[22] – 1995 (9/19/1995) – Dr. Michael A. Friedman to Burzynski (2 pgs.)

This page is linked to:
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Critiquing: Dr. Michael A. Friedman, Dr. Mark G. Malkin, Dr. Mario Sznol, Robert B. Lanman, Memorial Sloan-Kettering Cancer Center, Mayo Clinic, Department of Health & Human Services (HHS), Public Health Service, Quality Assurance and Compliance Section, Regulatory Affairs Branch (RAB), Cancer Therapy Evaluation Program (CTEP), Division of Cancer Treatment (DCT), National Cancer Center (NCI) at the National Institutes of Health (NIH), Stanislaw Burzynski: On the arrogance of ignorance about cancer and targeted therapies
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https://stanislawrajmundburzynski.wordpress.com/2013/09/08/critiquing-stanislaw-burzynski-on-the-arrogance-of-ignorance-about-cancer-and-targeted-therapies/
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[22] – 1995 (9/19/1995) – Dr. Michael A. Friedman, Michael A. Friedman, M.D., Associate Director, Cancer Therapy Evaluation Program (CTEP), Division of Cancer Treatment (DCT), National Cancer Institute (NCI), Department of Health & Human Services (HHS), Public Health Service, National Institutes of Health (NIH) 2 page letter to Burzynski

I am replying to your 8/29/1995, letter in which you requested “detailed records” of the patients treated in the National Cancer Institute sponsored trials of antineoplastons

Our records indicate that the data has been regularly supplied to you by our contractor, Theradex, as listed below:

Date Report

7/18/1994 Clinical Studies Summary
8/24/1994 Clinical Studies Summary
9/19/1994 Clinical Studies Summary
10/24/1994 Clinical Studies Summary
Monitors Detail Report
Clinical Studies Detail Report
11/14/1994 Clinical Studies Summary
12/19/1994 Clinical Studies Summary
1/13/1995 Clinical Studies Summary
Monitors Detail Report
Clinical Studies Detail Report
2/21/1995 Clinical Studies Summary
3/15/1995 Clinical Studies Summary
4/10/1995 Clinical Studies Summary
Monitors Detail Report
Clinical Studies Detail Report

Pg. 2

I am enclosing a summary of the categories of data that are included in the reports you have received

These reports are the same ones that have been provided to us by the contractor during the conduct of the Antineoplaston studies

Both the format and frequency of these reports are routine for reporting data of ongoing NCI Phase II trials to the Cancer Therapy Evaluation Program staff

These are also the same types of reports that are provided to pharmaceutical companies when they are cosponsors of a study

We have no individual patient records in our possession in addition to the Theradex reports

As of the last report provided to you of 4/10/1995, prior to the studies being put on hold and subsequently closed, you were sent the same reports that were provided to CTEP staff and protocols T93-0078 and T93-0134

However, enclosed for your convenience is a recent print-out of the data that was prepared for our staff in a slightly different format

Once the routine quality control review of data entry has been completed, we will send you a final print-out
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1995 (9/19/1995) – Friedman to Burzynski [18]
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[19] – 1995 (6/6/1995) Dr. Michael A. Friedman to Burzynski (3 pgs.)

This page is linked to:
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Critiquing: Dr. Michael A. Friedman, Dr. Mark G. Malkin, Dr. Mario Sznol, Robert B. Lanman, Memorial Sloan-Kettering Cancer Center, Mayo Clinic, Department of Health & Human Services (HHS), Public Health Service, Quality Assurance and Compliance Section, Regulatory Affairs Branch (RAB), Cancer Therapy Evaluation Program (CTEP), Division of Cancer Treatment (DCT), National Cancer Center (NCI) at the National Institutes of Health (NIH), Stanislaw Burzynski: On the arrogance of ignorance about cancer and targeted therapies
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https://stanislawrajmundburzynski.wordpress.com/2013/09/08/critiquing-stanislaw-burzynski-on-the-arrogance-of-ignorance-about-cancer-and-targeted-therapies/
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[19] – 1995 (6/6/1995) – Michael A. Friedman, M.D., Associate Director, Cancer Therapy Evaluation Program (CTEP), Division of Cancer Treatment (DCT), National Cancer Institute (NCI), Department of Health and Human Services (HHS), Public Health Service, National Institutes of Health (NIH) 3 page letter to Burzynski

This letter is intended to respond to the major issues which have been raised in your recent correspondence of 4/20/1995 and 5/16/1995

Your accusations are serious and require comment

I will 1st address the questions you raised about individual patients participating in the NCI-sponsored antineoplaston studies

2 patients were treated at the National Cancer Institute

Patient .26-77-03-9 had evidence of focal glioblastoma multiforme on the biopsy reviewed at the NCI

A different specimen submitted to Dr. Rorke may or may not be relevant

This patient, however, had a brain scan 3 weeks prior to study entry

Patient .27-53-76-5 had a tumor which was 0.8 cm larger than the eligibility criteria dictated

Although pharmacologic data were obtained on both, neither patient is counted in an assessment of response

Both patients had objective tumor progression and are now off study

With respect to the other patients, I am including specific patient summaries from the treating investigators which address your other concerns; in particular, a response to your serious and unfounded statement that patient #196370 was treated in an unethical manner

Also contrary to your statement, you have been sent monthly clinical summaries of these patients since 7/1994 directly from Theradex

(see 3/9/1994 letter)

Having provided this information, I must convey my deep pessimism about the potential for continued interactions with you regarding these trials

Given recent events and your clearly articulated bias that the Mayo Clinic, Memorial Sloan Kettering Hospital and even the National Cancer Institute could not fairly test your product

(please see your letters of 10/26/1993 and 4/20/1995),

I now see a diminishing chance for a productive dialogue with you

Historically, the NCI has demonstrated pragmatism and flexibility in working with a wide variety of individuals and organizations to explore diverse interventions of potential benefit to the cancer patient

However, such a fruitful collaboration may simply not be possible with you

Pg. 2

The decision to suspend the NCI antineoplaston studies was reached by the investigators and the NCI and was explained in our letter of 5/12/1995

(see enclosed)

While we have frequently solicited your advice, we are in no way obligated to obtain your consent

Our interactions with you have been similar to those with pharmaceutical companies or other independent investigators

In the interest of testing antineoplastons, we have consistently considered your advice and recommendations but that in no way cedes control of these studies to you

(please refer to our letters of 7/15/1993, 10/20/1993, and 11/2/1993)

Your insistence on dictating the manner in which we conduct our review of these clinical trials is both presumptuous and inappropriate

The future of these trials rests entirely with the investigators and the NCI, since our primary obligation is to the American public

Recognizing your potential conflict of interest as the developer and the most visible proponent of antineoplastons, we could not responsibly act in any other manner

In contrast to the tenor of your unsupported statements, the NCI bases its position on scientific data

You have stated that you have a vast clinical experience with antineoplastons and we have generally been deferential to your demands despite the lack of substantive data

However, our scientific standards are broadly applied to all studies

The data and level of proof we require from you is much the same as that for other professional collaborators who make such claims

The 7 case records initially examined by the NCI hardly constitute a definition scientific result

It is naive and misleading for you to suggest that the experience of 2 of those patients who had tumors in excess of 5 cm provides adequate proof for all your contentions about tumor size, dose, etc., unless these were the only 7 brain tumor patients from your entire experience who had any hint of benefit

To be precise, in order to responsibly and properly assess your claims and accusations (as per your 4/20/1995 letter), we request that you provide the following information:

1. Exactly how many adult patients with primary brain tumors have you evaluated and treated with antineoplastons?

2. When analyzed by histological type, performance status, prior therapy, concurrent therapy (including chemotherapy), disease size and focality, how many adult brain tumor patients had objective responses?

Please characterize the quality and magnitude and duration of these responses

3. What dose, duration, schedule, and composition of antineoplastons did these patients receive?

Which of these patients benefited objectively?

What toxicities were encountered?

Do you have pharmacokinetic or pharmacodynamic data to support your contention that certain types of brain tumor patients require specific regimens?

4. For these patients, what statistical analyses relate patient or tumor characteristics with exact treatment regimen and outcome?

Pg. 3

If you provide such specific data, we can properly assess your claims

Lacking such information, we cannot

Moreover, your charges that patients received inappropriate care are not supportable without such detailed information

If, after careful consideration, the investigators at Memorial Sloan Kettering and Mayo Clinic do not reopen their studies, it is unlikely that the NCI will attempt to conduct further antineoplaston trials

Any unused antineoplaston material will, of course, be returned to you

Since we can make no judgement about the benefit or toxicity of antineoplastons at this time, we will be interested in the published outcome of peer reviewed studies that you or others may perform

If the NCI investigators choose to continue these studies, you will be so informed

In either circumstance, we will continue to sponsor clinical research of small molecules that may have differentiating properties (such as pure phenylacetate and phenylbutyrate)

cc:

Senator Joseph Biden
Senator Barbara Boxer
Senator Diane Feinstein
Senator Tom Harkin
Senator Barbara Mikulski
Congressman Berkley Bedell
Congresswoman Nancy Pelosi
Dr. Jan Buckner
Dr. Jay Greenblatt
Mr. Richard Jaffe
Dr. Wayne Jonas
Mr. Robert Lanman
Ms. Mary McCabe
Dr. Mark Malkin
Dr. Tony Murgo
Dr. Ralph Moss
Dr. David Parkinson
Dr. Edward Sondik
Dr. Mario Sznol
Dr. Dorothy Tisevich
Dr. Alan Trachtenberg
Mr. Frank Wiewel
Dr. Robert Wittes
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1993 (10/26/1993) – Burzynski to
1994 (3/9/1994) –
1994 (7/1994) – Burzynski to Theradex
1995 (4/20/1995) – Burzynski to
1995 (5/12/1995) – to Burzynski
1995 (5/16/1995) – Burzynski to
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[16] – 1995 (4/20/1995) – Burzynski to Dr. Mario Sznol

This page is linked to:
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Critiquing: Dr. Michael A. Friedman, Dr. Mark G. Malkin, Dr. Mario Sznol, Robert B. Lanman, Memorial Sloan-Kettering Cancer Center, Mayo Clinic, Department of Health & Human Services (HHS), Public Health Service, Quality Assurance and Compliance Section, Regulatory Affairs Branch (RAB), Cancer Therapy Evaluation Program (CTEP), Division of Cancer Treatment (DCT), National Cancer Center (NCI) at the National Institutes of Health (NIH), Stanislaw Burzynski: On the arrogance of ignorance about cancer and targeted therapies
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https://stanislawrajmundburzynski.wordpress.com/2013/09/08/critiquing-stanislaw-burzynski-on-the-arrogance-of-ignorance-about-cancer-and-targeted-therapies/
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[16] – 1995 (4/20/1995) – Burzynski to Dr. Mario Sznol
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Mario Sznol, M.D., Department of Health and Human Services, National Institutes of Health

Dear Dr. Sznol,

Your letter of 4/3/1995

(copy attached)

does not provide adequate justification for the changes in the protocol for

“Phase II Study of Antineoplastons A10 and AS2-1 in Patients with Advanced
Recurrent Astrocytomas.”

Let me make perfectly clear that, as the discoverer and developer of antineoplastons and the individual with nearly 20 years clinical experience using them, it is my professional opinion that the drugs will not produce substantial benefit in such advanced patients

The current protocol has had success only in patients who have tumors not exceeding 5 cm in diameter and who do not have multiple tumors or leptomeningeal or systemic metastases

As the Senior Investigator of NCI requested, patients should have Karnofsky Performance Status of not lower than 70%

(letter attached)

As I have repeatedly informed you, it is exactly because of the current protocol’s failure to benefit advanced patients that we developed new and more aggressive protocols for such advanced tumors, for example, provides antineoplaston A10 in doses 3 times greater than that specified in the protocol currently being used

In order to make such dosing possible, we are using a much higher concentration of A10 — 300mg/mL instead of 80mg/mL

The dosing schedule being used for such advanced tumors is also quite different

Instead of injections of each antineoplaston every 30 minutes, patients receive a much greater amount every 4 hours

Pg. 2

The acceptance of very advanced brain tumor patients to the current protocol would be highly unethical because there is no realistic chance they will have a meaningful response

The list attached to your letter of 4/3/1995 (enclosed), proves my observation that patients who had tumors substantially larger than 5 cm do not respond well under the current protocol

There were only 2 such patients, with the largest tumor diameter corresponding to 5.5 and. 6.5 cm

Both had less than 50% decrease in the size of their tumors

According to the existing protocol, patients should have more than a 50% decrease in tumor size to be classified as responders

Please bear in mind that the point of this trial is not to prove once again that this protocol does not work in patients with very large tumors, multifocal tumors, and low Karnofsky scores

We have already established this fact

Moreover, the informed consent form as currently written falsely implies that the discoverer of antineoplastons believes such advanced patients may benefit substantially from the current protocol

In fact, I have specifically informed you on several occasions that I do not believe advanced patients will obtain substantial benefit

Please be forewarned that you may face legal liability resulting from these unethical misrepresentations

We are anxiously awaiting the complete data on the 1st 5 patients as promised in your letter of 4/3/1995

Based on the limited information received from Theradex on the 1st 7 cases, we have reason to believe that the protocol has been violated in every case

5 cases have been accepted in violation of inclusion criteria

Due to interruptions in the treatment schedule and the time necessary to escalate the dosage, one of these patients received less than 3 weeks of full dose treatment

Such duration of treatment was not sufficient to show the effectiveness of the therapy

Finally, 2 additional patients were removed from the study and said to have progression of disease when in fact no progression was documented

One of these patients, #4369975, underwent tumor resection 3 weeks after discontinuation of the treatment with antineoplastons

Microscopic examination of the tumor specimen confirmed absence of viable tumor cells

It is clear that what was classified as tumor progression corresponded to extensive necrosis or tumor death

What I thought was especially inexcusable and unethical is that the 30 year old patient #196370, who clearly did not have progression of the tumor, was removed from the study against the criteria for removal listed in the protocol

This patients died a few months later
I strongly believe that if the patient had continued the treatment under the protocol, his life would have been saved

Attached to this letter, you will find a list of

Pg. 3

violations of the protocol

Based on these violations, it is clear that the current investigators are unable to conduct this study under the current protocol

I hereby request that:

1) The National Cancer Institute immediately terminate the current investigators and appoint mew investigators at different medical institutions acceptable to Burzynski Research Institute

2) Patient accrual must cease until such investigators and institutions are appointed

Until you appoint the new investigators, I will provide free treatment and medical care under my supervision as long as necessary to the patients currently being treated under the protocol

SRB/cf

Enclosure

cc:

Senator Joseph Biden
Senator Barbara Boxer
Senator Diane Feinstein
Senator Tom Harkin
Senator Barbara Mikulski
Congressman Berkly Bedell
Congresswoman Nancy Pelosi
Dr. Jan Buckner
Dr. Daniel Eskinazi
Dr. Michael Friedman
Dr. Jay Greenblatt
Mr. Richard Jaffe
Dr. Mark Malkin
Ms. Mary McCabe
Dr. Ralph Moss
Dr. David Parkinson
Ms. Dorothy Tisevich
Mr. Frank Wiewel
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1995 (4/20/1995) – Burzynski to [14]
1995 (4/20/1995) – Burzynski to [15] (3 pgs.)
1995 (4/3/1995) – Dr. Mario Sznol to Burzynski
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[7] – 1993 (10/20/1993) – Dr. Michael A. Friedman to Burzynski (4 pgs.)

This page is linked to:
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Critiquing: Dr. Michael A. Friedman, Dr. Mark G. Malkin, Dr. Mario Sznol, Robert B. Lanman, Memorial Sloan-Kettering Cancer Center, Mayo Clinic, Department of Health & Human Services (HHS), Public Health Service, Quality Assurance and Compliance Section, Regulatory Affairs Branch (RAB), Cancer Therapy Evaluation Program (CTEP), Division of Cancer Treatment (DCT), National Cancer Center (NCI) at the National Institutes of Health (NIH), Stanislaw Burzynski: On the arrogance of ignorance about cancer and targeted therapies
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https://stanislawrajmundburzynski.wordpress.com/2013/09/08/critiquing-stanislaw-burzynski-on-the-arrogance-of-ignorance-about-cancer-and-targeted-therapies/
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[7] – 1993 (10/20/1993) – Dr. Michael A. Friedman to Burzynski (4 pgs.)

Michael A. Friedman, M.D., Associate Director, Cancer Therapy Evaluation Program (CTEP), Division of Cancer Treatment, National Cancer Institute (NCI), Department of Health & Human Services (HHS), National Institutes of Health (NIH) letter to Burzynski [4 Pgs.]

Dear Dr. Burzynski:

This letter is in response to your correspondence of 10/11/1993

(addressed to Dr. Sznol)

and of 10/13/1993

(to Dr. Greenblatt)

Your most recent comments regarding the approved study of antineoplastons in adults brain tumor patients, faxed to Dr. Greenblatt on 10/13/1993, come as quite a surprise

Particularly confusing are your comments regarding dose and schedule of antineoplastons proposed in that study (your comment #1)

Originally the dosage and schedule for this study was based on your protocol BT4

This version of BT4 was entitled,
“Therapy of high-grade glioma with continuous infusions of antineoplastons A10 and AS2-1”,
and was accompanied by 12 case histories

(patients with either anaplastic astrocytoma or glioblastoma multiforme treated apparently according to BT4)

In your letter of 4/26/1993, however you stated that protocol BT4 was only for low-grade gliomas

Furthermore, you noted that protocols BT5 or BT6 should be used for patients with anaplastic astrocytoma and gliobastoma multiforme

In that same letter (4/20/1993), you noted that AS 2-1 was tolerated well at doses of .5 gm/kg/24h by adult patients when administered in intermittent injections (this is method of administration in BT6 and in the IND study)

You stated that if given by continuous infusion, adults would experience increased sleepiness and tiredness, and specifically stated that the dosage of AS2-1 by continuous infusion for low-grade gliomas should be reduced to 0.4 g/kg/24h

You did not provide data to support these assertions, nevertheless, based on these comments and our review of the protocols BT4, BT5, BT6, we instructed the investigators to revise their protocol in accordance with your instructions

In the Consensus Review sent 5/5/1993, we instructed the Memorial Sloan Kettering investigators to pattern their protocol according to BT5, which was written for both children and adults
We specifically pointed out that BT6 was written for children

In your letter of 6/9/1993, regarding our Consensus Review, you specifically asked that the investigators use the treatment program according to BT6, knowing that the Memorial protocol was for adults with AA and/or GM

You did not at any time mention that dose escalation should be modified for adults, or mention any dose limitation for adults given the intermittent as specified in the BT6 protocol

Page 2

Your concerns regarding dose limitation in the previous letter appeared to be related to continuous infusion administration

The letter of 6/9/1993, contained only 4 comments and at that time you had both the protocol and Consensus Review in your possession

We transmitted your letter of 6/9 directly to the investigators, and all your requested changes were made

Our sincere efforts to attempt to duplicate your findings and follow your recommendations are frustrated by receiving contradictory, incomplete, and inconsistent information from you

We have, at multiple points in the protocol development, solicited your input and followed your guidance in getting recommended dose escalation and modification guidelines for adults

Please note that, one last time, we will ask the investigator to revise the protocol with regard to dose and schedule in compliance with your latest letter

However, we plan that the study will begin immediately and this will be the last such modification

Although you have not provided data to support each of your specific recommendation, we have incorporated them

With regard to comment #2 of your Fax of 10/13/1993, you have misinterpreted the protocol

The total number of potential patients is 35/stratum, (ie a total of 70 patients) allowing for an adequate Phase II evaluation of each group of patients

With regard to the statistical section, your #3 comment, there is little reason to assume that the modified Fleming design currently used in the protocol for the first stage of accrual is less appropriate than a design using 15 patients in the first stage

If the true response rate of the antineoplastons is 20% (standard criteria for activity in all our phase II trials considered worthy of further study), the chance of proceeding to the second stage of accrual with the current design is 93.1%

The chance of proceeding to the second stage using 15 patients in the first stage of accrual is 96.5%

These differences are not considered meaningful

With regard to your comment #4, we wish to maintain the standard clinical trials methodology used to evaluate new agents

We know of no evidence that obtaining a brain scan within 7 days of treatment versus within 14 days of treatment will in any way affect the evaluation of activity of a drug in this disease

The protocol clearly states that scans must be obtained within 2 weeks of study entry

Please also note that the practical difficulties in scheduling scans and completing the pretreatment work-up in just one week; the costs of repeating tests simply to meet this artificial deadline could not be justified and probably would not be covered by insurance companies

With regard to your point #5, (performance status) your own protocols allow patients with Karnofsky performance status of 60

We see no reason to demand a more stringent entry criteria for performance status than you have employed for your own patients

Page 3

With regard to your point #6, the use of neurologic status as well as CT scans/MRI findings to determine response, this was suggested to the investigators in our Consensus Review of 5/5/1993

You made no comment regarding this in your letter of 6/9/1993

This use of neurologic function as an additional criteria to determine response is an objective measurement and is standard among protocols we sponsor for glioma patients . .

It is scientifically acceptable to include the criteria for response as currently written in the protocol

At analysis, both scan data and objective neurologic assessment can be described

With regard to your letter of 10/11/1993, concerning data reviews, we are satisfied that reviewing the data after accrual of the first 14 patients/stratum is sufficient

We share your concerns about patient safety but believe that these investigators have extensive experience treating glioma patients, are superb and careful physicians, and have extensive experience administrating a range of investigational agents to these patients

Furthermore, the patients will be followed carefully, and dose reductions for expected toxicities will be carried out as specified in the protocol

Nevertheless, your experience with the agents is valuable and the availability of your guidance is much appreciated

If necessary, we will arrange a conference call at the end of treatment of the first 5 patients, or sooner if problems occur

Your participation in such a conference call, if necessary, would be welcome

We will provide the Theradex (CTMS) printout to you on a monthly basis as we receive it

We do not believe it is practical or necessary to supply data on an every 2 week basis

The most important unresolved issue at this time is that we are still waiting to receive the promised supply of antineoplastons to conduct these studies

Your letter of 11/5/1992, guaranteed a supply of the antineoplastons by 3/31/1993

(see attached)

As of today we still have not received it

Believing that you would be shipping drug to the NCI, and since the protocol is approved at Memorial Sloan Kettering, recruitment of patients has begun

As you point out, these patients have aggressive disease, and cannot afford to wait to begin treatment

We are prepared to try to assist you in meeting this commitment, but we know of no obstacle here at NCI

We urgently request, again, that you ship the drug immediately

Please be aware that our mission is to find and develop better therapies for cancer patients, and our only obligation is to those patients

Our agreement to pursue these studies with antineoplastons was based on suggestive evidence

Page 4

of activity noted in your best case studies

If you are unable or unwilling to provide the antineoplastons in the near future, we will pursue alternative sources to procure the drug or its active components, and will proceed with a clinical development plan to determine whether these chemicals have activity and are beneficial for patients

Michael A. Friedman, M.D., Associate Director, Cancer Therapy Evaluation Program, Division of Cancer Treatment, NCI, Department of Health and Human Services, National Institutes of Health

cc:

Dr. Samuel Broder
Dr. Jan Buckner
Dr. Bruce Chabner
Dr. Jay Grabnett
Dr. Joseph Jacobs
Dr. Mark Malkin
Ms. Mary McCabe
Dr. David Parkinson
Dr. Mario Sznol
Ms. Dorothy Tisevich
——————————————————————

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1993 (10/20/1993) – Dr. Michael A. Friedman to Burzynski [8]
1992 (11/5/1992) – Burzynski ANP 3/31/1993
1993 (4/20/1993) – Burzynski (4/26/1993)? in that same letter
1993 (4/26/1993) – Burzynski
1993 (5/5/1993) – Consensus Review
1993 (6/9/1993) – Burzynski re Consensus Review
1993 (10/11/1993) – Burzynski to Dr. Mario Sznol
1993 (10/13/1993) – Burzynski fax to Dr. Jay Greenblatt
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DJT’s Comments – September 28, 2013 “The Skeptics™” Burzynski discussion: By Bob Blaskiewicz – 2:19:51

Yes
Okay
Well as I put in my about page, I agreed with the juror that he was neither guilty or innocent
So, so since I see all this opposition by these Skeptics, and I see that the they’re getting all of their facts straight
I decided to take the position of being a Skeptic Skeptic
In other words I am skeptical of Skeptics who do not fact-check their information before they post it on social media
And since I see ahhh y’all pretty much trying to take over the net with y’all’s information I decided to come back and correct all the false information that was being put out by other Skeptics
Well the major issue is that the FDA’s own information says if phase 3 trials are approved – phase 2 trials is to see if there’s evidence of effectiveness
And so if phase 3 trials are approved, that means you’ve provided evidence of effectiveness
That’s the FDA’s own information – I have that clearly on my blog
Also the FDA has given Burzynski uhhh Orphan Drug Designation in 2004 for uhhh brainstem glioma and then in 2009 for all gliomas
So that must mean that there is evidence of effectiveness, otherwise I don’t think they would be doing that
Well the issue is he was given 2 phase 3 trials that we know of
One was on uh Clinical Trials . gov – the one about eye cancer
The vision cancer
And then the other one was not posted on there, but then again the FDA has said, and I posted this on my blog because I specifically contacted and asked them and they said we don’t post all clinical trials on our web-site
And so he obviously had that other one about brainstem glioma, that he was trying to get started
But the other issue is that Skeptics have posted on there that he could not get that accelerated approval until he had published a phase 2 trial and that is exactly not the case because other drugs have been given accelerated approval before their results were published in phase 2 clinical trial publications, cuz, so that question remains as well
Well, what we do know is that in the movie, Merola showed that one page rejection from The Lancet
where Burzynski was trying to show his results from like 8 to 16 years, and they said we think your uh publication would be seen best elsewhere, or some ridiculous statement like that
And so, I thought that funny of The Lancet
Of course, I understand their 2nd response, which came out, which Eric posted on his Facebook page, y’all, that y’all have talked about – that, you know, they’re busy, they get a lot of
submissions
I understand that, so obviously he would have to look for a different publication for both of those, things he’s trying to get published
Well a lot of the time I’m making fun of y’all’s favorite oncologist, the way he words his blogs, and uhmmm I cite specifically from the FDA, from from the National Cancer Institute, from these other scientific sources, from scientific publications
I give people specific information so they can fact-check me, unlike a lot of The Skeptics who just go out there and say things and publish things on social media, they provide no back-up for their uhhh sayings
And so when I critique an oncologist or any other Skeptic I always provide source material so people can always fact-check me and I specifically said that people should fact-check everything ummm that the oncologist should say because he has, I’ve proven him to be frequently incorrect about his information and misleading
And so I’ve tried to add those things and allow people to search, on specific things like publications, or what I posted about The Lancet, or specifically about The Skeptics, or specifically about the oncologist
So whenever I see something posted new on Twitter, by y’all, sometimes I’ll check it out and sometimes I won’t, and sometimes I’ll comment on it
I was, on there just yesterday to see some more of your post on there
Well the thing is, when you accepted this hangout, I published my newest blog article and I specifically listed all the information I had critiqued from you previously including Amelia, and I posted the specific Twitter responses by BurzynskiMovie; which is probably Eric, to your issues with Amelia, and he disagrees with what the oncologist posted, and so I pretty much let his Twitter responses stand to what the oncologist said
Well I also did a critique of the newspaper story that was put out about Amelia in the U.K.
And they had 2, 2 patients that were dealt with
And
I believe, yes
And one of the patients, Burzynski has specifically published in one of his scientific publications that maximum dosage is not reached for a month
So if someone, so if someone only goes in there and has treatment for a month, they’re not even, you know, they’re finally going to reach the uh maximum dosage
And I think that was maybe the case with Luna, I think she was only there for a month
Well my only thing is, uh, we know that sometimes he will go to a maximum dosage, or you know, the suggested dosage, but he will back down off it, in fact in the uh adverse effects you mentioned those are specifically adverse effects mentioned in his publications, and when that happens normally they will subside within 24 to 48 hours is what it says once you take them off the treatment and let, you know, those conditions take care of themselves, and then you will slowly raise the medication again
So, you know, it just didn’t tell, if only one month of treatment was enough to even start to do anything for her
Well the thing is, the FDA has approved phase 3, and also given them the Orphan Drug Designation, which means they should have some knowledge about what’s going on, I would think
Plus we don’t know for sure, we’ve heard about, ummm, some of the things supposedly the oncologist has talked about, which is cutting off the blood flow, to the tumor, which is something that some uhhh drugs can do, and I think that’s one of the things Burzynski has tried to do, ah he’s specifically mentioned it in his personalized treatment
But I don’t know for sure if it’s also something that’s done with the ANP’s in just the clinical trials environment
So, that could be a possibility
Well
Well what I find interesting about these other doctors is like like the doctors mentioned in the movie and BBC Panorama’s report and in some of these newspaper articles where they are mentioned again is that these doctors never do a review of Burzynski’s scientific publications and including our favorite oncologist who refuses to do so
Uhhh
Oh yeah he says he’s read everything but uh you know he claims that he’s uhmmm reviewed, reviewed uh Burzynski’s personalized gene targeted therapy but he, but then just a few months ago he admitted, you know, I don’t know where Burzynski says which genes are targeted by antineoplastons
And I pointed out which specific publications that Burzynski published, publications which specifically mention which genes are targeted by antineoplastons, and I said how can you claim that you’ve read and reviewed every Burzynski publication and you didn’t know which genes are targeted by antineoplastons when that’s specifically in the publications ?
To me that tells me that you do not know how antineoplastons work be because you just admitted you don’t know which genes Burzynski talks about
I mean that’s just funny as heck to me that he would say that
Well I’ve, I’ve got it on my blog
Uhm
I mean I can forward it to you at some point
But I agree with you about I don’t remember seeing anything about antineoplastons cutting off the blood flow to the, you know the blood brain barrier for sure either
Well I think I know the point that you’re getting at uhhh about the IRB’s and all that good stuff
All I can say is that, you know the FDA can come in with any amount of investigators and say that you did this or that but you have the opportunity to respond, and so they can pretty much say anything, it’s only when the final report comes out that you can take that to the bank
And so all this speculation about what a investigative team may say about the clinic is, to me just like someone going into a lawsuit and saying so-and-so did this, you know, can you prove that, you know, did so-and-so do that
So it’s the same thing with the FDA, these um little reports, the final report is what counts, and so, also what I find interesting is some of Burzynski’s publications specifically said, you know this particular uh clinical trial, the IRB was agreed upon by the FDA
Well if if the FDA agreed upon it, you know, then some questions should arise about exactly what did the FDA agree upon
What would we find out from a Freedom of Information Act request on that ?
And, and what I also found interesting is when I did research on other clinical trials for brainstem glioma I found, you know, all these other science based medicine studies where 374 children had died in their studies
And what I found interesting is back in 1999, they reported on a clinical trial, they had better results then all these clinical trials afterwards
Well, I would have to find you one, there were like 3
There were like 3 major ones that Burzynski has mentioned in his publications to cross-reference his trials versus their trials as far as the results
And so, I, there was one back in 1999 that had better results than a lot of these clinical trials that come afterwards
So when we talk about, you know, what’s really right for the patients well we can see that the drug companies want to test their drugs through clinical trials and, you know, and if your kid dies, well, unfortunately the kid dies
Even though we showed better results in 1999 with a different type of treatment, you would have thought that maybe they would have poured more investment into that particular treatment but that’s not necessarily how the clinical trial system works
Well here’s my point, I mean, y’all probably get a better sense from, ummm, Hymas, about what’s going on with that
From her uh fiancé, or husband, whatever his status happens to be right now
And uh also from Ric, uh they’re more closer to Burzynski than I am, because I have never met Burzynski, I have never e-mailed Burzynski, uhmmm never talked to Burzynski, never met him, blah blah blah
Uh, my sense is that since 1996 when the FDA talked about antineoplastons, that specific FDA Commissioner that was in charge at the time, he set out 7 major points about how there was going to be less people required and there was going to be less paperwork, there was going to be less stringent things about Partial Response
And so, to me, the FDA is the final source to go to when people want to complain about how long their trials have lasted uh because the FDA is bottom line, you know, in charge of that
And
And my other point is that, uhmmm, when these trials finish, as I’ve pointed out on my blog, M.D. Anderson finished a trial in 2006 and didn’t publish the results electronically until January of this year
So, just think
Burzynski’s 1st trial we know that finished in 2009
So we would still have more years to go before he caught up to M.D. Anderson as far as publishing
So for him to actually be trying to publish stuff now and The Lancet not publishing because they have other stuff to do, put in there, that’s understandable
So, we know that he’s trying to publish, uh but they’re going to keep it close to the vest obviously, from, from how they do their things, and where they’re trying to publish
And plus, like I’ve said before
We’ve still got the accelerated approval thing that’s out there, you know, like the FDA’s given Temodar and, and Avastin, and another drug, whereas they’re not doing the same thing for antineoplastons, eve even though for all intents and purposes from what we know, antineoplastons have had better success rates than Temodar and Avastin when they were approved
Well from the information that’s been published in certain um publications
And in, and in not only Burzynski’s but elsewhere in, in newspapers or articles, or such like that
Well what I found interesting is when the FDA approved these other 1 or 2 drugs, some of them specifically said that, uhhh, some of these drugs had, you know, better survivability or they showed no better rate than any previous treatment but we’re approving it anyway
Basically that’s what the publication said and I published this on my blog in an article specifically about, you know, those 2 or 3 drugs that the FDA approved for brainstem or brain related cancers
And so, you know, I’m not going to buy that argument about that, about that specific thing
Well one of these newspaper articles specifically said, you know, Avastin would maybe keep you alive for maybe 4 more months
So, you know, take that
Well, we can wonder if some of Burzynski’s results are the same, otherwise why would the FDA say, you know, give the ODD, why would the FDA give the phase 3 approval
Plus I don’t buy some of these doctors coming out and saying stuff, they have the opportunity just like the other doctors in Egypt, in Russia, in Germany, in, in Poland in China in Taiwan that have done antineoplaston studies, I’m like, these people can do antineoplaston studies so what’s the excuse for all these other doctors who say that they supposedly can’t do them
You know, the information’s out there and
and like these other doctors can do it
Well, we kind of know that that’s a fact
Well what we know from 1996 from Burzynski’s own information that he’s published, is that not only does he have the original parent antineoplastons, but he’s developed 2nd and 3rd generations, but he can’t just stop in the middle of his clinical trial and use the 2nd and 3rd generations which may be better
He can’t uh use these other types of um antineoplastons that other researchers, researchers like Egypt, or Japan have found um that may be better because he can’t just switch in the middle of the clinical trial
Now if he, if the FDA approves his product, well then, maybe he can roll out the 2nd and 3rd generation and these other types of antineoplastons that may be less harsh, but that’s all he’s got to work on and that takes us back to the FDA, having control over the entire process, as far as the paperwork, how many people are in the trials, etcetera
Right
Well I find it interesting that you talk about the cost, because I’ve done a lot of research about the cost, and I was just looking at the cost again this morning, and put it into that particular blog article I was talking about, that I did for this particular program
And, um
The thing that’s funny is that people can say, ohhh Burzynski charges a lot, but the fact is, so does chemo, radiation, and some of these newspaper articles that have been published, and specifically in the movie, Burzynski 2, one of the people mentioned how much someone was paying for standard treatment
And I noticed our
favorite oncologist didn’t comment about that in his movie review
Well what I find interesting, you know, I’m not sure how people think he’s supposed to pay for the clinical trials, you know, if he’s supposed to go into debt, millions of dollars
I find that funny considering the FDA approved phase 3, has given him ODD for brainstem glioma and also also all gliomas
You know, that’s kind of ridiculous
And the people
gettin’ off about his house, well who cares ?
They don’t know where his money came for that particular source
Well, you know, when you have good tax lawyers your tax lawyers will tell you how to structure things, and everybody in America has the right to structure their taxes in a manner that effectively serves them according to our Supreme Court
So, if you have a tax lawyer who tells you, hey this is the best way to do it, to save money, well, you may do that uh based upon your lawyer’s advice
So, maybe Burzynski has taken his tax lawyers advice, just like I’m sure he’s taken Richard Jaffe’s ad advice (laugh), which has proved well, for him
You know, you know
That’s another thing
Well I guess we could ask, you know, Ben and Laura Hymas
What was their experience, you know ?
Did they have, did she have to drink uh a lot of water because she was thirsty ?
You know, did she have to drink a lot of water due to the high sodium ?
So I would ask her about her personal experience instead of saying, you know, instead of quoting some of these other people
Well we all know the FDA is in charge of this, and so hopefully they know what’s going on
No, I’m sure the FDA can look at the records because Burzynski sent them 2.5 million pages according to our friend Fabio
And uh, you know just something the doctors who came in and did the little ol’ one day, 6 patient records, where they reviewed all the records and slides, and MRI’s, etcetera, you know they can do the same thing, the FDA can do the same thing with all these patients
And see the same MRI’s and scans, etcetera
I mean, we, we know that with all these 374 children I mentioned dying in other science-based medicine clinical trials
I mean, they, FDA probably went through all their records
And, so, all these people didn’t look good either but, you know, the FDA still gave approval to Avastin and Te Temodar even though a lot of people died in their clinical trials
I mean, we could agree that since
Burzynski’s publication says that it’s going to take a month to get up to required dosage, and so we know, the tumor can still grow, like he said, up to 50%, he specifically acknowledges that in his publication, so, we know that can happen
Well we know from his own publications, he says he can’t just go in and start giving the maximum dose, or recommended dose right off the bat because a particular condition will occur, and he specifically mentions, in the publications what that condition is, I don’t remember it right off the top of my head
But then again, his 2nd generation, his 3rd generation, his other form of antineoplastons that may work in the future, if approved, well those could possibly have the same uh adverse effects that the current parent generation have
But we don’t know, and like I said the FDA I’m sure knows because they have all the records, we don’t have them, and so unlike our favorite oncologist I’m not going to speculate, about what the FDA knows and I do not know
Well we know they stopped this particular trial, supposedly because a patient died
So what’s the hold-up ?
I mean, hopefully they’ve done an autopsy
What was found
No
And we don’t have a final report from the FDA on what the findings wer
I don’t remember specifically
Possibly not
Well he’s using the same 1st generation drug
Well I’m sure a lot of people leave the doctors office not knowing things, for decades
Well we know the contin, the tumors can uh continue to grow for awhile, at least, and certain effects that they probably would
Well I’m sure, I mean, it’s going to continue to grow, in any other clinical trial too, for a certain awhile
I mean like
Well we know that all these other kids died in these science-based medicine trials, and, you know, we can assume that that was the case there too
The FDA not giving him phase 3 approval, the FDA not giving him ODD designation
And showing that, and showing the FDA that there’s evidence of effectiveness
Not until the FDA says it doesn’t work
Well they seem to be doing a good job at it
Well I’m sure, I’m sure they wouldn’t have done things if they didn’t see some evidence that it was working
No I haven’t read it
I know what it’s called
Right
Well I’m just gonna say, you know, the F, the FDA doing what they’ve done, since they approved those 72 initial trials, pretty much speaks for itself
I mean they’ve had every opportunity to shut this down, since then
No, I’m just concentrating on what we’re doing
Well #1 I don’t think the one with brainstem glioma where they wanted to use radiation with ANP was really the right way to go, I mean he’s already proven that uh he seems to have better results without
first starting radiation
Yeah but the thing is radi, I, the FDA was not saying, ok, one study, one side of the study we’re only going to use ANP, in the other side of the study we’re going to use radiation and and ANP like like they would normally do
No, they wanted to make him use radiation in both sides of the study
They don’t do that with other drugs
Well I don’t buy anything Guy Chapman sells, considering his past record
Well his theories are suspect, anything he hands out, let me tell ya
But the question may be bogus, because of where the messenger has been bogus a lot of times before
Well I’m just gonna say what I think about Chapman because he’s proven himself, many times to be questionable
I don’t see him on my blog responding to my criticism
That’s like, that’s like saying that Gorski’s web-site is disorganized, his blog is like anti vaccine one day, Burzynski the next, blah blah blah
Well how would I know ?
I don’t have
Well you didn’t when I tried to get you to do stuff the 1st time, did ya ?
Well I, the most, the mostly, excuse me, the most recent article I posted on there is the one about this particular conversation, where I went through all your comments that you had posted, and my response to them
And so I tried to consolidate everything into one, particular article
And that’s the newest article
Well I thought that was pretty funny because doing biblical research, you come upon, Didymus Judas Thomas, or he’s all, also known by other names
He’s basically The Skeptic
And so, like I said, I consider myself to be Skeptic of The Skeptics
I thought it was apropos
Of course
I’m doubting The Skeptics
Exactly
Exactly
Well I like how The Skeptics say, you know, all of Burzynski’s successes over the years are anecdotal and uh I consider on the same way that everything negative about Burzynski is anecdotal
Well my point is he’s proven them to the FDA because they’re the ones
Could be, but I would have to read, read the
Well when it comes to Guy Chapman, yeah
You still there ?
Yeah, something cut off there for awhile
Well I would certainly look at that, but then again I would also look at the FDA granting him Orphan Drug Designation
Orphan Drug for brainstem glioma and all gliomas
Right, it’s both AS10 AS2-1 and AS
Well not really, since you mentioned that you’d go in and look at my most recent article, anything you show in there or any reply you give is going to cover, what we’ve gone over
And so we can re debate it there
Well I’ve specifically stated on my blog that Marc Stephens uh obviously didn’t know what he was doing and went about it the wrong way
My position was he should of bou, got around it, gone about it the way I did, which is, I blog, and show where Rhys is wrong, I blog and show where Gorski is wrong, I blog and show where you are wrong, or Josephine Jones, or Guy Chapman, etcetera
And, eh, y’all have every opportunity to come on my blog, and I’ve had very few takers, uh, one claiming to be from Wikipedia, who I shot down
And hasn’t come back
So, you know, I am welcome to anybody trying to come on my blog, and prove what I posted is wrong, and debate anything
Unlike some of The Skeptics I don’t block people on my blog
I don’t give lame reasons for blocking people on my blog because I’m an American and I actually believe in “Free Speech”
Well to me it is when Forbes removes all my comments, in response to Skeptics some, and I showed this from screen-shots
You know, stuff like that
Oh no
It wasn’t down-voted
They, I mean I’ve got screen-shots of where my comments were there, between other people’s comments, and uh, and they just decided to remove all my comments, and I blogged specifically about, you know, what they did and, uh, Gorski’s good friend and pal who authored that particular article
So I, I like how The Skeptics run things, you know
Well I think that people who really believe in “Free Speech,” and when it’s done rationally, I mean, Gorski would never, really respond to any of my questions, so I
Well I know that he specifically removed a review I did uh of his review of Burzynski I on his web, on his blog
But he’s pretty much left a lot of my comments up that I’ve seen
Uh, but he never really responded to my questions about, what he based his beliefs upon
Well I would think, if you’re going to base your position on a certain thing, and then you can’t back it up with scientific literature, uh, you should answer, maybe not specifically to me, but answer the question
Answer to your readers
You know, I can tell his readers come on my blog because it shows that they come on my blog
Well the reason I have so many Twitter things is because, obviously, some of The Skeptics will be on there lying about some tweet I sent, and so Wikipedia, excuse me Twitter will do a little ol’, do their little, hey we’re going to block your account while we do blah blah blah, and I’m not gonna waste my time, going through their little review process, I’ll just create another uh Twitter address because, like, you know, if you read the Twitter information you can have a ridiculous amount of uh Twitter I.D.’s, and I’ll just use another Twitter I.D. and continue on
And so Wikipedia can say what they want, because I’ve only ever used one I.P., I’ve only got on there during one time, and when they finally said hey, you know, we’re not gonna uh grant your appeal, I completely left their web-site alone, so all that stuff
that they post
Yep
So all that garbage that they posted about me, about how I supposedly got on-line, on these other articles is just entirely B.S.
And if they can prove otherwise, I’d sure like to see it
But that’s what y’all always say
That’s what y’all like to say, about everything
Yeah I’m sure that’s what they like to say
I mean, you can report an e-mail, or report a twit, and they’ll block it
But um they’ll never come back and say, and this is why we blocked you, for this particular twit, for this particular reason
Wikipedia is a joke
Oh sure, I’m sure, that’s no problem
I don’t have any problem with them locking that
You know, I could tell when I was on there, and when Merola was on there, because he had a different I.P. address than me, I could tell they were his questions because of the way they were formed
So I said, well they’re not answering his questions, I’ll just take on that role, and uh ask his questions and ask further questions, and they didn’t wanna deal with it, you know
Expose them for what ?
For doing what they do, which is basically provide false information and one-sided information ?
Oh, please
They get on there and they say hey, Lola Quinlan filed a lawsuit, but they don’t tell you anything else
They don’t tell you, you know, Jaffe’s side of the story, and her lawyer’s side of the story
Oh Jaffe’s on there but on that specific article about Lola, they didn’t say, here’s the article that was posted on uh Lola’s attorney’s web-site that, that mentions both his responses and Jaffe’s responses, to the uh lawsuit
Uh, trust me, I tried to add that and they wouldn’t add it
You know, The Skeptics like to be nasty, and so, I’ve been like Josephine Jones
If she wants to play anonymous, I’ll play anonymous
Well, I don’t threaten people
I don’t threaten Gorski
I don’t send letters to people’s employers
I deal with them directly, and, you know, if if they won’t answer questions, then, you know, I’ll just post them on my blog for other people to see, and question uh themselves
Like I said, I’m going to be like Josephine Jones
Because I’ve said so
I’m not even in Texas
I was born in Texas, but I don’t live in Texas
I don’t even, didn’t even, uh live in Houston
Wasn’t even close to Houston
Oh, of course, I, I’ve seen a lot of stuff goes on Twitter
I’ve see y’all saying “Oh, we’re “The Skeptics” and y’all know are names,” but, there’s a lot of Skeptics that post on there with pseudonyms, also
Well, I’m just not sure how some of these uh Skeptics will react considering their past behavior
I mean, when Skeptics refuse to, I mean they block you on your blogs
They block your comments
You know, they decide, “Well, I’m maybe going to accept one comment from you, but I won’t accept anymore
You know, to me that’s just ridiculous
Uh, the action on Forbes that happened, the action on The Guardian that happened, where, you know, you had someone on Gorski’s blog basically lie to the Gua, to The Guardian to get them to get them to uh block my comment
So, you know, I’m Skeptical of The Skeptics and their uh and what they would do
Not really
I like my anonymity just like Josephine Jones likes hers
I mean, I will read her stuff and reply to it and treat it seriously jus, just like any other blogger
Well the thing is, some of these Skeptics use names, and they’re not necessarily their real names
So, you know, I’ve seen
Well I think that some people just have bad manners
I mean see, I’ve seen Skeptics on Twitter basically harass someone pro-Burzynski and keep sending them tweets, and that person specifically send them a tweet saying please keep, stop sending me tweets
You know, they didn’t go in and ask Twitter to block the, that particular person
That person just kept sending them tweets
So, you know, I’ve seen that stuff before
Yeah, I’ll look at it, and if you notice, I don’t uh, I usually don’t reply to Skeptics individually because I pretty much figure that y’all are gonna try and get my next account blocked whenever I do that kind of junk, so, well, you know, I just post what I want to post, under the Hashtag
Well I’ll just keep reviewing the, any inaccurate statements I see posted
You know, it depends on if it’s Gorski, you know
Gorski’s gone on there and posted inaccurate stuff, and I call him out, you know he’s basically said on his blog, you know, if I do something inaccurate, you know, I’ll ‘fess up to it
Well, I’ve pointed out where he’s done that and said “Hey, you said you were gonna ‘fess up to it”
If I said on my blog that I was going to ‘fess up to doing something wrong, and you caught me, well, then I should, come out and say, “Okay, you got me”
But Gorski won’t even do that, you know, he just continues to go on down the road, as if
I mean one of the
excuse
I find, I find
You know, I’m just going to let the FDA do their job, and let y’all speculate all y’all want
Uh, I mean
See, I’m here for full discussion
And y’all don’t seem to want to discuss, after y’all just go out there and spam the Internet with garbage, that you don’t back-up with citations and references and links
But some of your other stuff that you tweeted that you haven’t backed up with links, and some of the stuff on thehoustoncancerquack isn’t backed-up with links, and Gorski’s stuff
Well, that and the anp4all one
isn’t backed up
When the FDA says he’s wrong
I mean, I’m not, I’m not just gonna accept your story
Burzynski provides the FDA with the evidence, and the FDA makes the
the FDA doesn’t approve a drug
if something’s not proved
Well you know that he’s trying
I mean, y’all can sit there and jump up and down all you want
Well, I’m gonna go with what the FDA is gonna do still because they’re running the show
What I find funny is that y’all complain, “Well, he hasn’t published, uh a final report”
Well his 1st final, was completed in 2009, and like I said, the M.D. Anderson 2006 study wasn’t published until 2, 2013
I mean, so y’all can jump up and down all you want
Y’all want a final report
Well, the final report will be done when the clinical trial is over
Well, unless you’re The Lancet, I guess
Well, I’m not gonna get into speculation, I’m just going to wait and see
Well how have I been speculating ?
what the journals keep saying, in response
You know, are they going to give The Lancet response, like they did in 2 hours and such, saying, “Well, we think your message would be best heard elsewhere,” or they gonna gonna give The Lancet response of, “Well, we don’t have room in our publication this time, well, because we’re full up, so, try and pick another place
Well, you like to jump up and down with the 15 year quote, but then again I always get back to, Hey, it’s when, when the report, when the clinical trial is done
Not that he’s been practicing medicine medicine for 36 years, or whatever, it’s when the clin, clinical trial was done
The FDA A believes there is evidence of efficacy
Well, we don’t know that
We don’t have the Freedom of Information Act information
Well, we know what happened in the movie because Eric particularly covered that when they tried to get what, what, was it 200 or 300 something institutions to take on a phase 3, and they refused
Well, Eric gave the reasons that they said they would not take a particular uh phase 3
And so using that excuse that you you just gave there, I’m not even gonna buy that one, because that’s not one of the reasons
Eric said they gave
Well I’m
Well, I’m, I’m sure that they’re going to keep you appraised just like they have in the past, just like Eric has done in the past
So
I mean, we’ll see what happens with the Japanese publication
Well that’s like me asking “How long is it going to take for y’all’s, y’all’s Skeptics to respond to my questions ?”
Because y’all haven’t been forthcoming
Well, he gave you The Lancet information and he posted the e-mail in the movie, and Josephine Jones posted a copy of it
Well, y’all are free to, you know, claim that all you want, because I don’t always agree with Eric, and uh, he’s free to express his opinion
Well I don’t necessarily believe, what Eric would say about, you know, The Lancet that refused to publish the 2nd one, for the reasons he stated, and which y’all have commented on, including Gorski
You know, I don’t necessarily agree with that
I am more agreeable to y’all, saying that, you know, they’re busy, they’ve got other things to do, but I’m kind of still laughing at their 1st response which he showed in the movie about how they felt about, you know his results would be better in some other publication
I thought that was kind of a ridiculous response to give someone
Well you would think that if its a form letter they would use the same form that they used the 2nd time
You know, they didn’t use the same wording that they used the 1st time
I would have think that, you know, their 2nd comment
Nah, I’m not saying that they did that all
I’m just sayin’, you know, that they gave, 2 different responses, and I would think that the 2nd one they gave
Well I find it funny, something along the lines of, you know, “We believe your message would be received better elsewhere,” you know
I don’t see that as a normal response, a scientific publication would send to someone trying to publish something
I mean, to me that sounds, like, if you’re doing that, and you’re The Lancet Oncology, maybe you need to set some different procedures in place, ‘cuz you would think that with such a great scientific peer-reviewed magazine, that they would have structured things in as far as how they do their operations
Well, I’m sure, I’m sure Gorski would have a comment about that, as he’s commented previously about how he thinks uh Burzynski should publish
Like I said before
Like I said before on my blog, you know, even if Burzynski publishes his phase 2 information, Gorski can just jump up and down and say, “Well, that just shows evidence of efficacy, you know, it’s not phase 3, so it doesn’t really prove it”
So then he can go on, you know, for however many years he wants to
Well,
This is, this is a guy who must phone it in because, he went in there and posted the old Josephine Jones response that, you know, no drugs had been approved by the FDA without their final phase 2 publication 1st being published, which was not a factual statement, and you’ve made the same statement
So I, I’m thinking that Gorski just bought her statement and took it and ran with it, and before he fact-checked it, and what, what happened, it was wrong
I mean, Gorski needs to stop phoning stuff in, and check his sources before he posts stuff, because I’ve found many cases where, he hasn’t seemed to do that, and that’s why I question him
Well, I found it interesting that uh the one on the, Burzynski 2, you know he gave his ex excuses for not, working with uh, that patient, and, but yet, he was the same doctor that treated a another Burzynski patient, according to the movie
I mean, so what does he do ?
Pick and choose ?
Or do doctors pick and choose over there in Britain ?
Well, the movie didn’t say anything
Well, I fail to see these doctors on there, providing any factual information, anywhere on the Internet about, uh their disagreements, in a serious way, instead of just making these over-broad statements, you know, “He hasn’t published anything in the blah blah blah,” and
Well, he’s provided some data, and specifically 4 publications
He’s given more than the case studies
He’s done more than the case studies
He’s specifically given uh, almost all the information om an oncologist would want
And Gorski, and Gorski
I mean, I love Gorski, but he comes up with these stupid excuses like, “Well, Burzynski is not an oncologist”
Well, Gorski doesn’t go go in there and look at his other, his phase 2 clinical trial publications, as far as the preliminary reports, and look at the co-authors, and see if any of those guys are oncologists, and that they’re working with Gorski, I mean they’re working with Burzynski
I find that ridiculous
Well y’all, y’all can call things what y’all want
I mean, y’all can give these, fallacy arguments and all that garbage that y’all like, because that’s what y’all like to talk about instead of dealing with the issues
I mean, Gorski doesn’t want to deal with the issues
Hey, I’ve said it to Gorski
He liked to back his stuff up on the Mayo study, yet he wouldn’t, he wouldn’t uh debate about the Mayo study
He likes to say, “Well, Burzynski is not an oncologist,” but he won’t, say Hey, look at the publications, are any of the guys on the publications oncologists ?
We know that Gorski, we know that Burzynski works with oncologists in his practice
So, just because Burzynski himself is not an an oncologist, does not necessarily mean anything
Do we need to go out, onto PubMed, and, and review every particular person that’s published something about cancer and see if they’re all oncologists ?
Seriously
I mean, Gorski will just
post a lot of stuff without backing it up
Well, I, you know, that’s up to someone’s opinion, considering some of the information that’s that the FDA has accepted, as far as giving these guys approval
How did I say I, I didn’t trust them ?
Well, I didn’t say that they weren’t trustworthy, I just raised questions that no one wants to answer about ‘em
No, I’m just sayin’ that I’ve raised questions and none of The Skeptics wanna to uh talk about ‘em
Well, to me the FDA owes Burzynski for a lot of the garbage they pulled off against him (laugh), not to say, you know, they owe him in that way, but they owed him
Well, we know a lot stuff they did, but that still doesn’t impress me that they pulled out of the prosecution
I mean
Right
Well I find it interesting a lot of this uh, a lot of these letters that were provided between, you know, the government and Burzynski, when the uh phase 2 study was going on, at the behest of the NCI
You know, anybody who reads that stuff knows, that when just ignore the person that’s been doing, do treating their patients for 20 something years, or close to 20 years, and you change the protocol without his approval, and you don’t use the drugs in the manner that he knows works
Well, he says they work together and they’re not going to work if you don’t use them that way
Why would he leave the country ?
I think he’s made it clear
Well, I think The Skeptics, Skeptics are falling short because, you know, they don’t own up to
So I can say that since the Mayo Clinic finished their study in 2006, and it took them until 2013, to actually publish it, then I can say, well, Burzynski finished his in 2009, which was 3 years later, which would give Burzynski until 2016
for me to make up my mind
Well I can say, well I’m going to have to wait, the same amount of time I had to wait for Mayo to publish their study; which was from 2006 to 2013
How do you know it was delayed ?
I mean, has anybody
done a review of when a clinical trial is studied, and completed, and how long it took the people to publish it ?
You know
If they could point to me a study that’s done that, and say, well here’s the high end, here’s the low end of the spectrum, here’s the middle
Sure
Sure, but that’s not gonna, you know like, answer an overall question of, you know, somebody did a comparative study of all clinical trials, and, when they were finished, and at, and when the study was actually published afterwards
You know, that’s only gonna be one, particular clinical study
Well, we know that the Declaration of Helsinki doesn’t even give a standard saying, “You must publish within x amount of years,” you know ?
So, I’ve yet to find a Skeptic who posted something that said, “Here are the standards, published here”
Again, we get back to, when the clinical trial is finished, not when Burzynski started
I mean, you would expect to find a results to be published after, the final results are in
You would expect some people would want to have confidentiality, and maybe not want to be included
Why am I unsure ?
I just gave you an example
Oh, who said I was unsure ?
I just gave you an example
I mean, I’m just, I believe in free and open debate
I mean, I believe, if y’all are gonna spam the Internet, the Internet with garbage that y’all do not back-up, with specific
references
Like your tweet that said uh, “antineoplastons is uron, is Unicorn pee,” right ?
“Burzynski is a vampire”
Good one
He sucks their blood out of ‘em right ?
Yeah
Humor
Okay, I understand humor
Well, that’s because he’s Polish
What I defend, is that, y’all post stuff, a lot of Skeptics post stuff, including Gorski, and they do not back it up, with references, citations, or links
Gorski will just post stuff, like he did about saying, you know, the FDA would not approve, uh, accelerated approval, without a final phase 2 clinical trial being published, which was an incorrect statement, he did not provide any link
We know it’s false
Well, I’m just
I’m just
Not
That’s
Well, that is just lame
Y’all, Skeptics, like to sh spam Twitter, and social media, with all this negative stuff about Burzynski, but then when I ask you to back it up, you can’t back it up, and then, and then on this conversation you want to come down and pinhole it, to a specific subject, you know, the nitty-gritty
Well, if y’all were only debating the nitty-gritty, we would only be d debating the nitty-gritty, but that’s not what y’all do
Well, we know the FDA’s said there is
And I’ll give you those links that I told you I would give you
Yeah, that’s fine
Well, I thought it was productive too
You know, I don’t see why Gorski is afraid of debating issues
on the Internet, on his blog
Hey, he has time to post about, “Hey, uh, Burzynski got a Catholic award from somebody,” which, has nothing to do with antineoplastons, whatsoever
So, you know, he’s not focusing just in on, “Do antineoplastons work, yes or no?,” “When will Burzynski publish ?,” yes or no ?
You know, he’s putting all this ridiculous side junk, you know
So, I am not going to take that seriously
Exactly
You bet
Thank you
You too

Critiquing: Aetna: Antineoplaston Therapy and Sodium Phenylbutyrate

[1] – Aetna, Clinical Policy Bulletin: Number: 0240 Policy claims:

Aetna considers antineoplaston therapy (auto-urine therapy) and associated medical services experimental and investigational because there is insufficient evidence published in the peer-reviewed medical literature validating the effectiveness of antineoplaston therapy for any indication“
====================================
Interestingly, the above “claim” does NOT provide any specific citation(s), reference(s), or link(s) to support this claim

[2] – “auto-urine therapy” is generally defined as using one’s own urine, drinking urine, etc., which is NOT what “antineoplaston therapy” is, according to the National Cancer Institute (NCI) at the National Institutes of Health (NIH)
——————————————————————
[3] – 10/4/1991 – Five doctors (3 from the Cancer Therapy Evaluation Branch (CTEP); including the Head of the Quality Assurance and Compliance Section, Regulatory Affairs Branch, Cancer Therapy Evaluation Program, Department of Health &Human Services, Public Health Service, National Institutes of Health, National Cancer Institute, and 2 invited consultants; including one from the National Institutes of Health (NIH) Clinical Center) visited the offices of Dr. Stanislaw R. Burzynski
——————————————————————
[4] – 10/31/1991 – Michael A. Friedman, M.D. Associate Director, Cancer Therapy Evaluation Program (CTEP), Department of Health &Human Services, National Institutes of Health, National Cancer Institute, sent a one page Memorandum to Bruce A. Chabner, M.D., Director, Division of Cancer Treatment, which stated, in part:

“I thought you would be interested in this for several reasons:”

“3. Antineoplastons deserve a closer look”

“It turns out that the agents are well defined, pure chemical entities
=======================================
=======================================
“The human brain tumor responses are real”

20130911-102213.jpg
=======================================
[5] – 11/15/1991 – Michael J. Hawkins, M.D., Chief, Investigational Drug Branch, Department of Health &Human Services, Public Health Service, National Institutes of Health, National Cancer Institute, sent a 7 page letter to Decision Network, which stated, in part, on page one:
=======================================
=======================================
“It was the opinion of the site visit team that antitumor activity was documented in this best case series … “

20130911-122216.jpg
=======================================
[6] – 12/2/91 – NCI (National Cancer Institute), Decision Network Report on Antineoplastons, states in part, on page 11:

20130911-134634.jpg
=======================================
“The site visit team determined that antitumor activity was documented in this best case series … “
=======================================
=======================================
[7] – CANCER FACTS
National Cancer Institute • National Institutes of Health Department of Health and Human Services, Antineoplastons, pg. 1

=======================================
=======================================
“The reviewers of this series found evidence of antitumor activity … “

20130911-094155.jpg
=======================================
[8] – Page 1 of 6, BlueCross BlueShield of Alabama, Antineoplaston Cancer Therapy, Policy #: 280, Category: Medicine, states, in part, on page 2 of 6:

Key Points:
=======================================
=======================================
“The reviewers of this series found evidence of antitumor activity … “
=======================================
=======================================
[9] – ANTINEOPLASTON THERAPY, HS-183, pg. 2
=======================================
=======================================
“After the reviewers found some evidence of antitumor activity … “
=======================================
=======================================
These facts indicate to me that Aetna’s claim about “antineoplastons”, is “debatable”

Maybe they should have learned how to use the Freedom of Information Act (FOIA)
=======================================
REFERENCES:
=======================================
[1]
——————————————————————
http://www.aetna.com/cpb/medical/data/200_299/0240.html
=======================================
[2]
——————————————————————
http://m.cancer.gov/topics/CAM/antineoplastons/Patient
——————————————————————
http://cancer.gov/topics/CAM/antineoplastons/Patient
——————————————————————
http://cancer.gov/topics/CAM/antineoplastons/Patient?print=1
——————————————————————
http://m.cancer.gov/topics/CAM/antineoplastons/Patient?print=1
=======================================
[7]
——————————————————————
http://www.emory.edu/KomenEd/PDF/Treatment/Antineoplastons.pdf
=======================================
[8]
——————————————————————
https://www.bcbsal.org/providers/policies/final/280.pdf
=======================================
[9]
——————————————————————
https://www.wellcare.com/WCAssets/corporate/assets/HS183_Antineoplaston_Therapy.pdf
=======================================

Critiquing: Cancer Research UK What we know about antineoplastons

[1] – Cancer Research UK claims:

“Some people promote antineoplaston therapy as a cancer treatment

“But available scientific evidence does not support claims that antineoplaston therapy is effective in treating or preventing cancer

” Although Dr Burzynski’s own clinic have reported positive results for these trials, no other researchers have been able to show that this type of treatment helps to treat cancer
====================================
Interestingly, the above “claim” does NOT provide any specific citation(s), reference(s), or link(s) to support this claim
——————————————————————
[2] – 10/4/1991 – Five doctors (3 from the Cancer Therapy Evaluation Branch (CTEP); including the Head of the Quality Assurance and Compliance Section, Regulatory Affairs Branch, Cancer Therapy Evaluation Program, Department of Health &Human Services, Public Health Service, National Institutes of Health, National Cancer Institute, and 2 invited consultants; including one from the National Institutes of Health (NIH) Clinical Center) visited the offices of Dr. Stanislaw R. Burzynski
——————————————————————
[3] – 10/31/1991 – Michael A. Friedman, M.D. Associate Director, Cancer Therapy Evaluation Program (CTEP), Department of Health &Human Services, National Institutes of Health, National Cancer Institute, sent a one page Memorandum to Bruce A. Chabner, M.D., Director, Division of Cancer Treatment, which stated, in part:

“I thought you would be interested in this for several reasons:”

“3. Antineoplastons deserve a closer look”

“It turns out that the agents are well defined, pure chemical entities
=======================================
=======================================
“The human brain tumor responses are real”

20130911-102213.jpg
=======================================
[4] – 11/15/1991 – Michael J. Hawkins, M.D., Chief, Investigational Drug Branch, Department of Health &Human Services, Public Health Service, National Institutes of Health, National Cancer Institute, sent a 7 page letter to Decision Network, which stated, in part, on page one:
=======================================
=======================================
“It was the opinion of the site visit team that antitumor activity was documented in this best case series … “

20130911-122216.jpg
=======================================
[5] – 12/2/91 – NCI (National Cancer Institute), Decision Network Report on Antineoplastons, states in part, on page 11:
=======================================
=======================================
“The site visit team determined that antitumor activity was documented in this best case series … “

20130911-134634.jpg
=======================================
[6] – CANCER FACTS
National Cancer Institute • National Institutes of Health Department of Health and Human Services, Antineoplastons, pg. 1

=======================================
=======================================
“The reviewers of this series found evidence of antitumor activity … “

20130911-094155.jpg
=======================================
[7] – Page 1 of 6, BlueCross BlueShield of Alabama, Antineoplaston Cancer Therapy, Policy #: 280, Category: Medicine, states, in part, on page 2 of 6:

Key Points:
=======================================
=======================================
“The reviewers of this series found evidence of antitumor activity … “
=======================================
=======================================
[8] – ANTINEOPLASTON THERAPY, HS-183, pg. 2
=======================================
=======================================
“After the reviewers found some evidence of antitumor activity … “
=======================================
=======================================
These facts indicate to me that Cancer Research UK’s claim about “antineoplastons”, is “debatable”

Maybe they should have learned how to use the Freedom of Information Act (FOIA)
=======================================
REFERENCES:
=======================================
[1]
——————————————————————
http://www.cancerresearchuk.org/cancer-help/about-cancer/cancer-questions/what-is-antineoplaston-therapy
=======================================
[6]
——————————————————————
http://www.emory.edu/KomenEd/PDF/Treatment/Antineoplastons.pdf
=======================================
[7]
——————————————————————
https://www.bcbsal.org/providers/policies/final/280.pdf
=======================================
[8]
——————————————————————
https://www.wellcare.com/WCAssets/corporate/assets/HS183_Antineoplaston_Therapy.pdf
=======================================
Burzynski: Japan antineoplaston publications:
——————————————————————
https://stanislawrajmundburzynski.wordpress.com/2013/02/19/burzynski-japan/
=======================================
Burzynski: China antineoplaston publications:
——————————————————————
https://stanislawrajmundburzynski.wordpress.com/2013/04/25/burzynski-china-antineoplaston-publications/
=======================================

Critiquing: Wikipedia – Burzynski Clinic

[1] – Wikipedia, claims:
——————————————————————
“There is a scientific consensus that antineoplaston therapy is unproven and of little promise in treating cancer””
——————————————————————
“… a Mayo Clinic study found no benefit from antineoplaston treatment.[1]””
——————————————————————
“The Memorial Sloan-Kettering Cancer Center has stated: “Bottom Line: There is no clear evidence to support the anticancer effects of antineoplastons in humans.”[1]””
——————————————————————
Interestingly, the above 1st claim by “Wikipedia” does NOT provide any specific citation(s), reference(s), or link(s) to support this claim
——————————————————————
[2] – 2/1999 – What “Wikipedia” does NOT advise the reader about the 2nd and 3rd claims, is that the conclusion of the study was:

“Although we could not confirm any tumor regression in patients in this study, the small sample size precludes definitive conclusions about treatment efficacy
——————————————————————
[3] – 6/1999 – Wikipedia also does NOT point out that Burzynski replied to the 2/1999 publication, that:

[A] – Study tested dosing regimen known to be ineffective

[B] – Dosages of A10 and AS2–1 used in study were meant for treatment of single small lesion (<5 cm)

5 of the 6 evaluable patients had either multiple nodules or tumors larger than 5 cm

[C] – As the provider of A10 and AS2–1, I strongly suggested to the National Cancer Institute (NCI) that these patients receive a much higher dose, consistent with greater tumor load

[D] – Study was closed when I insisted the NCI either increase the dosage or inform the patients that the drug manufacturer believed that the treatment was unlikely to be effective at the dosages being used
(letter to Dr M. Sznol, NCI, on 4/20/1995)

[E] – Review of clinical data in the article by Buckner et al proves validity of my position

[F] – Study patients had extremely low plasma antineoplaston levels

My phase 2 study dosage regimen produced plasma phenylacetylglutamine (PG) levels 35 times greater, phenylacetylisoglutamine (isoPG) levels 53 times greater, and phenylacetate (PN) levels 2 times greater than those reported by Buckner et a1 [1]

[G] – Clinical outcomes reported by Buckner et al, based on inadequate dosage schedule, differ dramatically from my phase 2 studies in which higher dosage regimen was used

[H] – They reported no tumor regression

In contrast, in 1 of my ongoing studies on protocol BT-9, 4 of 8 evaluable patients with astrocytoma had objective responses [2]

[I] – Difference in outcomes primarily due to difference in dosage schedules

[J] – Another factor that may have caused a lack of response in the study by Buckner et al is duration of treatment was too brief

Almost all patients in their study received treatment for less than 30 days

1 patient received only 9 days of treatment

Current studies indicate objective tumor responses usually observed after 3 months of therapy

Additional 8 months of treatment usually needed to obtain maximal therapeutic effect

[K] – Ambiguities in response evaluation and analysis in article by Buckner et al

In.2 patients, tumor necrosis attributed to “radio-necrosis”

Interpretation’s clouded by fact antineoplaston-induced necrosis can be indistinguishable from radionecrosis

[L] – Analysis by Buckner et al could’ve highlighted 2 patients with recurrent glioblastoma who survived for more than 1 year

This is of interest because patients typically have life expectancy of 3 to 6 months

[M] – At time of the study by Buckner et al, the sponsor, NCI, decided against higher dosing regimen I proposed and closed the study

Study used dosing regimen known to be ineffective
======================================
[4] – 10/4/1991 – Five doctors (3 from the Cancer Therapy Evaluation Branch (CTEP); including the Head of the Quality Assurance and Compliance Section, Regulatory Affairs Branch, Cancer Therapy Evaluation Program, Department of Health &Human Services, Public Health Service, National Institutes of Health, National Cancer Institute, and 2 invited consultants; including one from the National Institutes of Health (NIH) Clinical Center) visited the offices of Dr. Stanislaw R. Burzynski
——————————————————————
[5] – 10/31/1991 – Michael A. Friedman, M.D. Associate Director, Cancer Therapy Evaluation Program (CTEP), Department of Health &Human Services, National Institutes of Health, National Cancer Institute, sent a one page Memorandum to Bruce A. Chabner, M.D., Director, Division of Cancer Treatment, which stated, in part:

“I thought you would be interested in this for several reasons:”

“3. Antineoplastons deserve a closer look”

“It turns out that the agents are well defined, pure chemical entities
=======================================
=======================================
“The human brain tumor responses are real”

20130911-102213.jpg
=======================================
[6] – 11/15/1991 – Michael J. Hawkins, M.D., Chief, Investigational Drug Branch, Department of Health &Human Services, Public Health Service, National Institutes of Health, National Cancer Institute, sent a 7 page letter to Decision Network, which stated, in part, on page one:
=======================================
=======================================
“It was the opinion of the site visit team that antitumor activity was documented in this best case series … “

20130911-122216.jpg
=======================================
[7] – 12/2/91 – NCI (National Cancer Institute), Decision Network Report on Antineoplastons, states in part, on page 11:
=======================================
=======================================
“The site visit team determined that antitumor activity was documented in this best case series … “

20130911-134634.jpg
=======================================
[8] – CANCER FACTS
National Cancer Institute • National Institutes of Health Department of Health and Human Services, Antineoplastons, pg. 1

=======================================
=======================================
“The reviewers of this series found evidence of antitumor activity … “

20130911-094155.jpg
=======================================
[9] – Page 1 of 6, BlueCross BlueShield of Alabama, Antineoplaston Cancer Therapy, Policy #: 280, Category: Medicine, states, in part, on page 2 of 6:

Key Points:
=======================================
=======================================
“The reviewers of this series found evidence of antitumor activity … “
=======================================
=======================================
[10] – ANTINEOPLASTON THERAPY, HS-183, pg. 2
=======================================
=======================================
“After the reviewers found some evidence of antitumor activity … “
=======================================
=======================================
These facts indicate to me that Wikipedia’s claim about “antineoplastons”, is “debatable”

Maybe they should have learned how to use the Freedom of Information Act (FOIA)
=======================================
REFERENCES:
=======================================
[1]
——————————————————————
http://en.wikipedia.org/wiki/Burzynski_Clinic
——————————————————————
http://en.m.wikipedia.org/wiki/Burzynski_Clinic
——————————————————————
Antineoplastons, Memorial Sloan-Kettering Cancer Center
======================================
[2] – 2/1999 – A10 and AS2-1 – Phase II
Mayo Clinic Proceedings
http://www.ncbi.nlm.nih.gov/m/pubmed/10069350
Phase II Study of Antineoplastons A10 (NSC 648539) and AS2-1 (NSC 620261) in Patients With Recurrent Glioma

Material & Methods:

Patients received escalating doses of A10 and AS2-1 by multiple intermittent intravenous injections with use of portable programmable pump to the target daily dose of 1.0 g/kg for A10 and of 0.4 g/kg for AS2-1

Mean steady-state plasma concentrations of phenylacetate & phenylacetylglutamine after escalation to the target doses of A10 and AS2-1 were 177 +/-101 ug/mL & 302 +/- 102 ug/mL, respectively

Results:

9 patients were treated, in 6 of whom treatment response was assessable in accordance with protocol stipulations
http://linkinghub.elsevier.com/retrieve/pii/S0025-6196(11)63835-4
Comment in Jun; 74 (6): 641-2
http://www.sciencedirect.com/science/article/pii/S0025619611638354
Mayo Clin Proc 74(2):9 (1999), PMID .10069350
http://www.mayoclinicproceedings.org/article/S0025-6196(11)63835-4/fulltext
DOI: 10.4065/74.2.137
http://download.journals.elsevierhealth.com/pdfs/journals/0025-6196/PIIS0025619611638354.pdf
Mayo Clin Proc 1999; 74: 137–145
http://onlinelibrary.wiley.com/doi/10.1046/j.1365-2796.2003.01098.x/full
Mayo Clin Proc 1999; 74: 137–45
http://onlinelibrary.wiley.com/doi/10.1046/j.1365-2796.2003.01098.x/references
J C Buckner, M G Malkin, E Reed, T L Cascino, J M Reid, M M Ames, W P Tong, S Lim, W D Figg
http://onlinelibrary.wiley.com/store/10.1046/j.1365-2796.2003.01098.x/asset/j.1365-2796.2003.01098.x.pdf?v=1&t=hbs6xce2&s=3423e3cd1955667e8e8cdf33323faf0bd85b6a29
Department of Oncology, Mayo Clinic Rochester, Minnesota USA
http://onlinelibrary.wiley.com/store/10.1046/j.1365-2796.2003.01098.x/asset/j.1365-2796.2003.01098.x.pdf?v=1&t=hbrndkdf&s=e0af2d3bfb13841852d92a839d3a4932a5f4bb48
======================================
[3] – 6/1999 – A10 and AS2-1
http://www.ncbi.nlm.nih.gov/pubmed/10377942
Efficacy of antineoplastons A10 and AS2-1
http://www.ncbi.nlm.nih.gov/m/pubmed/10377942
S R Burzynski
Mayo Clin Proc 74 (6): 641-2 (1999),
Mayo Clin Proc. 1999 Jun; 74 (6): 641-2
http://linkinghub.elsevier.com/retrieve/pii/S0025-6196(11)64143-8
Comment on
Mayo Clin Proc. 1999 Feb; 74 (2): 137-45 PMID .10377942
http://www.mayoclinicproceedings.org/article/S0025-6196(11)64143-8/fulltext
Mayo Clin Proc. 1999
http://download.journals.elsevierhealth.com/pdfs/journals/0025-6196/PIIS0025619611641438.pdf
Comment on
Mayo Clinic Proc. 1999; 74: 641–642 (letter)
http://linkinghub.elsevier.com/retrieve/pii/S0025-6196(11)64143-8
Mayo Clin Proc
74 (6): 641-2
http://download.journals.elsevierhealth.com/pdfs/journals/0025-6196/PIIS0025619611641438.pdf
Mayo Clin Proc 74 (6): 1 (1999),
Elsevier Ltd.
DOI: 10.4065/74.6.641
1999 – A10 and AS2-1 – Mayo
Buckner, Reid, & Malkin
Mayo Clin Proc 74 (6): 2 (1999),
Elsevier Ltd.
DOI: 10.4065/74.6.641-a
http://www.mayoclinicproceedings.org/article/S0025-6196(11)64144-X/fulltext
Mayo Clinic Proceedings
74(6):2 1999 Elsevier Ltd.
http://download.journals.elsevierhealth.com/pdfs/journals/0025-6196/PIIS002561961164144X.pdf
=======================================
[8]
——————————————————————
http://www.emory.edu/KomenEd/PDF/Treatment/Antineoplastons.pdf
=======================================
[9]
——————————————————————
https://www.bcbsal.org/providers/policies/final/280.pdf
=======================================
[10]
——————————————————————
https://www.wellcare.com/WCAssets/corporate/assets/HS183_Antineoplaston_Therapy.pdf
=======================================

Critiquing: Memorial Sloan-Kettering Cancer Center (MSKCC)

[1]Memorial Sloan-Kettering Cancer Center (MSKCC), How It Works,, claims:

”Bottom Line: There is no clear evidence to support the anticancer effects of antineoplastons in humans”
——————————————————————
Interestingly, the above “Bottom Line” does NOT provide any specific citation(s), reference(s), or link(s) to support this claim
——————————————————————
[2] – 10/4/1991 – Five doctors (3 from the Cancer Therapy Evaluation Branch (CTEP); including the Head of the Quality Assurance and Compliance Section, Regulatory Affairs Branch, Cancer Therapy Evaluation Program, Department of Health &Human Services, Public Health Service, National Institutes of Health, National Cancer Institute, and 2 invited consultants; including one from the National Institutes of Health (NIH) Clinical Center) visited the offices of Dr. Stanislaw R. Burzynski
——————————————————————
[3] – 10/31/1991 – Michael A. Friedman, M.D. Associate Director, Cancer Therapy Evaluation Program (CTEP), Department of Health &Human Services, National Institutes of Health, National Cancer Institute, sent a one page Memorandum to Bruce A. Chabner, M.D., Director, Division of Cancer Treatment, which stated, in part:

“I thought you would be interested in this for several reasons:”

“3. Antineoplastons deserve a closer look”

“It turns out that the agents are well defined, pure chemical entities
=======================================
=======================================
“The human brain tumor responses are real”

20130911-102213.jpg
=======================================
[4] – 11/15/1991 – Michael J. Hawkins, M.D., Chief, Investigational Drug Branch, Department of Health &Human Services, Public Health Service, National Institutes of Health, National Cancer Institute, sent a 7 page letter to Decision Network, which stated, in part, on page one:
=======================================
=======================================
“It was the opinion of the site visit team that antitumor activity was documented in this best case series … “

20130911-122216.jpg
=======================================
[5] – 12/2/91 – NCI (National Cancer Institute), Decision Network Report on Antineoplastons, states in part, on page 11:
=======================================
=======================================
“The site visit team determined that antitumor activity was documented in this best case series … “

20130911-134634.jpg
=======================================
[6] – CANCER FACTS
National Cancer Institute • National Institutes of Health Department of Health and Human Services, Antineoplastons, pg. 1

=======================================
=======================================
“The reviewers of this series found evidence of antitumor activity … “

20130911-094155.jpg
=======================================
[7] – Page 1 of 6, BlueCross BlueShield of Alabama, Antineoplaston Cancer Therapy, Policy #: 280, Category: Medicine, states, in part, on page 2 of 6:

Key Points:
=======================================
=======================================
“The reviewers of this series found evidence of antitumor activity … “
=======================================
=======================================
[8] – ANTINEOPLASTON THERAPY, HS-183, pg. 2
=======================================
=======================================
“After the reviewers found some evidence of antitumor activity … “
=======================================
=======================================
These facts indicate to me that Memorial Sloan-Kettering Cancer Center’s (MSKCC) claim about “antineoplastons”, is “debatable”

Maybe they should have learned how to use the Freedom of Information Act (FOIA)
=======================================
REFERENCES:
=======================================
[1]
——————————————————————
http://www.mskcc.org/cancer-care/herb/antineoplaston
=======================================
[6]
——————————————————————
http://www.emory.edu/KomenEd/PDF/Treatment/Antineoplastons.pdf
=======================================
[7]
——————————————————————
https://www.bcbsal.org/providers/policies/final/280.pdf
=======================================
[8]
——————————————————————
https://www.wellcare.com/WCAssets/corporate/assets/HS183_Antineoplaston_Therapy.pdf
=======================================

Critiquing: American Cancer Society – Antineoplaston Therapy

[1] – The American Cancer Society Antineoplaston Therapy Overview claims:
=====================================
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” In other words, there is no convincing evidence showing that antineoplastons actually work
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Interestingly, the above Overview does NOT provide any specific citation(s), reference(s), or link(s) to support this claim
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[2] – 10/4/1991 – Five doctors (3 from the Cancer Therapy Evaluation Branch (CTEP); including the Head of the Quality Assurance and Compliance Section, Regulatory Affairs Branch, Cancer Therapy Evaluation Program, Department of Health &Human Services, Public Health Service, National Institutes of Health, National Cancer Institute, and 2 invited consultants; including one from the National Institutes of Health (NIH) Clinical Center) visited the offices of Dr. Stanislaw R. Burzynski
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[3] – 10/31/1991 – Michael A. Friedman, M.D. Associate Director, Cancer Therapy Evaluation Program (CTEP), Department of Health &Human Services, National Institutes of Health, National Cancer Institute, sent a one page Memorandum to Bruce A. Chabner, M.D., Director, Division of Cancer Treatment, which stated, in part:

“I thought you would be interested in this for several reasons:”

“3. Antineoplastons deserve a closer look”

“It turns out that the agents are well defined, pure chemical entities
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“The human brain tumor responses are real”

20130911-102213.jpg
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[4] – 11/15/1991 – Michael J. Hawkins, M.D., Chief, Investigational Drug Branch, Department of Health &Human Services, Public Health Service, National Institutes of Health, National Cancer Institute, sent a 7 page letter to Decision Network, which stated, in part, on page one:
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“It was the opinion of the site visit team that antitumor activity was documented in this best case series … “

20130911-122216.jpg
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[5] – 12/2/91 – NCI (National Cancer Institute), Decision Network Report on Antineoplastons, states in part, on page 11:
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“The site visit team determined that antitumor activity was documented in this best case series … “

20130911-134634.jpg
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[6] – CANCER FACTS
National Cancer Institute • National Institutes of Health Department of Health and Human Services, Antineoplastons, pg. 1

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“The reviewers of this series found evidence of antitumor activity … “

20130911-094155.jpg
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[7] – Page 1 of 6, BlueCross BlueShield of Alabama, Antineoplaston Cancer Therapy, Policy #: 280, Category: Medicine, states, in part, on page 2 of 6:

Key Points:
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“The reviewers of this series found evidence of antitumor activity … “
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[8] – ANTINEOPLASTON THERAPY, HS-183, pg. 2
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“After the reviewers found some evidence of antitumor activity … “
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These facts indicate to me that the American Cancer Society’s claim about “antineoplastons”, is “debatable”

Maybe they should have learned how to use the Freedom of Information Act (FOIA)
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REFERENCES:
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[1]
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http://m.cancer.org/treatment/treatmentsandsideeffects/complementaryandalternativemedicine/pharmacologicalandbiologicaltreatment/antineoplaston-therapy
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[6]
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http://www.emory.edu/KomenEd/PDF/Treatment/Antineoplastons.pdf
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[7]
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https://www.bcbsal.org/providers/policies/final/280.pdf
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[8]
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https://www.wellcare.com/WCAssets/corporate/assets/HS183_Antineoplaston_Therapy.pdf
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