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Medical Forum / Diseases and Disorders / Prostate Cancer / April 2007

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I wonder about this new vaccine for advanced PC.

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R.W. L. - 02 Apr 2007 20:36 GMT
I looked through a few sites that mentioned the tentative status of the
vaccine and I also noted  the position of some skeptics in the field.
The four or five month difference between experimental group and control
group did not seem very impressive, to me. (If I interpreted it
correctly).

Another thing....it is not just a simple injection....it involves a
rather complicated procedure of treating all of the white blood cells in
the body,several times.....I wondered how much such a procedure would
cost?  Someone was speculating on it being a one-billion dollar bonanza
for the company.  

I may not have all of the facts straight, but I tend to join the ranks
of the skeptics...from what I have read thus far.

Can anyone straighten me out?
Thanks,
Ralph
I.P. Freely - 02 Apr 2007 22:52 GMT
> The four or five month difference between experimental group and control
> group did not seem very impressive, to me.

The same goes for HT (aka ADT), except the ADT average is larger by a
whopping couple of months. And ADT is no piece of cake either. The
reason people pursue these things is the hope they will be the
exceptions who gain years, not just months, of longevity, and the hope
that ADT will improve, rather than degrade, their overall comfort.

I.P.
Steve Jordan - 03 Apr 2007 00:10 GMT
On April 2, Mike Freely wrote:

Quoting Ralph

>> The four or five month difference between experimental group and control
>> group did not seem very impressive, to me.

Mike pontificated:

> The same goes for HT (aka ADT), except the ADT average is larger by a
> whopping couple of months. And ADT is no piece of cake either. The
> reason people pursue these things is the hope they will be the
> exceptions who gain years, not just months, of longevity, and the hope
> that ADT will improve, rather than degrade, their overall comfort.

On March 31, Leonard Evens posted, in pertinent part:

"The figure of so and so many months added life expectancy is a
statistical measure which helps researchers (comprehend) different
treatments.  It doesn't tell you how long any one person using it can
expect to survive."

Otherwise, we can conclude that Mike is correct, there is nothing to be
done, and we are all doomed doomed doomed.

Take your pick. Surrender or fight.

Regards,

Steve J

"Never -- never -- never give up!  Never go gently.  There will be plenty of
gentle after we die, so until then, fight! Control the rhythms and tempo
of the dance, even when you have to let the PCa dancing bear lead for awhile
-- even when you have to wear the lead suit as you dance -- never let the
bear set the rhythm and tempo of your dance with life -- when the bear
finally takes control, it will be a very hollow feeling for him, because I
will be gone -- dancing in a better place."
--E. B. (Burns) Mixon, PCa survivor, June 14, 2005 on The Prostate
Problems Mailing List
Thank you, Burns. Live long and prosper.
Richbro - 03 Apr 2007 00:36 GMT
> > The four or five month difference between experimental group and control
> > group did not seem very impressive, to me.
[quoted text clipped - 6 lines]
>
> I.P.

If my memory is serving me, taxotere had a 2 or 3 month differential
between groups. I believe it is statistically significant that a
sample finds a difference - the number of months being less
significant. I'll take it and keep on fighting.

Rich
Alan Meyer - 03 Apr 2007 00:38 GMT
>I looked through a few sites that mentioned the tentative status of the
> vaccine and I also noted  the position of some skeptics in the field.
> The four or five month difference between experimental group and control
> group did not seem very impressive, to me. (If I interpreted it
> correctly).

I think that's right.  However I.P.'s point that some individuals will
have better responses is well taken.  There are individuals, for
example, who have had many years of remission on hormone
therapy, although the averages are less.

I also like Steve J's point that life is worth fighting for.

It may also be that we can develop an arsenal of 10 treatments,
each good for an average of six months, and give someone
5 years of life by applying all of them sequentially.  Maybe.
Maybe not.

> Another thing....it is not just a simple injection....it involves a
> rather complicated procedure of treating all of the white blood cells in
> the body,several times.....I wondered how much such a procedure would
> cost?  Someone was speculating on it being a one-billion dollar bonanza
> for the company.

This is a tough one.  There are multiple aspects to this
question.  First of all, all people who buy insurance pay
for this treatment.  So there is a stiff societal cost for
treatments that are ultra-expensive but have limited
benefit.

I don't think it's illegitimate to consider those costs.  For
example, a treatment that adds one day of life but costs
ten million dollars clearly seems like something that
insurance shouldn't pay for.  A treatment that adds ten
years of life buts costs a few dollars clearly should be
paid for.  So where does the line fall in between?

Another dimension to this problem has to do with the
costs of this drug that have nothing to do with the cost
to develop, manufacture or administer it.  The drug
companies invest millions in developing this kind of
drug and only do so because they expect to get patent
protection that allows them to charge whatever the
market will bear.  So they may well charge 2, 3, 4, 5
or 10 times the cost while they still hold the patent.
They may well hire a thousand sales people to sell
it full time, pay for hundreds of millions in television
ads, spend millions on gifts and "educational seminars"
in exotic resorts for doctors, and so on, all of which
must ultimately be paid for by the insurance
consumer.

These are tough social questions.  I have some
ideas about them, but no hard and fast answers.

    Alan

> I may not have all of the facts straight, but I tend to join the ranks
> of the skeptics...from what I have read thus far.
>
> Can anyone straighten me out?
> Thanks,
> Ralph
chasjac - 03 Apr 2007 01:09 GMT
One of the things reearchers will do is to look beyond the current
state of affairs and see what's possible and what's worth pursuing.
The research on Provenge is a big deal in this regard, I believe,
since it means that the idea of stimulating the immune system to
attack prostate tumor cells does do something useful.  Had the
clinical trials not shown any effect, continuing along this avenue of
research would have been harder to justify.

Provenge is the first of what we all should hope will be many
treatments of this form.  I wouldn't be surprised if in a few years,
Provenge is supplanted by another drug that does the same thing but
better.

For now, for the men with PCa who need it and want it, the average of
four months extension is worth the cost, if it keeps researchers on
the hunt.

--charlie
Dave P - 03 Apr 2007 14:49 GMT
A few years back a researcher at Johns Hopkins advocated this vaccine
or others similar to it for early recurrence prostate cancer along
with salvage radiation and/or hormone treatment.

Is everyone missing the boat here.

Why not try it on early stage prostate cancer?

We may already have found a new therapy that works for early
recurrence and no entitiy is testing this vaccine on men.

Or are they? I heard of provenge for early recurrence but have not
found any data on it so far.
Alan Meyer - 03 Apr 2007 15:28 GMT
> Why not try it on early stage prostate cancer?

I believe that the way these trials are done is that they always
try the experimental therapies on patients who have nothing to
lose.  The idea is that, if the therapy kills the patient, or if
it has no benefit, the amount of harm done will have been less
than if it had been tried on someone who had other options.

This makes more sense still when you realize that the majority of
new therapies tested are not as good as existing therapies.
Drugs that look promising in tissue cultures and in mice just
don't always turn out as good as the existing ones.

However, once a drug has been approved by the FDA, then other
uses can be tried, including earlier use.  I expect that
individual doctors will try that and that, at some point, a
clinical trial will be attempted.

All of this goes so much slower than we would like.  Yet not
surprisingly, some of the most effective drugs are the ones that
the researchers put more time into to get the science and the
technology right before trials even start.

   Alan
MAS - 04 Apr 2007 01:07 GMT
Provenge is currently in a Phase III Trial.

 a.. In Phase I clinical trials, researchers test a new drug or treatment
in a small group of people (20-80) for the first time to evaluate its
safety, determine a safe dosage range, and identify side effects.
 b.. In Phase II clinical trials, the study drug or treatment is given to a
larger group of people (100-300) to see if it is effective and to further
evaluate its safety.
 c.. In Phase III studies, the study drug or treatment is given to large
groups of people (1,000-3,000) to confirm its effectiveness, monitor side
effects, compare it to commonly used treatments, and collect information
that will allow the drug or treatment to be used safely.
 d.. In Phase IV studies, the post marketing studies delineate additional
information including the drug's risks, benefits, and optimal use.
These phases are defined by the Food and Drug Administration in the Code of
Federal Regulations.

At this point in time you qualify for the trial if your:

a.. Cancer that has spread outside the prostate (metastatic).
a.. Cancer that has worsened while on hormone therapy.

Thank the Code of Federal Regulations as defined by the FDA for not allowing
you to be a guinea pig.....\

GD

>A few years back a researcher at Johns Hopkins advocated this vaccine
> or others similar to it for early recurrence prostate cancer along
[quoted text clipped - 9 lines]
> Or are they? I heard of provenge for early recurrence but have not
> found any data on it so far.
Alan Meyer - 05 Apr 2007 05:06 GMT
> Provenge is currently in a Phase III Trial.
>
[quoted text clipped - 11 lines]
> These phases are defined by the Food and Drug Administration in the Code of Federal
> Regulations.

GD,

Are those numbers (20-80, 100-300, 1,000-3,000) quoted from
somewhere?

I suspect that they are ideals that are not often realized in practice.
Many clinical trials don't have the money to treat that many
patients and, even if they do, have trouble recruiting that many.

I was in a Phase II trial that was hoping to recruit 30 patients.
They only got 14.

   Alan
MAS - 06 Apr 2007 01:44 GMT
Alan, I understand that is ideal to get a varied populace. The key is how
many locations the same trial is being offered- Houtson, Cinncinati, Los
Angelos, etc; as that would be the only way to get the numbers needed.

GD

>> Provenge is currently in a Phase III Trial.
>>
[quoted text clipped - 26 lines]
>
>    Alan
Alan Meyer - 07 Apr 2007 16:55 GMT
> Alan, I understand that is ideal to get a varied populace. The key is how many locations
> the same trial is being offered- Houtson, Cinncinati, Los Angelos, etc; as that would be
> the only way to get the numbers needed.
>
> GD

I'm sure you're right that a multi-center trial is going to get more
people than a single center trial.  There aren't necessarily a
large number of people who would both qualify and be interested
in any one city.

Another problem is that a lot of people are afraid of being
guinea pigs for new treatments.

As far as primary treatments are concerned, most people,
quite understandably, want to try the standard treatments first.
They only want to try experimental treatments if and when
the standard ones fail.

   Alan
MAS - 07 Apr 2007 23:27 GMT
And Standard of Care continues first when the final results are probable and
clinical trials are viewed as a last ditch effort...... Albert Einstein -
"Insanity is doing the same thing over and over again while expecting
different results."

As you know, Phase II trials has no placebos.....

Somehow, I just can't shake the notion that stopping a runaway train early
is alot better than trying to stop it after the train nears maximum
velocity.

:)

>> Alan, I understand that is ideal to get a varied populace. The key is how
>> many locations the same trial is being offered- Houtson, Cinncinati, Los
[quoted text clipped - 16 lines]
>
>    Alan
I.P. Freely - 08 Apr 2007 00:18 GMT
> Somehow, I just can't shake the notion that stopping a runaway train early
> is alot better than trying to stop it after the train nears maximum
> velocity.

Depends on how we stop it (e.g., with our bodies, in the case of severe
SEs) and whether we could have just side-stepped it and watched it sail
by harmlessly (if our PC was cured).

I.P.
 
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