Response to the FDA - re: denial of Provenge

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JoelTNowak@gmail.com - 11 May 2007 16:18 GMT

The prostate cancer community is outraged with the recent FDA
decision. Malecare is coordinating a response to the FDA. Visit
www.malecare.com and read our letter which we will be sending to the
FDA. If you agree with it please add your signature to the letter.

The PC community needs your support. Please pass on this information
to your support groups.
Have your family members sign on to the letter

This letter will be released to the FDA and the press on May 18.

Joel T. Nowak
Program Director for Advanced Prostate Cancer
Malecare, Men helping men fight cancer

Reply to this Message

Steve Kramer - 11 May 2007 18:49 GMT

> The prostate cancer community is outraged with the recent FDA
> decision. Malecare is coordinating a response to the FDA. Visit
[quoted text clipped - 6 lines]
>
> This letter will be released to the FDA and the press on May 18.

I have a lot at stake here. Without a cure, I'm pushing up daisies within a
decade. However, before I put my name to a response, I would like to know
why it was denied or why it should not have been denied.

Signature

PSA 16 10/17/2000 @ 46
Biopsy 11/01/2000 G7 (3+4), T2c
RRP 12/15/2000 G7 (3+4), T3cN0M0 Neg margins
PSA <.1 <.1 <.1 .27 .37 .75 PSAD 0.19 years
EBRT 05-07/2002 @ 47
PSA .34 .22 .15 .21 .32 PSAD .056 years
Lupron 07/03 (1 mo) 8/03 and every 4 months there after
PSA .07 .05 .06 .09 .08 .132 .145 PSAD 1.4 years
Casodex added daily 07/06
PSA <0.04, <0.05
Non Illegitimi Carborundum

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fred - 11 May 2007 19:34 GMT

Steve,,,the WSJ article that I mentioned in my post this morning is on
the front page of yesterday's Journal, Personal Journal sectiion. The
article is long and contains a listing of other PCa drugs in the
approval pipeline. You may want to get a copy of the article, or
perhaps someone who is a subscriber to the online WSJ will copy and
post it for all of us.

Essentially, the article states that; Provenge was recommended for
immediate release by the FDA advisory panel at the end of March, but
the FDA reversed that recommendation, on the grounds that the
statistics had not yet demonstrated a proven benefit, using rigid and
traditional statistical analysis,even though the stats that they have
to date indicate an average extra 4.5 months survival time in those
taking Provenge over those who did not. The FDA is requiring
completion of a new study involving 500 patients (now underway) before
it will grant approval for release of the drug. The best estimates are
that if all goes well now, it will be another 2 years before the
product reaches patients in the general population, compared with
immediate release if the drug had been approved yesterday. The
manufacturer does not plan to offer the drug on a compassionate basis
to non-study participants (which it apparently could legally do),
preferring to focus on getting the approval process completed ASAP.

Seems to me that we should be upset; there doesn't seem to be a lot of
reason to deny access to patients who are otherwise terminal, and who
know the risks/rewards of taking the drug.

Fred

Reply to this Message

Alan Meyer - 11 May 2007 20:55 GMT

> .... The
> manufacturer does not plan to offer the drug on a compassionate basis
> to non-study participants (which it apparently could legally do),
> preferring to focus on getting the approval process completed ASAP.

I hadn't heard of this, so I did some searching. There are useful articles
about compassionate use of unapproved drugs at:

http://www.cancer.gov/cancertopics/factsheet/Therapy/investigational-drug-access

and

http://www.curetoday.com/backissues/v3n3/departments/specialreport/index.html

> Seems to me that we should be upset; there doesn't seem to be a lot of
> reason to deny access to patients who are otherwise terminal, and who
> know the risks/rewards of taking the drug.

Like Steve, I wish I had more information about this.

I know that the FDA is not composed of idiots. Their advisory panel
voted 13 to 4 for approval. I wonder why the four were against it, and
what arguments did they make that seemed to convince the FDA?

Apparently the panel was unanimous in saying that the drug is safe.
I presume that means it won't kill anyone or make them horribly sick.
That would seem to make it more reasonable to release this drug
for interim use while further research is conducted.

I wonder if cost is a factor. No one has said what the cost will
be. My understanding is that each dose of the drug has to
be individually grown and developed for each patient, using his
own blood or tissue samples to provide inputs. If that's right, I
wouldn't be surprised if the cost is astronomical. Maybe some
of the FDA mavens don't like the idea of bankrupting a man's
family to provide unproven benefits? Or maybe that has nothing
to do with it.

Alan

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ron - 11 May 2007 21:19 GMT

Take a look over at PSA Rising

http://psa-rising.com/

they have posted a number of letters, comments, etc. from individuals
directly involved in the Provenge - FDA process...ron

Reply to this Message

Steve Jordan - 11 May 2007 21:55 GMT

On May 11, Ron wrote:

> Take a look over at PSA Rising
>
> http://psa-rising.com/
>
> they have posted a number of letters, comments, etc. from individuals
> directly involved in the Provenge - FDA process.

PSA Rising is Jacqueline Strax's site. She is a PCa widow who continues
the struggle.

Her website is one of the best. Her story on the FDA "Approvable Letter"
was very timely, posted as it was on the same day the letter was issued.

BTW, as I understand it, an "Approvable Letter" is not an outright
rejection of a drug. It undertakes to approve the drug *if* certain
additional data are provided. As may be, there will still be at least a
year's delay in formal approval, assuming the supplemental information
is what FDA wants. And what FDA wants is more evidence of efficacy.

Further BTW, the Phase III study Dendreon is performing is still looking
for about 100 more participants. There is a two out of three probability
of a participant receiving the treatment.

Lastly, I have seen a figure of just under $20,000 cited as the likely
cost.

Regards,

Steve J

"Do not go where the path may lead. Go instead where there is no path
and leave a trail."
-- Ralph Waldo Emerson

Reply to this Message

Dick Smith - 11 May 2007 22:50 GMT

FDA Delays Approving Cancer Vaccine
Dismayed Prostate Patients
To Launch Flood of Protests;
A Question of Efficacy
By MARILYN CHASE
May 10, 2007; Page D1

Patient activists, stunned by a Food and Drug Administration decision
to put off approval of a promising new prostate-cancer vaccine, vowed
to shower the agency with protest emails as part of a continued push
for early access to the experimental treatment.

The FDA late Tuesday asked Dendreon Corp. to provide more data to
support the claim that its prostate-cancer vaccine called Provenge
works to prolong survival. The company has a 500-patient study now
under way to answer that question. But FDA's so-called approvable
letter could mean another two years at least until the product reaches
patients.

"My mind is bouncing around. I feel very, very let down," said Steve
Fleischmann, a Seattle businessman whose 2003 diagnosis at age 47
launched him on a career in advocacy that began in his hospital bed as
he recovered from prostate surgery. His activist group Survivors
Celebration raised $4 million in research funding for the nonprofit
Prostate Cancer Research Institute. "What does this say to men who
have prostate cancer and want to stay alive?" Mr. Fleischmann asked.

The decision was a bitter defeat for patient advocates, many of whom
attended an FDA advisory panel on March 29 wearing blue lapel ribbons
-- a symbol of prostate-cancer activism -- to speak in favor of the
vaccine. Their presence was credited with helping win over the panel,
which voted 13-4 in favor of recommending approval, even though
evidence from two clinical trials was weak in showing benefit. Mr.
Fleischmann called on every man with prostate cancer to send an email
to the FDA to protest its refusal to go along with the panel's
recommendation.

MORE ON DENDREON

· Health Blog: Did FDA make the right decision?1

· Dendreon's Gains Spur Heavy Call Activity2
03/31/07

· FDA Panel Backs Prostate-Cancer Drug3
03/30/07

· FDA Questions Dendreon Cancer Drug4
03/28/07

Prostate cancer is expected to strike 218,000 American men in 2007,
and to cause an estimated 27,500 deaths in the U.S. Provenge is
designed to treat a subset of men -- estimated at 45,000 to 55,000 --
with advanced cancer that is spreading and is no longer responsive to
hormone blockers. The main alternatives include radiation and
Taxotere, a chemotherapy drug. But these treatments generally are
considered to have limited duration and harsh side effects.

Prostate-cancer advocates seized on Provenge as a hopeful new approach
-- and one they wanted to see available even after only limited study.
Their efforts echo growing calls by patients with a range of
afflictions for quicker access to promising medicines. When lives are
at stake, the argument goes, patients can't afford to wait for enough
data to be gathered to do a rigorous analysis of risks and benefits.
Groups advocating for Alzheimer's disease patients are similarly
planning campaigns to press the FDA to move quickly to make drugs for
that debilitating condition available. The strategy recalls campaigns
by AIDS patients in the early 1990s that successfully persuaded
regulators to make AIDS drugs available much sooner than conventional
standards for approval would allow.

But a resurgence of patient activism comes at a time when the FDA is
also under pressure from other critics who believe it has been too
quick to approve drugs and too cozy with the industry it regulates.

In the case of Provenge, both of the studies submitted to make the
case for approval failed to meet their primary "endpoints" -- the
target findings that would have proven the vaccine slowed the growth
of the tumor. And while the panel unanimously vouched for the safety
of Provenge, the agency was concerned about hints of an increased
number of strokes among patients taking the vaccine.

But an analysis that wasn't planned at the start of the study -- and
was thus akin to moving the finish line after the race was over --
suggested patients taking the drug lived 4½ months longer than those
who didn't. To scientists, the analysis was neither reliable nor
statistically valid. But advocates seized on that number to advance
their position in support of approval.

Provenge is the first candidate in a new approach to cancer treatment
called immunotherapy. It is referred to as a "vaccine" because it is
intended to marshal the body's immune system into attacking the
tumors.

'Open to Anything'

In Sanibel, Fla., prostate-cancer advocate Jan Manarite, who leads an
advocacy group called Raise a Voice and whose husband is battling
advanced prostate cancer, vowed to redouble her educational campaign.
She said Raise a Voice is evaluating in the next day or so whether to
join Mr. Fleischmann's email campaign and is planning other actions
including press releases and meetings with other activist
organizations.

"We're open to anything that serves these men with prostate cancer,"
she said in an interview. "Our commitment is unwavering."

But their push for expanded access to Provenge will leave many empty
handed for now. Dendreon's CEO Mitchell Gold, calling the FDA move
"extremely disappointing," said the company will move to finish its
500-patient study -- the only way patients can get access for now.

Asked whether Dendreon will offer compassionate access to nonstudy
participants, Dr. Gold said, "No, the company does not have that kind
of resources. We look forward to completing the trial and working with
the FDA to bring the drug to patients that way." Dr. Gold said he
expects an interim analysis in 2008 with final data in 2010.

Volatile Dendreon stock which has traded in the $4 to $25 range over
the past year had surged after an FDA advisory panel recommended that
the agency approve licensure based on early data. Yesterday shares
plunged 64% to $6.33 on the Nasdaq.

A major point of tension in the deliberations over Provenge was the
company's claim that the drug added 4½ months of survival. "A 4.5-
month life extension probably doesn't sound like a lot to those of you
who are blessedly healthy," Joel Novak of Brooklyn, N.Y., testified at
the advisory panel hearing. "But to me, this is a 20% extension of my
life expectancy."

Analysis Criticized

Critics pointed out that the problem with Dendreon's claim was that it
came from an unplanned analysis of a 127-patient study that failed to
meet its primary goal. Such "sub-analyses" aren't generally considered
to be statistically valid. One panel member, prostate-cancer
researcher Maha Hussain of the University of Michigan, during the
panel hearing called it "incredibly under-powered."

After the favorable panel vote, Howard Scher, a prominent prostate-
cancer researcher at Memorial Sloan Kettering Cancer Center, New York,
and a panel member who voted against approval, wrote a letter to FDA
officials urging rejection of the Provenge licensing application. The
letter, leaked to The Cancer Letter, an influential newsletter,
prompted furious protests in emails posted on blogs and Web sites.

Data and Evidence

"We want Provenge to work; that's our raison d'etre," Dr. Scher said
in a recent interview. But "they need to complete the study."

Yesterday following word that the FDA essentially followed his advice,
Dr. Scher said, "I think that was the correct decision. At the end of
the day, it's the data and the evidence. It's not an emotional
decision."

Paul Goldberg, editor of The Cancer Letter, said "FDA didn't have much
of a choice." Basing decisions on reliable evidence, he added, is also
"patient advocacy. This is just another form of it through science."

None of this assuages Mr. Fleischmann. The father of two children,
ages 5 and 9, he recently experienced a return of his cancer. "I'm on
seven weeks of radiation starting June 1," Mr. Fleischmann said.
"Let's say I get my cancer back again. Then my options are chemo or
Provenge." He added: "I don't want to go on a study. I don't want a
placebo. I want the drug."

URL for this article:
http://online.wsj.com/article/SB117876198051797991.html

Reply to this Message

Paul B - 12 May 2007 00:07 GMT

Here's more from Marilyn Chase's health blog. Apparently one of
the main objectors to Provenge at the advisory committee, the
first one to leak a letter to the FDA, has been caught in a
massive lie. Consider the last two paragraphs of this story, then
the comments:

May 11, 2007, 4:42 pm
Dendreon’s Ups and Downs at FDA and on Nasdaq
Posted by Marilyn Chase

Dendreon has taken investors on a stomach-wrenching rollercoaster
ride this year. Company shares soared from less than $5 in early
January to as much as $25.25 in late March, before trading at
$6.11 late Friday.

The stock skidded this week after FDA asked for more data on the
company’s prostate cancer vaccine, called Provenge. The request
could delay the FDA’s decision on the vaccine for years and
dimmed hopes of both patients and investors. null

Before the stock tanked some savvy investors cashed in. One of
them was businessman Steve Fleischmann, who became a prostate
cancer patient, activist and Dendreon shareholder all in the same
year. “I bought Dendreon in 2003; I’ve owned it for years,” he
told the Health Blog. But he shed some of his shares after
Dendreon surged at the end of March on a panel of experts’
recommendation that FDA approve the vaccine. He declined to
quantify his holdings or profits, but said, “I wanted to take
some of my chips off the table so I wasn’t so invested. It’s
natural.”

Still, Fleischmann decried the protracted tug of war among
investors in the company: “The sad thing is that Dendreon became
more of a stock play than a humanistic play – a game between
longs and shorts – and all about padding people’s pockets.”

Dendreon CEO Mitchell Gold also told the Health Blog he sold
“less than 20%” of his holdings in the company following the
upbeat FDA advisory panel vote. “It’s all public,” he said,
without elaborating.

When some dissenting advisory panel members last month wrote
letters urging FDA to demand more data – as the agency ultimately
did — irate Provenge boosters went on the offensive. “You should
get cancer,” read one message to FDA panel member and outspoken
Provenge skeptic Howard Scher, a prostate cancer specialist at
Memorial Sloan-Kettering Cancer Research Center in New York.
Another email implied Scher’s view was financially driven,
alleging incorrectly that his wife ran a hedge fund. Scher’s wife
runs a senior-care company, he told the Health Blog.

“I try to keep to the high ground,” Scher said, adding that he
doesn’t work with any companies in direct competition with
Dendreon. He serves as advisor to Innovive, a small biotech not
involved in prostate cancer, and works with Bristol-Myers Squibb
in an unpaid capacity on early stage drugs that may hold promise
in prostate cancer. He and his wife hold small amount of stock in
Biogen Idec and Pfizer, he said.

http://blogs.wsj.com/health/2007/05/11/dendreons-ups-and-downs-at-fda-and-on-nas
daq/trackback/

Comments

Scher can lie all he wants. The fact of the matter is there is no
reason to stop a safe bioloic from the market that shows promise
and a better quality of life then the cheomtherapy, which he
supports 100%.
Comment by Charles - May 11, 2007 at 4:55 pm

How do you explain to a cancer patient that there may be
something out there which could improve their lot on life and the
FDA won’t approve the drug.How about approving it for testing .
Comment by r belliveau - May 11, 2007 at 5:05 pm

Ummm… “Disclosure: Howard I. Scher, MD, has disclosed that he has
received grants for clinical research from Sanofi-Aventis.” from
http://www.medscape.com/viewarticle/524950.

Sanofi-Aventis makes Taxotere, currently the only approved
therapy for advanced prostate cancer, a therapy so toxic that
most patients decline. Had Provenge been approved, Taxotere would
have moved from first-line to second-line therapy.
Comment by Dr. M - May 11, 2007 at 5:22 pm

Another ummm: “April 12, 2006 — Novacea, Inc. today announced the
initiation of ASCENT-2, its pivotal Phase 3 clinical study
evaluating the combination of the Company’s novel oral
anti-cancer agent, DN-101, and Taxotere® (docetaxel) in men with
prostate cancer for whom hormonal therapy is no longer working,
also known as androgen-independent prostate cancer (AIPC)….

“Results from the 250-patient Phase 2 ASCENT clinical study
showed that DN-101 appeared to improve survival while reducing
some of the serious side effects of chemotherapy,” said Howard
Scher, M.D., Chairman of the ASCENT-2 study and Chief of the
Genitourinary Oncology Service at Memorial Sloan Kettering Cancer
Center.

So Scher runs a trial on behalf of Novacea for another competing
therapy to Provenge.
Comment by Anonymous - May 11, 2007 at 5:25 pm

Marilyn, now that you have Dr. Scher on record lying about
working with Dendreon’s competitors, perhaps you’d like to
investigate this issue more deeply, perhaps ask why he would deny
this and then print the explanation? Thanks.
Comment by Anonymous - May 11, 2007 at 5:30 pm

Scher is a total liar. He has a direct conflict of interest with
Provenge. His hospitals receive research fundings for an approved
drug in direct competition against Provenge. He disclosed this in
the FDA waiver himself!
Comment by Sam - May 11, 2007 at 5:32 pm

“DR.” Sher/Hussain are a disgrace. I watched the AC Meeting and
know of there past comments about survival. Hypocrites also.I
Care For the people they let Die. If it looks like a duck,walks
like a duck etc…
Comment by Edward belanger RNDNS - May 11, 2007 at 5:39 pm

Patients are getting active on this. There’s a petition for
prostate cancer patients to sign, at www.malecare.org It will go
to the FDA, demanding Provenge and other prostate cancer drugs be
made available. Go and sign the action letter at www.malecare.org
!
Comment by William Sloan - May 11, 2007 at 5:42 pm

It seems that the same old tactics still rule, while all around
us men and their families are fighting for their lives.

Provenge can’t hurt folks by trying it, and considering the only
men who can get it are in late stage cancer with poor prospects
anyway, what possible motive can there be in denying this
promising medical advancement?

The answer? None.
Comment by cpKallister - May 11, 2007 at 5:46 pm

There is proof that Scher admitted to in his disclosure statement
to the FDA that proves he lied…He himself voted for safety..and
the efficacy vote was 13-4 in favor..What else can I say…Should I
tell all my patients who have been asking about this drug to just
wait 3 more years or use some that makes you wish you were
already dead. It is a disgrace for this to happen in the United
States of America.
Comment by Steve - May 11, 2007 at 5:49 pm

I am a cancer survivor and until you are face with this disease,
you have no idea what it’s like to have a death sentence staring
you right in the face. I have lost some very special people in my
life and everyone of them would have taken a drug that could have
saved their lives. Yes, I have a small investment in the company
but, my hopes for a cure is much more. The FDA needs to get a
grip on life and see just how precious it really is.
Comment by Pat C. - May 11, 2007 at 5:51 pm

This is a huge lie on Scher’s part. Nobody said Scher’s wife
works for a hedge fund she used to work for Warbug Pincus, and
her cousin Barry Lafer runs a huge offshore hedgefund called
Lafer Equity. Last quarter according to the SEC they had tons of
stock in chemo/cancer insurance.

I for one will continue to demand a further investigation of
Howard Scher and his wife’s family’s hedge fund. He should never
be able to rule on another FDA panel b/c of this fact. He did not
disclose this fact to the FDA before participating. I can not
believe Dr. Howard Scher continues to lie about this. All you
have to do is search for Lafer-Scher and there is a New York
Times article stating that his wife used to work for Warburg UBS.
Furthermore search for Lafer Equities, it belongs to his wife’s
family. Over 200 million dollars in an offshore hedge fund in the
Cayman Islands. Howard can run, hide, and try to distort the
truth, but it will all shine through. For now he is trying to
play the ‘victim’ in the media.

Maha also did no disclose that her husband also recieves grants
for clinical research from Sanofi-Aventis just like Scher! He is
conducting tests for Taxotore which would be the only competing
drug for Provenge if approved. Hussain’s husband is Jafar Salam
Hussain.
They both ( Scher and Hussain) had/have serious conflicts of
interests.
Comment by Mike - May 11, 2007 at 5:57 pm

Wade a go doc it’s about time the silent started speaking
up.Instead of DR,HUSSAIN,AND DR.SCHER.
Comment by SAM - May 11, 2007 at 6:00 pm

Scher and Hussain should never have been allowed on this panel.
The conflicts of interest are disqualifying, serious and appear
to have been partially obscured during the disclosure process.
The decision to Complete Response instead of Approve must be
reexamined by a fresh and untainted panel. Cancer patients are
owned nothing less than a new panel.
Comment by carl in pa - May 11, 2007 at 6:12 pm

Marilyn - evidence and proof of lies, deceit, corruption and
manipulation have been presented quite clearly and unequivocably
for you. Might I suggest you dig deeper into the
Dendreon/Scher/hedge fund/FDA story to not only save face, but to
come away with a far more interesting - and accurate - report to
write.
Comment by CJ - May 11, 2007 at 6:13 pm

Sher is a liar and hypocite. What high ground? All BS. FDA
approved many drugs like Vioxx or placebo like. He has hidden
agenda. Where are those lawyers?
Comment by Jay Y - May 11, 2007 at 6:14 pm

“Taking the high ground Doc?” Laughable no doubt! Dr. Scher is
simply not telling the truth! He is opposed the immuno-therapy
drugs like Provenge because it would immediately make his
expertise and knowledge about injecting humans with Drano and
Clorox obsolete……period! He would be out of a job!!!
Comment by Ray - May 11, 2007 at 6:16 pm

Shouldn’t there be some proceedings against Sher given that he’s
lied about his current and past relationships with Sanofi and
others.
Comment by DJ - May 11, 2007 at 6:29 pm

How about this post put a retraction on Scher objectivity given
so much evidence to the contrary has been presented on this blog.
Its the least WSJ Healthblog should do.
Comment by DJ - May 11, 2007 at 6:35 pm

Maha Hussain’s husband apart from owning stock that are viewed as
competitors for Provenge, is running clinical trials for Taxotore
as well just like Scher is.

CCOP - Michigan Cancer Research Consortium, Ann Arbor, Michigan,
48106, United States; Recruiting
Salam A. Jafar, MD 734-712-3596.
If you want verifcation that he is Maha’s husband just do a
search for Jafar Hussain/Maha Hussain on Inetlluis.com. I suppose
he goes by Salam Jafar b/c his real name Salam Hussain.. would be
tough to work with that name here in the US.

http://aschoff.blogspot.com/2007/04/paul-goldberg-fights-cancer-right-wing.html
Comment by Mike - May 11, 2007 at 6:40 pm

Scher - guilty as charged.
Comment by Trial by Truth - May 11, 2007 at 6:42 pm

FDA is still playing games with our lives. Hope they all get
cancer, then let us decide what treatment they can have!
Comment by Comment by Tracy - May 11, 2007 at 6:47 pm

FDA is still playing games with our lives. Hope they all get
cancer, then let us decide what treatment they can have!
Comment by Comment by Tracy - May 11, 2007 at 6:47 pm

FDA is still playing games with our lives. Hope they all get
cancer, then let us decide what treatment they can have!
Comment by Comment by Tracy - May 11, 2007 at 6:47 pm

Marilyn Chase, you are no worse than several other “journalists”
who have NOT done the homework, i.e. due dilligence”, to write a
truly balanced and comprehensive story.

Do the homework before the next unwittingly weak piece.

For the sake of thousands of late-state prostate cancer patients
… PLEASE DO YOUR HOMEWORK FIRST.
Comment by moiliiliquarry - May 11, 2007 at 6:48 pm

Reply to this Message

Paul B - 12 May 2007 03:00 GMT

Here's another example of Dr. Scher's integrity in action. This
is his philosophy toward statistical significance when a drug
he's involved with is on the line. Compare this with his attack
on Provenge in his leaked FDA letter after the favorable advisory
committee vote on Provenge's efficacy.

To this observer, it certainly looks like career is more
important than patients' welfare to some people.
p.

KISSIMMEE, Fla., Feb. 26 -- Docetaxel (Taxotere)-based
combination therapy using is being investigated in a dozen trials
for hormone refractory prostate cancer, investigators reported
here.

During an industry-sponsored satellite symposium held in
conjunction with a prostate cancer symposium here, the
investigators said there were four phase III docetaxel-based
combination trials and eight phase I and II trials.

In the symposium titled, "Improving Upon Current Standards: The
Integration of Novel Therapies in the Treatment of
Androgen-Independent Prostate Cancer," sponsored by Novacea,
Howard Scher, M.D., chief of the Genitourinary Oncology Service
at the Memorial Sloan-Kettering Cancer Center in New York
described a number of these trials.

Dr. Scher said the ongoing phase III studies include trials of
docetaxel in combination with bevacizumab (Avastin), DN-101
(calcitrol), atrasentan; GVAX; and VEGF-trap compounds.

He suggested that when doctors consider whether to prescribe
certain treatments, "it may be time we focus less on statistical
significance alone, and more on patient benefit." He noted, for
example, that just-released data from a trial of satraplatin plus
prednisone did not confirm a survival benefit, but did suggest
that the combination was effective against pain, which appeared
to translate into a slowing in progression of clinical symptoms.

He said, too, that many researchers are shifting focus from
statistical significance alone to outcomes that are softer and
more difficult to measure.

Reply to this Message

Alan Meyer - 13 May 2007 02:00 GMT

...

> The decision was a bitter defeat for patient advocates, many of whom
> attended an FDA advisory panel on March 29 wearing blue lapel ribbons
> -- a symbol of prostate-cancer activism -- to speak in favor of the
> vaccine. Their presence was credited with helping win over the panel,
> which voted 13-4 in favor of recommending approval, even though
> evidence from two clinical trials was weak in showing benefit.

...

Hmmm.

That casts the 13-4 vote in a somewhat different light, doesn't it?

I feel that I just don't have enough facts, or enough qualifications,
to have a strong opinion about all this. Of course I do not (yet at
least) have androgen independent prostate cancer - which
makes it much easier for me to adopt a detached view of the
matter.

It would be nice if there were more formalized stages of
approval for drugs, for example a formal stage that allowed
drug companies to market drugs that have shown some
efficacy and reasonable safety, perhaps with reduced
legal liability, to terminally ill patients, even though full
approval is not yet justified.

Apparently Dendreon is not offering the drug under the
more informal compassionate use arrangements that the
FDA sanctions. So perhaps those who are lobbying the
FDA should consider lobbying Dendreon as well.

Alan

Reply to this Message

Steve Kramer - 12 May 2007 02:00 GMT

> Essentially, the article states that; Provenge was recommended for
> immediate release by the FDA advisory panel at the end of March, but
> the FDA reversed that recommendation, on the grounds that ...

[Sound testimony redacted]

Thanks, Fred. That clears up a couple of my questions. And, Paul B's
letter examplar was informative.

So, what is the motive?

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