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Medical Forum / Diseases and Disorders / Prostate Cancer / January 2005

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Casodex (bicalutamide) 150mg, cost effective treatment for the    managem

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c palmer - 18 Jan 2005 18:04 GMT
Casodex (bicalutamide) 150mg, cost effective treatment for the
management of locally advanced prostate cancer

18 Jan 2005

New data published in the European Journal of Hospital Pharmacy -
New health economic data published today in the European Journal of
Hospital Pharmacy outline the cost benefits of the non-steroidal
anti-androgen bicalutamide 150mg for the treatment of locally advanced
prostate cancer. By delaying disease progression in patients with
locally advanced prostate cancer, bicalutamide 150mg reduces the
additional healthcare costs associated with treating advanced disease.

The paper by Dr Heather Payne, Middlesex Hospital UCL, London states
that bicalutamide 150mg impacts less on healthcare budgets compared to
other types of cancer treatments.1* An analysis of the
cost-effectiveness of bicalutamide 150mg based on the first analysis of
the Early Prostate Cancer (EPC) Trial, shows that its estimated
cost-effectiveness per quality-adjusted life year (£10,067) falls well
below the commonly used threshold for cost-effectiveness (£29,212) and
compares well with the cost-utilities of other approaches used in
oncology.2,3

The cost of bicalutamide 150mg (administered for three years) plus
radical prostatectomy or radiotherapy for locally advanced prostate
cancer is also significantly lower compared to the cost of other
oncology treatments.2,3
Progression of locally advanced prostate cancer can result in costly
complications such as bone metastases and serious skeletal
complications.4

In addition, Dr Payne highlights in her paper, that bicalutamide 150mg
gives a significant improvement in progression-free survival in patients
with locally advanced disease, reducing the risk of objective disease
progression by 42% in radiotherapy patients, 47% in watchful waiting
patients, and 29% in radical prostatectomy patients.5

As well as being as effective as castration in prolonging survival in
non-metastatic prostate cancer6, bicalutamide 150mg has significant
quality-of-life benefits, with improvements over castration-based
therapies in terms of maintaining bone mineral density, physical
capacity and sexual activity.6,7 A recent study of the risk of
osteoporosis in men with non-metastatic prostate cancer revealed that
those who were treated with bicalutamide 150mg maintained bone mineral
density (BMD), whilst those who received castration were associated with
a progressive loss of BMD, which can result in costly complications such
as increased risk of fractures.7

Dr Payne concludes: "Bicalutamide 150mg is a cost-effective therapy for
patients with locally advanced prostate cancer, delaying disease
progression, and offers a valuable alternative to castration in this
setting".

Bicalutamide 150mg is indicated in the UK in patients with locally
advanced prostate cancer (T3-T4, any N, MO; T1-T2, N+, MO), as immediate
therapy either alone or as adjuvant to treatment by radical
prostatectomy or radiotherapy. Bicalutamide 150mg is also indicated for
the management of patients with locally advanced, non-metastatic
prostate cancer for whom surgical castration or other medical
intervention is not considered appropriate or acceptable.8
-ends-

*Data is based on UK NHS costs and may vary in other countries

NOTES TO EDITORS:
-- Exchange rate: 1 British Pound (GBP) = 1.42633 Euro (EUR)

-- The bicalutamide ('Casodex') Early Prostate Cancer (EPC) programme is
evaluating bicalutamide 150mg/day plus standard care (watchful waiting,
radical prostatectomy or radiotherapy) in patients with localised or
locally advanced prostate cancer.
-- The EPC programme is the largest prostate cancer treatment study to
date including over 8,000 patients from 23 countries around the world.
-- Bicalutamide 150mg belongs to a group of medicines called
anti-androgens. This means that it interferes with some of the actions
of androgens (male sex hormones) within the body.
For further information, please contact:
Rosie Allen
Hill & Knowlton
Tel: (UK) 020 7413 3141
Mob: (UK) 07913 172597
Tara Breen
Hill & Knowlton
Tel: (UK) 020 7413 3760
Mob: (UK) 07813 252 673

References:
1. Payne, H. The value of delaying disease progression with bicalutamide
('Casodex') 150mg in locally advanced prostate cancer. European Journal
of Hospital Pharmacy. 2004.
2. Moeremans K, Caekelbergh K, Annemans L. Cost-effectiveness analysis
of bicalutamide (CasodexTM) for adjuvant treatment of early prostate
cancer. Value Health 2004; 7: 472-81.
3. Earle CC, Chapman RH, Baker CS, Bell CM, Stone PW, Sandberg EA,
Neumann PJ. Systematic overview of cost-utility assessments in oncology.
J Clin Oncol 2000; 18:3302-17.
4. Groot MT, Boeken Kruger CG, Pelger RC, Uyl-de Groot CA. Costs of
prostate cancer, metastatic to the bone, in the Netherlands. Eur Urol
2003; 43: 226-32.
5. Wirth M et al. Bicalutamide (Casodex) 150mg as adjuvant to radical
prostatectomy significantly increases progression-free survival in
patients with early non-metastatic prostate cancer: analysis at a median
follow-up of 5.4 years. J Urol. 2004; 172: 1865-1870.
6. Iversen P, Tyrell CJ, Kaisary AV et al Bicalutamide monotherapy
compared with castration in patients with nonmetastatic locally advanced
prostate cancer: 6.3 years of followup. J.Urol 2000; 164: 1579-1582.
7. Sieber PR, Keiller DL, Kahnoski RJ et al Bicalutamide 150 mg
maintains bone mineral density during monotherapy for localized or
locally advanced prostate cancer. Urology 2004; 171: 2272-6.
8. AstraZeneca; Casodex (bicalutamide)150mg Summary of Product
Characteristics.

knowledge is power - growing old is mandatory - growing wise is optional    
"Many more men die with prostate cancer than of it. Growing old is
invariably fatal. Prostate cancer is only sometimes so."
http://community.webtv.net/PALMER_ENT/doc
Alan Meyer - 20 Jan 2005 16:56 GMT
> Casodex (bicalutamide) 150mg, cost effective treatment for the
> management of locally advanced prostate cancer

Has anyone in the group had treatment with Casodex by itself,
not in combination with Lupron or Zoladex?

If so, can you comment on the side effects?

Thanks,

   Alan
ron - 20 Jan 2005 18:47 GMT
Since the health warning issued on Casodex 150 late in 2003, I think
many Casodex users have migrated down to the 50 mg dosage...Best wishes
and good health, Ron
I.P. Freely - 20 Jan 2005 18:59 GMT
But that's the ADT2/3 dosage, which I think even the manufacturer's trials
showed to be ineffective as monotherapy. Why waste money and SEs on 50mg
monotherapy? (Or am I wrong? I'm only 80% sure of the last half of my
opening sentence.)

I.P.

> Since the health warning issued on Casodex 150 late in 2003, I think
> many Casodex users have migrated down to the 50 mg dosage>
c palmer - 21 Jan 2005 06:47 GMT

But that's the ADT2/3 dosage, which I think even the manufacturer's
trials showed to be ineffective as monotherapy. Why waste money and SEs
on 50mg monotherapy? (Or am I wrong? I'm only 80% sure of the last half
of my opening sentence.)
I.P.
=================

i'm going out of a limb, because it's been years since i research
casodex.  it was quite common in the arsenal of drugs against pca at one
time.

if i remember correctly, what makes casodex so effective against the
growth of pca was the drug's ability to "plug" the receptor of the pca
cell so that it couldn't reproduce and if it can't reproduce, then, at
least you have something you can work with against the cancer.  

and like all drugs, there are positives and negatives to each side.  i
don't remember that much on the negative side because the ones who were
using the drug never complained about it.  

i could see where casodex would be a cheaper treatment than others in
how the drug works.  

by dropping from 150 mg to 50mg, i guess my question would be - can you
maintain the same level of resistance to pca reproduction at a 50mg
level or are you giving up QOL for the reduced dosage.  now, i haven't
seen anything that address that issue.

just my 02 cents..........

~ curtis

knowledge is power - growing old is mandatory - growing wise is optional    
"Many more men die with prostate cancer than of it. Growing old is
invariably fatal. Prostate cancer is only sometimes so."
http://community.webtv.net/PALMER_ENT/doc
I.P. Freely - 20 Jan 2005 18:54 GMT
"Alan Meyer" <ameyer2@yahoo.com> wrote >
> Has anyone in the group had treatment with Casodex by itself,
> not in combination with Lupron or Zoladex?
>
> If so, can you comment on the side effects?

And if anyone who has tried Casodex monotherapy lives in the U.S., how did
you obtain it and at what price? It's not approved in the U.S., so we'd have
to a) buy it from a foreign source (thus pay for it ourselves and risk
paying $7,200 a year for a fake or worse) or b) get it as part of a
self-administered ADT2 or 3 protocol and just not take the other parts of
the protocol (until our insuror or physician caught us at it and lowered the
boom). OTOH, if anyone can show clinical proof that Casodex monotherapy does
any good, I may be willing to run those gauntlets. Its primary, almost sole,
SE is supposed to be diarrhea, and I'd risk that for a trial period given
proof it helps significantly. So far I've not found that proof.

I.P.
Alan Meyer - 21 Jan 2005 00:15 GMT
> "Alan Meyer" <ameyer2@yahoo.com> wrote >
>> Has anyone in the group had treatment with Casodex by itself,
[quoted text clipped - 14 lines]
>
> I.P.

I remember someone posting to this group, he might have been
English, Canadian, or Australian, saying that he was on an
intermittent HT treatment plan that alternated casodex and one
of the LHRH agonists (Lupron or Zoladex, don't remember which).

It would be impossible to say whether his cancer was being
held at bay more effectively by this treatment than other hormone
therapies but, IIRC, he did report that the Casodex alone portion
of the treatment did lower his PSA pretty effectively.

   Alan
bocacerrada@yahoo.com - 21 Jan 2005 15:09 GMT
> > Casodex (bicalutamide) 150mg, cost effective treatment for the
> > management of locally advanced prostate cancer
[quoted text clipped - 7 lines]
>
>     Alan

Original DX in 02 after PSA 13 and Gleasons of 6,7,7,and 9 at age 69.
Cryo in January 03 - PSA dropped below 1, but began to rise.  Biopsy DX
indicated small Gleason 6, and repeat cryo done in January 04.  PSA
down to .54, but increased over 1.  RX for casodex (50 mg) and proscar
(5 mg) in June 04.  PSA down to .04 in August and stable in October.
Off casodex until Dec. when PSA .15.  Resumed casodex 01/05.  Next PSA
due in March 05.  Anticipated continuation of casodex until 07.
Urologist indicates no aggresive ADT indicated until current treatment
no longer effective.

Side effects minimal - primarily tenderness and some swelling of
breasts, and some fatigue.  No SE usually associated with lupron.

Rack rate for casodex and proscar in U.S. about $500.00 per month
(Casodex is around $380-$420, and available at any major drug chain,
but don't know about 150 mg).  Currently being purchased in Mexico for
half that price.  Canadian prices slightly higher than Mexico, but
product available in Mexico is produced by Astra-Zeneca and in sealed
packaging.

Celebrex (200 mg) being taken with casodex and proscar.  Urologist
indicated OK to stop celebrex, but probably OK to continue since no
cardiovascular problems.  Also taking vitamin E, selenium, pomegranate
juice, and lycopene.  Diet otherwise normal.

So far, so good.  But, as the Indians say, "Only the rocks live
forever."

Jack in Phoenix
Steve Kramer - 22 Jan 2005 12:43 GMT
Hi, Jack!  Glad to see you back, but sorry to hear 2004 has been a problem
for you.  I'm sure you were always wary of that 9 Gleason.  I think I am
becoming a proponent of IHT or IADT, but if that was the intent of your doc,
I gotta feeling he began a little too early.  I don't know what the right
time to start is, but I suspect it's at least a year after initial HT
treatment.

Signature

Prostate Cancer Survivor (so far), not a doctor
PSA 16 10/17/2000 @ 46
Biopsy 11/01/2000 G7 (3+4), T2c
RRP 12/15/2000 G7 (3+4), T3bN0M0
PSA  .1  .1  .1  .27  .37  .75
EBRT 05-07/2002 @ 47
PSA  .34 .22 .15 .21 .32
Lupron (1 mo) 07/21/2003 @ 48
PSA  .07 .05 .06
Lupron (4 mo) 8/03 (48), 12/03, 4/04 (49), 09/04 (50)
non Illegitimi carborundum

> > > Casodex (bicalutamide) 150mg, cost effective treatment for the
> > > management of locally advanced prostate cancer
[quoted text clipped - 37 lines]
>
> Jack in Phoenix
bocacerrada@yahoo.com - 22 Jan 2005 15:59 GMT
My understanding is that the usual plan with casodex and proscar is to
stop treatment after PSA is down and stable and to restart when it
rises.  Some urologists prescribe it on a schedule of nine months on
and three months off.  I guess this is more proof that, "No two doctors
agree on PCa treatment."

The schedule was discussed with the uro in October when I was given the
alternative to go with the nine month schedule.  I elected to take a
couple of months off, so I can't blame the MD if it was too soon.

Incidentally, I have tried to find out the half life of casodex, but
can't come up with any answers.

Jack in Phoenix

> Hi, Jack!  Glad to see you back, but sorry to hear 2004 has been a problem
> for you.  I'm sure you were always wary of that 9 Gleason.  I think I am
[quoted text clipped - 57 lines]
> >
> > Jack in Phoenix
Steve Kramer - 23 Jan 2005 00:08 GMT
I suspect IP will have an answer for you on that one.

> Incidentally, I have tried to find out the half life of casodex, but
> can't come up with any answers.
>
> Jack in Phoenix
I.P. Freely - 23 Jan 2005 02:28 GMT
No, but Google did: I entered Casodex bicalutamide half life, and it spat
out http://www.bccancer.bc.ca/HPI/DrugDatabase/DrugIndexPro/Bicalutamide.htm
.
More than we'd ever want to know about the pharmacokinetics of Casodex.

The short answer: one week.
The long answer includes a huge array of data, come of it even interesting,
including a big chart on its SEs.

I.P.

> I suspect IP will have an answer for you on that one.
>
> > Incidentally, I have tried to find out the half life of casodex, but
> > can't come up with any answers.
ALottoWin@yahoo.com - 24 Jan 2005 05:22 GMT
I have a longer post on here today, but will reply to this too. I took
Casodex for about a month and the urologist wanted to add Lupron. That
one caused real sexual problems for me before and I think Casodex did
too, but maybe it is all in my head. Because of my concerns with the
sexual side effects, I got a second opinion from my oncologist. He took
me off the Casodex and said to come back in a couple of months after a
new PSA. The reason I was on the drug was due to my PSA going up over 3
years, after my radical prostectomy, to 2.0 from 0 and a Gleason score
of 8 with some other concerns about possible spread beyond the
prostate. Fortunately for me the PSA stopped going up even w/o the
Casodex and I am taking nothing now. The oncologist says not to worry,
that he has guys walking around with 800 PSA scores. He said that he
does not treat the numbers. He did order a full CAT scan and Bone Scan
and nothing showed up.

Casodex is available in the USA. Mine was paid for by my health plan,
but I know the price is high.  Those economic studies don't impress me
as I figure my life is worth more than a million dollars or whatever.
Heck we will pay hundreds of thousands to fix up a criminal who gets
shot up by the police after trying to kill them or someone else. Our
medical costs are not so simple as some people like to think. I also
want to be able to sue any doctor who messes me up or messes up a
member of my family. I do try to pick a good doctor, just to avoid
that. Those doctors, like good drivers, need to be rewarded with low
cost insurance, even it is provided by the government. They also need
insurance companies or the government that is not afraid to fight
lawsuits when the doctor is innocent of wrong doing.
Now that is getting off the subject.  Sorry.

Bye,  George
I.P. Freely - 24 Jan 2005 21:35 GMT
You took Casodex alone, as in monotherapy, in the U.S.? That's good to hear.
I knew they were tying to get FDA approval for that, but could find no
record of its approval. I was set to pay for it myself if I had to and it
will help me without intolerable SEs.

<ALottoWin@yahoo.com> wrote >
> Casodex is available in the USA. Mine was paid for by my health plan,
> but I know the price is high.
Steve Kramer - 26 Jan 2005 13:51 GMT
Now THERE is a topic for discussion!  How much is a life worth?  Or the
temporary extension of life?

Whether it be national health care to which you contributed less than
$100,000 in taxes in the last 30 years or insurance to which you personally
and/or your employer paid premiums of less that $100,000 in 30 years.

How much should be spent on YOU (pl)?  or ME?

No, wait?  National health care is even more interesting.  How much should
be spent on the criminal who contributed almost nothing and, often, took
more than he contributed.  Or the on the billionaire who contributed
millions of dollars in taxes?  Or the lotto winner who contributed $100,000
until he hit the state's mother lode and was taxed before dispersement of
the winnings?

I'm thinking I may have already used up my $100,000.  What is my value
beyond that?  I lived 50 years.  I sired three children, each of whom are
upstanding members of the community and are each producing offspring.  I've
contributed to my community beyond anyone's expectations.  But, I have
little else to contribute.  In five years, maybe two, or maybe tomorrow, I
will sit on my laurels and reap the supposed reward of my work -- pension
checks and tax-deferred savings.

Though this may sound like depression, this is a philosophical question.

Signature

Prostate Cancer Survivor (so far), not a doctor
PSA 16 10/17/2000 @ 46
Biopsy 11/01/2000 G7 (3+4), T2c
RRP 12/15/2000 G7 (3+4), T3bN0M0
PSA  .1  .1  .1  .27  .37  .75
EBRT 05-07/2002 @ 47
PSA  .34 .22 .15 .21 .32
Lupron (1 mo) 07/21/2003 @ 48
PSA  .07 .05 .06
Lupron (4 mo) 8/03 (48), 12/03, 4/04 (49), 09/04 (50)
non Illegitimi carborundum

> I have a longer post on here today, but will reply to this too. I took
> Casodex for about a month and the urologist wanted to add Lupron. That
[quoted text clipped - 26 lines]
>
> Bye,  George
Leonard Evens - 26 Jan 2005 14:53 GMT
> Now THERE is a topic for discussion!  How much is a life worth?  Or the
> temporary extension of life?
[quoted text clipped - 21 lines]
>
> Though this may sound like depression, this is a philosophical question.

Steve.  You ask an interesting question, but perhaps you should first
try to get an accurate idea of the accounting.  I don't myself know the
answers, but I already see some problems with your arithmetic.  First,
of all, I'm pretty sure my employer plus myself contributed more than
$100,000 during the last 30 years towards health insurance.  In
addition, because health costs have been escalating rapidly,  there has
to be some correction for inflation.  There are other serious issues of
this kind to take into account.  This is best left to experts, but
unfortunately even experts may differ.   In any case,  faulty arithmetic
can bias your philosophical answer.

Getting back to the basic question, let me give my slant on the thing.
There are two extremes here.  Either everyone pays his own way, or we
group together to share risk.  In reality, we always have some
combination of the two.   If we all pay our own way, then some of us who
are unlucky because we incur large medical expenses probably won't
receive adequate care.  A single serious illness can wipe out even the
most prudent middle class family's resources.  Sharing risk is handled
by insurance schemes where everyone contributes roughly the same
premium, but the benefits are returned unequally according to need.
Then some people get more than their "fair share" and others get
relatively little returned.  They do get some peace of mind, of course.

Insurance schemes work best if the pool is large and not restricted.
Insurance companies are in business to make money, so they prefer to
divide the pool up into categories which help them minimize their risk,
but don't particularly help those being insured.  Also, smaller
insurance companies can fail, and in reality they do, leaving the
insured out in the cold no matter how much they have contributed.  So
the best insurance schemes are those which are very wide spread and in
which the insurer is as safe and financially sound as possible.

Under the present system, in the US we are managing to pay for the
medical care we receive, more or less.  So their must be some rough
balance between input and output.  Some people without medical insurance
or with inadequate insurance don't get very good care, but they usually
get some.  Of course, there also has to be some way to control the
costs, and whether you like it or not, that has to involve some scheme
for price controls on the providers.   There is already such a system
for Medicare which, believe it or not, was instituted under the Reagan
administration,  the most consevative in recent history except for the
current Bush administration.  If the government doesn't do it, then
private insurers will do it, as they do today under managed care, but
less effectively and more unequally.

Part of the control of prices involves when and if society will pay for
unusual or experimental treatments.   This will be partly based on
science and partly based on politics.   For example, because of an
alliance between a very conservative Republican and a moderate Democrat,
dietary and herbal supplements are subject to less control today than
prescription medicines.  Public pressure also intrudes when private
insurers are involved, but it is not as effective.

With all that in mind,  I would say the following about your case.  I
think your contribution to society is not really relevant.   In the case
of health care, it is your need that should determine how much care you
should receive, subject of course to the limits of what is likely to be
effective.  In this, in extreme cases, cost might be a factor.   If I
end up being lucky and my cancer never recurs,  I don't object to more
being spent on taking care of your prostate cancer than will be spent on
mine.  I hope that I will remain relatively healthy for the rest of my
life and die relatively quickly and inexpensively.  If offered the
opportunity to extend my life for a few weeks or months by an
astonomically expensive treatment,  my inclination would be to refuse
it, even if I don't have to pay for it.  So if I never use what I've
contributed towards paying for health, it doesn't bother me one bit.  It
might go the other way, and the peace of mind is worth it.
Steve Kramer - 28 Jan 2005 22:47 GMT
> With all that in mind,  I would say the following about your case.  I
> think your contribution to society is not really relevant.   In the case
> of health care, it is your need that should determine how much care you
> should receive, subject of course to the limits of what is likely to be
> effective.

Interesting.  To each man in accordance with his needs.  I believe I read
that somewhere.

You are correct, of course, that $100,000 is no longer the 30-year average
for healthcare insurance or tax burden.  I do believe that if you think
about how much you paid 30 years ago, that in the last 30 it was $100,000 or
less.  But, in reality, $100,000 is a nice round figure.

You are also correct that for prostate problems, I will surpass $100,000
sooner than you.  With a 4-day hospital stay for Diverticulitis, a 4-day
hospital stay for a jellyfish sting, an 8-day RPP, 35 EBRTs and several
Lupron shots, I suspect I already passed it.

Signature

Prostate Cancer Survivor (so far), not a doctor
PSA 16 10/17/2000 @ 46
Biopsy 11/01/2000 G7 (3+4), T2c
RRP 12/15/2000 G7 (3+4), T3bN0M0
PSA  .1  .1  .1  .27  .37  .75
EBRT 05-07/2002 @ 47
PSA  .34 .22 .15 .21 .32
Lupron (1 mo) 07/21/2003 @ 48
PSA  .07 .05 .06
Lupron (4 mo) 8/03 (48), 12/03, 4/04 (49), 09/04 (50)
non Illegitimi carborundum

I.P. Freely - 27 Jan 2005 01:00 GMT
On the positive (?) side, many others died without getting any of their
$100,000. Part or their $100k is now yours, guilt-free.

I.P.

> Now THERE is a topic for discussion!  How much is a life worth?  Or the
> temporary extension of life?
[quoted text clipped - 21 lines]
>
> Though this may sound like depression, this is a philosophical question.
Danny McCarty - 28 Jan 2005 03:28 GMT
>Subject: Re: Casodex (bicalutamide) 150mg, cost effective treatment for
>themanagem
>From: ALottoWin@yahoo.com
>Date: 1/23/2005 11:22 PM Central Standard Time
>Message-id: <1106544141.046814.114690@z14g2000cwz.googlegroups.com>

Two years.  2.0  It is growing somewhere, probably not in the prostate bed.
Doc is right, as long as you are not experiencing symptoms you can wait, and
some men don't have symptoms 'til 800 or 1000.  Hormones will bring that right
back down to near zero, for a while.  My doc is aggresive- I've never been
above 153 but I'm in my second program of chemotherapy. All symptoms so far are
directly attributable to the treatments ;-}

>I have a longer post on here today, but will reply to this too. I took
>Casodex for about a month and the urologist wanted to add Lupron. That
[quoted text clipped - 26 lines]
>
>Bye,  George
Danny McCarty - 24 Jan 2005 02:50 GMT
>Subject: Re: Casodex (bicalutamide) 150mg, cost effective treatment for
>themanagem
>From: "Steve Kramer" skramer@cinci.rr.com
>Date: 1/22/2005 6:43 AM Central Standard Time
>Message-id: <ATrId.48162$re1.10400@fe2.columbus.rr.com>

Casodex and Proscar cut my PSA from 12 to 0.5 in just over two months, in 2001,
just after RRP.  I took it for about two years.  Sore breasts for a while.

>Hi, Jack!  Glad to see you back, but sorry to hear 2004 has been a problem
>for you.  I'm sure you were always wary of that 9 Gleason.  I think I am
[quoted text clipped - 44 lines]
>>
>> Jack in Phoenix
 
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