DID Dr. Michael A. Friedman FIB ?

[1] – 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:

“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 … at the NCI“

“Patient .27-53-76-5 … “
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6/6/1995 we know “2 patients were treated at the National Cancer Institute” [1]

[2] – 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; which he copied Dr. Michael A. Friedman on, to Burzynski’s attorney, Richard A. Jaffe, Esq., which was in response to his letter of 7/21/1995, and 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”

“The NCI does not possess any individual patient records to provide to Dr. Burzynski”
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6/6/1995 we know per Dr. Michael A. Friedman’s letter that “2 patients were treated at the National Cancer Institute” [1]

8/23/1995 we know that the National Cancer Institute (NCI) did NOT have “any individual patient records” for those 2 patients per National Institutes of Health (NIH) Legal Advisor Robert B. Lanman [2]

[3] – 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“

Pg. 2

“We have no individual patient records in our possession in addition to the Theradex reports”
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6/6/1995 we know from Dr. Michael A. Friedman’s letter that “2 patients were treated at the National Cancer Institute”[1]

8/23/1995 we know that the National Cancer Institute (NCI) did NOT have “any individual patient records” for those 2 patients per National Institutes of Health (NIH) Legal Advisor Robert B. Lanam’s letter [2]

9/19/1995 we know that Dr. Michael A. Friedman advised that “We have no individual patient records in our possession …”[3]

8/23/1995 we know that Dr. Michael A. Friedman was copied on Robert A. Lanman’s letter which stated that the National Cancer Institute (NCI) did NOT have “any individual patient records” for those 2 patients [2]

All Americans are “presumed to know the law”, so we know that Dr. Michael A. Friedman would have advised Robert B. Lanman if his 8/23/1995 written statement to Burzynski’s attorney, Richard A. Jaffe, Esq., was NOT TRUE [2]

[0] – Title 18, Part I, Chapter 47, § 1001

18 USC § 1001 – Statements or entries generally

(3) “makes or uses any false writing or document knowing the same to contain any materially false, fictitious, or fraudulent statement or entry”

[4] – 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”

“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 … through the Clinical Center and hence … the Clinical Center … has medical records for those 2 individuals”
——————————————————————
6/6/1995 we know from Dr. Michael A. Friedman’s letter that “2 patients were treated at the National Cancer Institute” [1]

8/23/1995 we know that the National Cancer Institute (NCI) did NOT have “any individual patient records” for those 2 patients per National Institutes of Health (NIH) Legal Advisor Robert B. Lanam’s letter [2]

8/23/1995 we know that Dr. Michael A. Friedman was copied on Robert A. Lanman’s letter which stated that the National Cancer Institute (NCI) did NOT have “any individual patient records” for those 2 patients [2]

9/19/1995 we know that Dr. Michael A. Friedman advised that “We have no individual patient records in our possession …” in his letter to Burzynski [3]

10/5/1995 we know that Robert B. Lanman admitted that ” … the National Institutes of Health’s Clinical Center … has medical records for those 2 individuals”, in his letter [4]

All Americans are “presumed to know the law”, so we know that Dr. Michael A. Friedman would have advised Robert B. Lanman if his 8/23/1995 written statement to Burzynski’s attorney, Richard A. Jaffe, Esq., was NOT TRUE [2], and / or would have advised Burzynski in his 9/19/1995 letter that the National Cancer Institutes Clinical Center had “medical records for those 2 individuals” [3]

Dr. Michael A. Friedman

6/6/1995 you advised Burzynski that “2 patients were treated at the National Cancer Institute” [1]

8/23/1995 you were copied on Robert A. Lanman’s letter which stated that the National Cancer Institute (NCI) did NOT have “any individual patient records” for those 2 patients [2]

8/23/1995 we know that you did NOT advise Burzynski that National Institutes of Health (NIH) Legal Advisor Robert B. Lanman’s written statement was NOT TRUE [2]

9/19/1995 you advised Burzynski that “We have no individual patient records in our possession …” [3]

10/5/1995 – Robert B. Lanman admitted that ” … the National Institutes of Health’s Clinical Center … has medical records for those 2 individuals” [4]

Dr. Michael A. Friedman, I know that you would NOT break the law

Title 18, Part I, Chapter 47, § 1001

18 USC § 1001 – Statements or entries generally

(3) “makes or uses any false writing or document knowing the same to contain any materially false, fictitious, or fraudulent statement or entry”

Dr. Michael A. Friedman, please let me know why what you did was NOT a LIE

My primary obligation is to the American public, because, I know you would tell the TRUTH, since, in your words, you “could not responsibly act in any other manner”
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[0] – Title 18, Part I, Chapter 47, § 1001

18 USC § 1001 – Statements or entries generally
——————————————————————
http://www.law.cornell.edu/uscode/text/18/1001
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[24] – 1995 (10/27/1995) – Burzynski to Dr. Richard Klausner (7 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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[24] – 1995 (10/27/1995) – Burzynski 7 page letter to Richard Klausner, M.D., Director, National Cancer Institute (NCI), National Institutes of Health (NIH)

I was shocked to read the Cancernet “fact sheet” the NCI has been distributing about the cancellation of the clinical trials of antineoplastons, the anti-cancer drugs I discovered and developed

I find it scandalous that a government agency is putting out a public document containing such blatantly false information

Let me remind you that the only reason the clinical trials of antineoplastons were stopped is that NCI would not conduct them as per our written agreement

NCI’s “fact sheet” tries to obscure that simple fact with misinformation such as the following:

“In 1991, a “best case series” review was conducted by the National Cancer Institute (NCI) to evaluate clinical response in a group of patients treated at Dr. Burzynski’s Houston facility

For this review, Dr. Burzynski selected from his entire clinical experience 7 brain tumor patients whom he felt had a beneficial effect from antineoplastons.”

This misstatement is obviously calculated to make the reader think that in my entire clinical experience I have had only 7 patients who benefitted from antineoplaston treatment, which is wildly untrue

In fact, I prepared not 7, but dozens of cases for the NCI reviewers

As you must know, the reviewers were able to spend just one day at the clinic–enough time to review only 7 cases

Cancernet then compounds that misstatement with the following:

“This series did not constitute a formal clinical trial, since it was a retrospective review of medical records, did not include all available information, and included only cases selected by Dr. Burzynski” (my italics)

To the contrary, the patient medical records that NCI scientists reviewed were exhaustive and did contain “all available patient information.”

In fact, Michael Hawkins, M.D., leader of the site visit team, specifically complimented me on how complete and well-organized they were

The next misstatement is the following:

“The reviewers of this series determined that there was presumptive evidence of antitumor activity . . .”

Pg. 2

Now that the NCI’s Cancer Therapy Evaluation Program (CTEP) is under fire for misconduct in these clinical trials, it is rewriting history

The statement of the NCI scientists who actually reviewed patient records was quite different from the above

Their report (minutes of Decision Network committee meeting enclosed) stated that “The site visit team determined that antitumor activity was documented in the best case series and that the conduct of Phase II trials was indicated to determine the response rate” (my italics)

In other words, according to the site visit team, there was no question that the treatment worked in the cases reviewed

All that remained to be determined were the numerator and the denominator

Even the NCI’s own previous “fact sheet” on antineoplastons, dated 2/17/1994, (enclosed), states that

“The NCI reviewed 7 cases of patients with primary brain tumors that were treated by Dr. Burzynski with antineoplastons and concluded that antitumor responses occurred” (my italics)

But by far the most outrageous misstatement is the following:

“On 8/18/1995, the studies were closed because a consensus could not be reached with Dr. Burzynski on the proposed changes to the protocol to increase accrual, and there was no hope of completing the studies in a timely manner.”

The NCI never made any effort to “reach a consensus.”

Instead, it simply violated the written protocol we had agreed upon

Without informing me, NCI changed the rules to allow patients with any size or number of tumors, low performance scores, and spinal cord metastases

in other words, NCI was accepting patients whose brains and spinal cords were literally consumed by large malignant tumors–patients so advanced as to have no chance whatsoever

When I found out and insisted that NCI either conduct the study as agreed or inform patients that I felt it was conducting the study improperly, NCI cancelled it

The above is all well documented

While we were still in the negotiating stages, Michael Friedman, M.D. of the NCI wrote me a letter dated 11/2/1993 (enclosed) “. . . we will accede to all the modifications that you have stipulated.”

Dr. Friedman specifically agreed to exclude patients with:

* tumors larger than 5 cm (2 inches)
* multiple tumors
* metastases to spinal cord
* Karnofsky performance scores less than 70%

Based on Dr. Friedman’s written assurance that NCI would honor this exclusion criteria, I provided NCI with a large quantity of antineoplastons, and the clinical trial began

on 3/23/1994, Mario Sznol, M.D., of NCI wrote me proposing that NCI drop the exclusion for multiple tumors and spinal cord metastases, increase the maximum tumor size from 5 cm to 8 cm, and lower the Karnofsky score from 70 to 60 (enclosed)

in a response dated 4/19/1994 (enclosed), I wrote back that I would be glad to help NCI design a separate trial for such advanced patients, using a more aggressive dosage schedule

But I made it clear that it would be unethical to use the current dosage schedule on such patients since my experience had shown that such patients do not respond well to it

Pg. 3

As proof , I pointed out that in the NCI’s own review of patients treated with antineoplastons, the only ones who had less than 50% tumor shrinkage were exactly those with tumors greater than 5 cm

I did not hear back from NCI and assumed the matter had been dropped

Nearly one year later–in 3/1995–I learned that NCI had made all the changes to which I had objected

In fact, NCI went even further

Rather than raising the maximum tumor size from 5 to 8 cm as the NCI earlier suggested, it began accepting patients with any size tumor

I insisted that NCI either honor our agreement or change the Informed Consent statement (which patients must read and sign) to reflect the fact that I, the drug’s discoverer and developer, felt that the treatment was unlikely to be effective in such advanced patients in the doses being used

Rather than honor it’s commitment to conduct the study as agreed, NCI cancelled it

I find it particularly curious that now neither NCI nor Memorial Sloan-Kettering Cancer Center (MSK) will take responsibility for changing the exclusion criteria, and are instead pointing fingers at each other

in his letter of 4/3/1995 (enclosed), Dr. Sznol repeatedly refers to the “revised” eligibility criteria proposed by the [Memorial Sloan-Kettering] investigators” (my italics)

But, in a letter to John Lewis, M.D., of Memorial Sloan-Kettering’s Institutional Review Board dated 1/31/1995 (enclosed), the Chief Investigator, MSK’s Mark Malkin, M.D., writes that

“Further amendments, as described below, have been made at the request of NCI” (my italics)

If the changes to the protocol are as the NCI would have the world believe, why is everyone connected to them scurrying to disavow responsibility?

An even more serious matter is what appears to be the investigator’s relentless violations of the treatment protocol

Looking at the treatment summaries compiled by Theradex Corporation, the medical reporting company hired by NCI to compile and tabulate patient treatment data, it would appear that investigators violated the agreed-upon protocol in every patient treated

Apparent violations include the removal of patients from treatment who had no tumor growth (including one patient who, during subsequent surgery, was found to have no cancer cells remaining), and the removal of a patient for “skin reactions” caused not by antineoplastons, but by another drug patient was receiving, DPH

This is clear due to the fact that the patient’s skin condition worsened when he was taken off antineoplastons

It improved only after DPH was discontinued

The summaries provided by Theradex are somewhat sketchy, so I asked to review the complete records of patients tested–which Dr. Friedman had specifically promised to provide

NIH lawyer Robert Lanman replied in a letter dated 8/23/1995 (enclosed) that the NCI did not have any such records

In fact, several patients were treated at NCI and of course NCI has their complete medical records

When I demonstrated this by sending Mr. Lanman copies of patient records obtained by a patient’s family from NCI, he admitted in fact NCI does have patient records, but refused to release them

And he disregarded his own misstatements of fact by saying that

“Given that you apparently have already obtained at least one of the patient’s records, we fail to understand why you are perusing this matter” (letter from Robert Lanman dated 10/5/1995 enclosed)

Mr. Lanman also claims that NCI has “no such commitment” to release medical records of patients treated with antineoplastons

And Dr. Friedman, in a letter dated 9/19/1995 (enclosed), writes that Dr. Burzynski’s request for “detailed records” has been satisfied by the sketchy Theradex treatment summaries

Pg. 4

Both these statements directly contradict Dr. Friedman’s letter of 11/2/1993 (enclosed), in which he promises that

“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

This should be sufficient to assure that the conduct of the study is satisfactory

The Theradex database is also available . . .” (my italics)

In other words, Dr. Friedman promised to provide me with patient medical records, recognizing that the Theradex summaries are something quite separate

In that same 9/19/1995 letter, Dr. Friedman writes that

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

Either he is deliberately misstating the facts, or he is out of touch with the Cancer Therapy Evaluation Program that he runs

Dr. Klausner, I request that you immediately withdraw the “fact sheet” the NCI is distributing which contains numerous and outrageous misstatements and distortion of fact

Thank you for your attention to this matter

SRB/cf

cc:

3+ pgs cc:
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1993 (11/2/1993) – Dr. Michael Friedman to Burzynski
1994 (2/17/1994) – NCI “fact sheet”
1994 (3/23/1994) – Dr. Mario Sznol to Burzynski
1994 (4/19/1994) – Burzynski to Dr. Mario Sznol
1995 (1/31/1995) – Dr. John L. Lewis
1995 (4/3/1995) – Dr. Mario Sznol to Burzynski
1995 (8/18/1995) –
1995 (8/23/1995) – Robert B. Lanman to Burzynski
1995 (9/19/1995) – Dr. Michael A. Friedman to Burzynski
1995 (10/5/1995) – Robert B. Lanman to Burzynski
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[23] – 1995 (10/5/1995) – Robert B. Lanman to Burzynski (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/
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[23] – 1995 (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 1 page letter to Richard A. Jaffe, Esq.

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

We have reviewed the protocols and have not found any such commitment

Moreover, it is not the practice of the National Cancer Institute (NCI) to obtain individual patient records from Principal Investigators

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

However, without the consent of the patient or the next of kin in the event that the patient is deceased, we cannot release these records

See 45 CFR S 5b.9.

Given that you apparently have already obtained at least one of the patient’s records, we fail to understand why you are pursuing this matter

cc:

D. Parkinson, M.D.
M. McCabe, R.N.
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1995 (10/5/1995) – Robert B. Lanman to Richard A. Jaffe [19]
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[22] – 1995 (9/19/1995) – Dr. Michael A. Friedman to Burzynski (2 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/
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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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[21] – 1995 (8/23/1995) – Robert B. Lanman to Burzynski (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/
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[21] – 1995 (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 1 page letter to Richard A. Jaffe, Esq.

This is in response to the issues raised in your 7/21/1995 letter

First, you raised questions as to how clinical trials of antineoplastons could proceed absent Dr. Burzynski’s concurrence

Although NCI clearly prefers to conduct or sponsor studies with permission of such an individual is not required

In the present case, even assuming that the clinical trials involved some of Dr. Burzynski’s patented products or processes, the use of antineoplastons would be permissible under the research exemption

However, in light of the recent decision to close the studies at the Mayo Clinic and Memorial Sloan-Kettering, conveyed to Dr. Burzynski in a letter from Dr. Michael A. Friedman dated 8/18/1995, these issues now seem moot

In addition, 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

Finally, we are not aware of any “committee” investigating Dr. Burzynski’s allegations regarding the protocols

cc:

M. Friedman, M.D.
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1995 (8/23/1995) – Robert B. Lanman to Richard A. Jaffe [17]
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[15] – 1995 (4/3/1995) – Dr. Mario Sznol to Burzynski

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/
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[15] – 1995 (4/3/1995) – Dr. Mario Sznol to Burzynski
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Department of Health and Human Services, Public Health Services, National Institutes of Health, National Cancer Institutes

Dear Dr. Burzynski,

Dr. Friedman asked me to respond to your letter of 3/29/1995 regarding the change we have been considering in eligibility criteria for the Memorial Sloan-Kettering and Mayo Clinic phase II studies of antineoplastons

At the investigator’s request, the amendments to modify the eligibility restrictions for size of tumor, number of tumors, and leptomeningeal spread, and to allow entry of patients with KPS of 60, have been approved

These amendments were initiated by the investigators when it became apparent that many good candidates for the study were being excluded because of what were perceived to be overly stringent and unnecessary eligibility restrictions

Approximately a year ago, we wrote to you asking for your concurrence to make similar changes to the protocol

(see enclosed letter)

We have documented that the revised eligibility criteria are consistent with those used in your very own protocols that employ identical or nearly identical treatment regimens

Furthermore, in a review of the 7 patients in the best case series presented to NCI, we have found that perhaps 4 of the 7 patients who apparently had tumor shrinkage would not have been eligible to enter the NCI phase II studies under the original stringent eligibility criteria

(see attached)

These types of patients will now be eligible for study using the revised eligibility criteria proposed by the investigators and recently approved by CTEP

Despite the difficulties in accrual, we are committed to completing the phase II evaluation of the antineoplastons

Our goals remain unchanged, that is, we wish to determine whether the drugs used in the similar manner as you recommend, and in the similar population of patients, will yield results consistent with those in the best case series

As noted above, our careful evaluation of the materials you have provided indicate that the amendments to the eligibility criteria do not deviate from the eligibility criteria and methods you have employed in your experience

We would appreciate the opportunity to review your data, alluded to in your letter, that support the contention that inclusion of theses patients requires a different treatment regimen or is unsafe

In the meantime, we will allow the amendments to stand, since all evidence you have provided to date indicates that these newly eligible patients may have a chance for benefit without undue risk of harm, and are appropriate candidates for evaluation of the drug

We will forward the data on the 1st 5 patients in a separate mailing as you requested

Pg. 2

However, you have asked that we suspend accrual while you review the data

There is no medical or regulatory reason to suspend accrual at this time

Suspending accrual will likely further damage the efforts the investigators have made to increase accrual to the trial

Mario Sznol, M.D.

cc:

Dottie Tisevich
Michael Friedman, M.D.
Mary McCabe
Office of Alternative Medicine

Pg. 3

Antineoplaston Cases

1. Histology partial lobe glioblastoma multiforme
Size 2.3 cm largest diameter
Response CR possible
prior Tx RT, surgery

2. Histology anaplastic astrocytoma stage IV grade 3
Size 3.0 tumor 3.5 tumor and edema
Response CR possible
prior Tx RT

3. Histology infiltrating glioma (astrocytoma or mixed astrocytoma / oligodendroglioma)
Size 4.4
Response good PR, possible CR
prior Tx RT and BUdR; Procarbazine, CCNU, VCR; B-Interferon; DFMO and MGBG

4. Histology well differentiated Stage IV astrocytoma, possible juvenile pilocytic astrocytoma
Size 5.5 X 3.3
Response 40-50% decrease of solid component
prior Tx vitamins and laetrile

5. Histology glioblastoma multiforme
Size 6.5 x 5.0
Response 39% decrease
prior Tx RT

6. Histology glioma consistent with anaplastic astrocytoma, differential: anaplastic astrocytoma or spindle cell variant of oligodendroglioma
Size 5.1 x 2.2
Response CR
prior Tx RT

7. Histology Infiltrating anaplastic astrocytoma
Size 4.0 (L) 4.8 (bifrontal)
Response good response – possible CR
prior Tx RT
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1995 (4/3/1995) – Dr. Michael A. Friedman to Burzynski [16]
1995 (4/3/1995) – Dr. Mario Sznol to Burzynski [21] (3 pgs.)
1995 (3/29/1995) – Burzynski to Dr. Michael A. Friedman
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[14] – 1995 (3/29/1995) – Burzynski to Dr. Michael A. Friedman (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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[14] – 1995 (3/29/1995) – Burzynski to Dr. Michael A. Friedman (2 pgs.)
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Michael A. Friedman, M.D., Associate Director,Cancer Therapy Evaluation Program, Division of Cancer Treatment, NCI, National Institutes of Health

Dear Dr. Friedman,

It has been brought to my attention that the protocol

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

has been amended to accept patients with tumors measuring over 5 cm in diameter, multiple tumors, or with leptomeningeal or systemic metastases

Another change involves lowering of the Karnofsky Performance Status score to 60%

You assured me in your letter of 11/2/1993 that

“The dose and schedule will be modified exactly as you require”

and

“The eligibility criteria will be modified to accept only patients with Karnofsky Performance Status of 70% – 100%

I am outraged that without my knowledge Memorial Sloan-Kettering Cancer Center with NCI’s permission changed the protocol

Treatment of patients with tumors larger than 5 cm, with multiple tumors, and leptomeningeal spread or distant metastases will require a different protocol with a different schedule and different dosages

the use of the existing protocol for such very advanced brain tumor patients will only expose them to unnecessary risks without giving them substantial benefit

I hereby request that the amendments described above be cancelled immediately and the original protocol be used for the treatment as promised in your letter of 11/2/1993

We will be glad to propose a different protocol for patients with larger and multiple tumors and meningeal involvement

In addition, the procedure we agreed upon calls for a thorough review by us of the 1st 5 patients as soon as they are accrued

Your last annual report indicates

Pg. 2

that you had accrued that number of patients 6 months ago

As a result, the review of data is long overdue

Please send us the complete records of the 1st 5 patients so that we may review them as specified

Please do not accrue any more patients until this data has been sent and our review completed

SRB/cf

cc:

Dr. Jan Bruckner
Dr. Michael C. Christian
Dr. Jay Greenblatt
Dr. Mark Malkin
Ms. Mary McCabe
Dr. David Parkinson
Dr. Mario Sznol
Ms. Dorothy Tisevich
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1993 (11/2/1993) – Dr. Michael A. Friedman to Burzynski
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[12] – 1994 (4/19/1994) – Burzynski to Dr. Mario Sznol [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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[12] – 1994 (4/19/1994) – Burzynski to Dr. Mario Sznol [2 Pgs.]
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Mario Sznol, M.D., Head, Biologics Evaluation Section, Investigational Drug Branch, CTEP, DCT, National Cancer Institute

Dear Dr. Sznol,

I am glad to learn from your letter of 3/23/1994 that some patients have already been enrolled in the NCI-sponsored trials of Antineoplastons and there is a strong interest of the NCI and the Investigators to broaden the study

While I think that, ultimately, Antineoplastons would prove useful in the treatment of more advanced cases of malignant brain tumors, I think that to expand the trials now through admission of such difficult cases is premature

The 1st stage of the studies which are currently in progress should be completed in order to have the most accurate preliminary evaluation of anticancer activity

I sincerely hope that the Investigators conducting the study will report good results in the treatment of at least some of the initial 15 patients involved in stage I

However, if the reverse is true, then it won’t make any sense to conduct trials in very advanced cases if less advanced cases do not respond

I would expect that there would be a significant difference in response between the patients admitted under current acceptance criteria and the expanded eligibility criteria proposed in your letter of 3/23/1994

Therefore, I think that such patients should be involved in a separate trial for large and multifocal tumors, and treated and evaluated according to a modified protocol

SRB/cf

cc:

David Parkinson, M.D.
Mike Friedman, M.D.
Dale Shoemaker, Ph.D.
Jay Greenblatt, Ph.D.
Dean Mouscher, BRI
Mary McCabe, R.N.
Samuel Broder, M.D.
Bruce Chabner, M.D.
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1994 (3/23/1994) – Dr. Mario Sznol to Burzynski
1994 (4/19/1994) – Burzynski to Dr. Mario Sznol [20] (2 pgs.)
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[11] – 1994 (3/23/1994) – Dr. Mario Sznol 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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[11] – 1994 (3/23/1994) – Dr. Mario Sznol to Burzynski [2 pgs.]
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Department of Health and Human Services, Public Health Services, National Institutes of Health, National Cancer Institutes

Dear Dr. Burzynski,

As you know, the NCI-sponsored trials of antineoplastons have been initiated and some patients have been enrolled

However, a great many more have sought access to the trial but have not been allowed to participate because of their inability to meet all the eligibility criteria

Because of this, there is strong interest on our part and that of the investigators to broaden the eligibility criteria

While we recognize the need for and value of clear eligibility criteria, we believe that the protocol now excludes some patients who would otherwise be good candidates for the trial

Specifically, we would propose the following changes in the eligibility criteria:

1. Change the allowable Karnofsky performance status from 70 to 60, as originally written in the protocol

2. Change the exclusion for size of tumor from greater than 5 cm to greater than 8 cm

3. Drop the exclusion for multifocal tumors or leptomeningeal spread

By keeping the performance status score at 60 as a requirement for entry, we believe that the protocol will still be safe for patients, and the drug will get a fair test for antitumor efficacy

We have noted that your protocols for adults (copies of which you have provided to CTEP) have similar eligibility criteria to those proposed above (ie, KPS of 60 required and no exclusion for size of tumor, multifocal tumor, or leptomeningeal spread)

We have also noted that some patients eligible for treatment on NCI-sponsored protocols appear to have been told by your staff that they could receive the antineoplastons at your institute

They have asked us the obvious question, that is, if you have enough evidence of efficacy to offer the antineoplastons as treatment to those patients, why is it that they would not be good candidates for a protocol attempting to determine and confirm the antitumor activity of the agent?

We would appreciate any help you might give us in responding to these inquiries

Pg. 2

Mario Sznol, M.D., Head, Biologics Evaluation Section, Investigational Drug Branch,Cancer Therapy Evaluation Program, Division of Cancer Treatment,
National Cancer Institute

cc:

David Parkinson, M.D.
Mike Friedman, M.D.
Dale Shoemaker, Ph.D.
Jay Greenblatt, Ph.D.
Dean Mouscher, BRI
Mary McCabe
Samuel Broder, M.D.
Bruce Chabner, M.D.
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1994 (3/23/1994) – Dr. Mario Sznol to Burzynski [20] (2 pgs.)
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[9] – 1993 (11/2/1993) – Dr. Michael A. Friedman to Burzynski

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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[9] – 1993 (11/2/1993) – 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), Public Health Services, National Institutes of Health (NIH) to Burzynski [3 pgs.]

Department of Health and Human Services, Public Health Services, National Institutes of Health

Dear Dr. Burzynski:

With regard to your letter of 10/26/1993, you specifically state

“The medicine will be sent to you immediately once you make the corrections to the protocol that we have requested”

We have substantial factual disagreements and scientific reservations with many of the comments made in your 10/26/1993 letter, including your preposterous claim that the NCI wasted 8 months

Nonetheless, we will accede to all the modifications that you have stipulated

We do so because we are committed to beginning the clinical studies as quickly as possible

We presume that these are your final comments, since all the changes will have been made and we will have addressed all of your concerns regarding these studies

The revised protocol will be sent to you as soon as it is received from the investigators

Based on the promise in your letter, we expect that the drug will be shipped to the NCI repository the next day

The changes to made to the protocol are as follows:

1. The dose and schedule will be modified as exactly as your require

We believe this to be the dose and schedule found in your protocol BT6, with dose escalation and maximum dose guidelines for adults clarified in your letter of 10/13/1993

2. The Memorial study, as written, has 2 separate components, one for patients with glioblastoma multiforme and one for patients with anaplastic astrocytoma

Accrual to each stratum proceeds independently, and analyses of each stratum is separate

However, we will ask the investigators from Mayo Clinic to join the Memorial study, rather than conducting an independent trial

This will effectively evaluate on the one hand patients with glioblastoma multiforme, and on the other hands those with anaplastic astrocytoma

Pg. 2

Patients with either disease will be enrolled at both Memorial and Mayo sites

This modification has 2 advantages — it limits total accrual to 35 patients per histology, as you request; and it accelerates accrual, since each institution can enter both types of patients on the studies

3. As you stipulated, Fleming’s original statistical design will be used utilized
15 patients will be entered independently to each stratum; for each stratum, if there is 1 response, accrual will proceed to a total of 35 patients

Thus total accrual will be 70 patients if both strata proceed past the 1st stage

(the initial 15 patients per histology)

4. According to your wishes, all scans for tumor measurements and laboratory test will be performed within 7 days of initiating protocol therapy, rather than the standard 14 days now specified in the protocol

5. The eligibility criteria will be modified to accept only patients with a Karnofsky performance status of 70-100%

6. As you require, the protocol response criteria will be based on objective tumor measurements and will not include assessment of neurologic status

Neurologic status will be evaluated separately

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

This should be sufficient to assure that the conduct of the study is satisfactory

The Theradex database is also available to precisely determine if the conduct of the study has followed protocol guidelines; the study centers will also be audited on-site by Theradex (independent contractors) every 3 months

In your letter you express concern regarding what you perceive to be bias against alternative treatments by Mayo Clinic and Memorial investigators

Please note that the investigators participating in the antineoplaston studies volunteered to do so because of the findings of the NCI review of your best case series

To my knowledge none of the participating investigators have expressed (publicly or privately) a position for or against Antineoplastons

Both institutions have a distinguished record in clinical investigations, and have been leaders in subjecting all treatments (including alternative interventions) to fair and objective clinical research

We are confident that credible clinical studies will be conducted

Pg. 3

Finally, if even after modifying these studies in accordance with your stated wishes, you are unwilling to supply the antineoplaston materials, please inform me as quickly as possible

We will then seek alternative sources of this family of molecules for proper clinical evaluation

Michael A. Friedman, M.D., Associate Director, Cancer Therapy Evaluation Program, Division of Cancer Treatment, NCI

cc:

Dr. Samuel Broder
Dr. Jan Bruckner
Dr. Bruce Chabner
Dr. Jay Greenblatt
Dr. Joseph Jacobs
Dr. Mark Malkin
Ms. Mary McCabe
Dr. David Parkinson
Dr. Mario Sznol
Ms. Dorothy Tisevich
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1993 (11/2/1993) – Dr. Michael A. Friedman to SRB [9]
1993 (11/2/1993) – Dr. Michael A. Friedman to Burzynski [14]
1993 (11/2/1993) – Dr. Michael A. Friedman to SRB [19] (3 pgs.)
1993 (11/2/1993) – Dr. Michael A. Friedman to Burzynski [24]
1993 (10/13/1993) – Burzynski to Dr. Michael A. Friedman
1993 (10/26/1993) – Burzynski to Dr. Michael A. Friedman
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