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PARKINSN Archives
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PARKINSN@LISTSERV.UTORONTO.CA
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Dear List:
I am proud to confirm that a significant improvement in the treatment of
patients with advanced PD, whose medications do not work satisfactorily, has
been approved by the FDA with conditions. Deep brain stimulation, already
approved for tremor control, can now be used to treat the major debilitating
symptoms of PD (tremor, rigidity, bradykinesia, and postural instability).
As the "patient representative" with no vote (but a voice) on the FDA panel,
I can attest that the decision which was taken is in the best interests of
PWP, but not without cautions.
A wave of consumer participation appears to be sweeping over Federal
Agencies. The FDA is required to have patient reps for some conditions, such
as cancer and HIV, but this the first time that the agency has used a patient
representative for PD. In addition PD advocates have been substantially
involved in developing the NIH PD Research Agenda sent to Congress this week
(another story). This participation is an indicator of the arrival of the PD
community into the big leagues (politically) which means we get attention
from policy makers. Overall, I found the experience to be very positive,
because I felt the right decisions were made for patients.
Approval of DBS as "safe and effective" here means risks are acceptable and
relatively safe (e.g., compared to alternatives such as Pallidotomy) and that
significant improvements (25% or more) are likely. The data show dramatic
improvement in most patients, in terms of the amount and quality of ON time
during the day, but 10% experienced significant adverse effects, primarily
due to the surgical procedure, not the stimulater itself. The study design,
however, was flawed and may have introduced bias and thus weakened the
findings by the way data for drop-outs were handled, by the sample size, by
failure to control for documented "placebo" effects from tests of other PD
treatments, and by lack of controlled randomization for key questions.
Further documentation on these issues will be provided by Medtronic to
determine the extent of the bias.
My biggest concern was the need to have the procedure performed by a highly
qualified and trained surgeon in a well equipped and staffed facility. Even
with the best academic surgeons, significant serious adverse effects were
observed. The panel felt that training and credentials available currently
from the Company and from professional organizations were sufficient. I
believe that specific information about the training and experience of
individual surgeons and hospitals and some criteria to assess this
information will be important for consumers and their doctors to make
informed choices.
Another concern was the need to specify of the kind of patient that would
benefit from DBS. The panel stayed close to the data by indicating only
certain kinds of patients were tested (e.g. under 75, not suffering from
dementia, etc). The issue of cost and access to this very expensive
procedure was not raised in the context of safe and effective, but is an
issue for patients, insurance carriers and public policy.
Perry Cohen
Charlie Myers wrote:
Hi again, And thanks for the warm welcome back from so many of my old friend
here on the list.
I was down and not getting mail again today due to a bad disk sector which
included my registry. But all is ok now.
MARJORIE i WAS IN FORT Lauderdale. My Mother lives in Coconut Creek and I
was there for the 90th Birthday Party of her sister. Sorry we didn't think
of getting
together sooner rather than later.
Charlie
What follows is a Medtronics Press release:
FDA Advisory Committee Recommends Approval for
Revolutionary Application Of
Brain Stimulation to Treat Parkinson's Disease If Approved, Medtronic
Activa(R) Parkinson's Control Therapy Could be Used In
U.S. to Treat All Four Major Motor Symptoms of Debilitating Neurological
Disorder
MINNEAPOLIS, March 31 /PRNewswire/ -- Medtronic, Inc. (NYSE:
MDT), today announced that its Activa(R) Parkinson's Control Therapy,
which uses bilateral brain stimulation to treat the symptoms of advanced,
levodopa-responsive Parkinson's disease, received a unanimous conditional
approval for marketing clearance by the Neurological Device Panel
Advisory Committee to the U.S. Food and Drug Administration (FDA).
Conditions include: a three-year, long-term clinical follow-up, including
cognitive and neuropsychological factors; physician instruction on selecting
electrodes and programming; and several recommended label changes.
Medtronic does not anticipate a delay of marketing clearance based on
these conditions. (Photo:
http://www.newscom.com/cgi-bin/prnh/20000224/MDTLOGO )
If approved by the FDA, Activa Parkinson's Control Therapy would
become the first new approach to treating U.S. patients with Parkinson's
disease in more than 30 years. Activa Parkinson's Control Therapy is
designed to treat the four major motor symptoms of Parkinson's disease:
stiffness (rigidity), slowness or lack of movement (bradykinesia/akinesia),
shaking (tremor) and poor balance (postural instability). While tremor is
the
most widely recognized symptom of Parkinson's disease, it is the
combination of symptoms that makes Parkinson's disease such a debilitating
condition. More than 500,000 people in the U.S. currently have Parkinson's
disease, and approximately 50,000 new cases are diagnosed each year.
"Patients in the advanced stages of Parkinson's disease cannot be
satisfactorily controlled with currently available therapies and as a
consequence, suffer unacceptable levels of disability," says C. Warren
Olanow, M.D., a neurologist and movement disorders specialist at Mount
Sinai Medical Center in New York and a lead investigator in the clinical
studies for Activa Parkinson's Control Therapy. "Patients lose their
ability to
independently control their activities of daily living, and eventually,
they can
become completely dependent on others for their care. Brain stimulation
can help improve these patients' motor function and can help improve their
ability to perform their activities of daily living."
Oral medications and irreversible surgical procedures (which destroy part of
the brain) are currently the only treatments available for patients with
Parkinson's disease. Oral medications, such as levodopa, can gradually lose
their effectiveness over time and can induce side effects. Dyskinesia, or a
series of abnormal involuntary movements, is one side effect that can be
induced by oral medications.
Activa Parkinson's Control Therapy is designed to work by stimulating the
structures deep within the brain that influence motor control and by
blocking
brain signals that cause the four major motor symptoms of Parkinson's
disease. A medical device called a neurostimulator, which is similar in size
to a cardiac pacemaker and implanted near the collarbone, generates mild
electrical signals that are delivered to the brain via a thin implanted wire
with electrodes attached to the other end. The stimulation can be adjusted
non-invasively to meet each patient's needs.
In 1997, Medtronic received FDA marketing clearance for Activa(R)
Tremor Control Therapy, a unilateral therapy that uses brain stimulation to
treat tremor, the only symptom of Essential Tremor and one of the four
major motor symptoms of Parkinson's disease. Activa Parkinson's Control
Therapy represents an extended application of this technology and has been
available in Europe, Canada and Australia since 1998. It is still considered
investigational in the United States.
Most side effects related to stimulation can be treated by adjusting the
stimulation settings. These side effects can include slurred speech
(dysarthria), abnormal involuntary movements (dyskinesia), contractions of
opposing muscles (dystonia) and paresthesia. Risks associated with the
surgery and device can include confusion, intracranial hemorrhage,
infection, interruption of stimulation, loss of effect or lead migration.
Medtronic, Inc., headquartered in Minneapolis, is the world's leading
medical technology company, providing lifelong solutions for people with
chronic disease. Its Internet address is http://www.medtronic.com
Any statements made about the company's anticipated financial results and
regulatory approvals are forward-looking statements subject to risks and
uncertainties such as those described in the company's Annual Report and
Form 10-K for the year ended April 30, 1999. Actual results may differ
materially from anticipated results. SOURCE Medtronic, Inc.
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2000, Week 2 April 2000, Week 1 March 2000, Week 5 March 2000, Week 4 March 2000, Week 3 March 2000, Week 2 March 2000, Week 1 February 2000, Week 5 February 2000, Week 4 February 2000, Week 3 February 2000, Week 2 February 2000, Week 1 January 2000, Week 5 January 2000, Week 4 January 2000, Week 3 January 2000, Week 2 January 2000, Week 1 December 1999, Week 5 December 1999, Week 4 December 1999, Week 3 December 1999, Week 2 December 1999, Week 1 November 1999, Week 5 November 1999, Week 4 November 1999, Week 3 November 1999, Week 2 November 1999, Week 1 October 1999, Week 5 October 1999, Week 4 October 1999, Week 3 October 1999, Week 2 October 1999, Week 1 September 1999, Week 5 September 1999, Week 4 September 1999, Week 3 September 1999, Week 2 September 1999, Week 1 August 1999, Week 5 August 1999, Week 4 August 1999, Week 3 August 1999, Week 2 August 1999, Week 1 July 1999, Week 5 July 1999, Week 4 July 1999, Week 3 July 1999, Week 2 July 1999, Week 1 June 1999, Week 5 June 1999, Week 4 June 1999, Week 3 June 1999, Week 2 June 1999, Week 1 May 1999, Week 5 May 1999, Week 4 May 1999, Week 3 May 1999, Week 2 May 1999, Week 1 April 1999, Week 5 April 1999, Week 4 April 1999, Week 3 April 1999, Week 2 April 1999, Week 1 March 1999, Week 5 March 1999, Week 4 March 1999, Week 3 March 1999, Week 2 March 1999, Week 1 February 1999, Week 4 February 1999, Week 3 February 1999, Week 2 February 1999, Week 1 January 1999, Week 5 January 1999, Week 4 January 1999, Week 3 January 1999, Week 2 January 1999, Week 1 December 1998, Week 5 December 1998, Week 4 December 1998, Week 3 December 1998, Week 2 December 1998, Week 1 November 1998, Week 5 November 1998, Week 4 November 1998, Week 3 November 1998, Week 2 November 1998, Week 1 October 1998, Week 5 October 1998, Week 4 October 1998, Week 3 October 1998, Week 2 October 1998, Week 1 September 1998, Week 5 September 1998, Week 4 September 1998, Week 3 September 1998, Week 2 September 1998, Week 1 August 1998, Week 5 August 1998, Week 4 August 1998, Week 3 August 1998, Week 2 August 1998, Week 1 July 1998, Week 5 July 1998, Week 4 July 1998, Week 3 July 1998, Week 2 July 1998, Week 1 June 1998, Week 5 June 1998, Week 4 June 1998, Week 3 June 1998, Week 2 June 1998, Week 1 May 1998, Week 5 May 1998, Week 4 May 1998, Week 3 May 1998, Week 2 May 1998, Week 1 April 1998, Week 5 April 1998, Week 4 April 1998, Week 3 April 1998, Week 2 April 1998, Week 1 March 1998, Week 5 March 1998, Week 4 March 1998, Week 3 March 1998, Week 2 March 1998, Week 1 February 1998, Week 5 February 1998, Week 4 February 1998, Week 3 February 1998, Week 2 February 1998, Week 1 January 1998, Week 5 January 1998, Week 4 January 1998, Week 3 January 1998, Week 2 January 1998, Week 1 December 1997, Week 5 December 1997, Week 4 December 1997, Week 3 December 1997, Week 2 December 1997, Week 1 November 1997, Week 5 November 1997, Week 4 November 1997, Week 3 November 1997, Week 2 November 1997, Week 1 October 1997, Week 5 October 1997, Week 4 October 1997, Week 3 October 1997, Week 2 October 1997, Week 1 September 1997, Week 5 September 1997, Week 4 September 1997, Week 3 September 1997, Week 2 September 1997, Week 1 August 1997, Week 5 August 1997, Week 4 August 1997, Week 3 August 1997, Week 2 August 1997, Week 1 July 1997, Week 5 July 1997, Week 4 July 1997, Week 3 July 1997, Week 2 July 1997, Week 1 June 1997, Week 5 June 1997, Week 4 June 1997, Week 3 June 1997, Week 2 June 1997, Week 1 May 1997, Week 5 May 1997, Week 4 May 1997, Week 3 May 1997, Week 2 May 1997, Week 1 April 1997, Week 5 April 1997, Week 4 April 1997, Week 3 April 1997, Week 2 April 1997, Week 1 March 1997, Week 5 March 1997, Week 4 March 1997, Week 3 March 1997, Week 2 March 1997, Week 1 February 1997, Week 5 February 1997, Week 4 February 1997, Week 3 February 1997, Week 2 February 1997, Week 1 January 1997, Week 5 January 1997, Week 4 January 1997, Week 3 January 1997, Week 2 January 1997, Week 1 December 1996, Week 5 December 1996, Week 4 December 1996, Week 3 December 1996, Week 2 December 1996, Week 1 November 1996, Week 5 November 1996, Week 4 November 1996, Week 3 November 1996, Week 2 November 1996, Week 1 October 1996, Week 5 October 1996, Week 4 October 1996, Week 3 October 1996, Week 2 October 1996, Week 1 September 1996, Week 5 September 1996, Week 4 September 1996, Week 3 September 1996, Week 2 September 1996, Week 1 August 1996, Week 5 August 1996, Week 4 August 1996, Week 3 August 1996, Week 2 August 1996, Week 1 July 1996, Week 5 July 1996, Week 4 July 1996, Week 3 July 1996, Week 2 July 1996, Week 1 June 1996, Week 5 June 1996, Week 4 June 1996, Week 3 June 1996, Week 2 June 1996, Week 1 May 1996, Week 5 May 1996, Week 4 May 1996, Week 3 May 1996, Week 2 May 1996, Week 1 April 1996, Week 5 April 1996, Week 4 April 1996, Week 3 April 1996, Week 2 April 1996, Week 1 March 1996, Week 5 March 1996, Week 4 March 1996, Week 3 March 1996, Week 2 March 1996, Week 1 February 1996, Week 5 February 1996, Week 4 February 1996, Week 3 February 1996, Week 2 February 1996, Week 1 January 1996, Week 5 January 1996, Week 4 January 1996, Week 3 January 1996, Week 2 January 1996, Week 1 December 1995, Week 5 December 1995, Week 4 December 1995, Week 3 December 1995, Week 2 December 1995, Week 1 November 1995, Week 5 November 1995, Week 4 November 1995, Week 3 November 1995, Week 2 November 1995, Week 1 October 1995, Week 5 October 1995, Week 4 October 1995, Week 3 October 1995, Week 2 October 1995, Week 1 September 1995, Week 5 September 1995, Week 4 September 1995, Week 3 September 1995, Week 2 September 1995, Week 1 August 1995, Week 5 August 1995, Week 4 August 1995, Week 3 August 1995, Week 2 August 1995, Week 1 July 1995, Week 5 July 1995, Week 4 July 1995, Week 3 July 1995, Week 2 July 1995, Week 1 June 1995, Week 5 June 1995, Week 4 June 1995, Week 3 June 1995, Week 2 June 1995, Week 1 May 1995, Week 5 May 1995, Week 4 May 1995, Week 3 May 1995, Week 2 May 1995, Week 1 April 1995, Week 5 April 1995, Week 4 April 1995, Week 3 April 1995, Week 2 April 1995, Week 1 March 1995, Week 5 March 1995, Week 4 March 1995, Week 3 March 1995, Week 2 March 1995, Week 1 February 1995, Week 4 February 1995, Week 3 February 1995, Week 2 February 1995, Week 1 January 1995, Week 5 January 1995, Week 4 January 1995, Week 3 January 1995, Week 2 January 1995, Week 1 December 1994, Week 5 December 1994, Week 4 December 1994, Week 3 December 1994, Week 2 December 1994, Week 1 November 1994, Week 5 November 1994, Week 4 November 1994, Week 3 November 1994, Week 2 November 1994, Week 1 October 1994, Week 5 October 1994, Week 4 October 1994, Week 3 October 1994, Week 2 October 1994, Week 1 September 1994, Week 5 September 1994, Week 4 September 1994, Week 3 September 1994, Week 2 September 1994, Week 1 August 1994, Week 5 August 1994, Week 4 August 1994, Week 3 August 1994, Week 2 August 1994, Week 1 July 1994, Week 5 July 1994, Week 4 July 1994, Week 3 July 1994, Week 2 July 1994, Week 1 June 1994, Week 5 June 1994, Week 4 June 1994, Week 3 June 1994, Week 2 June 1994, Week 1 May 1994, Week 5 May 1994, Week 4 May 1994, Week 3 May 1994, Week 2 May 1994, Week 1 April 1994, Week 5 April 1994, Week 4 April 1994, Week 3 April 1994, Week 2 April 1994, Week 1 March 1994, Week 5 March 1994, Week 4 March 1994, Week 3 March 1994, Week 2 March 1994, Week 1 February 1994, Week 4 February 1994, Week 3 February 1994, Week 2 February 1994, Week 1 February 1994 January 1994 December 1993 November 1993
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