Those are serious allegations, Greg. I must admit, that this is the first i have heard of them. Whats your source?

I survey my group for the percentages and talk with surgeons. Lets get some definitions working here.


1. "Successful" you keep your DBS on 24/7, because you feel better with it on.
2.UNsuccessful, you feel worse with it on than off.


first we must factor the installation teams expertise.
secondly are their broken wires or fluids leaking into connections.
IS the programming off? I have had 50+ cases of bad programming since I started my group.
So these people who were vocal in their disparaging DBS are now off living their lives and not being nearly as vocal in groups such as this one.
IF I were a motivational speaker, I probably say mine was not that successful, but I am not and I could care less about my inability to speak clearly. SO even those who had unrealistic expectations and disparage their DBS, keep theirs on 24/7. That, to me, qualifies as successful.
I will try to get Dr Ronald Young's thoughts on the subject .He has 900 DBS's to his credit, with no bleeds or deaths.


Charlie

Charlie,

Information about Medtronic's illegal dealings are detailed in the links in Greg's post in this thread:

http://neurotalk.psychcentral.com/thread86327.html

An article on a falsified study on the use of Infuse published by one of Medtronics consultants (and an army doctor at Walter Reed) was in today's NY Times. Here are a few exxcerpts and a link to the full text. Medtronics was not accused of any wrong doing in this article -- so far only the doctor is being held responsible. But we've seen many times the potential for abuse of the truth and of trust when highly paid consultants are involved .

THE NEW YORK TIMES
May 13, 2009
Army Disputes Doctor's Claim in Study of Injured
By DUFF WILSON and BARRY MEIER

"A former surgeon at Walter Reed Army Medical Center, who is a paid
consultant for a medical company, published a study that made false claims
and overstated the benefits of the company's product in treating soldiers
severely injured in Iraq, the hospital's commander said Tuesday.

An investigation by Walter Reed found that the study cited higher numbers of
patients and injuries than the hospital could account for, said the
commander, Col. Norvell V. Coots.

"It's like a ghost population that were reported in the article as having
been treated that we have no record of ever having existed," Colonel Coots
said in a telephone interview on Tuesday. "So this really was all falsified
information."

The former Army surgeon, Dr. Timothy R. Kuklo, reported that a bone-growth
product sold by Medtronic Inc. had much higher success in healing the
shattered legs of wounded soldiers at Walter Reed than other doctors there
had experienced, according to Colonel Coots and a summary of an Army
investigation of the matter....
"While at Walter Reed and since, Dr. Kuklo has given talks to other doctors
around the country about the bone-growth product, a protein called Infuse,
according to meeting agendas and published documents.

A Medtronic spokeswoman, Marybeth Thorsgaard, confirmed that Dr. Kuklo was a
paid consultant to the company and that the company financially supported
some of his research at Walter Reed, through a foundation affiliated with
the hospital.

But she said Medtronic did not finance or review the Infuse study, which was
published in Britain last August in The Journal of Bone and Joint Surgery.
She declined to say when Medtronic had hired Dr. Kuklo or how much it had
paid him over the years.

Infuse is widely used in civilian hospitals and trauma centers around the
country for spinal surgeries and to treat broken bones. The Food and Drug
Administration issued a safety alert last year that Infuse, if used in neck
surgeries - for which it has not been approved - could cause breathing
difficulties.

Since last year, the Justice Department and Senator Charles E. Grassley of
Iowa, ranking Republican on the Senate Finance Committee, have been
investigating whether Medtronic illegally promoted unapproved uses of Infuse
by paying doctors, among other measures. The company has denied those
charges.

During the six-month period ending last October, sales of Medtronic's
bioengineered products, principally Infuse, reached $419 million, according
to a company filing....

full text at:
http://www.nytimes.com/2009/05/13/bu...1&ref=business

So, is there a place on the Net that one can find the "20 questions" a patient needs to ask before, 1) finalizing the surgeon, and 2) understand what to expect, and 3) finding the right programer, and 4)???

If not, do we need a place like this were a patient can go and find the right questions to put on their asking list?

Seriously!! It sounds like the answer is NO!

I looked at another forum and found these thread titles. Even if the title doesn't sound like someone seeking opinions/advice about DBS the thread usually turns into such discussion...usually there is someone considering...and then there are all the lurkers who don't ask, but read-only:

1. Just beginning to think about DBS
2. Why not DBS as a first in line treatment in early PD?
3. DBS ........three questions ............ everyone is "pushing it" ...............1. any regrets out there? 2. who is best neurosurgeon? 3. anyone had ans/st jude dbs? and is it worth waiting for (expected approval 2010?
4. Hello to all, DBS problems
5. DBS
6. DBS vs best medical management with tablets
7. Response to post about dbs from Oct. 23
8. Aftershock-How to survive an unsuccessful DBS
9. DBS - To have or not to have?
10. DBS Update - personal progress
11. DBS surgery results for PD patients without tremors?
12. DBS again
13. Why not DBS as a first in line treatment in early PD?
14. Post DBS Complications experience
15. finding the right DBS surgeon
16. DBS Cartoon
17. DBS and meds
18. Hello to all, DBS problems

Carolyn;
I am not allowed to post it here but my Yahoo group is an excellent source of information about things DBS. I do not talk people into a DBS because it is a fruitless exercise. You know when it is time for a DBS, no one has to convience you.

We have a unique system here what with the FDA, but it works! No other country has the money to research and develop drugs like the USA does. Look at all the drugs developed here as opposed to other countries.
Greg;

I look at site like the one referred to with a healthy dose of disbelief. Is there any independant confirmation of these allegations?? I find myself reading this stuff with a lot of skepticisim. The few bits I read all seemed to be written by the same hand.

hows AJ????

love you guys!!!

Charlie

OK - So why am I picking on Medtronic instead of some arguably more egregious Big PhRMA companies like Pfizer or Merck or GSK. This is my reasoning.

I do think that we as relatively well-informed PWP, and our national and regional organizations have a special duty to PD patients to make certain that we are not endorsing, explicitly or impliedly, therapies that benefit industry but put patients at risk for serious injury or death. That is the situation that I think we find ourselves in with regard to Medtronic.

I think the distinction between companies that manufacture PD pharmaceuticals and then bribe or payoff medical professionals to push their products, and the same kind of activities by Medtronic, is a clear one. Pharmaceutical manufacturers are generally engaging in criminal activity in order to gain a greater market share for competing drugs that have proven to be effective, or at least show little evidence of doing active harm to patients. When GSK or Pfizer, among others, pays kickbacks to doctors to push their drugs ahead of others the worst that generally can happen is that the patient gets fleeced by having to pay a higher price for medication.

With Medtronic, however, we have an entirely different situation. Medtronic promotes and provides equipment for extremely invasive brain surgery. They don't know why it works when it works, and they don't know why it doesn't work when it doesn't work. The operation is pushed everywhere by everyone, but no one seems to have knowledge of the serious adverse effects which can and do result from the surgery. Numerous deaths , injuries to speech, facial expression, and gait and balance, among others, are not insignificant. It is my anecdotal observation, shared by many in the patient community, that for every apparently perfect and beneficial DBS surgery, there are others that involve complications from misplaced leads, crossed leads, broken wiring, improper placement of wiring, and to my personal knowledge more than one instance of the wires to the leads breaking out through the scalp necessitating another surgery. And infections are all too common.

As to FDA protection, it is being investigated in relation to its approval of DBS. Since the FDA did not require the standard double-blind, placebo-controlled clinical trials for DBS before approving it for commercial use, our opinions about the surgery become even more important.


Just as frightening are Medtronic's plans to apply this surgery to relieve "mental pathologies" such as OCD and depression. By taking Medtronic's money to fund its activities, every major Parkinson's group, both national and regional, is impliedly endorsing this surgery for the Parkinson's community. NPF even has commercial spots on NPR advertising it’s “long partnership” with Medtronic. The information requests from the investigation of Medtronics currently underway in Congress (that's why Micheal Kinsely was testifying) have specifically asked those receiving contributions from Pharma and medical device manufacturers if they have given exhibit space to such companies during conferences and seminars. They are also questioning the widespread use of Pharma money to finance continuing education of medical professionals, including those still in training to be MD's.

From my research it is clear that Medtronic has and continues to engage in criminal activity on a massive scale to push its products. So why do we blindly support DBS? We support it because doctors and researchers and the FDA recommend it. Of course the real question is, do they recommended DBS because of their objective and uninfluenced assessment of the value of the procedure, or will we find a year or two or three down the road that physicians and researchers have been recipients the same payments and "perks" that have tainted other Medtronic devices such as defibrillators, pacemakers and spinal products.

This pattern of illegal payoffs by almost every major pharmaceutical and medical device company is threatening to pervert the model of patient/physician consultation about therapeutic alternatives. Relying on your physician to give his or her best advice, uncompromised by drug and device companies payments, is becoming less and less reliable.

The bottom line is that if we can't trust the medical community to make an objective assessment of the safety and efficacy of DBS surgery, then how can we trust that we as PWP's, and our patient organizaions are not, by taking Medtronic's money and allowing them to exhibit at our conferences, putting the safety and lives of patients in our community at risk.

Given Medtronic's pervasive pattern of lying about their products and bribing the medical community to do so as well, we have a special obligation in this particular case to see that we do not contribute to any undue risk of injury or death by our association with the company. Give bad or incomplete advice about Requip or Mirepex, generally the worst outcome is a few bad days. Recommending DBS without knowing important facts about its maker and the maker's marketing techniques, somebody could suffer serious adverse effects or even death. This is a special place where folks rely on the members for reliable answers. We owe it to them to educate ourselves fully about a product before sending them willy-nilly to the neurosurgeon.

wow greg!!

First we know now that DBS affects the neurons that connect the cells.

I just can't believe that MEdtronic are a bunch of crooks.

There is a cadre, albeit a small one, of teams that have DBS down to an art.

As brain surgery goes, DBS is minimally imvasive.

I have never heard of anyone misconnecting the leads. (they only fit one way)

again, properly done, there are NO problems with the wiring. Mine is 7 years old.

There is a study out that says some big centers have a 2 0% rate of complications. However there are surgeons out there with 700 procedures and NO complications, such as infections.

I hsaid it before, your choice of surgeons will determine whether you have a successful DBS. Get a good team and success is as close to a slam dunk as you can get in the medical profession.

There are two studies out and both found that DBS was superior to medications for symptom relief.

We KNOW all the nuances of the Soletra and Kinetra and we know most of them in the surgery too.

more later
Charlie

No patient should follow only their doctor's recommendations. We are not only patients, we are consumers. I was told I should not have the surgery. One neurologist told me I had delayed stress syndrome, another told me I was very similiar to a patient whom had the procedure and committed suicide when he was depressed afterwords.

A responsible consumer needs to do as much as possible to understand their disease as possible. I had an F-Dopa scan at Mt. Zion which found me to be moderately severe. I also had the genetic test which found be to have two mutations in my Parkin gene; a rare finding. I then researched to discover other research done on patients with similiar findings, and discovered that the genetic component caused patients to be overly sensitive to carpidopa/levodopa. The summer before my surgery I was hospitalized twice because dyskenesias I had were severe enough to shut down my Kidneys.

I found research (not done by Medtronic) stating that persons with the genetic mutations responded extremely well to Activa therapy. I insisted on the surgery. I had enough documentation to know it was right for me.

Debora Seltzer, on the other hand, also fought for the surgery. Many of you oldies may remember her as tenacity wins. She worked harder than I did to understand her illness. She had Activa therapy and developed a staph infection. She also found out later she never had PD and the surgery was wrong for her Malcharia formation. The surgery left her with permanent brain damage.

Was I right in insisting on the surgery because it allowed me to cut my carpadopa/levodopa to 1/3 what I needed prior to surgery? Was Deborah in error because she chose to have the surgery prior to getting a correct diagnosis? Both of us felt it was worth the risk. I was lucky. Tenacity wasn't. I had the surgery against my physician's advice. Tenacity had 100% support from her specialist.

Many give Mirapex a bad rap and want to see that drug taken off the market. I don't want to live without it as I have restless legs and it is the only drug that helps me.

We all are different. If you took all the drugs or implants off the market because someone reacted badly to it, none of us would find any relief from our symptoms. Everyone wants life to be fair, or in other words, no one could be different from anyone else. We don't work with what we want; We work with what we have.

Viva the difference,
Vicky

If we ever go for DBS, we will simply ask our neuro if he receives any compensation, trips, travel, conferences, incentives, etc. for recommending the procedure or particular device. I think most docs would be pretty offended by being asked this, but they should understand why you ask.

I am reading more and more about how ldopa "turns on you" after you have used it awhile and it sounds like it may actually make you progress faster? I don't know, but I do know that of the drugs that are FDA approved, only 40% actually work for those for whom they are prescribed...Charlie's point about no other country having the $$$ to develop drugs like the USA may be true, but so what, if we end up with a bunch of drugs that don't help 60% of the folks they are designed for?

My point: we have an alternative to drugs that has given a LOT of folks their lives back. If a device is defective, liability should be imposed, same as anywhere else. But that should be as far as it goes. Someone who installs or programs it incorrectly should not create liability for the maker of the device, no more than you could sue Michelin because the mechanic put the tires on wrong and one blew out and caused a wreck.

My worry is with the money-grubbing lawyers who would try to get some class-action going, which pretty much can guarantee a bankruptcy and then everyone suffers because the produce is no longer available to anyone.

If your doc gets compensated to recommend DBS, switch docs. But think about this: you don't think he's getting any incentives for writing all those scripts you take, every day? I don't want to ask ours, because I'm afraid I know the answer.

Vicky;

You know, my MDS took one look at DEborahs MRI (I think it was) and shook his head slowly and said words to the effect that if her doctors actually looked at her films, they would have seen her Chari malformation.

A good doctor is worth his/her weight in gold!!

Charlie

PS I am so happy to hear you are doing well!