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.

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!!!!

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.

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.

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. 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!!!!!

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.

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!

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.