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PARKINSN Home

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PARKINSN  October 2004, Week 1

PARKINSN October 2004, Week 1

Subject:

Re: DBS for PD and Dystonia: Long term Results

From:

"Phil E.Gesotti" <[log in to unmask]>

Reply-To:

[log in to unmask]

Date:

Sat, 2 Oct 2004 10:36:18 -0400

Content-Type:

text/plain

Parts/Attachments:

Parts/Attachments

text/plain (167 lines)

Hi Mackenzie and others,

Sorry that I didn't answer sooner. I have been off list and I also get
the digest version of this list which seems to be delayed some days.
First of all I want to make it clear that I believe that DBS is a
wonderful intervention. As others have posted, whether or not to have
DBS is a personal influenced by the guidance of our physician based on
our individual situation. I personally started the process to have DBS
back in January, but  a second neurologist helped me adjust my
medication to restore efficacy. I'm sure that I will eventually need to
have the procedure down the line. Now to address your post.

You wrote>>

"What I would like to know is, given that there is a 30% chance of
developing dyskinesia after two years of
levodopa therapy, and a 50% chance after five years of levodopa therapy,
is anyone else disturbed by
levodopa being held up as the "best" treatment for PD, the treatment
that must be surpassed (by therapies
requiring brain surgery, at least) in order for them to be considered
successful?"

I can't really give a definitive answer. I'm not sure where these
statistics came from. The problem with quoting statistics out of context
is that you can't assess how valid they are nor what they represent. Are
they from a peer reviewed journal? How large was the study? Were the
research methods valid? Researchers also like to extrapolate their data
in the discussion sections of their manuscripts suggesting that their
data show a trend that needs further study. Sometimes these suggestions
get promoted by others as study results not something for further
investigation..

Now I can only speak from my limited experience with PD over the last
eight years, but it seems like the levodopa boogie man is unleashed
every time a new agonsist or other PD drug is released. Comtan was
hailed as smoothing out the levodopa response; thus, reducing the on/off
fluctuations. The theory was that the long term side effects of levodopa
were due to fluctuating plasma levels. Comtan would extend the
longitudinal effectiveness of levodopa  by inhibiting levodopa breakdown
in the blood stream. Comtan is a good drug and I take it, but I recently
saw a study that appeared to refute the claim that it reduces the
fluctuations in plasma levels of levodopa. Neurologist promote the use
of agonist alone as the first intervention to supposedly extend the
longitudinal benefits of pharmacological interventions. They sometimes
throw in that agonists may slow the progression of the disease. It has
also been suggested that levodopa use my accelerate progression of the
disease. But none of these things have been proven in robust studies. I
think that these things come from suggestions that get embellished into
results. The bottom line is that it is difficult to separate the beef
from the baloney.

But enough rambling, get to the point Phil. Theoretically, levodopa is
the closest thing we have to restoring normal physiology. Levodopa is a
precursor amino acid of dopamine. Theoretically it can be converted into
dopamine in the brain and stored in the striatum and globus pallidus and
released when the neuron fires. This is contrast to the agonist that sit
in the synaptic cleft and statically change the firing thresholds of the
neurons. The surgical interventions shut off some of the basil ganglia
output all together. So one could speculate that they are disabling
function. Indeed as some have posted on the list, DBS doesn't restore
normal function. The problem with all the interventions available today
is that the disease progresses and thereby reduces the longitudinal
efficacy of the intervention. As I mentioned in a previous post, current
thinking is that it is the loss of the ability to store dopamine that
eventually leads to a reduction in efficacy of levodopa and side
effects.

This brings me to a final point. I stated in my previous post that DBS
had only been in wide spread use for about the last 5 years. Another
post made the point that it had been in use in France for 10 years. The
Medtronics web site indicates that it has been available since 1996. My
point is that 8-10 years ago it was experimental but within the last 5
years it has seen exponential growth as surgeons are trained throughout
the world. The Medtronics web site states that 15,000 implants have been
performed. The bottom line is that as an intervention it is still in its
infancy. The device will continue to improve and the procedure will
continue to improve.

But that same infancy makes it impossible to predict the longitudinal
(long term) efficacy of the device. With the high degree of variability
in the progression of the disease itself, it takes a large sample
population over a long period of time (10-20 years) to separate out
variability in disease progresssion from variability in long term
efficacy of the device. We now have a large enough sample population to
start conducting meaningful longitudinal studies. So if you have DBS,
get enrolled in one. If it indeed is shown to have a limited
longitudinal efficacy as is the case with Pallidotomy, it might not make
sense to have the procedure as the first intervention. Thus the
motivation to ride the drug horse as long as you can - a decision to be
made by you and your physician.

Now if you go to the Medtronics web site, you will see that response to
levodopa is one of the selection criteria for DBS. Why? Because response
to levodopa is another indicator that you have idiopathic PD. Idiopathic
PD goes along with the substantia nigra cell loss story that results in
a dopamine deficiency. Once again replace the dopamine and in early
stages symptoms can be relieved. As the disease progresses, dopamine
storage in the striatum and globus pallidus is reduced and levodopa is
not as effective. But the longitudinal effectiveness of levodopa is
highly variable due to the highly variable rate of progression of the
disease in each individual.

So it's not so much that surgical procedures must "surpass" the effects
of levodopa, but that in the absence of side effects levodopa provides
the best functional performance. It's replacing dopamine. Remember that
the theory behind DBS is that it inhibits output from the basil ganglia.
Since we really don't know the function of the basil ganglia, it's
difficult to say what function we lose when we shut part of them off. We
aren't restoring normal physiology.  So until we have sufficient
longitudinal data on DBS, it might be best to reserve it for when the
medication is no longer tolerable. We have a pretty good understanding
of the levodopa devil.

When you get a device approved by the FDA, you have to specify the
symptomatic indications that it treats. You also need to provide data
demonstrating efficacy for those indications. So one set of indications
are those associated with idiopathic PD. DBS has also been approved for
non-levodopa responsive Parkinsonism indications, such as, dystonia. I
don't know all of them, but you can read the web site as well as I can.
There are other indications, such as, essential tremor.

So you need selection criteria for patients to increase the probability
that DBS will be effective for the patient and to be compliant with the
use approved by the FDA. Also, failures detract from your efficacy
statistics and make your product look bad especially if the patient has
an adverse effect, such as, psychosis. Bad for business.

The Medtronics web site states that 15% of the PD population could
benefit from the device. I don't know how they came up with that. The
web site is rather sparse on references. I can speculate that they are
basing it on patients that are levodopa responsive, but cannot tolerate
the levodopa side effects. I heard an ad on the radio the other day
promoting DBS at a local medical center. A local producer recorded his
DBS procedure and has made it available on tape. The ad claimed that 87%
of the patients that had DBS at this center had dramatic results like
Ray. I thought that was cool. We're advertising for DBS surgery. What
isn't said is that patients were carefully screened for the procedure
and yet 1 out of 10 did not have dramatic results. Just another example
of buyer beware.

But the good news is that 9 of 10 patients did have dramatic results.
DBS needs to be seriously considered when quality of life is affected by
medication side effects. Once again a decision for you and your
physician.

Unfortuantely, levodopa is the closest thing that we have to restoring
normal physiology. It does well in the early stages when the disease is
dominated by the dopamine deficiency, but it doesn't do anything for the
cell loss in the striatum and basil ganglia that eventually dominates
and reduces its efficacy. The good news is that there is a lot of
reseach exploring the function of the basil ganglia,  the factors
contributing to cell death, use of growth factor to restore function in
the striatum and use of animal models to explore how the basil ganglia
develop from conception. So I implore all to get involved in a research
study. It gives you the opportunity to stick your nose under the
research tent and say "hey, what's going on in here?" Many studies
include examination by a research neurologist, so you essentially get a
free second opinion on your diagnosis. Much to the surprise of a small
number of people, they sometimes discover that they don't have PD.  Now
wouldn't that make your day!

Phil Gesotti 55/ dx 46

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June 2005, Week 4
June 2005, Week 3
June 2005, Week 2
June 2005, Week 1
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April 2005, Week 1
March 2005, Week 5
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March 2005, Week 3
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March 2005, Week 1
February 2005, Week 4
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January 2005, Week 3
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January 2005, Week 1
December 2004, Week 5
December 2004, Week 4
December 2004, Week 3
December 2004, Week 2
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November 2004, Week 5
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November 2004, Week 3
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July 2004, Week 5
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April 2004, Week 3
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March 2004, Week 1
February 2004, Week 5
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February 2004, Week 1
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January 2004, Week 1
December 2003, Week 5
December 2003, Week 4
December 2003, Week 3
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December 2003, Week 1
November 2003, Week 5
November 2003, Week 4
November 2003, Week 3
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October 2003, Week 1
September 2003, Week 5
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July 2003, Week 1
June 2003, Week 5
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April 2003, Week 5
April 2003, Week 4
April 2003, Week 3
April 2003, Week 2
April 2003, Week 1
March 2003, Week 5
March 2003, Week 4
March 2003, Week 3
March 2003, Week 2
March 2003, Week 1
February 2003, Week 4
February 2003, Week 3
February 2003, Week 2
February 2003, Week 1
January 2003, Week 5
January 2003, Week 4
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December 2002, Week 5
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November 2002, Week 5
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September 2002, Week 1
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July 2002, Week 1
June 2002, Week 5
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June 2002, Week 1
May 2002, Week 5
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April 2002, Week 5
April 2002, Week 4
April 2002, Week 3
April 2002, Week 2
April 2002, Week 1
March 2002, Week 5
March 2002, Week 4
March 2002, Week 3
March 2002, Week 2
March 2002, Week 1
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February 2002, Week 1
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January 2002, Week 1
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November 2001, Week 5
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November 2001, Week 3
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November 2001, Week 1
October 2001, Week 5
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June 2001, Week 5
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June 2001, Week 3
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June 2001, Week 1
May 2001, Week 5
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April 2001, Week 5
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April 2001, Week 3
April 2001, Week 2
April 2001, Week 1
March 2001, Week 5
March 2001, Week 4
March 2001, Week 3
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March 2001, Week 1
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February 2001, Week 3
February 2001, Week 2
February 2001, Week 1
January 2001, Week 5
January 2001, Week 4
January 2001, Week 3
January 2001, Week 2
January 2001, Week 1
December 2000, Week 5
December 2000, Week 4
December 2000, Week 3
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December 2000, Week 1
November 2000, Week 5
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November 2000, Week 3
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November 2000, Week 1
October 2000, Week 5
October 2000, Week 4
October 2000, Week 3
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October 2000, Week 1
September 2000, Week 5
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September 2000, Week 3
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September 2000, Week 1
August 2000, Week 5
August 2000, Week 4
August 2000, Week 3
August 2000, Week 2
August 2000, Week 1
July 2000, Week 5
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July 2000, Week 3
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July 2000, Week 1
June 2000, Week 5
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February 2000, Week 1
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October 1998, Week 1
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May 1998, Week 2
May 1998, Week 1
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April 1998, Week 3
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March 1996, Week 3
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February 1996, Week 1
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January 1996, Week 3
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December 1995, Week 5
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September 1995, Week 2
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August 1995, Week 3
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June 1995, Week 1
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April 1995, Week 1
March 1995, Week 5
March 1995, Week 4
March 1995, Week 3
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