On May 21, Richbro replied to "kh":

(snip)

Judging from what I've read, it would not be prudent to expect approval
in less than two years, if ever.

I suggest keeping a close eye on GVAX, an immunotherapy drug that is
designed to stimulate the immune system to destroy cancer cells. It's
also far less complex to use than Provenge.

It's now in Phase III testing, one step from submission for approval.

There are several studies in process, and they are still recruiting. See
one of them at:
http://www.clinicaltrials.gov/ct/show/NCT00089856?order=2

From the Clinical Trials website, this is the definition of a Phase III
trial: "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."

Regards,

Steve J

They must have taken it down when the copyright holder complained (it
was on the FOX network).

Here's a summary:

-----------------------------------------------------

The week was capped off with the former FDA Deputy Commissioner, Dr.
Scott Gottlieb appearing on the, "Journal Editorial Report on Fox
News."

Dr. Gottlieb acknowledged that there is a definite split in the Cancer
community on what level of efficacy must be demonstrated in order
drugs to be approved."

When asked, "where do you come down", Dr. Gottlieb responded, "I think
we should be able to tolerate a little more uncertainty when it comes
to these drugs, in a therapeutic space where the clinicians are very
good at reading literature and very good at explaining things to their
patients and should be given an opportunity to try out these drugs..."

-----------------------------------------------------

Not quite a silver bullet but promising and many thought Provenge
would be on the market shortly.  Guesses now are 2008 or 2010 but
people are lobbying hard.  http://www.provengenow.org

I just went on Lupron and Casodex.   If something like Provenge can
"CURE" prostate cancer, great.  I'll take a chance on it.  Even if
it's 5 or 10 %.

-kh

Stever,
3+4 negative margins and no lymph nodes.
What makes you think you still have prostate cancer?

J

I've seen several reports of potential silver bullets.  The majority
are probably marketing hype or way too early to tell.   Provenge has
had some good numbers (far from perfect) but good.

There's pressure on the FDA to approve it.   Even if they don't, your
low PSA looks good.  The Lupron and Casodex is doing good for you.

-kh

I think this is the transcript, it was at http://www.opinionjournal.com/jer/?id=110010104

---------------------------------------------
Submitted for Your Approval
Cancer drugs, immigration and Jerry Falwell.

Monday, May 21, 2007 12:01 a.m. EDT

Paul Gigot: This week on "The Journal Editorial Report": Warning,
government bureaucracy could be hazardous to your health. How the
FDA's red tape is keeping lifesaving cancer drugs out of the hands of
the people who need them most. Plus, key senators strike a bipartisan
deal aimed at bringing 12 million illegal immigrants out of the
shadows. And the Falwell legacy--the founder of the Moral Majority is
dead, but what influence will evangelicals have in 2008? First, these
headlines.

Gigot: Welcome to "The Journal Editorial Report." I'm Paul Gigot. The
Food and Drug Administration last week succeeded in killing two more
promising cancer therapies, the latest victim of that agency's
regulatory obstacles and red tape.

Dr. Scott Gottlieb is a practicing physician who recently left the
FDA, where he served as deputy commissioner. He joins me now from
Washington.

Scott Gottlieb, welcome. Good to have you here.

Gottlieb: Thank you. Thank you.

Gigot: About 1,500 Americans die of cancer every day, more or less,
yet the FDA recently didn't approve those drugs for prostate cancer
and bone cancer--a rare kind of bone cancer in children. Were those
good decisions?

Gottlieb: Well, these were two drugs, Provenge and Junovan, which were
new kinds of therapies. They're immunotherapies. They work by boosting
the body's ability to fight the cancer. So it's a completely new
paradigm in cancer treatment.

In each case, there wasn't really a question about the safety of these
products. That was pretty well established. The questions that the
agency had were around just how effective were they, and in each case
there was evidence that they were effective, but that evidence didn't
rise to the bar that the agency's setting which is a new statistical
standard--a higher standard, if you will, than what it's looked at in
the past.

And in at least one of the cases with one of these drugs, Provenge,
the drug for prostate cancer, an outside advisory committee to the FDA
of medical experts actually voted 13-4 that the drug should be
approved, and the agency didn't go with that decision.

Gigot: Well, you're talking about a standard--I think a statistical
standard that the FDA says you have to have 95% certainty that the
drug is effective. That might be fine if you have flu or something
commonplace or cure for a cold, but if you have terminal cancer or
very serious cancer, wouldn't you want to settle for a 50% chance of
effectiveness, or even maybe a 10% chance? Give you the chance to
extend your life?

Gottlieb: Well, I think a lot of people would be willing to tolerate
more uncertainty, especially with cancers that are otherwise terminal.
It's not just the statistical certainly by which a product needs to
demonstrate effectiveness to meet the FDA's requirements, but also the
kind of trial that needs to be conducted. And so increasingly, the
FDA's requiring placebo-controlled trials that are randomized, which
means that patients who enter the clinical trials either get a sugar
pill or the active drug, and they don't know what they're getting.

Gigot: Is that fair for cancer patients? Somebody who's really sick?

Gottlieb: I think in a lot of cases it's probably not fair, and it
does test ethical boundaries. But particularly with the
immunotherapies, it could be the wrong paradigm for testing drugs,
because the immunotherapies might well work better in people who have
earlier-stage cancers, who still have immune systems that are capable
of being boosted, but the placebo-controlled trials--when you run a
placebo-controlled trial, it's often the case that people with early-
stage cancers don't want to enter the trials, and so you're forced to
have to recruit people who have very late-stage cancers, and those
might be the very people who don't respond to these drugs. So it could
very well be that we have the wrong model for testing these kinds of
drugs.

Gigot: How much of this is the fallout from the Vioxx controversy,
where that drug--it was a pain killer--was pulled from the market
after it was found to increase the risk of heart attack in some
patients. There was a big political flare-up over that. A lot of
people said the FDA moved too fast to approve it. Are we seeing this
as a counterreaction, a blowback against that political uproar?

Gottlieb: Well, I don't think you've seen that in the cancer space.
This has been a movement that's been under way for a number of years
now to try to increase the statistical, the mathematical certainty of
effectiveness of drugs that are approved in the cancer space. Usually
safety questions aren't the issue when it comes to approvability of a
new cancer drug.

It is true that Vioxx and some other drug issues have increased the
scrutiny of the agency. I think what that's caused to happen inside
the agency is that it's given a little bit more voice to people who
might have had a minority point of view inside the agency, and that
could be affecting some of these reviews, where people who otherwise
might not have been in the majority in terms of their view of the
science and their opinion are now able to have more sway in the
process.

Gigot: But just so I understand, you're saying there is a difference
of opinion among cancer doctors and oncologists about whether or not
the FDA is now getting too worried about these safety and efficacy
concerns and should perhaps move faster to approve these new kinds of--
let's face it, exciting kinds of therapy.

Gottlieb: Well, there's certainly a split in the cancer community.
When you talk to cancer experts, you talk to people at the NCI, some
people have misgivings about the effort that's under way--and it
really is an effort. I think it's a conscious effort. And other people
support it. Other people say that we shouldn't be approving very
expensive new cancer drugs unless we are absolutely certain of their
efficacy and we have very good clinical data to guide their use. So
there is a split in the cancer community, no question, among leading
cancer--

Gigot: Where do you come down?

Gottlieb: Well, I think we should be able to tolerate a little more
uncertainty when it comes to these kinds of drugs. And I think you're
dealing with a therapeutic space where the clinicians are very good at
reading the literature and very good at explaining things to their
patients. And they should shall given the opportunity to try out new
drugs.

And it's also the case, Paul, that cancer patients don't just choose
medications based on effectiveness but sometimes on the side-effect
profile. And in fact, there was a case with the drug Zarnestra, that
the FDA didn't approve that drug for a very terminal form of blood
cancer because it was worried the drug might not have been as
effective as the leading therapy, but was far more tolerable. And they
literally worried that patients would be encouraged to use this drug
rather than the standard of care, which might have been more
effective, because the drug was more tolerable. I would say that
that's a decision patients ought to be able to make.

Gigot: All right, I agree with you. Patients should be in on that
decision.

All right, thank you, Scott Gottlieb.

---------------------------------------------

-kh

I think this is the transcript, it was at http://www.opinionjournal.com/jer/?id=110010104

---------------------------------------------
Submitted for Your Approval
Cancer drugs, immigration and Jerry Falwell.

Monday, May 21, 2007 12:01 a.m. EDT

Paul Gigot: This week on "The Journal Editorial Report": Warning,
government bureaucracy could be hazardous to your health. How the
FDA's red tape is keeping lifesaving cancer drugs out of the hands of
the people who need them most. Plus, key senators strike a bipartisan
deal aimed at bringing 12 million illegal immigrants out of the
shadows. And the Falwell legacy--the founder of the Moral Majority is
dead, but what influence will evangelicals have in 2008? First, these
headlines.

Gigot: Welcome to "The Journal Editorial Report." I'm Paul Gigot. The
Food and Drug Administration last week succeeded in killing two more
promising cancer therapies, the latest victim of that agency's
regulatory obstacles and red tape.

Dr. Scott Gottlieb is a practicing physician who recently left the
FDA, where he served as deputy commissioner. He joins me now from
Washington.

Scott Gottlieb, welcome. Good to have you here.

Gottlieb: Thank you. Thank you.

Gigot: About 1,500 Americans die of cancer every day, more or less,
yet the FDA recently didn't approve those drugs for prostate cancer
and bone cancer--a rare kind of bone cancer in children. Were those
good decisions?

Gottlieb: Well, these were two drugs, Provenge and Junovan, which were
new kinds of therapies. They're immunotherapies. They work by boosting
the body's ability to fight the cancer. So it's a completely new
paradigm in cancer treatment.

In each case, there wasn't really a question about the safety of these
products. That was pretty well established. The questions that the
agency had were around just how effective were they, and in each case
there was evidence that they were effective, but that evidence didn't
rise to the bar that the agency's setting which is a new statistical
standard--a higher standard, if you will, than what it's looked at in
the past.

And in at least one of the cases with one of these drugs, Provenge,
the drug for prostate cancer, an outside advisory committee to the FDA
of medical experts actually voted 13-4 that the drug should be
approved, and the agency didn't go with that decision.

Gigot: Well, you're talking about a standard--I think a statistical
standard that the FDA says you have to have 95% certainty that the
drug is effective. That might be fine if you have flu or something
commonplace or cure for a cold, but if you have terminal cancer or
very serious cancer, wouldn't you want to settle for a 50% chance of
effectiveness, or even maybe a 10% chance? Give you the chance to
extend your life?

Gottlieb: Well, I think a lot of people would be willing to tolerate
more uncertainty, especially with cancers that are otherwise terminal.
It's not just the statistical certainly by which a product needs to
demonstrate effectiveness to meet the FDA's requirements, but also the
kind of trial that needs to be conducted. And so increasingly, the
FDA's requiring placebo-controlled trials that are randomized, which
means that patients who enter the clinical trials either get a sugar
pill or the active drug, and they don't know what they're getting.

Gigot: Is that fair for cancer patients? Somebody who's really sick?

Gottlieb: I think in a lot of cases it's probably not fair, and it
does test ethical boundaries. But particularly with the
immunotherapies, it could be the wrong paradigm for testing drugs,
because the immunotherapies might well work better in people who have
earlier-stage cancers, who still have immune systems that are capable
of being boosted, but the placebo-controlled trials--when you run a
placebo-controlled trial, it's often the case that people with early-
stage cancers don't want to enter the trials, and so you're forced to
have to recruit people who have very late-stage cancers, and those
might be the very people who don't respond to these drugs. So it could
very well be that we have the wrong model for testing these kinds of
drugs.

Gigot: How much of this is the fallout from the Vioxx controversy,
where that drug--it was a pain killer--was pulled from the market
after it was found to increase the risk of heart attack in some
patients. There was a big political flare-up over that. A lot of
people said the FDA moved too fast to approve it. Are we seeing this
as a counterreaction, a blowback against that political uproar?

Gottlieb: Well, I don't think you've seen that in the cancer space.
This has been a movement that's been under way for a number of years
now to try to increase the statistical, the mathematical certainty of
effectiveness of drugs that are approved in the cancer space. Usually
safety questions aren't the issue when it comes to approvability of a
new cancer drug.

It is true that Vioxx and some other drug issues have increased the
scrutiny of the agency. I think what that's caused to happen inside
the agency is that it's given a little bit more voice to people who
might have had a minority point of view inside the agency, and that
could be affecting some of these reviews, where people who otherwise
might not have been in the majority in terms of their view of the
science and their opinion are now able to have more sway in the
process.

Gigot: But just so I understand, you're saying there is a difference
of opinion among cancer doctors and oncologists about whether or not
the FDA is now getting too worried about these safety and efficacy
concerns and should perhaps move faster to approve these new kinds of--
let's face it, exciting kinds of therapy.

Gottlieb: Well, there's certainly a split in the cancer community.
When you talk to cancer experts, you talk to people at the NCI, some
people have misgivings about the effort that's under way--and it
really is an effort. I think it's a conscious effort. And other people
support it. Other people say that we shouldn't be approving very
expensive new cancer drugs unless we are absolutely certain of their
efficacy and we have very good clinical data to guide their use. So
there is a split in the cancer community, no question, among leading
cancer--

Gigot: Where do you come down?

Gottlieb: Well, I think we should be able to tolerate a little more
uncertainty when it comes to these kinds of drugs. And I think you're
dealing with a therapeutic space where the clinicians are very good at
reading the literature and very good at explaining things to their
patients. And they should shall given the opportunity to try out new
drugs.

And it's also the case, Paul, that cancer patients don't just choose
medications based on effectiveness but sometimes on the side-effect
profile. And in fact, there was a case with the drug Zarnestra, that
the FDA didn't approve that drug for a very terminal form of blood
cancer because it was worried the drug might not have been as
effective as the leading therapy, but was far more tolerable. And they
literally worried that patients would be encouraged to use this drug
rather than the standard of care, which might have been more
effective, because the drug was more tolerable. I would say that
that's a decision patients ought to be able to make.

Gigot: All right, I agree with you. Patients should be in on that
decision.

All right, thank you, Scott Gottlieb.

---------------------------------------------

-kh