Trying to find the fly in the ointment.

[Jim091866]

OK so here we are, the election is over. So I'm wondering what could cause the delay with Abbott and the status of the LCIG. It is clearly a therapy that works. It is already in use in over 40 countries. So what gives? Obamacare and its effect? Some people have said they were waiting on Medtronics patent to expire on the DBS but this doesn't make sense. The LCIG is far better and less invasive. Many other countries are using this treatment and you would think they would be biting at the bit to get something this revolutionary out there. AHHH, but these other countries have a national medical system-socialized medicine. That is the only thing I can think of, the price they would want is prohibitive to bring it to market. I'm afraid we aren't going to see this one. Some kind of "OMG, we didn't know that" will happen and just like with Amgen it will be shelved.

Why else couldn't they get it out there? They have already had extensive studies. Published results, and IT IS PROVEN to be an effective and superior treatment.

I can appreciate the work that the MJFF and others are doing for research but this is a treatment that can benefit us NOW, not in 4 or 5 yrs. I promise you that if you respond to levodopa. You will respond and probably better to the LCIG. Because you won't need as much! I forsee that Parkinson's patients will not want to be on oral medication and have all the ups and downs and dyskinesia @@@@ that when you have an alternative that has had the groundwork done and yet the FDA still jerked around and wanted more studies. Although the FDA can't approve something that has not been submitted so where is the holdup? I'll betcha if you put your nose to the ground and start sniffing for the money trail that will lead you straight to the answer but you'll have to be careful what other smells you'll run into.

Now where did I put that fly swatter...

[Jim091866]

Originally Posted by Jim091866

OK so here we are, the election is over. So I'm wondering what could cause the delay with Abbott and the status of the LCIG. It is clearly a therapy that works. It is already in use in over 40 countries. So what gives? Obamacare and its effect? Some people have said they were waiting on Medtronics patent to expire on the DBS but this doesn't make sense. The LCIG is far better and less invasive. Many other countries are using this treatment and you would think they would be biting at the bit to get something this revolutionary out there. AHHH, but these other countries have a national medical system-socialized medicine. That is the only thing I can think of, the price they would want is prohibitive to bring it to market. I'm afraid we aren't going to see this one. Some kind of "OMG, we didn't know that" will happen and just like with Amgen it will be shelved.

Why else couldn't they get it out there? They have already had extensive studies. Published results, and IT IS PROVEN to be an effective and superior treatment.

I can appreciate the work that the MJFF and others are doing for research but this is a treatment that can benefit us NOW, not in 4 or 5 yrs. I promise you that if you respond to levodopa. You will respond and probably better to the LCIG. Because you won't need as much! I forsee that Parkinson's patients will not want to be on oral medication and have all the ups and downs and dyskinesia @@@@ that when you have an alternative that has had the groundwork done and yet the FDA still jerked around and wanted more studies. Although the FDA can't approve something that has not been submitted so where is the holdup? I'll betcha if you put your nose to the ground and start sniffing for the money trail that will lead you straight to the answer but you'll have to be careful what other smells you'll run into.

Now where did I put that fly swatter...

I am going to go in depth here and try and assemble some talking points on this issue. LCIG or DBS or continue with oral levodopa.

For now we will concentrate on the first two LCIG vs DBS. We all know the third choice sucks.

It is Monday morning when you go into clinic. You are on your normal med regimen. After checking in with the staff and going through all the registration etc. you are in your room. This begins the "washout phase" you are off your PD meds to allow them to run out of your system. As much as possible you have a typical night feeling off, rigid, tremulous, cramping, muscle spasms,etc.
Tuesday morning your greet the staff and that morning you have a nasogastric tube placed. For the rest of the day they give you the LCIG and try to workout the best doseage for you. The medication goes down the tube and into your intestine, bypassing the stomach. The NG tube was placed to where it goes through the stomach and ends in the duodenum. If you were taking 9 sinemet a day or whatever your dose they try to mimic that and even regulate it down a little because now you are getting the full effect of the drug. Its not being used up in the stomach or impaired by food or lack of bowel activity.
Wednesday they fine tune your doseage and go through some instruction on the pump.
You are scheduled to have the NG tube replaced by a peg tube that will go in your abdomen.
That's it, you have the peg placed and take the pump home with you.
The pump is about the size of a bible, a little smaller.
You can now walk, move around, no rigidity, no spasms, no tremor. Ut-oh time for a pill? NOPE! The medication is being given constantly to your system! No more pills, no more forgetting a dose, no more sudden offs! You can have a life, go for a walk, a picnic, maybe garden a little bit, just simply be more comfortable without the ups and downs!

[Jim091866]

I will add part 2 after lunch.

[Jim091866]

So now we will discuss DBS. I had mine done in 2007. I have had also had surgery for the stimulator (batteries) replaced in 2010.

After extensive screening and discussion with your neurosurgeon you arrive at the hospital that morning off medication. After the check in procedures, usual lab work, ekg etc. you're all set.
It starts by fitting a halo device to your head. This is a stainless steel ring that goes around your head just above your eyebrows. It has about 6 anchors that are sharp metal studs that are screwed into your head fastening this halo to you. I am serious, I dont remember it being very painful but it was uncomfortable. They are like screws and the staff literally used a craftsman wrench to tighten it down!
You are taken to the OR and they have a clamping device that attaches to the halo and secures you to the table. You could not move your head if you wanted to. After some preliminary what nots and various steps the procedure begins. You are wide awake, the reason they don't want to medicate you is so that you can be fully functional during the placement of the leads.
The neurosurgeon starts by drilling into your skull. Remember I said you are wide awake and NOT medicated, NADA, NONE. They told me to make sure I had my mouth open lest it will rattle your teeth out of your mouth! This is the worst pain that I have ever had and could not imagine worse! Like childbirth I have forgotten it now. Then they have to drill for the other lead, bilateral DBS. Another 30 seconds of utter excruciating pain.
The procedure goes well-at least it did for me but it is a long procedure 6-8 hours easily as they map the target and try and find optimal placement.
Patients with a tremor respond well, very well to DBS. I do not have a tremor so they had to go by the computerized MRI to try and find the best placement. Once the leads are placed you are then given the general anesthesia and they secure the leads and you awaken in the recovery room. My leads and the battery stimulator were not done at the same time so I went back one week later to have a 2nd surgery where they "tunnel" the leads behind your head and down your neck. They place the stimulators which are like pacemakers under the skin in your upper chest/shoulder area.
Now the part begins where they try and determine your settings, they have an idea of what parameters should be used from the surgery where they determined placement of the leads. This is very consuming and at times discouraging if it takes a while to determine your settings. This part can take 3-4 visits or it could take a few months because you have to see how you respond to various settings. There are also changes in how the brain responds as you go.
In the interest of brevity this is about it for DBS, you try and find your best settings to control your symptoms. It is NOT a cure, may allow you to reduce your medication but it is not expected that you will be able to cut them out altogether. You also have to frequently return to the office for adjustments.

[Jim091866]

I have tried to describe my experience with DBS, I have been through that. As well as what I know of the LCIG after speaking to about 8 people who have the pump in trial and what I have read, mostly at this site.

I understand that there are complications to any surgery and I do not mean to sound diminishing of that in any way. We all would respond differently to the same treatment. You have to make up your own mind.

I for one wish they would do something with this treatment modality. They (Abbott) have said that they plan to submit to the FDA later this year. Well, it's getting near turkey time and I for one have had enough lame duck.

[Bob Dawson]

Jim,
Excellent post; thank you for all the work you put into it. I had not paid attention to this issue before - you have awakened me to it.

I went to the Health Canada website - it says duodopa is approved with conditions. Is the USA being overly strict, or is Health Canada being overly lax?

http://www.hc-sc.gc.ca/dhp-mps/alt_f...139124-eng.pdf

[lurkingforacure]

Originally Posted by Bob Dawson

Jim,
Excellent post; thank you for all the work you put into it. I had not paid attention to this issue before - you have awakened me to it.

I went to the Health Canada website - it says duodopa is approved with conditions. Is the USA being overly strict, or is Health Canada being overly lax?

http://www.hc-sc.gc.ca/dhp-mps/alt_f...139124-eng.pdf

I would be very curious to know just what those "conditions" are....I have read that in other countries those "conditions" are that you have to be so bad off that it is cheaper to give you this than pay for your stay in a nursing home...gee, thanks so much. If they make you wait that long, years, decades even, what kind of a choice is that?

[Jim091866]

Originally Posted by Bob Dawson

Jim,
Excellent post; thank you for all the work you put into it. I had not paid attention to this issue before - you have awakened me to it.

I went to the Health Canada website - it says duodopa is approved with conditions. Is the USA being overly strict, or is Health Canada being overly lax?

http://www.hc-sc.gc.ca/dhp-mps/alt_f...139124-eng.pdf

Thanks Bob, you know what I'm doing tommorrow, lol! I would love to raise the awareness of this therapy. The FDA has had an almost obstructionist position on this, the company was ready to ditch it in the preliminary stages. Now I think it is the company that is the holdup. It's a no brainer, if you respond to levodopa by mouth you will respond to it and at a better level by use of the pump. How would you like to be "on" all the time and not have to worry about forgeting a pill, what you ate, dyskinesia and all the hassle. If you were to get the pump this weekend. Next week would be a new day in your life! I am that sure of it. Look it up on you tube.

[Jim091866]

Originally Posted by Bob Dawson

Jim,
Excellent post; thank you for all the work you put into it. I had not paid attention to this issue before - you have awakened me to it.

I went to the Health Canada website - it says duodopa is approved with conditions. Is the USA being overly strict, or is Health Canada being overly lax?

http://www.hc-sc.gc.ca/dhp-mps/alt_f...139124-eng.pdf

Ths is taken from the Canadian health ministry's website:

DUODOPA™ (levodopa/carbidopa intestinal gel) FOR USE IN THE
TREATMENT OF ADVANCED LEVODOPA-RESPONSIVE PARKINSON’S
DISEASE WHEN SATISFACTORY CONTROL OF SEVERE, DISABLING,
MOTOR FLUCTUATIONS AND HYPER-/DYSKINESIA CANNOT BE
ACHIEVED WITH AVAILABLE COMBINATIONS OF PARKINSON
MEDICINAL PRODUCTS
FACT SHEET


Sounds like having unpredictable off time, dyskinesia fits the bill to me!

[lurkingforacure]

Originally Posted by Jim091866

Ths is taken from the Canadian health ministry's website:

DUODOPA™ (levodopa/carbidopa intestinal gel) FOR USE IN THE
TREATMENT OF ADVANCED LEVODOPA-RESPONSIVE PARKINSON’S
DISEASE WHEN SATISFACTORY CONTROL OF SEVERE, DISABLING,
MOTOR FLUCTUATIONS AND HYPER-/DYSKINESIA CANNOT BE
ACHIEVED WITH AVAILABLE COMBINATIONS OF PARKINSON
MEDICINAL PRODUCTS
FACT SHEET


Sounds like having unpredictable off time, dyskinesia fits the bill to me!

Ok, so if I dissect this, you cannot get this in Canada unless you

1. have ADVANCED PD (this will probably mean that you are really bad off)-to me, this seems like a very good way to significantly limit this option only to those who they expect will not need it very long
2. your PD responds to ldopa
3. you have to be able to show that you have tried all the available combinations of PD meds and that they were not sufficient to obtain "satisfactory control" (aka we-are-not-giving-this-to-just-any-PWP)...in other words, if someone decides that you get "satisfactory control" with drugs, you will not meet the criteria to get this treatment
4. you have motor fluctuations that are not only severe (again, who gets to decide this, what may be severe to the patient may not be considered such by the person making the decision (and I doubt that person will be the patient's doctor, that decision-maker maybe won't ever have even seen the patient, but I'm cynical)...so they have to be "severe" as well as "disabling", again, a subjective definition. What is disabling to a patient might not be considered disabling to a healthy administrator sitting behind a desk reading application after application....again,

It would be really interesting to see how many PWP there are in Canada...then see how many applications have been made for this....and how many have actually been granted. Because I'm a glutton for punishment, I'd also be curious to see just what the stated reason(s) were for each denial.

I can see those purported justifications now:

PD not advanced enough
motor fluctuations not severe or disabling enough
drugs are working well enough to control satisfactorily said fluctuations

Like I said, I'm cynical. But the gel inserts alone cost over 10K a month-120K a year from what I have read-does anyone really think government will pick up the tab for this on a large scale? Conversely, has the company that sells the inserts reduced the cost for those inserts at all in the last decade that this has been available in other countries? That's why this is not available yet here in the US...someone please tell me I am wrong.