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

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Rally for FDA Reform and Call for Congressional Action Provenge NOW

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Paul B - 05 Sep 2007 15:15 GMT
I'm trying to find out if a ride-sharing system is being
implemented to help get people to the 9/18 rally. I believe some
financial assistance is available for cancer patients.
p.

http://www.prnewsnow.com/PR%20News%20Releases/Legal%20And%20Law/A%20Right%20To%2
0Live%20Supporters%20to%20Rally%20for%20FDA%20Reform%20and%20Call%20for%20Congre
ssional%20Action%20Provenge%20NOW


A Right To Live Supporters to Rally for FDA Reform and Call for
Congressional Action Provenge NOW

A Right To Live ( http://www.arighttolive.com ), a cancer patient
advocacy group formed to promote cancer patients' Right to Live
through access to potentially life-saving therapies, today
announces "A Right To Live Day" to be held September 18, 2007
from 10:00 am to 12:00 noon at the FDA offices in Rockville, MD.

The group will ask the FDA to immediately reconsider its flawed
decision on Provenge, among others, and approve this new therapy
for immediate use by late-stage prostate cancer patients with no
viable alternatives. This new immunotherapy has already been
endorsed by an FDA-appointed panel of experts who unanimously
(17-0) determined it to be safe for its intended use. Further,
the panel voted 13-4 in favor of the 'substantial evidence of
efficacy' of Provenge, meeting the statutory requirements for
immediate FDA approval. Never in its history had the FDA
overturned a positive panel recommendation to deny terminal
patients their right to live.

"It has become very clear over the past few years that the FDA
has instituted a decelerated approval process for cancer
therapies, in stark opposition to Congress' intent in legislating
for accelerated approval pathways," said Scott Riccio, founding
member and advocate for A Right To Live. The Wall Street Journal
lamented this problem back in 2005, noting:

"The problem here is the FDA's unethical--and let us stress,
unscientific--placebo-controlled trials, in which a subset of
study patients are knowingly denied the new treatment and in some
cases denied access to any active treatment at all. This may be
moral with an antihistamine; it's certainly not with treatments
for a terminal disease. What's more, it's entirely unnecessary.
We already know what happens to most cancer patients who don't
get treated. They die." (Wall Street Journal, March 24, 2005)

"There has never been such an incredible, irrational and
unjustifiable denial of the rights of dying patients by such a
dysfunctional agency," according to Mr. Riccio. "Approximately
27,000 men will die this year alone from late-state prostate
cancer and tens of thousands of other cancer patients will lose
their own fights against cancer this year while they wait in vain
for new therapies to make their almost ten-year march from
discovery to FDA review. We believe patients have a right to
live. We're not asking for the FDA to forego scientific review,
we're asking the Agency to catch up to the science that already
exists and use it to approve and monitor these lifesaving new
therapies while patients and their doctors get informed access to
them. We hope that if the FDA continues to abdicate its duty to
patients, Congress will make the necessary inquiries and
legislative changes to reinstate a true accelerated approval
process for them."

Patients, doctors, advocates, and other interested parties should
visit http://www.arighttolive.com for more details on getting
involved and supporting the public cry for immediate relief for
the suffering of patients being denied their right to live.

The rally will be held at 5600 Fishers Lane, Rockville, Maryland,
in front of the FDA's offices and will begin at 10:00 am.
Featured speakers will include Mr. Frank Burroughs, co-founder of
the Abigail-Alliance, Mr. Ray Matyshyn and Mr. Bruce Towers who
are both Provenge clinical trials participants, and Mr. Charles
Reinwald, President of Cancer Cure Coalition, Inc., along with
other distinguished guests.

Who is A Right To Live

A Right To Live is an all-volunteer advocacy group formed in
response to the FDA's refusal to follow the language and intent
of Congress regarding an accelerated approval process for
oncology drugs/therapies and the hundreds of thousands of
patients dying while they wait for new therapies and options to
make their way through the FDA's corrupted processes. We believe
the review process employed by the FDA is not consistent with the
law as written by Congress and as applied by current FDA
reviewers is fundamentally broken. We believe that Provenge,
Genasense, and Junovan should be approved now and would be but
for an FDA system highlighted by aggressive incompetence,
conflicts of interest, and an incorrect understanding of
Congressional intent regarding the accelerated approval process
as whole.

For media inquiries, please visit http://www.arighttolive.com or
call Scott Riccio at 312-420-3296.
Steve Jordan - 05 Sep 2007 18:47 GMT
(snip)

> A Right To Live ( http://www.arighttolive.com ), a cancer patient
> advocacy group formed to promote cancer patients' Right to Live
> through access to potentially life-saving therapies, today announces
> "A Right To Live Day" to be held September 18, 2007 from 10:00 am to
> 12:00 noon at the FDA offices in Rockville, MD.

Well, so long as Paul wishes to post political propaganda from (primarily)
investors in Dendreon and others who have filed suit against the FDA and
at least one of its panel members, I'll post this:

> The answer, as far as I am concerned, is that Dendreon made major and
> obvious mistakes in developing Provenge and not that the FDA is some
[quoted text clipped - 4 lines]
> In the end, they forced the FDA’s hand with their poor clinical trial
> design.

> ...please think carefully about what you would use as a basis for
> approval if you do not want to use the current criteria. After all,
> is it really unreasonable to ask for proof that a drug is reasonably
> safe and either improves survival or quality of life? This seems
> pretty basic to me and is what I would ask as a patient myself.

-- Charles E. Myers, Jr., MD
Medical Oncologist
PCa patient

From his bulletin "Prostate Forum" Volume 10 Number 2
www.prostateforum.com

Regards,

Steve J
Paul B - 05 Sep 2007 22:31 GMT
> (snip)
>
[quoted text clipped - 33 lines]
>
> Steve J

Steve, that is the argument from the other side. The argument
from this side is that Provenge is the first of the oncoming
immunotherapies, and it was not clear back then how best to test
its efficacy. Thus it was forced into the paradigm of looking for
time to progression, which is a surrogate for overall survival,
rather than survival itself. The problem is that the surrogate
works well for chemo, which hits hard and fast, but not for
immunotherapies, which train the body to fight its own battles
against cancer, a process which takes time.

Thus, the front end of the benefit curves for Provenge do not
look wonderful, but the back ends, when the body begins to
benefit from the training, does.

Yes, the tests have some troublesome elements. We've learned a
lot about testing immunotherapies. The question now is whether
Provenge should be held to the letter of the law, and thereby be
penalized for what we didn't know several years ago when its
tests were first designed, or whether we should be flexible in a
space that is so badly underserved. Many of us believe that it
makes no sense to withhold a treatment that all agree is safe.

Add to that the unbelievable conflicts of interest among those
who most vocally opposed, and in an unprecedented way, the
approval of Provenge, and you have a most interesting political
scenario indeed.

Full disclosure - I have a small stake in Dendreon because I
believe in the science and see the need, and I also have
prostatitis. AISI, honest investors are vital to medical
progress, and are disease sufferers' good friends. The FDA's
denial of provenge was an abomination to humanitarianism and to a
free people.
p.
Steve Jordan - 05 Sep 2007 23:40 GMT
On September 5, Paul B replied to me:

> Steve, that is the argument from the other side.

And it is unanswerable.

> The question now is whether
> Provenge (sic: Dendreon) should be held to the letter of the law, and thereby be
> penalized for what we didn't know several years ago when its
> tests were first designed

Look again. Per Dr. Myers, Dendreon changed "endpoints midway through
the clinical trial."

> or whether we should be flexible in a
> space that is so badly underserved. Many of us believe that it
> makes no sense to withhold a treatment that all agree is safe.

But is it efficacious? That is the point at issue, and it is unproven.

Gobbling chocolate cake is safe (in moderation) but is it efficacious
against my PCa?

> Add to that the unbelievable conflicts of interest among those
> who most vocally opposed, and in an unprecedented way, the
> approval of Provenge, and you have a most interesting political
> scenario indeed.

Ah yes, the scurrilous and "unbelievable" allegations that "conflicts of
interest" somehow cause Dr. Harold Scher to write his famous letter to
the FDA. BTW, to the extent there were conflicts or the appearance
thereof, they were disclosed to and waived by the FDA.

One more time: the scurrilous attacks by Paul's fellow investors
(there's the greed motive), primarily on Dr. Scher are an attempt to
punish him for writing a letter to the FDA that is perfectly
unassailable on the facts. Dr Scher now must defend himself from a
vicious and unmerited lawsuit filed by, mainly, investors. Paul might be
one of them for all I know. And I rather suspect that Paul might know
the source of the death threats sent to Dr. Scher.

Uh, "science?" What's that? If anyone prevents me from making a profit
on my investment, I'll make him suffer! The truth be damned!

> Full disclosure - I have a small stake in Dendreon

Thanks. Any other conflicts of interest?

> because I believe in the science and see the need,

And also want to make money.

> and I also have prostatitis.

Well now. What does Provenge do for prostatitis? Nothing.

So why invest? Oh! To make money.

> The FDA's
> denial of provenge was an abomination to humanitarianism and to a
> free people.

Was it good science? Answer: Yes. The rest is political polemics and of
zero factual value.

There is no "humanitarianism" in foisting upon an unsuspecting public a
tx that is unproven. The FDA exists to prevent that very thing!

The abomination in this matter is the injection of greed and politics
into the field of scientific inquiry.

BTW, I'm as greedy as the next guy. But I didn't go bonkers when, frex,
the very promising phenoxodiol was denied approval a few months ago.
Oddly enough, because the manufacturer had erred in its clinical trial
design. Sound familiar? It should.

Regards,

Steve J

"What are the facts? Again and again and again -- what are the facts?
Shun wishful thinking, ignore divine revelation, forget 'what the stars
foretell,' avoid opinion, care not what the neighbors think, never mind
the unguessable 'verdict of history' -- what are the facts, and to how
many decimal places? You pilot always into an unknown future; facts are
your single clue. Get the facts!"
--Lazarus Long
Paul B - 06 Sep 2007 00:49 GMT
> On September 5, Paul B replied to me:
>
[quoted text clipped - 83 lines]
> your single clue. Get the facts!"
> --Lazarus Long

You've jumped to plenty of innuendo here about my integrity, yet
we've never met, to my knowledge. I'm in it for greed, I might
have intimate knowledge of death threats, etc. Usually the one
who jumps to smear his opponent by baseless innuendo is the one
without a substantive argument.

Scher's most serious conflicts were in fact not disclosed to the
FDA. For some examples, see today's op ed in the Bucks Co.
Courier, copied below. Also see Scher's post advisory committee
comments at
http://blogs.wsj.com/health/2007/05/11/dendreons-ups-and-downs-at-fda-and-on-nasdaq
and compare them with the reader comments that follow or, more
concisely, to the .pdf file at
http://caretolive.com/ScherOnThe4OfJuly.pdf.

There's plenty of troubling information out there that suggests
that the FDA decision against Provenge was highly questionable.

p.

Congress must take action to end FDA abuses, conflicts
By Theodore J. Cohen
Theodore J. Cohen, Ph.D., is a research scientist

The so-called “Durbin Amendment,” Amendment SA 1034, was proposed
in the U.S. Senate on May 9, 2007, to amend the Federal Food,
Drug, and Cosmetic Act and, specifically, to ensure that
participants in FDA advisory committees (AC) are free of
financial conflicts of interest that would compromise their
participation as unbiased Government employees.

Just what kind of situation might the Durbin amendment have
protected against?  Consider the recent case in which Dendreon
Corporation brought its prostate cancer drug Provenge to an AC
for review on March 29, 2007.  One of the members of the AC was
participating as a special Government employee under an approved
waiver request in which he had first been required to declare his
relevant conflicts of interest (COIs).

However, the COIs declared did not reveal the full extent of the
conflicts.  For example, they did not reveal that he was on
Novacea, Inc.'s, scientific advisory board and is co-chair of the
company’s ASCENT Phase III clinical trials investigating the use
of Novacea’s Asentar drug together with Sanofi-Aventis’
chemotherapy drug Taxotere (docetaxel) to treat prostate cancer –
a trial that some in the prostate cancer community believe would
be adversely affected by Provenge approval. (Asentar is an oral
treatment for prostate cancer.)

Further, he also is listed as a scientific advisor to ProQuest
Investments., which owns a substantial interest in Novacea.
Interesting, too, is the fact that in a highly unusual move for a
special Government employee, this AC member wrote a letter to the
FDA following the March 29th meeting, calling upon the agency not
to approve Provenge.

More surprisingly, this letter was leaked by party or parties
unknown to a non-peer-reviewed newsletter, and published in an
obvious move to discredit the AC’s recommendation of approval
(the AC voted 17-0 that the drug was safe and 13-4 that is
demonstrated substantial efficacy).  And finally, just three
weeks after the FDA issued a Complete Response (CR) letter to
Dendreon, asking for more data before it would approve Provenge,
Schering Plough signed a $440 million deal with Novacea for the
development of Asentar. What’s wrong with this picture?!

This is what the Durbin Amendment was meant to stop.  “Was” is
the operative word, because on May 9, 2007, the Amendment was
rejected by a vote of 47 to 47, with 6 senators not voting.
Senator Bob Casey (D, PA) voted “Yea;” Senator Arlen Specter (R,
PA), for some inexplicable reason known only to him, voted “Nay.”

You’ll have to ask the senator why he rejected an amendment that
was intended to stop egregious abuses such as that described
above.  But until Congress acts, we can expect more of the same
from members of FDA ACs, who fail to reveal significant conflicts
of interest before sitting in judgment of drugs that potentially
could save the lives of tens of thousands of patients every year.
Steve Jordan - 06 Sep 2007 01:58 GMT
> You've jumped to plenty of innuendo here about my integrity, yet
> we've never met, to my knowledge. I'm in it for greed, I might have
> intimate knowledge of death threats, etc. Usually the one who jumps
> to smear his opponent by baseless innuendo is the one without a
> substantive argument.

Ah. It stings when the roles are reversed, doesn't it? But of course
what I wrote that Paul complains about was neither baseless nor innuendo.

> Scher's most serious conflicts were in fact not disclosed to
> theimpetus FDA. For some examples, see today's op ed in the Bucks Co.
[quoted text clipped - 4 lines]
> concisely, to the .pdf file at
> http://caretolive.com/ScherOnThe4OfJuly.pdf.

And blah blah blah. Were Scher's comments factual or not? No strained
interpretations of his supposed impetus is relevant. So: Yes or no?

> There's plenty of troubling information out there that suggests that
>  the FDA decision against Provenge was highly questionable.

Unless there are facts to support "troubling" suggestions that the FDA
decision was "questionable" whatever that means, it's just so much lawn
fertilizer. And so much innuendo in support of the profit motive.

And the verbiage Paul B attached to his last post is so much wasted
space, having zero to do with evidence.

Regards,

Steve J

Epitaph for a wasted life:

 "He lived beneath the moon
    And slept beneath the sun.
    He lived a life of going to do
    And died with nothing done."
-- Anonymous
 
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