I need to know the specifics about the Medtronic Synchromed2
intrathecal pump that is available for clinical trial in the US.  It
is not available for the general public.  I know that there are about
10 hospitals that are performing these clinical trials, and my Dad
needs to get one for his cancer pain.  He has been told that he can
not get the current Synchromed 1 pump that is shaped like a hockey
puck.  The new one is supposed to be more spherical, thinner and may be OK for
him.  Intrathecal pumps are implanted by Pain Doctors or sometimes
anesthesia docotrs.  He is in serious pain, and needs one - but we can
not find out where to go.  The company will not tell us.  I think
there must be someone out there who used to work for the company who
can tell me where these clinical trials are going on.  I would also
like to know more about these new pumps.

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Clarification of Question by crystal4290-ga on 29 Oct 2002 07:08 PST

Just to clarify.  I do not need to know what is an intrathecal pump or
anything about the current intrathecal pumps that you can see on the
Medtronics website.  This is a brand new pump that is coming out that
is somehow different from the one that is out there now.  We have
heard it is more futuristic looking and sleeker and does not need to
be refilled as often which would be good for him.  Thanks for helping.

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Clarification of Question by crystal4290-ga on 29 Oct 2002 15:42 PST

I see this locked for a very long time.  I have never sent in a
question before.  It that how it goes?  One person tries to find the
answer, and then if they can not find it then another person tries?

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Request for Question Clarification by bcguide-ga on 29 Oct 2002 22:57 PST

Just to answer your question - yes - when a researcher is working on
your question they lock the question so we don't have everyone
spending time on the same information. If the research doesn't turn up
any answers, the lock is released and someone else takes a turn at
finding your answer.

It's a tough request,as you know, so bear with us a nd one of us will
come up with something. We know how urgent it is for you to find the
best treatments for your dad!

Prayers...

bcguide-ga

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Clarification of Question by crystal4290-ga on 29 Oct 2002 23:19 PST

I have been asked to respond, but I am not certain what I am supposed
to respond to exactly.

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Clarification of Question by crystal4290-ga on 30 Oct 2002 14:11 PST

Thank you for your help vitalmed-ga.  There is quite a "Pain
community" out here, with about 25 websites many with patients trying
to get pain relief like my Dad.  We understood that the Synchromed 2
trial was started, and then when we called Medtronic they said all the
trials are now "closed".  She said they had been working on the new
Synchromed2 for a few years and beleived it might be getting close to
being submitted to FDA soon?  This did not agree with two people, one
guy in the New England area who said that they were just getting
started.  We also heard that the new Synchromed2 can hold 20 and 40ml
which would really help in the time to refill, but that somehow they
made them more streamlined, spherical and not as angular as SynchroMed
I (the hockey puck one).  That part is really important to my Dad
because of his physical shape.
I do not know the sizes of the new Synchromed2 pump and how much they
hold, but that is important to know.

It would be helpful to know about an article published in May 2002
about the Synchromed I that gave the locations of where the trials
were done for Synchromed I and contact information.

However it would also be helpful to know what is the real status of
the Synchromed 2 trials.  Were some of them done in Europe already? 
He could go there to get one.  Or are they really finished....

Hope this helps to clarify.  Thanks again -

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Request for Question Clarification by tehuti-ga on 02 Nov 2002 07:05 PST

Hello again crystal,

I cannot answer all your question, but here is some of the information
you wanted.

Results from the Synchromed trial were presented in May 2002 at the
38th Annual Meeting of the American Society for Clinical Oncology. 
Abstracts are available on the ASCO web site at:

1.http://www.asco.org/asco/ascoMainConstructor/1,1003,_28-007-00_12-002326-00_29-00A-00_18-002002-00_19-002835,00.asp
Predictors of improved survival in a randomized clinical trial
comparing therapy for refractory cancer pain with an implantable drug
delivery system to comprehensive medical management

2. http://www.asco.org/asco/ascoMainConstructor/1,1003,_28-008-00_12-002326-00_29-00A-00_18-002002-00_19-001436,00.asp
An implantable drug delivery system (IDDS) for refractory cancer pain
improves pain control, drug related toxicity, and survival compared to
comprehensive medical management (CMM)

3. http://www.asco.org/asco/ascoMainConstructor/1,1003,_28-008-00_12-002326-00_29-00A-00_18-002002-00_19-001428,00.asp
Impact of pain and pain therapy on the quality of life (QOL) of cancer
patients and their families

4. http://www.asco.org/asco/ascoMainConstructor/1,1003,_28-008-00_12-002326-00_29-00A-00_18-002002-00_19-001461,00.asp
Impact of pain therapy with an implantable drug delivery system on
systemic opioid dose and toxicity in cancer patients

With some additional searches, I got the following contact details:

1. Thomas Smith, M.D
Chair of Hematology and Oncology
Virginia Commonwealth University 
Massey Cancer Center and the School of Medicine
 If you search VCU’s physician directory
(http://www.communicationcenter.vcu.edu/physiciansdir.html )  you get
the following contact details:
E-mail:tsmith@hsc.vcu.edu
Address: Box 980230
Patient Office(s):
      Massey Cancer Center at Stony Point
            Phone: (804) 327-3055 Fax: (804) 327-3065
      Nelson Clinic Hematology/Oncology
            Phone: (804) 828-8337 Fax: (804) 828-2910
      New Patient Referral
            Phone: (804) 828-5116
Smith was principal investigator for the trial
http://www.vcu.edu/uns/ucn/top072301.html (last item on the page)

2. Patrick J Coyne RN MSN, Richmond Virginia (I could not find further
details, but assume he is a colleague of Thomas Smith

3. Peter S Staats, Johns Hopkins University Medical Center, Baltimore
Director- Division of Pain Medicine, Dept. of Anesthesiology, Johns
Hopkins Kimmel Cancer Center  and Associate Professor-
Anesthesiology/Critical Care Medcine and Oncology, Johns Hopkins
Kimmel Cancer Center
http://www.hopkinskimmelcancercenter.org/experts/doctor.cfm?DoctorID=311
No further contact details were given, however I found the following
about the Kimmel Center:
“Our database of cancer clinical trials is under construction.  We
apologize for the inconvenience.  In the meantime, if you have
questions about Hopkins Kimmel Cancer Center clinical trials, please
call the Cancer Center's Public Affairs Office at 410-955-1287, and we
will direct you to the appropriate person.”
“To make an appointment with a specialist at the Sidney Kimmel
Comprehensive Cancer Center at Johns Hopkins, you may call our
Referral Office at (410) 955-8964
Our referral specialists will answer your questions, collect the
necessary information required for pre-registering, and schedule an
appointment.  Please understand that we are not able to offer medical
advice over the telephone or through the internet or mail.”

4. Timothy Deer, Center for Pain Relief , St. Francis Hospital 
331 Laidley Street, Suite #606, Charleston W Virginia, 25301   USA
Main telephone for hospital:: (304)347-6500
Hospital web site: http://www.stfrancishospital.com/

5. Lisa J Stearns, Valley Pain Treatment Center, Scottsdale, AZ 
I have found her listed at:
http://www.valleyanesth.com/anesthesia/dr17.html#stearns
“Valley Anesthesia Consultants of Arizona is a private practice board
certified group of anesthesiologists providing comprehensive
anesthesia and pain management services in the metropolitan Phoenix
area. Valley Anesthesiology Consultants main office is located at 2200
North Central Ave. Suite 203, Phoenix, Arizona 85004.” (email
vac@anesthesia.net)
I could not find any other contact details.

6. Richard L Rauck, Center for Clinical Research, Winston-Salem NC
Associate Professor of Anesthesia and Pain Management
Wake Forest University School of Medicine, Wake Forest University.

Medical Director of the Pain Control Center
Department of Anesthesia
Wake Forest University School of Medicine
Medical Center Blvd
Winston-Salem, NC 27157-1077 
Telephone for the Pain Center: (336) 716-5530

On site of the World Institute of Pain, I found the following
telephone numbers for Richard Rauck
Tel: (336) 716-1211
Fax: (336) 716-5537
http://www.iapsar.org/WIP/WIP-base.htm

7. David A Bryce, 
Marshfield Clinic - Marshfield Center
1000 N Oak Avenue, Marshfield, WI 54449

Google gives the following number for David Bryce at the Center: (715)
389-3344,

General contact numbers for the Center
Phone: 715-387-5511 or 1-800-782-8581
Fax: 715-387-5240
http://www.marshfieldclinic.org/provider/detail.asp?ID=5426
http://www.marshfieldclinic.org/centers/center.asp?code=MFLD

8. Richard L Boortz-Marx,
Department of Anesthesiology
University of Minnesota
420 Delaware Street, SE, MMC 294
Minneapolis, Minnesota 55455
Email 
boort001@umn.edu 
Telephone
612-624-9990 Department Office
612-626-4811 Personal Office
612-273-5416 FUMC-Riverside
Fax
612-626-2363 Department Office
612-273-9945 FUMC-Riverside

http://www.anesthesiology.umn.edu/rlbm/

9. George E Pool, Medtronic Inc, Minneapolis, MN (you say you already
have contact with Medtronic)

10. Dr. med. Eric Buchser 
eric.buchser@hospvd.ch 
Hôpital de Morges 
Anästhesie 
Ch. du Crêt 2 
1110 Morges, Switzerland
http://www.swiss-icu.ch/SGI_OM_020723.pdf

11 Dra. Elena Catala
Hospital Universitario Santa Creu i Sant Pau
C/ St. Antoni Mª Claret, 167.
08025 Barcelona,  Spain
tel: 93 2919167  fax: 93 2919514  (presumably with the country code
for Spain)
E- mail : ecatala@hsp.santpau.es
http://www.sedolor.es/infpublica/dir/catalu%F1a.htm

Additionally, The NYU Pain Management Center has the following ongoing
trial: H6990-05 "An Open-Label, Long-Term Safety and Efficacy Study of
SNX-111 Administered Intrathecally to Patients Suffering From Chronic
Pain Using the Synchromed Infusion System"
http://www.med.nyu.edu/PainManagement/professionals/research.html

Hope this is of use
tehuti

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Request for Question Clarification by tehuti-ga on 02 Nov 2002 08:34 PST

Sorry, I didn't make it clear above, that the contact information I
found is for the authors listed on the ASCO abstracts about the trial.

I have gathered information pertinent to your question.

Medtronic indicates that the dimensions of Synchromed 2 do not differ
significantly from Synchromed EL, the one that is currently available
on the market, and also that clinical trials with Synchromed 2 have
not yet begun, at least in the United States.

I am not sure whether the trials that you heard about are the same as
the multicenter trial involving Synchromed 1 that I believe concluded
and was reported in May, 2002. Synchromed 2 may already be in clinical
trial in some countries in Europe and possibly even available on the
market there, but I do not suppose that would be helpful to your Dad
now.

Would it help for me to provide you as part of answer with a list
which I gathered of centers and clinics where this trial took place,
and the investigators? One or more of them may be planning to
participate as investigators when trials of Synchromed 2 begin.

If you can tell me more about the trials that you heard about and from
where, and we might determine whether they are those that I have
noted. I shall be glad to see also if we can reconcile information you
have about how the size may differ and what I understand from
Medtronic.

I would suggest that you contact the oncology department of the
clinic, where your father is being treated.  If you're not in a major
city, I would suggest you contact Sloan-Kettering in NYCIty,
Dana-farber in Boston, or the University of Chicago clinics, at the
University of Chicago, in Chicago.

They will know the latest about technologies and also could help you
handle some of the hurdles associated with the trials.