Re: How to measure success with Provenge

[Guest guest]

As I have said before there is no way to measure if Provenge is working. I have had a number of conversations with both medical people at Dendreon and some of the researchers. Dr shore and I talked about this problem on the Provenge Teleconference which is available at the Malecare web site ( Malecare.org) under the Advanced Prostate Cancer Program page. The bottom line is that we know Provenge extends life as demonstrated in the phase III clinical trials. After reviewing the data the FDA agree with this conclusion. This is despite the fact that Provenge has NO effect on PSA or disease progression. The scientific people at Dendreon do admit that they do not understand why it does extend life while not effecting PSA or disease progression, just know that for many (not all) Provenge does extend life. Well known Medical Oncologist specializing in the treatment of recurringandadvanced prostate cancer, Strum, provides this explanation whenPSAis elevating (or not dropping sufficiently) while on either LHRH agonistsorthe GnRH antagonist:Testosterone level not falling to or below 20ng/dl while on LHRH agonistorGnRH antagonist:What if a castrate level of T is not obtained? If the testosterone is >20and the PSA is rising or not falling to desirable levels, we check to seeifthe LHRH agonist or GnRH antagonist is working. To do this, we check LH tosee if it is suppressed to <1. If it is, the LHRH agonist or GnRHantagonistis effecting its desired goal.An LH level >= 1, however, indicates an inadequate suppression of LH. Thiscould be remedied by increasing the dose of the LHRH agonist or GnRHantagonist, by decreasing the dosing interval between injections, or byswitching the LHRH agonists or moving to or from the GnRH antagonist. Inaddition, we have seen the four-month depot injections wearing off beforefour months. Therefore, going back to monthly injections may be tried. Itisalso of value to point out that three-month or four-month intervals fordosing with an LHRH agonist are actually 28 days x 3 (84 days) or 28 x 4(112 days) and not three or four calendar months from the previousinjection.If the T is >20 and the LH is <1, we check to see if the adrenal androgen(AA) levels are normal or elevated. If so, then these precursors are beingtransformed within the prostate cell to T to account for the non-castrateTlevels found. If T is < 20, we check to see if the AA levels arediminished. If so, then an androgen receptor mutation (ARM) may havedeveloped. The androgen receptor, if mutated, may regard an antiandrogensuch as FlutamideR, CasodexR or Nilutamide as an androgen. If this isoperative, positive feedback at the hypothalamic-pituitary level resultsina drop in AA. Lastly, if the testosterone is <20, and the AA are notdecreased, AIPC is likely.For a much more thorough explanation regarding androgen deprivationtherapy,visit:http://www.prostate-cancer.org/education/andeprv/Strum_IADT.htmlChuckAlways as close T Nowak, M.A., M.S.W.Director of Advocacy & Advanced Prostate Cancer ProgramsMalecarewww.malecare.comwww.advancedprostatecancer.net

Not sure I can actually answer your question but the best place to start is to get a hold of an issue of Dr. Strum's PCRI in which he dedicated it almost entirely to the recruitment of patients for the first Phase III clinical trial of Provenge. Once you have located and read that, I think it might be worth contacting Strum's organization directly and see if you can get an answer from him , Strum, because he was closely involved with both the clinical trial itself and the company and would have access to information and perhaps company personnel that none of us would. People at the company would perhaps be able to answer such questions, and might be willing to answer such questions if the right people were asking.

The statement itself that you refer to appears to be saying that Provenge is intended to extend life of PCa patients who are in the final stages of their disease but it does not, and has not been observed to provoke a remission in any of the patients in which it has been tested or used. Which I believe to be a statement of fact admitted to by the company. The issue of PSA and the mechanism by which Provenge extends life is an issue that the FDA had to wrestle with when Provenge completed it's first Phase III trial and why the FDA ordered a second Phase III trial. The company , Dendreon, was unable to explain how and why Provenge worked in the papers they submitted to the FDA when they sought approval of Provenge. They could only explain and show conclusively that it did work in extending life.

The FDA was expecting to see the drugs performance measured in terms of PSA levels but that was not to be the case. They used other data to make their points and I think that understanding that data may provide some explanations. I called Strum's PCRI publication myself prior to the first Phase III trial because after reading it over, it was apparent that the acronym PSA had not been mentioned even once. Which seemed very strange to me as Strum is a very strong supporter of PSA testing at all stages of the disease process. And I myself was specifically searchiing to see what was to be said about PSA levels of the men involved in the Phase I and II trials. Even though such trials were not performed to observe the effect on their PSA's, I merely assumed that as part of any clinical trial with respect to PCa that PSA measurements would have been meticulously measured and recorded. Yet none appeared in

Strums presentation. What I found even more confounding is that in that same issue, Strum found space to once again write a 2 paragraph article lambasting the British Medical Authorities for not making PSA testing a standard test for all men as it has become here in the U.S.. That made the Provenge presentatioin seem all the more strange for it's lack of mention or reference to PSA. Strum has written many articles over the years criticizing British Medical Authorities for not making PSA testing a standard test of the National Health Service for men over a certain age.

Yes, how Provenge works to extend life without regard to PSA is a pivotal question. One which Dendreon to my knowledge has been unable itself to explain. Yet, in two clinical Phase III trials it has been shown to have a median extension of life of 4 1/2 months compared to standard treatment alone. I believe that if PCa had been a lesser disease , and by that I mean something not as serious in it's dimensions as cancer, that the FDA would have been very likely not to have approved Provenge. But because PCa is such a serious illness , and by the time they give you Provenge it has actually become a terminal illness, I think that the FDA would have had a very difficult road ahead of itself had it not approved it. Sometimes not everything can be explained and I would hope that in the future should another treatment appear that successfully treats PCa and extends life and similarly cannot be

explained with reference to standard markers like PSA, that it too is approved. Yet the fact that PSA does not seem to play a role in the effectiveness of Provenge or the mechanism by which it works actually is quite promising as it seems to be suggestive that there are ways to treat PCa other than blunt protocols like hormonal manipulation, surgery and radiation. . I'm hopeful that Provenge respresents a new path in the treatment of PCa that is a radical departure from current medical definition of definitive treatments.

As for using the drug , to my knowledge , and what had been hoped for by the company, is that after proving that Provenge could extend the lives of men with terminal stage cancer that trials could be conducted with men at much earlier stages of the disease. However the same questions the FDA has asked would plague the researchers even more , which is how would you track the progress of the patient? In the trial that was approved by the FDA the researchers were able to show that it extended life in the sickest of PCa patients at the end stage of their disease. This was easily measurable by comparing them with men in the same stage of the disease that did not get Provenge. However, giving Provenge to men at much earlier stages of the disease presents unique problems. The most obvious of which is the one you yourself brought to the fore as to my knowledge no one

has as of yet figured out the mechanism by which it actually works it's magic. If PSA is not relevant, than what marker do you use to show that Provenge is doing something beneficial for the patient? I think that this is still a question that the company has been unable to answer. And it is a very important question as the only other methods to track the patients success or failure would have to be other measurable lab tests and imaging studies of tumors. The problem with imaging tests of course has to do with how reliable and how detailed they could be in order to be able to measure tumors that were almost microscopic and yet determine if they are growing or shrinking. Despite the fact that such imaging studies have gotten much better than those that were available 10 years ago, i'm not sure if they are yet good enough to measure tumors down to the cellular level. Which would be needed to be able to track the effectiveness of any

treatament. Ten years ago I had socalled medical experts and patient experts telling me that this was possible then. Yet it was not possible then and I do not think that it is possible now. And i'm sure that there are going to be men who will insist that yes we are that technologically advanced today. All I know is that on several occasions when I have taken MRI''s and Ultrasounds to medical facilities other than the ones at which they were done the new doctors and technicians always smiled and told me that they would not know what they were looking at had I not told them what the films were a representation of. Which told me what I needed to know. We are not there yet but i''m forever hopeful that we could be soon.

I know that this does not answer your question Terry but that is my two cents of it and i'm sure that perhaps others may join in with theirs which I am very eager to read. Strum has yet to give a presentation regarding the use of PSA testing and patients getting Provenge and explain why PSA was not relevent to the use of Provenge. I think he could have and should have dedicated an entire issue of PCRI to answering those questions as i'm sure that I was not the only one who noticed. I do believe that giving Provenge to men at the earliest stages of their disease is what most men want to have happen. Also, I still cannot understand why such trials with Provenge of early stage PCa have not been conducted with dogs, the only other creature on earth that naturally develops PCa. That is afterall how Huggins and Labrie made their breakthrough observations on androgen

deprivation 60 years ago. To my knowledge there was only one dog involved. They did not use many dogs in their experiments. I see an urgency and I too often fail to understand why companies like Dendreon do not. These are trials that could have been done even before the Phase III trials on humans as the restrictions are few and the cost minimal in the testing of animals.

I do not know if you Terry will ever have the occasion to use Provenge or one of it's follow on cocktails that are sure to come in due time. What I do know from my extensive travels about the globe is this: although a course of treatment with Provenge will cost Americans about 93,000 dollars per patient, you as an Australian will probably be able to get it for 5 to 6 times less. And people living in the developing world will get it for 10 times less. So, cost will not be a factor as the Australian government's health authorities work on your behalf and negotiate Pharamceutical prices directly with Phama firms for it's citizens. As do most other countries on the planet. That is a process which is actually illegal here in the U.S. as our congress has passed laws at the behest of the Pharma industry lobbyists (I call it bribery myself) to prevent any U.S. government agency from doing

so. The Pharma industry cliams that unless they can charge Americans such fantastic sums of money, they will not have the resources to do the kinds of cutting edge research that they do. They make no mention of the fact that this does not occur anywhere else on the planet. Nor do they mention that the the same drugs they sell overseas are marketed at greatly reduced prices.

A few years back there was this huge debate here regarding the importation of drugs from Canada where they are often 10 times cheaper than they are here. Actually, Glaxokiline, the big British drug firm threatened the country of Canada two years ago with not sending any drugs to Canada if they continued to allow those drugs to be sold to Americans across the border. Glaxo was exporting it's drugs to both Canada and the U.S. with Canada paying one price and Americans paying another. Americans were told by our media that drugs from Europe were inferior and not to be trusted. It got to the point of irrational hyseria as I recall. No one ever mentioned that 100 pct of all of our flu vaccines are produced in just two countries and neither one of them is the U.S.. All flu vaccines are produced in the U.K. and France with licensing agreements for importation into the U.S..

So there are a whole lot of questions surrounding the drug industry and most of them revolve around money. The issues with regards to Provenge involve money and of course technical medical explanations as to the mechanisms by which it is supposed to work. The money issues we are not even involved in but we are capable of tackling the technical medical explanations if we can get access to the right people at Dendreon.

I still think that on that issue, Strum is the man.

Cheers, BOB

Subject: How to measure success with ProvengeTo: "'Prostate Problems Mailing LIst'" , ProstateCancerSupport Date: Friday, July 22, 2011, 6:23 PM

I confess that I have not paid too much attention to all the detail of Provenge since there is no chance, as far as I can see, of my ever using the drug. But I have had a couple of questions put to me off my site and feel I’d better get up to speed and perhaps put some basic information on my site.

One of the first questions I had was “How will I know if Provenge is working if PSA is no longer a measure of success?†In starting to look for the answer to that I came across this comment on the June 2011 ASCO meeting item <snip> Knowing more specifically how Provenge extends survival without causing remissions is one of the pivotal new questions in prostate cancer oncology. <snip>

I am not too sure just what this means – can anyone enlighten me? If there is no remission, is it possible that the observed extended survival is merely be another dot in the range of survival periods in men taking Provenge?

Does anyone know of a site – preferably not a Dendreon funded one – that sets out the basic information for Provenge to save me a bit of a search?

All the best

Prostate men need enlightening, not frightening

Terry Herbert - diagnosed in 1996 and still going strong

Read A Strange Place for unbiased information at http://www.yananow.org/StrangePlace/index.html

[Guest guest]

I still don’t understand……

It

is disease progression that kills us: if this therapy does not stop

progression how can it stop you dying?

If

no one can say WHY it stops some men from dying it does not meet the

scientific requirements of explanation of cause and effect. Anyone posting

a study showing that some men who take Xxxxx (name the product) do not die

at the same rate as other men who have not taken Xxxxxxx would be accused

of quackery.

Given some of the financial background to

the development of this therapy and the enormous amounts of money involved and

the fact that the FDA knocked back the initial application I have to say that,

from a scientific point of view, there seems to be something odd: from a cynical

point of view …………………….well!!!

All the best

Prostate men need enlightening, not

frightening

Terry Herbert - diagnosed in 1996 and

still going strong

Read A Strange Place for unbiased information at http://www.yananow.org/StrangePlace/index.html

From:

ProstateCancerSupport

[mailto:ProstateCancerSupport ] On Behalf Of TNowak

Sent: Sunday, 24 July 2011 2:06 AM

To:

ProstateCancerSupport

Subject: Re:

How to measure success with Provenge

As I have said before there is no way to measure if Provenge is

working. I have had a number of conversations with both medical people at

Dendreon and some of the researchers. Dr shore and I talked about this

problem on the Provenge Teleconference which is available at the Malecare web

site ( Malecare.org) under the Advanced

Prostate Cancer Program page.

The bottom line is that we know Provenge extends life as demonstrated

in the phase III clinical trials. After reviewing the data the FDA agree

with this conclusion. This is despite the fact that Provenge has NO

effect on PSA or disease progression. The scientific people at Dendreon

do admit that they do not understand why it does extend life while not

effecting PSA or disease progression, just know that for many (not all)

Provenge does extend life.

[Guest guest]

Terry Herbert wrote:

> I still don’t understand……

> 1. It is disease progression that kills us: if this therapy

> does not stop progression how can it stop you dying?

....

I don't understand that either.  Maybe it doesn't " stop " disease

progression but does slow it down.

Other treatments do stop and reverse disease progression for a

while, then eventually it comes back.  But if you can slow it

down even without " stopping " it, it might still extend life.

If you get the answer, please let us know.

    Alan

[Guest guest]

My view of the value of PSA when drugs are being reviewed by the FDA is different then this expressed. Yes, most, maybe all clinical trials, look at PSA values and most also look at disease progression, but each approved drug over the past recent history had to show an extended survival time. PSA and disease progression are very nice numbers, but they do not show a drugs ability to extend life. The FDA has made it very clear they are interested only in survival numbers, that was the very reason they made Dendreon go back and run an additional phase III trial, the IMPACT trial. Basically this trial, to be evaluated by the FDA, required only survival numbers. The only thing the FDA wanted to confirm was that men lived longer, the PSA numbers and disease progression did not enter into the equation.Since it takes so long for most men to die from prostate cancer (thank God) obtaining these survival numbers takes a long time. Basically we wait for men to die. This is the reason that we need to develop alternative biomarkers that will measure survival. The FDA has made it very clear that PSA numbers and disease progression do not measure survival, in prostate cancer the only really acceptable measure is survival, or should I say death? T Nowak, M.A., M.S.W.Director of Advocacy & Advanced Prostate Cancer ProgramsMalecarewww.malecare.comwww.advancedprostatecancer.net

Terry, you are absolutely right and what you have said is precisely what has been said about herbal medicines and all sorts of alternative practices all along. If you can't prove how and why they work, then we (the FDA) won't approve them. Well, not so fast. Like HIV, PCa and BCa have become political diseases as well with constituencies that have been growing exponentially. The FDA has to answer to the congress and congress has to answer to the voters. Unfortunately for the FDA, Dendreon's Phase III trial (two of them in fact) met their end points. There would have been hell to pay and heads would have rolled had they not approved the therapy with hundreds of thousands being Dx annually and millions of men walking around with the disease. This is a new reality. And yes what you say is

true. If the same results were to be found using some alternative unapproved modality, it would be called quackery even if it did improve survival . Call it a hypocrisy or whatever you like but that's the way it is. This in fact has been a reoccurring issue with regards to many products. I can think of Stanislaw Burzynski and he has a lot more credible scientific data and proof than does Dendreon for it's product.

It all comes down to this; Provenge stops men from dying and allows them to live longer and no one knows why. So, the hands of the FDA are tied because the PCa lobby is growing by leaps and bounds and includes a whole lot of legislators. And the ones it does not include , well, they know that it may include them too someday so they want Provence around for themselves should they need it. It's common knowledge now that PCa is not one of those rare cancers that someone else is expected to get. Most men over 40 today realize that they have a good chance of getting it and that those chances appear to be increasing over time.

It's also the first immunotherapy drug to be approved and there are literally dozens more in the wings just waiting to enter Phase III trials. The other political issue is had Provenge not been approved, it would have dealt a very big blow to all of those other companies out there who are trying to get their drugs through trials as well. It would have sent a message at a time when it was the wrong kind of message to send considering how tenuous but potentially promising the immunotherapy industry is at the moment. The approval of Provenge , for good or for bad , has been a big boost to those companies.

Venture capital seeing the success in the approval of Provenge will invest billions of dollars into budding Biotech companies that are researching immunotherapy and have products in various stages of clinical trials. The major drug companies are still playing mix and match with chemical one molecule wonder cocktails. They have only recently begun to explore and take notice of Biotech and immunotherapy protocols and products. If no one thinks there is a future in this part of the industry, no one will invest money into it. That is why the approval of Provenge has been such a boon to this sector of the Pharma industry. Two decades ago when the housing market was lagging, the government changed the tax laws such as to initiate a huge housing expansion here in the U.S.. The tax terms for the purchase and sale of real estate are far more favourable than the tax terms for investing in equities. But, that is what the government wanted to do at the

time. And the laws did in fact help foster the boom in real estate. Well, the FDA is an agency of the government and is fully aware of how and why it's actions effect the Pharmaceutical and medical device industry.

Against the backdrop of all existing treatment protocols, immunotherapy appears to be the next best hope in treating cancer. Approving Provenge based on the fact that it met it's endpoints despite the fact that neither the company or anyone can explain how it works is a plus for PCa patients and the tentative future of the Biotechnology immunotherapy industry. Which is being fostered by the government. That's how I see it.

BOB

Subject: RE: How to measure success with ProvengeTo: ProstateCancerSupport Date: Saturday, July 23, 2011, 5:41 PM

I still don’t understand……

It is disease progression that kills us: if this therapy does not stop progression how can it stop you dying?

If no one can say WHY it stops some men from dying it does not meet the scientific requirements of explanation of cause and effect. Anyone posting a study showing that some men who take Xxxxx (name the product) do not die at the same rate as other men who have not taken Xxxxxxx would be accused of quackery.

Given some of the financial background to the development of this therapy and the enormous amounts of money involved and the fact that the FDA knocked back the initial application I have to say that, from a scientific point of view, there seems to be something odd: from a cynical point of view …………………….well!!!

All the best

Prostate men need enlightening, not frightening

Terry Herbert - diagnosed in 1996 and still going strong

Read A Strange Place for unbiased information at http://www.yananow.org/StrangePlace/index.html

From: ProstateCancerSupport [mailto:ProstateCancerSupport ] On Behalf Of TNowakSent: Sunday, 24 July 2011 2:06 AMTo: ProstateCancerSupport Subject: Re: How to measure success with Provenge

As I have said before there is no way to measure if Provenge is working. I have had a number of conversations with both medical people at Dendreon and some of the researchers. Dr shore and I talked about this problem on the Provenge Teleconference which is available at the Malecare web site ( Malecare.org) under the Advanced Prostate Cancer Program page.

The bottom line is that we know Provenge extends life as demonstrated in the phase III clinical trials. After reviewing the data the FDA agree with this conclusion. This is despite the fact that Provenge has NO effect on PSA or disease progression. The scientific people at Dendreon do admit that they do not understand why it does extend life while not effecting PSA or disease progression, just know that for many (not all) Provenge does extend life.

[Guest guest]

That was a very interesting discussion of Provenge.  Comments

below:

> .. I can think of Stanislaw Burzynski and he has a lot more

> credible scientific data and proof than does Dendreon for it's

> product.

Let me take some time out from Provenge to talk about Burzynski.

I won't get on my soapbox here, I'll just point you to the

quackwatch site:

http://www.quackwatch.com/search/webglimpse.cgi?ID=1 & query=Burzynski

and to the one trial run by the Mayo Clinic that attempted to

replicate his findings:

http://www.ncbi.nlm.nih.gov/pubmed/10069350

> It all comes down to this; Provenge stops men from dying and

> allows them to live longer and no one knows why.

Well, let me qualify that a little.  We know why it works.  It

stimulates the immune system to attack the cancer.  We have a

good understanding of the effects of the drug on a cellular and

molecular level.  What we don't know is why it extends life

without regressing the biomarkers (like PSA) of the disease -

something that all of the other successful treatments do.

> So, the hands of the FDA are tied because the PCa lobby is

> growing by leaps and bounds and includes a whole lot of

> legislators.  And the ones it does not include , well, they

> know that it may include them too someday so they want Provence

> around for themselves should they need it. It's common

> knowledge now that PCa is not one of those rare cancers that

> someone else is expected to get.  Most men over 40 today

> realize that they have a good chance of getting it and that

> those chances appear to be increasing over time.

That's a good point.  One of the things that scientists working

on cancer can be thankful for in this era of government cutbacks

is that, as they say, " rich, white senators " get the disease.

> It's also the first immunotherapy drug to be approved and there

> are literally dozens more in the wings just waiting to enter

> Phase III trials. The other political issue is had Provenge not

> been approved, it would have dealt a very big blow to all of

> those other companies out there who are trying to get their

> drugs through trials as well. It would have sent a message at a

> time when it was the wrong kind of message to send considering

> how tenuous but potentially promising the immunotherapy

> industry is at the moment.

I had never thought about that but it strikes me as a good point.

If Dendreon had spent hundreds of millions of dollars on this and

then lost it all, what would have happened to investment in other

immunotherapies?

I've vacillated in my thinking about Provenge.  However if you're

right, and I think you are, the approval of Provenge may indeed

have been critical for progress.

> ... If no one thinks there is a future in this part of the

> industry, no one will invest money into it. That is why the

> approval of Provenge has been such a boon to this sector of the

> Pharma industry.

Indeed!

> ... Well, the FDA is an agency of the government and is fully

> aware of how and why it's actions effect the Pharmaceutical and

> medical device industry.

Again, indeed!

> Against the backdrop of all existing treatment protocols,

> immunotherapy appears to be the next best hope in treating

> cancer. Approving Provenge based on the fact that it met it's

> endpoints despite the fact that neither the company or anyone

> can explain how it works is a plus for PCa patients and the

> tentative future of the Biotechnology immunotherapy industry.

> Which is being fostered by the government. That's how I see it.

Thanks for posting this.

    Alan

[Guest guest]

That was a very interesting discussion of Provenge.  Comments

below:

> .. I can think of Stanislaw Burzynski and he has a lot more

> credible scientific data and proof than does Dendreon for it's

> product.

Let me take some time out from Provenge to talk about Burzynski.

I won't get on my soapbox here, I'll just point you to the

quackwatch site:

http://www.quackwatch.com/search/webglimpse.cgi?ID=1 & query=Burzynski

and to the one trial run by the Mayo Clinic that attempted to

replicate his findings:

http://www.ncbi.nlm.nih.gov/pubmed/10069350

> It all comes down to this; Provenge stops men from dying and

> allows them to live longer and no one knows why.

Well, let me qualify that a little.  We know why it works.  It

stimulates the immune system to attack the cancer.  We have a

good understanding of the effects of the drug on a cellular and

molecular level.  What we don't know is why it extends life

without regressing the biomarkers (like PSA) of the disease -

something that all of the other successful treatments do.

> So, the hands of the FDA are tied because the PCa lobby is

> growing by leaps and bounds and includes a whole lot of

> legislators.  And the ones it does not include , well, they

> know that it may include them too someday so they want Provence

> around for themselves should they need it. It's common

> knowledge now that PCa is not one of those rare cancers that

> someone else is expected to get.  Most men over 40 today

> realize that they have a good chance of getting it and that

> those chances appear to be increasing over time.

That's a good point.  One of the things that scientists working

on cancer can be thankful for in this era of government cutbacks

is that, as they say, " rich, white senators " get the disease.

> It's also the first immunotherapy drug to be approved and there

> are literally dozens more in the wings just waiting to enter

> Phase III trials. The other political issue is had Provenge not

> been approved, it would have dealt a very big blow to all of

> those other companies out there who are trying to get their

> drugs through trials as well. It would have sent a message at a

> time when it was the wrong kind of message to send considering

> how tenuous but potentially promising the immunotherapy

> industry is at the moment.

I had never thought about that but it strikes me as a good point.

If Dendreon had spent hundreds of millions of dollars on this and

then lost it all, what would have happened to investment in other

immunotherapies?

I've vacillated in my thinking about Provenge.  However if you're

right, and I think you are, the approval of Provenge may indeed

have been critical for progress.

> ... If no one thinks there is a future in this part of the

> industry, no one will invest money into it. That is why the

> approval of Provenge has been such a boon to this sector of the

> Pharma industry.

Indeed!

> ... Well, the FDA is an agency of the government and is fully

> aware of how and why it's actions effect the Pharmaceutical and

> medical device industry.

Again, indeed!

> Against the backdrop of all existing treatment protocols,

> immunotherapy appears to be the next best hope in treating

> cancer. Approving Provenge based on the fact that it met it's

> endpoints despite the fact that neither the company or anyone

> can explain how it works is a plus for PCa patients and the

> tentative future of the Biotechnology immunotherapy industry.

> Which is being fostered by the government. That's how I see it.

Thanks for posting this.

    Alan

[Guest guest]

> <wiech89@... <mailto:wiech89%40yahoo.com>>

>

> That was a very interesting discussion of Provenge. Comments

> below:

>

> > .. I can think of Stanislaw Burzynski and he has a lot more

> > credible scientific data and proof than does Dendreon for it's

> > product.

>

> Let me take some time out from Provenge to talk about Burzynski.

>

> I won't get on my soapbox here, I'll just point you to the

> quackwatch site:

>

> http://www.quackwatch.com/search/webglimpse.cgi?ID=1 & query=Burzynski

> <http://www.quackwatch.com/search/webglimpse.cgi?ID=1 & query=Burzynski>

>

> and to the one trial run by the Mayo Clinic that attempted to

> replicate his findings:

>

> http://www.ncbi.nlm.nih.gov/pubmed/10069350

I thank Alan for his research and his post.

Burzynski has for years been well-known for his antineoplaston

garbage.

Regards,

Steve J

" A man's most valuable trait is a judicious sense of what not to

believe. "

-- Euripides

[Guest guest]

> <wiech89@... <mailto:wiech89%40yahoo.com>>

>

> That was a very interesting discussion of Provenge. Comments

> below:

>

> > .. I can think of Stanislaw Burzynski and he has a lot more

> > credible scientific data and proof than does Dendreon for it's

> > product.

>

> Let me take some time out from Provenge to talk about Burzynski.

>

> I won't get on my soapbox here, I'll just point you to the

> quackwatch site:

>

> http://www.quackwatch.com/search/webglimpse.cgi?ID=1 & query=Burzynski

> <http://www.quackwatch.com/search/webglimpse.cgi?ID=1 & query=Burzynski>

>

> and to the one trial run by the Mayo Clinic that attempted to

> replicate his findings:

>

> http://www.ncbi.nlm.nih.gov/pubmed/10069350

I thank Alan for his research and his post.

Burzynski has for years been well-known for his antineoplaston

garbage.

Regards,

Steve J

" A man's most valuable trait is a judicious sense of what not to

believe. "

-- Euripides

[Guest guest]

Whenever I read remarks like this one <snip>

Burzynski has for years been well-known for his antineoplaston garbage.<snip> I am reminded of the radiologist in Houston who was

good enough to help me in the early days of my diagnosis. He did a very

through series of scans, free of charge because he was a pal of my brother’s,

and who put me and my wife up in his house for the best part of a week while I

consulted, free of charge thanks to his introductions, three local prostate

cancer specialists.

During the corse of one conversation over

dinner, I asked him about Burzynski and his claims. He told me that he had

scanned some children with brain tumours before and after they were treated by

Burzynski and was absolutely amazed at the outcome. The tumours simply

disappeared.

Now of course this is anecdotal evidence,

and Steve does not like anecdotal evidence, but I wonder why that good man

would have lied to me about what he had seen and experienced. Could it be that,

as he claims and as seems to have been demonstrated in two FDA approved

studies, Burzynski’s approach has some merit and the opposition to him is

based on the fact that he appears to be an arrogant man who despises the

attitudes of his colleagues? So I am personally still in two minds about

Burzynski – on balance I think his therapies may be better than they are

made out to be.

All the best

Terry Herbert

in Melbourne

Australia

Diagnosed ‘96: Age

54: Stage T2b: PSA 7.2: Gleason 7: No treatment. Jun '07 PSA 42.0 - Bony

Metastasis: Aug '07: Intermittent ADT: PSA 3.4 May '11

It is a

tragedy of the world that no one knows what he doesn’t know, and the less

a man knows, the more sure he is that he knows everything. Joyce

Carey

From: ProstateCancerSupport [mailto:ProstateCancerSupport ] On Behalf Of Steve

Jordan

Sent: Monday, 25 July 2011 9:05 AM

To: ProstateCancerSupport

Subject: Re:

How to measure success with Provenge

On

7/24/11, Alan Meyer wrote:

> <wiech89@...

<mailto:wiech89%40yahoo.com>>

>

> That was a very interesting discussion of Provenge. Comments

> below:

>

> > .. I can think of Stanislaw Burzynski and he has a lot more

> > credible scientific data and proof than does Dendreon for it's

> > product.

>

> Let me take some time out from Provenge to talk about Burzynski.

>

> I won't get on my soapbox here, I'll just point you to the

> quackwatch site:

>

> http://www.quackwatch.com/search/webglimpse.cgi?ID=1 & query=Burzynski

> <http://www.quackwatch.com/search/webglimpse.cgi?ID=1 & query=Burzynski>

>

> and to the one trial run by the Mayo Clinic that attempted to

> replicate his findings:

>

> http://www.ncbi.nlm.nih.gov/pubmed/10069350

I thank Alan for his research and his post.

Burzynski has for years been well-known for his antineoplaston

garbage.

Regards,

Steve J

" A man's most valuable trait is a judicious sense of what not to

believe. "

-- Euripides

[Guest guest]

Whenever I read remarks like this one <snip>

Burzynski has for years been well-known for his antineoplaston garbage.<snip> I am reminded of the radiologist in Houston who was

good enough to help me in the early days of my diagnosis. He did a very

through series of scans, free of charge because he was a pal of my brother’s,

and who put me and my wife up in his house for the best part of a week while I

consulted, free of charge thanks to his introductions, three local prostate

cancer specialists.

During the corse of one conversation over

dinner, I asked him about Burzynski and his claims. He told me that he had

scanned some children with brain tumours before and after they were treated by

Burzynski and was absolutely amazed at the outcome. The tumours simply

disappeared.

Now of course this is anecdotal evidence,

and Steve does not like anecdotal evidence, but I wonder why that good man

would have lied to me about what he had seen and experienced. Could it be that,

as he claims and as seems to have been demonstrated in two FDA approved

studies, Burzynski’s approach has some merit and the opposition to him is

based on the fact that he appears to be an arrogant man who despises the

attitudes of his colleagues? So I am personally still in two minds about

Burzynski – on balance I think his therapies may be better than they are

made out to be.

All the best

Terry Herbert

in Melbourne

Australia

Diagnosed ‘96: Age

54: Stage T2b: PSA 7.2: Gleason 7: No treatment. Jun '07 PSA 42.0 - Bony

Metastasis: Aug '07: Intermittent ADT: PSA 3.4 May '11

It is a

tragedy of the world that no one knows what he doesn’t know, and the less

a man knows, the more sure he is that he knows everything. Joyce

Carey

From: ProstateCancerSupport [mailto:ProstateCancerSupport ] On Behalf Of Steve

Jordan

Sent: Monday, 25 July 2011 9:05 AM

To: ProstateCancerSupport

Subject: Re:

How to measure success with Provenge

On

7/24/11, Alan Meyer wrote:

> <wiech89@...

<mailto:wiech89%40yahoo.com>>

>

> That was a very interesting discussion of Provenge. Comments

> below:

>

> > .. I can think of Stanislaw Burzynski and he has a lot more

> > credible scientific data and proof than does Dendreon for it's

> > product.

>

> Let me take some time out from Provenge to talk about Burzynski.

>

> I won't get on my soapbox here, I'll just point you to the

> quackwatch site:

>

> http://www.quackwatch.com/search/webglimpse.cgi?ID=1 & query=Burzynski

> <http://www.quackwatch.com/search/webglimpse.cgi?ID=1 & query=Burzynski>

>

> and to the one trial run by the Mayo Clinic that attempted to

> replicate his findings:

>

> http://www.ncbi.nlm.nih.gov/pubmed/10069350

I thank Alan for his research and his post.

Burzynski has for years been well-known for his antineoplaston

garbage.

Regards,

Steve J

" A man's most valuable trait is a judicious sense of what not to

believe. "

-- Euripides

[Guest guest]

Terry Herbert wrote:

> Whenever I read remarks like this one <snip> Burzynski has for

> years been well-known for his antineoplaston garbage.<snip> I

> am reminded of the radiologist in Houston who was good enough

> to help me in the early days of my  diagnosis. He did a very

> through series of scans, free of charge because he was a pal of

> my brother’s, and who put me and my wife up in his house for

> the best part of a week while I consulted, free of charge

> thanks to his introductions,  three local prostate cancer

> specialists.

>

> During the corse of one conversation over dinner, I asked him

> about Burzynski and his claims. He told me that he had scanned

> some children with brain tumours before and after they were

> treated by Burzynski and was absolutely amazed at the outcome.

> The tumours simply disappeared.

>

> Now of course this is anecdotal evidence, and Steve does not

> like anecdotal evidence, but I wonder why that good man would

> have lied to me about what he had seen and experienced. Could

> it be that, as he claims and as seems to have been demonstrated

> in two FDA approved studies, Burzynski’s approach has some

> merit and the opposition to him is based on the fact that he

> appears to be an arrogant man who despises the attitudes of his

> colleagues? So I am personally still in two minds about

> Burzynski - on balance I think his therapies may be better than

> they are made out to be.

I apologize for the length of this posting but it's a difficult

subject and I don't believe it can be adequately discussed in a

short one.

I've given some thought to the issue of Dr. Burzynski's

credibility and I want to be as objective as I can be.  It's a

difficult problem because there are such wildly conflicting views

about the man.

One problem that clouds the issues is that each side accuses the

other of lack of objectivity and/or ulterior motives.  The

defenders of the " alternative " medicines are often thought to be

quacks and their shills who are in it for the money, or desperate

patients and families who are grasping at straws.  The opponents

are often thought to be drug company monopolists or their shills

in the FDA who are in it for the money, or deluded members of the

public who are too trusting of " authoritative " sources.

At the same time however, I have no doubt whatsoever that there

are honest and intelligent supporters of both sides.  I'm fully

prepared to believe that the story that the Houston radiologist

told to Terry was sincere and that the radiologist was not a

fool, a naif or an interested party.  And I'd argue that the same

is true for at least many of the FDA and university scientists

who have insisted that there is no credible evidence for these

alternative approaches.

So what should we believe?  Is there a rational way to come to an

objective conclusion?  What should we do as patients?  If we have

not seen conclusive evidence one way or the other, should we just

believe what we want to believe?

Here are some of my thoughts on those question:

1. There is a great deal of disinformation around.

   Although there are a great many honest people in the world,

   there are also dishonest people, some in alternative medicine,

   some in what I'll call established medicine, some in drug

   companies.  There are lots and lots of such people and they

   will look very sincerely into your eyes and tell you an

   outrageous lie that could end your life just in order to get

   some money from you.

   In addition to the dishonest people there is also a lot of

   disinformation spread by well meaning but ignorant people.  We

   have all met people who believe that astrology or palm reading

   or other pseudo-sciences are reliable guides to making medical

   decisions.  And even among the people who don't believe such

   things there are a great many, I'd venture to say a solid

   majority in the United States, who don't have enough

   scientific understanding to successfully evaluate medical

   claims.  Such people can be misled or simply mistaken in

   supporting statements that are not correct.

2. However, although there is a great deal of disinformation,

   there are also rules of evidence that we can use to

   distinguish sound information from disinformation.

   The National Cancer Institute uses two sets of rules to

   determine the soundness of cancer treatments.  The two sets

   are:

     - Strength of Study Design.

          These include:

            Randomized clinical trials

            Non-randomized trials

            Case series

           

          There are sublevels within each of those three.

     - Strength of Endpoints.

          These include:

            Total mortality

            Cause-specific mortality

            Carefully assessed quality of life

            Indirect surrogates

   In addition, to these, we can use rules of study design to see

   how well such things as randomization was conducted or

   mortality measured, and rules of statistics to tell us how

   significant any endpoint numbers are likely to be.

   To see the NCI Levels of Evidence for different areas of

   interest (treatment, screening, genetics, etc.) go to:

      http://www.cancer.gov

   and type " levels of evidence " in the search box.

Now where does Dr. Burzynski fit into this?

I'm not an expert on Dr. Burzynski.  I haven't spent weeks

researching him.  I have read some abstracts of his papers (most

of which were published in what looked to me like fairly dodgy

journals) but I'm not qualified to fully evaluate the articles

and have better things to do with my time than to try.  So I

can't say that I personally know that Dr. Burzynski is a fraud.

What I think I can say however is that, despite his running

" trials " for almost 20 years, his having plenty of patients

placed in those trials, and his having had many, many

opportunities both to produce standard protocol trials and to

cooperate with other scientific centers offering to test his

methods, the standard institutions that do professionally

evaluate trial results, including the U.S. National Cancer

Institute and the U.S. Food and Drug Administration, have not

found what they consider to be credible evidence of benefit from

his methods.

Terry knows a radiologist in Texas whom he has no reason to

distrust.  That's fair.  It's a good observation.  I have met

dozens of scientists at the National Cancer Institute whose

intelligence and knowledge have tremendously impressed me and

whom I would trust (and have trusted) with my life.  These are

people who, collectively, came up with the levels of evidence I

described above, have trained at top institutions around the

world, seen thousands of patients, conducted hundreds of

thousands of hours of research, discovered new principles of

cancer biology, written thousands of articles in leading

journals, and saved many lives.

These people have looked at Burzynski's output and found it

wanting.

I'm not just appealing to authority here.  I'm appealing to the

judgment of the people whom I consider to be using the best and

most rational rules for evaluating treatments, and who have the

most demonstrated knowledge and experience in applying those

rules.  It's not because the have PhDs or work for NCI that gives

them credibility in my eyes.  It's that they demonstrate every

day that they have the most knowledge and experience about cancer

of anyone at the current time.

The NCI and FDA have been careful to NOT say that Burzynski is a

fraud or even that his methods don't work.  What they have said

is that he has not produced credible evidence that they do work.

They won't go beyond the evidence and neither should I.  I also

can't say for sure that Dr. B is a fraud.  It's possible that

he's not.  I can't prove it one way or the other.  But I would

not leave my family and travel to Texas to see him.  I would not

pay his required $5,000 down payment on treatment, followed by

who knows how much.  I would not allow him to inject me with his

urine extract if, after all these years of " trials " , he has not

been able to demonstrate to the trials evaluation bodies that he

can do what he says he can do.

I wouldn't see him even if I knew that I was going to die of

cancer.  There are any number of unproven cancer treatments to

choose from, many of which are cheaper than his and can brandish

tons of " success " stories in their support.  I would prefer to

spend my time with my family and leave my money to my children

than to spend either time or money with him.

It is possible that one day we will know the truth about

Burzynski.  Perhaps a lab somewhere in the world will study his

treatment and prove it effective or ineffective.  Or perhaps an

FBI agent with a search warrant will seize his records and we'll

find out exactly what the real statistics are for his treatments.

If it turns out that he was a far thinking genius, I and Steve

Jordan and many others will owe him something of an apology.  If

it turns out that he's a fraud and a criminal, then he has a lot

to account for.

Either way, the whole circus of unproven treatments, doctors who

are either devils or saints, patients who offer their life

savings with stars in their eyes, testimonials from survivors,

and silence from non-survivors, will continue on into the future.

As long as people fear death and others sell hope, there will be

sellers and buyers.

    Alan

[Guest guest]

Terry Herbert wrote:

> Whenever I read remarks like this one <snip> Burzynski has for

> years been well-known for his antineoplaston garbage.<snip> I

> am reminded of the radiologist in Houston who was good enough

> to help me in the early days of my  diagnosis. He did a very

> through series of scans, free of charge because he was a pal of

> my brother’s, and who put me and my wife up in his house for

> the best part of a week while I consulted, free of charge

> thanks to his introductions,  three local prostate cancer

> specialists.

>

> During the corse of one conversation over dinner, I asked him

> about Burzynski and his claims. He told me that he had scanned

> some children with brain tumours before and after they were

> treated by Burzynski and was absolutely amazed at the outcome.

> The tumours simply disappeared.

>

> Now of course this is anecdotal evidence, and Steve does not

> like anecdotal evidence, but I wonder why that good man would

> have lied to me about what he had seen and experienced. Could

> it be that, as he claims and as seems to have been demonstrated

> in two FDA approved studies, Burzynski’s approach has some

> merit and the opposition to him is based on the fact that he

> appears to be an arrogant man who despises the attitudes of his

> colleagues? So I am personally still in two minds about

> Burzynski - on balance I think his therapies may be better than

> they are made out to be.

I apologize for the length of this posting but it's a difficult

subject and I don't believe it can be adequately discussed in a

short one.

I've given some thought to the issue of Dr. Burzynski's

credibility and I want to be as objective as I can be.  It's a

difficult problem because there are such wildly conflicting views

about the man.

One problem that clouds the issues is that each side accuses the

other of lack of objectivity and/or ulterior motives.  The

defenders of the " alternative " medicines are often thought to be

quacks and their shills who are in it for the money, or desperate

patients and families who are grasping at straws.  The opponents

are often thought to be drug company monopolists or their shills

in the FDA who are in it for the money, or deluded members of the

public who are too trusting of " authoritative " sources.

At the same time however, I have no doubt whatsoever that there

are honest and intelligent supporters of both sides.  I'm fully

prepared to believe that the story that the Houston radiologist

told to Terry was sincere and that the radiologist was not a

fool, a naif or an interested party.  And I'd argue that the same

is true for at least many of the FDA and university scientists

who have insisted that there is no credible evidence for these

alternative approaches.

So what should we believe?  Is there a rational way to come to an

objective conclusion?  What should we do as patients?  If we have

not seen conclusive evidence one way or the other, should we just

believe what we want to believe?

Here are some of my thoughts on those question:

1. There is a great deal of disinformation around.

   Although there are a great many honest people in the world,

   there are also dishonest people, some in alternative medicine,

   some in what I'll call established medicine, some in drug

   companies.  There are lots and lots of such people and they

   will look very sincerely into your eyes and tell you an

   outrageous lie that could end your life just in order to get

   some money from you.

   In addition to the dishonest people there is also a lot of

   disinformation spread by well meaning but ignorant people.  We

   have all met people who believe that astrology or palm reading

   or other pseudo-sciences are reliable guides to making medical

   decisions.  And even among the people who don't believe such

   things there are a great many, I'd venture to say a solid

   majority in the United States, who don't have enough

   scientific understanding to successfully evaluate medical

   claims.  Such people can be misled or simply mistaken in

   supporting statements that are not correct.

2. However, although there is a great deal of disinformation,

   there are also rules of evidence that we can use to

   distinguish sound information from disinformation.

   The National Cancer Institute uses two sets of rules to

   determine the soundness of cancer treatments.  The two sets

   are:

     - Strength of Study Design.

          These include:

            Randomized clinical trials

            Non-randomized trials

            Case series

           

          There are sublevels within each of those three.

     - Strength of Endpoints.

          These include:

            Total mortality

            Cause-specific mortality

            Carefully assessed quality of life

            Indirect surrogates

   In addition, to these, we can use rules of study design to see

   how well such things as randomization was conducted or

   mortality measured, and rules of statistics to tell us how

   significant any endpoint numbers are likely to be.

   To see the NCI Levels of Evidence for different areas of

   interest (treatment, screening, genetics, etc.) go to:

      http://www.cancer.gov

   and type " levels of evidence " in the search box.

Now where does Dr. Burzynski fit into this?

I'm not an expert on Dr. Burzynski.  I haven't spent weeks

researching him.  I have read some abstracts of his papers (most

of which were published in what looked to me like fairly dodgy

journals) but I'm not qualified to fully evaluate the articles

and have better things to do with my time than to try.  So I

can't say that I personally know that Dr. Burzynski is a fraud.

What I think I can say however is that, despite his running

" trials " for almost 20 years, his having plenty of patients

placed in those trials, and his having had many, many

opportunities both to produce standard protocol trials and to

cooperate with other scientific centers offering to test his

methods, the standard institutions that do professionally

evaluate trial results, including the U.S. National Cancer

Institute and the U.S. Food and Drug Administration, have not

found what they consider to be credible evidence of benefit from

his methods.

Terry knows a radiologist in Texas whom he has no reason to

distrust.  That's fair.  It's a good observation.  I have met

dozens of scientists at the National Cancer Institute whose

intelligence and knowledge have tremendously impressed me and

whom I would trust (and have trusted) with my life.  These are

people who, collectively, came up with the levels of evidence I

described above, have trained at top institutions around the

world, seen thousands of patients, conducted hundreds of

thousands of hours of research, discovered new principles of

cancer biology, written thousands of articles in leading

journals, and saved many lives.

These people have looked at Burzynski's output and found it

wanting.

I'm not just appealing to authority here.  I'm appealing to the

judgment of the people whom I consider to be using the best and

most rational rules for evaluating treatments, and who have the

most demonstrated knowledge and experience in applying those

rules.  It's not because the have PhDs or work for NCI that gives

them credibility in my eyes.  It's that they demonstrate every

day that they have the most knowledge and experience about cancer

of anyone at the current time.

The NCI and FDA have been careful to NOT say that Burzynski is a

fraud or even that his methods don't work.  What they have said

is that he has not produced credible evidence that they do work.

They won't go beyond the evidence and neither should I.  I also

can't say for sure that Dr. B is a fraud.  It's possible that

he's not.  I can't prove it one way or the other.  But I would

not leave my family and travel to Texas to see him.  I would not

pay his required $5,000 down payment on treatment, followed by

who knows how much.  I would not allow him to inject me with his

urine extract if, after all these years of " trials " , he has not

been able to demonstrate to the trials evaluation bodies that he

can do what he says he can do.

I wouldn't see him even if I knew that I was going to die of

cancer.  There are any number of unproven cancer treatments to

choose from, many of which are cheaper than his and can brandish

tons of " success " stories in their support.  I would prefer to

spend my time with my family and leave my money to my children

than to spend either time or money with him.

It is possible that one day we will know the truth about

Burzynski.  Perhaps a lab somewhere in the world will study his

treatment and prove it effective or ineffective.  Or perhaps an

FBI agent with a search warrant will seize his records and we'll

find out exactly what the real statistics are for his treatments.

If it turns out that he was a far thinking genius, I and Steve

Jordan and many others will owe him something of an apology.  If

it turns out that he's a fraud and a criminal, then he has a lot

to account for.

Either way, the whole circus of unproven treatments, doctors who

are either devils or saints, patients who offer their life

savings with stars in their eyes, testimonials from survivors,

and silence from non-survivors, will continue on into the future.

As long as people fear death and others sell hope, there will be

sellers and buyers.

    Alan

[Guest guest]

,

I'm sure everyone else is bored by our lengthy discussion

but, if you'll bear with me, I'll make one more posting about it

and then shut up.

A lot of what you have written makes a great deal of sense to me.

Prior to yours and Terry's defense of Burzynski I considered him

definitely to be a quack and a criminal, but the two of you have

convinced me that I had a prejudiced view.  As a result of your

last couple of postings in particular, I think I have moved from

considering him a quack into not knowing what to make of him -

but not classifying him certainly as a quack until I see more

evidence.

I'm not ready to call him a great doctor or to say that his

methods work, or even to assert that he's an honest man.  It is

still my gut feeling that the man is a crook.  But I can't prove

that and I really don't know.  However you're only arguing that

his methods _might_ work and that they have shown enough promise

that they should be encouraged, not suppressed.  It is a fair

position.

I'd like to respond to some of the points you made individually.

wrote:

> Alan, I think you should believe that there are 61 FDA

> authorized clinical trials currently with regards to

> Burzynski's antineoplastins.

Yes, I do understand that Burzynski has registered 60 or 70

trials.  I can tell you for sure that these are NOT the trials

that the FDA had in mind when they ordered him to stop treating

patients with unapproved drugs outside the clinical trials

process.  But they have duly registered the trials that he has

submitted since he has not violated the letter of the law.

One of the problems I'm having is that Burzynski has been doing

this since the 1990's, yet he has never once organized a

randomized trial.  It is my understanding that you have to have a

randomized trial, it has have enough patients for statistical

significance, and it should be double blind (neither patient nor

doctor knows which patients are getting the experimental

treatment) in order to prove the efficacy of the drug.

The FDA will not approve any new treatment without a randomized

trial.  It's an ironclad requirement.  Randomized trials have

time and again shown that much hyped drugs don't actually work,

or sometimes that they do.  They are the gold standard of

evidence.

Antineoplastons are not FDA approved.  It is illegal to

administer them in any context other than a clinical trial -

which is why Burzynski runs so many trials.  He needs the aegis

of a trial in order to avoid being arrested for treating people

with unapproved drugs.  But he keeps avoiding doing what a trial

ought to do.

Why won't he do it?  If the drugs work, what has he got to lose?

If I were him, and I believed in this treatment, I'd organize

such a trial and I'd invite people whose credentials are widely

respected to observe and participate in the trial organization,

implementation and evaluation.

The explanation you gave that Dr. B. is an eccentric person may

fully account for the problem.  But it's still disturbing because

we know that there is a long history of quacks who publish

distorted results of studies they have done in order to attract

patients.  The laetrile story is full of such events.

> That Burzynski is the acknowledged discoverer of

> antineoplastins with no co-discoverers. That the NIH and the

> FDA have accepted that antineoplastins exist and they do not

> consider them alternative medicine and they do not consider

> them quackery. They consider them legitimate compounds for

> investigation of use in cancer research.

The correct spelling is antineoplaston, ending in " on " , not " en " .

That's important as I'll describe in a moment.

Yes, the NIH does regard the compounds that Dr. B. uses to be

legitimate compounds for investigation.  I have seen articles by

well regarded researchers that take them seriously.

....

> If you do a search of antineoplastins on PUBMED there are over

> 770,000 abstracts, an astonishing amount by any ones standards.

I tried some PubMed searches.  Here are the results as of July

27:

    antineoplastic: 794660

    antineoplaston: 83

" Antineoplastic " is an adjective that simply means against

neoplasms, where a neoplasm is an abnormal growth of cells.  All

of the anti-cancer drugs are, by definition, " antineoplastic " .  A

search on that term retrieves articles about every anti-cancer

drug you can think of and many more besides.

There are only 83 articles, about " antineoplastons " including

most of the 45 articles published by SR Burzynski himself.

People other than Burzynski have indeed looked at

antineoplastons, but not so many.

> This is a link to the NCI, National Cancer Institute and their

> presentation on antineoplastins. They also acknowledge that

> Burzynski is the discoverer and chief investigator.

>

http://www.cancer.gov/cancertopics/pdq/cam/antineoplastons/healthprofessional/al\

lpages/print

That was an interesting article that I read thoroughly from

beginning to end.  As with all NCI publications on controversial

subjects, it attempts to be scrupulously neutral and not say

anything that goes beyond documented evidence.

They report the positive results reported by Burzynski, the

negative results reported by the Mayo Clinic, and the mix of

positive and negative results by other researchers, mainly by a

group in Japan.  They also report the _in vitro_ (test tube)

studies.

They don't argue that the drug works or that it doesn't.

> One of the problems that has plagued Burzynski all along has

> been his insistence that things had to be done his way and that

> he be recognized as the discoverer and the expert. . He was

> unwilling to work with others and unwilling to work beneath

> others and simply turn over his research to some Pharma firm

> and be one of their employees. Something by the way that has

> been offered to him many, many times.

One of the biggest problems with Burzynski's work is that we have

to take his word for everything.  Did X number of patients get Y

benefit?  Burzynski says so.  But did it really happen?

Is what he's done a scientific breakthrough, or is it a house of

cards, or is it something in between - a solid approach that

shows some benefit but which has been magnified in the telling.

As you say, he's an eccentric character.  Maybe that's all it is.

There are a lot of red flags but still no smoking gun.

One of the problems in the cancer community is that it's full of

bullshit artists who have discovered that, if you can offer a

cure for cancer, whether or not you have one, you can get huge

amounts of money from desperate patients.  It's a wonderful

opportunity for an unscrupulous person because it can take months

before anyone can discover that a quack treatment didn't work,

and it's easy to convince people either that it did work and they

lived longer than they would have, or that it's just hard luck

that the treatment failed.

There are plenty of people with MDs who do this.  It's not just

alternative medicine practitioners.  There are urologists who

tell their new patients:  " I can offer you a 98% chance of a cure

and a 98% chance of full potency at the end. "   And when you come

back with a recurrence and impotence they say, " Oh bad luck!

You're one of the 2%! "

It's a dog eat dog world and I've gotten very frustrated with the

vicious dogs that use it to make big bucks on the backs of cancer

patients.

....

    Alan

[Guest guest]

,

I'm sure everyone else is bored by our lengthy discussion

but, if you'll bear with me, I'll make one more posting about it

and then shut up.

A lot of what you have written makes a great deal of sense to me.

Prior to yours and Terry's defense of Burzynski I considered him

definitely to be a quack and a criminal, but the two of you have

convinced me that I had a prejudiced view.  As a result of your

last couple of postings in particular, I think I have moved from

considering him a quack into not knowing what to make of him -

but not classifying him certainly as a quack until I see more

evidence.

I'm not ready to call him a great doctor or to say that his

methods work, or even to assert that he's an honest man.  It is

still my gut feeling that the man is a crook.  But I can't prove

that and I really don't know.  However you're only arguing that

his methods _might_ work and that they have shown enough promise

that they should be encouraged, not suppressed.  It is a fair

position.

I'd like to respond to some of the points you made individually.

wrote:

> Alan, I think you should believe that there are 61 FDA

> authorized clinical trials currently with regards to

> Burzynski's antineoplastins.

Yes, I do understand that Burzynski has registered 60 or 70

trials.  I can tell you for sure that these are NOT the trials

that the FDA had in mind when they ordered him to stop treating

patients with unapproved drugs outside the clinical trials

process.  But they have duly registered the trials that he has

submitted since he has not violated the letter of the law.

One of the problems I'm having is that Burzynski has been doing

this since the 1990's, yet he has never once organized a

randomized trial.  It is my understanding that you have to have a

randomized trial, it has have enough patients for statistical

significance, and it should be double blind (neither patient nor

doctor knows which patients are getting the experimental

treatment) in order to prove the efficacy of the drug.

The FDA will not approve any new treatment without a randomized

trial.  It's an ironclad requirement.  Randomized trials have

time and again shown that much hyped drugs don't actually work,

or sometimes that they do.  They are the gold standard of

evidence.

Antineoplastons are not FDA approved.  It is illegal to

administer them in any context other than a clinical trial -

which is why Burzynski runs so many trials.  He needs the aegis

of a trial in order to avoid being arrested for treating people

with unapproved drugs.  But he keeps avoiding doing what a trial

ought to do.

Why won't he do it?  If the drugs work, what has he got to lose?

If I were him, and I believed in this treatment, I'd organize

such a trial and I'd invite people whose credentials are widely

respected to observe and participate in the trial organization,

implementation and evaluation.

The explanation you gave that Dr. B. is an eccentric person may

fully account for the problem.  But it's still disturbing because

we know that there is a long history of quacks who publish

distorted results of studies they have done in order to attract

patients.  The laetrile story is full of such events.

> That Burzynski is the acknowledged discoverer of

> antineoplastins with no co-discoverers. That the NIH and the

> FDA have accepted that antineoplastins exist and they do not

> consider them alternative medicine and they do not consider

> them quackery. They consider them legitimate compounds for

> investigation of use in cancer research.

The correct spelling is antineoplaston, ending in " on " , not " en " .

That's important as I'll describe in a moment.

Yes, the NIH does regard the compounds that Dr. B. uses to be

legitimate compounds for investigation.  I have seen articles by

well regarded researchers that take them seriously.

....

> If you do a search of antineoplastins on PUBMED there are over

> 770,000 abstracts, an astonishing amount by any ones standards.

I tried some PubMed searches.  Here are the results as of July

27:

    antineoplastic: 794660

    antineoplaston: 83

" Antineoplastic " is an adjective that simply means against

neoplasms, where a neoplasm is an abnormal growth of cells.  All

of the anti-cancer drugs are, by definition, " antineoplastic " .  A

search on that term retrieves articles about every anti-cancer

drug you can think of and many more besides.

There are only 83 articles, about " antineoplastons " including

most of the 45 articles published by SR Burzynski himself.

People other than Burzynski have indeed looked at

antineoplastons, but not so many.

> This is a link to the NCI, National Cancer Institute and their

> presentation on antineoplastins. They also acknowledge that

> Burzynski is the discoverer and chief investigator.

>

http://www.cancer.gov/cancertopics/pdq/cam/antineoplastons/healthprofessional/al\

lpages/print

That was an interesting article that I read thoroughly from

beginning to end.  As with all NCI publications on controversial

subjects, it attempts to be scrupulously neutral and not say

anything that goes beyond documented evidence.

They report the positive results reported by Burzynski, the

negative results reported by the Mayo Clinic, and the mix of

positive and negative results by other researchers, mainly by a

group in Japan.  They also report the _in vitro_ (test tube)

studies.

They don't argue that the drug works or that it doesn't.

> One of the problems that has plagued Burzynski all along has

> been his insistence that things had to be done his way and that

> he be recognized as the discoverer and the expert. . He was

> unwilling to work with others and unwilling to work beneath

> others and simply turn over his research to some Pharma firm

> and be one of their employees. Something by the way that has

> been offered to him many, many times.

One of the biggest problems with Burzynski's work is that we have

to take his word for everything.  Did X number of patients get Y

benefit?  Burzynski says so.  But did it really happen?

Is what he's done a scientific breakthrough, or is it a house of

cards, or is it something in between - a solid approach that

shows some benefit but which has been magnified in the telling.

As you say, he's an eccentric character.  Maybe that's all it is.

There are a lot of red flags but still no smoking gun.

One of the problems in the cancer community is that it's full of

bullshit artists who have discovered that, if you can offer a

cure for cancer, whether or not you have one, you can get huge

amounts of money from desperate patients.  It's a wonderful

opportunity for an unscrupulous person because it can take months

before anyone can discover that a quack treatment didn't work,

and it's easy to convince people either that it did work and they

lived longer than they would have, or that it's just hard luck

that the treatment failed.

There are plenty of people with MDs who do this.  It's not just

alternative medicine practitioners.  There are urologists who

tell their new patients:  " I can offer you a 98% chance of a cure

and a 98% chance of full potency at the end. "   And when you come

back with a recurrence and impotence they say, " Oh bad luck!

You're one of the 2%! "

It's a dog eat dog world and I've gotten very frustrated with the

vicious dogs that use it to make big bucks on the backs of cancer

patients.

....

    Alan