? WHAT!!!!

To cap or not to cap? What kind of question is that?
 

One of the top surgeons, who has been doing DBS for 16 years (which is really from the very earliest days) has NEVER used the cap.

80% of the operations are done without the cap.

What is the difference? Why use or not use? And Meditron wants to bring in a new design of cap, (why?) already being used in Europe, but (think Duodopa) it is being blocked for no visible reason by the FDA.

No, we are supposed to say, it is being studied day and night by a crack team of patient-oriented FDA scientists. (Laughs, falls on floor again.)

Back down the rabbit hole. Just ask Alice, when they make her feel very, very small.

Madamlash,
i am slow on the uptake today. Did your Medtronic sales rep just now offer to sell a treatment that the FDA has recalled, as a Class 1 threat to life?

Would that even be legal? Is a "recall", Class 1 Urgency just sort of a suggestion and nothing actually gets recalled?

Have they been installing them in the past three months, when the managers and the doctors and the stock market analysts were informed that there was a problem, but the PwP were kept in the dark?

So we have this conversation starting up 3 months too late, so we have less time left to make an evaluation and a decision? And we don't know who to trust? But we do know we are not being told the truth, the whole truth and nothing but the truth, because both stories cannot be right.
It cannot be "no problem" and "really deadly" at the same time.

We are not being told anything of substance, other than the usual bromides we have been hearing for years, and our questions go unanswered with a sneer.
Go see your doctor, is all we hear. Just shut up about it and stay inside patient-doctor confidentiality, so it doesn't become a public issue.

The issue I am talking about is not about the little piece of plastic. To hell with the caps - throw them out, unless one of the perps can give us a coherent explanation of why we should use the caps. The issue I am talking about is how there is some sort of bizarre and twisted event happening between two Jurassic dinosaurs, and once again Parkies are the cannon fodder, the monkeys in the middle, "les dindes de la farce" - the turkeys of the farce.
It would be funny if it weren't so stupid.

other considerations
 

We have Parkinson’s, but we are not mentally retarded. You do not have to spoon-feed us pabulum. Well, actually in the final stages you do, but you know what I mean. You don’t have to protect us from bad stories. Don’t assume that we must be told as little as possible, because we would not understand your concepts. Don’t assume that we are too impaired to notice the deck of cards you brought is missing the Jack and the Ace.

May 3, 2013, Violet Green and LindyLanka, Parkinson’s advocates, alert us to bizarre, brief articles in the Wall Street Journal, BusinessWeek, and later, Forbes. They say that the electrical system implanted in our brains might be defective and so the FDA has sent out an urgent warning that this thing-a-ma-jig installed through the skull is now subject to an Urgent Class One Recall.

Hey honey, look, we are number One!
Why is that a good thing?
The customer comes first. We are going First Class recall.
I think there is more to it than that.
Well it’s like when they recalled our Honda Civic; it cost us nothing and they even had free coffee.
But what do they mean when they say your brain is in a Class One Urgency?
It’s all a matter of perspective. It’s like having a spider in your bathtub.
I think you had better call the doctor.
During golf season?

Class 1 is the most extreme recall category in the FDA’s arsenal. It is only used when there is a clear and present danger.

This is very very serious:
"A deep brain stimulation device used to treat conditions like Parkinson’s disease was classified Thursday by the U.S. Food and Drug Administration as a Class I recall — meaning the FDA believes there is a “reasonable probability” that the device will cause “serious adverse health consequences or death.”

That’s not good. They BELIEVE there is…. Not a possibility; no, it’s a PROBABILITY, that this device will cause you serious and permanent damage, or DEATH.

Other than that, how are things? Keeping busy? Nice weather.

Go see the doctor. Where I live, that takes 4 to 6 months, to get squeezed in for a 15 minute appointment. And now everybody else is calling the same doctor at the same time.

And then we find the letter to “health professionals” sent out in February, by Medtronic, and it says this:


The exact opposite of what we are told by the other dinosaur.

Hey look, go fight that out with Godzilla. May the best reptile win.

People die from aspirin. People die from drinking too much water too fast. People die from the flu. Surgery is especially dangerous. And tinkering with the brain is at the very frontier of medicine.

Doctors have done thousands of these Deep Brain Stimulation operations, and they say they have not lost a single patient (in the recall group). Despite all difficulties that PWP can bring with them: old age, many symptoms, many potential complications… And yet not a fatality, not a single permanent injury.

To have created brain stimulation is worthy of a Nobel Prize. To do thousands of these operations and not lose one, is an extraordinary achievement.

ONE journalist, James Walsh of the Minnesota Star Tribune, the ONLY journalist who followed the story, called some doctors who have done a lot of DBS.
“No one’s going to die,” said Dr. Bryan Klassen, a Mayo Clinic neurologist who specializes in movement disorders and Parkinson’s.
Said Dr. Ali Rezai, a neurosurgeon and director of neuromodulation at Ohio State University: “It’s definitely not life-threatening. That is really incorrect. … I was very surprised by this.”
Rezai said he has been doing the procedure for 16 years. He never uses the lead cap, he said. Few other neurosurgeons do. Only when the lead cap is used can there be damage, he said.
Failure to deliver this therapy would mainly result in a patient’s symptoms returning. Not death or damage.
So we all agreed that the Class 1 Recall is a mistake. Nobody believed the FDA.

And then….
James Walsh:
… “an FDA spokesperson sent an e-mail to the Star Tribune, saying: “In making this risk-based assessment, the agency may consider factors about which local practitioners are unaware. The agency did not elaborate on what those factors may have been.” '

So we are back down the rabbit hole. The FDA has re-confirmed that there is a reasonable probability of the treatment being fatal. They offer no evidence.

They told us to see our local doctor but now they tell us “local practitioners are unaware.”

The local yokel doctors don’t know the secret reasons for the recall. Only the FDA knows what the risk-assessment factors are; and they won’t tell us.
And so the deadly Class 1 Recall has not only been re-confirmed by the FDA, it has been re-enforced.
'
This is not a big issue, compared to publication bias and science fraud, and other enormities. But we are pointing at it because it is a casual example of what Parkies face again and again. It is about as dysfunctional as it can get. And the position of the Parkies in these games is not at the bottom of the barrel, only because somebody sold the barrel too.
'
Now, you want the operation with the cap or without?

Evidence-based medical science? Where’s the evidence? It has been four months now, since the letter in February. But we have seen the same dynamic go on for years.

It’s a dirty rotten shame.

ABB, meet MDT. MDT, this is your co-sponsor of Parkinson's Unity and Proud PD Partner
 

This is the thread about re-wiring your brain for profit and pleasure.

There is a companion thread about the Duodopa Spring of 2013, located at:

http://neurotalk.psychcentral.com/thread185520.html

Just in case you need additional inventory.

Yep.... my choice.... what????!!!!
 

Yep. I was given to understand that I could choose to cap or not to cap. Maybe I could also chose to have a tassel on my cap and in my favorite team colors. What the F$%^k!!!!!
My rep said that she would be there for my operation and she'd tell my surgeon that I preferred not to have the cap. Oh yea!
Now I'm really feeling warm and fuzzy about this surgery. HELP!!!! I'm being attacked in a hospital operating room by IDIOTS!!!!!:eek:

Come hell or high water
 

MadamLash is crying “Help”.

Anybody got suggestions?

She is going in for the brain operation.

She needs to have confidence in her medical team. She is offered a choice: cap or no cap? Smoking or no smoking? Business Class or Steerage?

The FDA says the cap is probably deadly. The evidence does not. Or rather, we have seen no evidence. We don’t know if there is any evidence.

Ah, what the hell, it’s just your brain and your ability to function for the rest of your life. What could possibly go wrong? With the FDA and so many others looking out for our interests.

We are told that the caps have been recalled and are therefore illegal. But you can have one tomorrow.

We are told there is a recall, but we don’t see any calls, either in-going or out-going.

The FDA issued the recall May 2 and hit the press May 3, but if your doctor did not see the half-inch investor’s warning in the Wall Street Journal or Business Week or Forbes, or if your doctor does not read the Minnesota Star Tribune, then they may never have heard of it.

If MadamLash had been informed 4 months ago, at the same time as the stock market analysts, she would have had 4 months more to investigate and adjust and respond to this changed situation, to protect her health as much as the medical industrial complex had the extra 4 months to protect their assets.

Right now, we don’t know who to trust. The list of who not to trust is becoming very long.

It is all part of what Dr. Goldacre calls “the beginning of the end of a very dark period in medical history”.

The sales rep. from Medtronic is going to be with MadamLash for the operation! I take my hat off and bow

Maybe the sales rep. understands this Alice in Wonderland world and could report back to us what the doormouse said. But usually, silence is the decree in the medical industry. Transparency is the enemy of systems designed to deceive.

Your health team at the hospital may not be incompetent or idiots.

They may appear to be, as they are working for a system that has a completely different agenda. For every health worker in the field, there are a dozen pencil-pushers, power-trippers, empire builders, profit grabbers, law makers, rule breakers, financial takers, movers and shakers; elbowing each other out of the way, to be in the photo op, when it says “Medical catastrophe averted by upper-middle class university grad at FDA; now appointed President of (insert name of any big Pharma).”

Maybe your medical team just does not know what nonsense is going on, because they have been busy in the operating room.

I know of one doc., who unfortunately for us does not do Deep Brain; he does Open Heart.

He says he would not endanger the lives of his patients by following the ignorant and arrogant crap that comes out of both the FDA and the medical industry. His pact is with the patient. Come hell or high water.

MadamLash, I do not know how I can help you, but understand you have my unequivocal solidarity. Come hell or high water.

Remembering GDNF
 

Quoting Bob Dawson: "We have Parkinson’s, but we are not mentally retarded. You do not have to spoon-feed us pabulum. Well, actually in the final stages you do, but you know what I mean. You don’t have to protect us from bad stories. Don’t assume that we must be told as little as possible, because we would not understand your concepts. Don’t assume that we are too impaired to notice the deck of cards you brought is missing the Jack and the Ace."

Bob, I totally agree with you. Not in all cases or trials, but probably in 80% of them, they arent interested in the patient benefit. They are seeking profit, not just profit, but blockbuster steal-like-a- thief profit. It's disgusting!

I have been fortunate. I believe the folks that I worked with truly cared. Here's that report on the trial I promised you in the Spheramine or later called STEPS trial in which I participated:


Lancet Neurol. 2011 Jun;10(6):509-19. doi: 10.1016/S1474-4422(11)70097-7. Epub 2011 May 10.

Intrastriatal transplantation of microcarrier-bound human retinal pigment epithelial cells versus sham surgery in patients with advanced Parkinson's disease: a double-blind, randomised, controlled trial.

Gross RE, Watts RL, Hauser RA, Bakay RA, Reichmann H, von Kummer R, Ondo WG, Reissig E, Eisner W, Steiner-Schulze H, Siedentop H, Fichte K, Hong W, Cornfeldt M, Beebe K, Sandbrink R; Spheramine Investigational Group.
Collaborators (15)

Abstract
BACKGROUND:
Human retinal pigment epithelial (RPE) cells produce levodopa and their transplantation into the striatum might improve continuity of administration compared with that achieved with oral levodopa. We aimed to assess the safety, tolerability, and efficacy of transplantation of microcarrier-bound human RPE cells versus a sham surgery control in patients with advanced Parkinson's disease.

METHODS:
In this randomised, double-blind study eligible patients were aged 36-70 years, had been symptomatic for at least 5 years, were in Hoehn and Yahr stage 3-4 and had unified Parkinson's disease rating scale (UPDRS) motor scores of 38-70 when off medication (off state), and had symptoms that responded to oral levodopa but were insufficiently controlled by optimised pharmacotherapy. Randomisation was done in a 1:1 ratio. Only the neurosurgical team was aware of treatment assignments. During stereotactic transplantation around 325,000 cells per side were injected into the postcommissural putamen; sham surgery patients received partial burr holes. The primary efficacy endpoint was change in UPDRS off-state motor score at 12 months. This study is registered with ClinicalTrials.gov, number NCT00206687.

FINDINGS:
Of 71 enrolled patients, 35 underwent cell transplantation and 36 sham surgery. Change in mean motor scores did not differ significantly between groups (-10.5 [SD 10.26] for transplantation vs -10.1 [SD 12.26] for sham surgery, p=0.9). The overall rate of adverse events was similar in the two study groups, although the number attributable to surgery or RPE cells (mostly neurological or psychiatric) was higher in transplant recipients. Two and seven patients died in the sham surgery and transplantation group, respectively; one death in the latter group was possibly related to surgery or RPE cells.

INTERPRETATION:
Transplantation of human RPE cells provided no antiparkinsonian benefits compared with sham surgery.

FUNDING:
Bayer HealthCare AG.
Copyright © 2011 source www.pubmed.gov

This trial began with funding from Titan Pharmaceuticals , a small biotech company in New Jersey. Then they sold their company to Berlin's Schering AG. These people were so nice my husband and me. Then Bayer and Schering AG merged, and the big boys (Bayer) could have cared less - much like the first GDNF trials by Amgen. We advocates fought so hard for GDNF way back when, but Amgen retained the right to halt the trial when we saw great improvement in patients with our own eyes.

Bob, you know what the number 1 most promising therapy is today. Yep, it's GDNF. It is not cell transplants for dopamine production, it's growth factors. They have oversold DBS. I may have to eat my words and have a DBS, but I'd rather wait for GDNF. All they have to do is figure out how to deliver it to the brain. Keep close watch advocates, or big pharma will steal our cure - AGAIN!

speech speech
 

JStar said:
Bob, what would you and other patients want to see MDT do? I truly want to know.

Bob said: Set aside for a moment all the mysteries of cap / no cap / new European cap, / FDA cap inspection / when is a recall not a recall, / are you in Class One? NO, WE ARE IN CLASS P.D. and it changes like the shoreline and the sea; stop trying to classify me; I am not out of my tree, because THAT is not my tree.

And have your President attend a Parkie meeting, and put it on You-Tube:

Good afternoon,
It has come to my attention that there is some question about the relationship between Medtronic and People with Parkinson's, arising from reports about a safety notice issued by the FDA.

On an issue like that, even though it is more fear than fact, we must walk a mile in the patient’s shoes, and ask yourself, if I was the patient, or a loved one of the patient, what medical information would I want to have access to?

The answer: Everything.

Without further ado, let me be straight.

We stand by our people. They are changing the history of medicine with Deep Brain Stimulation. The doctors, the surgeons, the professors, the scientists, the territorial reps, and with special gratitude, the People with Parkinson’s, who offered up their living bodies and their living minds to make this medical revolution possible.

There are now 140,000 Americans who have received this treatment, and although it does not relieve all symptoms at all times, we know there are 140,000 people in less pain and with more functionality.

We would like the People with Parkinson’s to be as proud of themselves as we are of them. This technology has not only helped Americans suffering from Parkinsons, it is now used in at least 40 countries…. For a growing number of conditions: essential tremor, chronic intractable primary dystonia, severe treatment-resistant obsessive-compulsive disorder, refractory epilepsy…. And it has only just begun.

We stand by our people. Recently we discovered a minor problem with a device being screwed in too tight – we will provide you with all information about that at your request. It is not dangerous or fatal. It does not affect many people. For many, some simple adjustments can be done. A small number may require another operation to replace the leads. Whatever it takes, no matter how few or many they are, we will take care of them. We stand by our people.

We are proud of them, and we hope they too, will be proud of us.
We never could have done it, without each other. The day will come when the human brain will be fully explored and mapped. And you, all our people, the doctors and the surgeons and the professors…. And the People with Parkinsons; you were there when it started. Because of you, it was possible.

Future generations will marvel at how you dared to go where no one had gone before.

If you have any questions, know that we will hide nothing in our answers. We have come this far together, sign up for our next adventure.

Thank you.

Neuromodulation Market Driven by Rising Elderly Population
 

THANK YOU, Omar Ishrak CEO of Medtronic
 

THANK YOU, Omar Ishrak CEO of Medtronic

19th June 2013
US company Medtronic has just heard the results from its groundbreaking project on clinical trial transparency. Two years ago Medtronic gave all the clinical trial data it has for one of its back surgery products to researchers at Yale University. The Yale experts commissioned two groups of researchers at Oregon Health & Science University in the US and the University of York in the UK to conduct separate systematic analyses of the data. The groups have just reported the results which show that Medtronic’s product is no more effective than the older technique it was meant to replace and it increased the occurrence of some side effects.

Harlan Krumholz, the director of the Yale Centre for Outcome Research and Evaluation, devised the Yale Open Data Access Project, or Yoda. He describes Medtronic in this Forbes story as “declaring a whole different day where they are not hiding anything on this drug when every other company is hiding their data.”

CEO of Medtronic Omar Ishrak explains the decision to release all the data to researchers at Yale and to allow the Yale group to make the data available to any other researchers who want to analyse it, in a YouTube video. He said: “We recognize that our products and therapies must have the public and medical community’s trust.”

Ben Goldacre, co-founder of AllTrials said: “This is a fantastic and inspiring story. Medtronic and GSK are showing clear leadership, moving forward by example, and making clear that the simple ask of AllTrials is eminently achievable. There is an inevitable policy trajectory towards greater transparency. CEOs of companies who have not moved towards transparency are inflicting enormous and unnecessary reputational harm on their companies, by pretending they can wish this away. We need industry to do the right thing, show clear leadership, and regain the reputation they deserve, as the industry that makes lifesaving products. They can start by signing up to AllTrials, drawing a line, and moving forwards.”

Carl Heneghan, Director, Centre for Evidence-based Medicine and co-founder of AllTrials said: “Only a few years ago, it would have been inconceivable that a company’s CEO would find it helpful to provide data to an independent group of scientists, who would go on to find their intervention doesn’t work. Yet, this is the situation we now find ourselves in: with Medtronic’s move to provide access to their trial data on Infuse. Medtronic and GSK are trying to restore confidence in the current system, which has received substantial setbacks due to the withholding of data. This is to be welcomed: restoring trust by access to data for independent review means effective treatments can be made available for patients quicker, and as in this case, ineffective treatments removed before they cause harms. In the interest of patients, the time is right for manufacturers to follow Medtronic’s lead, and sign up to AllTrials.”

[QUOTE=Bob Dawson;983444]
JStar said:
Bob, what would you and other patients want to see MDT do? I truly want to know.

....have your President... put it on You-Tube... (QUOTE)

And here it is !!!! :

http://youtu.be/rRmRmSvcO-w

(Not about P.D., but that does not matter.)


What matters is the top guy at Medtronic is on the side of the angels.
Medtronic, plus GSK, have started an avalanche.

My heart is joyous.

No More Secrets
 

Great article in Forbes:

No More Secrets: Medtronic Shows How Open Science Might Work In The Real World

http://www.forbes.com/sites/matthewh...he-real-world/

honest, open discussion!

new era of data sharing
 

Safety review of bone growth product ushers in new era of data sharing
Yale News:

Yale University Open Data Access (YODA) Project

The YODA Project seeks to address the problem of unpublished and selectively published clinical evidence. Medtronic is the first drug or medical device company to contract with YODA and allow access to all of its clinical trial data for independent reanalysis.

/… “Open science and data sharing will create scientific enterprise that is better able to meet the needs of the public and is a sign of a company that is willing to compete in science rather than marketing,” Krumholz added. “Let’s hope that others adopt a similar approach.”…

The dataset is available free of charge to eligible researchers who wish to create scientific knowledge by replicating these analyses, or addressing different scientific aims.
http://news.yale.edu/2013/06/17/safe...a-data-sharing