Dr. Michael A. Friedman, DATA ?

[1] – 11/2/1993 – 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 Services, National Institutes of Health (NIH), sent a 3 page letter to Burzynski, which advised, in part, on page 1:

7. “In accordance with your letter we will arrange a review of data after accrual of the 1st 5-6 patients, which should occur 6 months after the study has been initiated”

“The Theradex database is also available … “
——————————————————————
[1] – 11/2/1993 – This makes it clear that: “review of data” is NOT the same “DATA” as “The Theradex database is ALSO available … “ “DATA” provided to Burzynski since the 7/18/1994 Theradex Clinical Studies Summary [5] + [8]

20130918-161419.jpg

20130918-152526.jpg
[2] – 1995 (4/3/1995) – Dr. Mario Sznol, Department of Health & Human Services (HHS), Public Health Services, National Institutes of Health (NIH), National Cancer Institutes (NIH), sent a 2 page letter for Dr. Michael A. Friedman, to Burzynski, in response to his letter of 3/29/1995, which advised, in part, on page 1:

“We will forward the data on the 1st 5 patients in a separate mailing as you requested”
——————————————————————
[2] – 4/3/1995 – This makes it clear that: “We will forward the data … “ is NOT the same “DATA” as “The Theradex database is ALSO available … “ “DATA” provided to Burzynski since the 7/18/1994 Theradex Clinical Studies Summary [5] + [8]

20130918-134020.jpg

20130918-134632.jpg
[3] – 1995 (4/20/1995) – Burzynski sent a letter to Dr. Mario Sznol, Department of Health & Human Services (HHS), National Institutes of Health (NIH), in response to his letter of 4/3/1995, which advised, in part, on page 2:

“We are anxiously awaiting the complete data on the 1st 5 patients as promised in your letter of 4/3/1995″
——————————————————————
[3] – 4/20/1995 – This makes it clear that: “We are anxiously awaiting the complete data … “ is NOT the same “DATA” as “The Theradex database is ALSO available … “ “DATA” provided to Burzynski since the 7/18/1994 Theradex Clinical Studies Summary [5] + [8]

20130918-162456.jpg
[4] – 1995 (5/16/1995) – Burzynski sent a letter to Dr. Michael A. Friedman, Associate Director, Cancer Therapy Evaluation Program (CTEP), Division of Cancer Treatment (DCT), National Cancer Institute (NCI), National Institutes of Health (NIH), in response to his letter of 5/12/1995, which advised, in part, on page 2:

“I still have not received the complete data on the 1st 5 patients, which was promised in your letter of 4/3/1995″
——————————————————————
[4] – 5/16/1995 – This makes it clear that: “I still have not received the complete data … “ is NOT the same “DATA” as “The Theradex database is ALSO available … “ “DATA” provided to Burzynski since the 7/18/1994 Theradex Clinical Studies Summary [5] + [8]

20130918-164323.jpg
[5] – 1995 (6/6/1995) – Dr. Michael A. Friedman, 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), sent a 3 page letter to Burzynski, in response to his letters of 4/20/1995 and 5/16/1995, which advised, in part, on page 1:

“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)
——————————————————————
[5] – 6/6/1995 – This makes it clear that: ” … you have been sent monthly clinical summaries … directly from Theradex IS the same “DATA” as “The Theradex database is ALSO available … “ “DATA” provided to Burzynski since the 7/18/1994 Theradex Clinical Studies Summary [5] + [8]

20130918-165840.jpg
[6] – 8/23/1995 – Robert B. Lanman, National Institutes of Health (NIH) Legal Advisor, Department of Health & Human Services (HHS), Office of the Secretary, Office of the General Council, Public Health Division, sent a 1 page letter to Burzynski’s attorney, Richard A. Jaffe, Esq., which he copied Dr. Michael A. Friedman on, which was in response to his letter of 7/21/1995, which advised, in part:

” … you requested in your letter that we provide you or Dr. Burzynski with the medical records of patients treated by the Principle Investigators”

“To our knowledge, Dr. Burzynski has received, on an ongoing basis, complete copies of the reports prepared by Theradex after the Principle Investigators submit their data”

“Dr. Burzynski has received precisely the same information that is provided to the National Cancer Institute (NCI)”

“The NCI does not possess any individual patient records to provide to Dr. Burzynski”
——————————————————————
[6] – 8/23/1995 – This makes it clear that: ” … Dr. Burzynski has received … complete copies of the reports prepared by Theradex after the Principle Investigators submit their data” IS the same “DATA” as “The Theradex database is ALSO available … “ “DATA” provided to Burzynski since the 7/18/1994 Theradex Clinical Studies Summary [5] + [8]

20130918-154154.jpg
[7] – 1995 (9/19/1995) – Dr. Michael A. Friedman, 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), sent a 2 page letter to Burzynski, which advised, in part:

“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:”

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

“We have no individual patient records in our possession in addition to the Theradex reports”
——————————————————————
[7] – 9/9/1995 – This makes it clear that: ” … data has been regularly supplied to you by our contractor, Theradex … :” IS the same “DATA” as “The Theradex database is ALSO available … “ “DATA” provided to Burzynski since the 7/18/1994 Theradex Clinical Studies Summary [5] + [8]

20130918-160216.jpg

20130918-161029.jpg
[8] – 10/5/1995 – Robert B. Lanman, National Institutes of Health (NIH) Legal Advisor, Department of Health & Human Services (HHS), Office of the Secretary, Office of the General Counsel, Public Health Division, sent a 1 page letter to Burzynski’s attorney, Richard A. Jaffe, Esq., which advised, in part:

“This is in response to your 9/8/1995 letter in which you reiterate your request for copies of individual patient records and argue that the protocol for the study of Antineoplastons specifically provides that medical records of patients treated by the Principal Investigators will be provided to Dr. Burzynski”

“It is our understanding that NCI offered to allow Dr. Burzynski to participate in an interim and final meeting in which patient data from the study was to be reviewed”

“However, these meetings never took place because of the insufficient patient accrual and decision not to complete the study”

“With regard to the portion of the medical record which you forwarded, the stamp does indicate that the patient was seen at the National Institutes of Health’s Clinical Center”

“We have learned that 2 patients were enrolled in the Sloan-Kettering study through the Clinical Center and hence, even though the Clinical Center did not have its own protocol, it has medical records for those 2 individuals”
——————————————————————
[8] – 10/5/1995 – This makes it clear that: “… these meetings never took place because of the insufficient patient accrual and decision not to complete the study”, is NOT Theradex, but the prior letters do NOT mention the word “MEETINGS”
=======================================
[1] – 11/2/1993 – This makes it clear that: “REVIEW OF DATA” is NOT the same “DATA” as “The Theradex database is ALSO available … “ “DATA” provided to Burzynski since the 7/18/1994 Theradex Clinical Studies Summary [5] + [8]

[2] – 4/3/1995 – This makes it clear that: “WE WILL FORWARD THE DATA … “ is NOT the same “DATA” as “The Theradex database is ALSO available … “ “DATA” provided to Burzynski since the 7/18/1994 Theradex Clinical Studies Summary [5] + [8]

[3] – 4/20/1995 – This makes it clear that: “We are anxiously awaiting the complete DATA … “ is NOT the same “DATA” as “The Theradex database is ALSO available … “ “DATA” provided to Burzynski since the 7/18/1994 Theradex Clinical Studies Summary [5] + [8]

[4] – 5/16/1995 – This makes it clear that: “I STILL HAVE NOT RECEIVED THE complete DATA … “ is NOT the same “DATA” as “The Theradex database is ALSO available … “ “DATA” provided to Burzynski since the 7/18/1994 Theradex Clinical Studies Summary [5] + [8]

[5] – 6/6/1995 – This makes it clear that: ” … you have been sent monthly clinical summaries … directly from Theradex IS the same “DATA” as “The Theradex database is ALSO available … “ “DATA” provided to Burzynski since the 7/18/1994 Theradex Clinical Studies Summary [5] + [8]

[6] – 8/23/1995 – This makes it clear that: ” … Dr. Burzynski has received … complete copies of the reports prepared by Theradex after the Principle Investigators submit their data” IS the same “DATA” as “The Theradex database is ALSO available … “ “DATA” provided to Burzynski since the 7/18/1994 Theradex Clinical Studies Summary [5] + [8]

[7] – 9/9/1995 – This makes it clear that: ” … data has been regularly supplied to you by our contractor, Theradex … :” IS the same “DATA” as “The Theradex database is ALSO available … “ “DATA” provided to Burzynski since the 7/18/1994 Theradex Clinical Studies Summary [5] + [8]

20130918-154926.jpg
Why would you advise Burzynski:

[2] – 4/3/1995 – “WE WILL FORWARD THE DATA” if you had FORWARDED “THE DATA” since

[5] + [8] – the 7/18/1994 Theradex Clinical Studies Summary ?

Dr. Michael A. Friedman, DATA ?

Where is the DATA ?
=======================================

Advertisements

[7] – 1993 (10/20/1993) – Dr. Michael A. Friedman to Burzynski (4 pgs.)

This page is linked to:
=====================================
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
——————————————————————
https://stanislawrajmundburzynski.wordpress.com/2013/09/08/critiquing-stanislaw-burzynski-on-the-arrogance-of-ignorance-about-cancer-and-targeted-therapies/
======================================
[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
——————————————————————

======================================
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
======================================

[4] – 1991 (10/31/1991) – Dr. Michael A. Friedman Memorandum to Dr. Bruce A. Chabner (1 pg.)

This page is linked to:
=====================================
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
——————————————————————
https://stanislawrajmundburzynski.wordpress.com/2013/09/08/critiquing-stanislaw-burzynski-on-the-arrogance-of-ignorance-about-cancer-and-targeted-therapies/
======================================
[4] – 1991 (10/31/1991) – Dr. Michael A. Friedman Memorandum to Dr. Bruce A. Chabner (1 pg.)
——————————————————————
Michael A. Friedman, M.D., Associate Director, Cancer Therapy Evaluation Program (CTEP), Department of Health &Human Services (HHS), National Institutes of Health (NIH), National Cancer Institute (NCI)

Memorandum

(Unconventional Therapy File. – written in)

Subject: Antineoplastons

To: Bruce A. Chabner, M.D.
Director, Division of Cancer Treatment

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

1. Our Unconventional Cancer Treatment approach seems to be working well (thanks to Mike Hawkins).

2. Our on-site review process is working well (thanks to Dorothy Macfarlane)

3. Antineoplastons deserve a closer look

It turns out that the agents are well defined, pure chemical entities

They are relatives of Thalidomide with presumed good CNS penetration

We are working with DTEP on them

The human brain tumor responses are real

We will keep you informed

(Mike Why not test These in a phase II trial – written in)

20130912-213924.jpg

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: Quackwatch: Stanislaw Burzynski and “Antineoplastons” – Saul Green, Ph.D.

[1] – Quackwatch has this article which claims, in part:

“Tracing the biochemistry involved in Burzynski’s synthesis of antineoplastons shows that the substances are without value for cancer treatment”

Burzynski has never demonstrated that A-2.1 (PA) or “soluble A-10″ (PA and PAG) are effective against cancer or that tumor cells from patients treated with these antineoplastons have been “normalized.””

“Tests of antineoplastons at the National Cancer Institute have never been positive”

“The drug company Sigma-Tau Pharmaceuticals could not duplicate Burzynski’s claims for AS-2.1 and A-10

“The Japanese National Cancer Institute has reported that antineoplastons did not work in their studies”

“These facts indicate to me that Burzynski’s claims that his “antineoplastons” are effective against cancer are not credible”

About the Author

Dr. Green (1925-2007) was a biochemist who did cancer research at Memorial Sloan-Kettering Cancer Center for 23 years

He consulted on scientific methodology and had a special interest in unproven methods

This article was adapted from his presentation at the American Association for Clinical Chemistry Symposium in Atlanta in July 1997

This page was revised on January 19, 2013
====================================
Interestingly, the above article does NOT provide any specific citation(s), reference(s), or link(s) to support any of these claims
——————————————————————
[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 Quackwatch, and Saul Green’s claims about “antineoplastons”, are “not credible”

Maybe they should have learned how to use the Freedom of Information Act (FOIA)
=======================================
REFERENCES:
=======================================
[1] – Stanislaw Burzynski and “Antineoplastons”
Saul Green, Ph.D.

——————————————————————
http://www.quackwatch.org/01QuackeryRelatedTopics/Cancer/burzynski1.html
=======================================
[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
=======================================