Thursday, February 23, 2012

Raw Report: The Burzynski Clinic, The Burzynski Research Institute and the Southern Family Pharmacy Investigative Report

Grab the formatted, linked PDF here: http://pdfcast.org/pdf/the-burzynski-clinic

Thanks to the Clinical Trial Gurus: http://theclinicaltrialsguru.com/
________________________________________________________________________________

Sara Elizabeth Siegler

One Daisy Lane, Pepper Pike, OH 44124

sara.siegler@gmail.com P: 216/870-9188 F: 216/831-9398

https://sites.google.com/site/saraelizabethsiegler/

________________

Date of Publication: February 13, 2012

________________

The Burzynski Clinic, The Burzynski Research Institute and the Southern Family Pharmacy Investigative Report

By: Sara Elizabeth Siegler and Adam Capps[1]

________________

TABLE OF CONTENTS

I. INTRODUCTION

A. The Burzynski Clinic

B. The Burzynski Research Institute, Inc.

C. The Southern Family Pharmacy, Inc.

II. FACTS

A. Antineoplastons

B. Previous Litigation/Complaints/Investigations/News Releases/Warnings Involving Burzynski, et al.

C. Burzynski’s Publications

D. Expanded Access Statutes

E. Informed Consent Statutes

III. QUESTIONS/ISSUES PRESENTED FOR CERTIORARI

A. Possible Legal Issues

IV. CONCLUSION/CORRECTIVE ACTIONS

________________

A. The Burzynski Clinic:[2] http://www.burzynskiclinic.com/

The Burzynski Clinic (9432 Katy Road, Suite 200, Houston, TX 77055) is the clinic of Stanislaw R. Burzynski, M.D., D.Msc. [3],[4],[5] located in Houston, Texas, which is registered to conduct business within the state of Texas.

B. The Burzynski Research Institute, Inc.: [6],[7]http://www.burzynskiresearch.com/index.html

The Burzynski Research Institute, Inc. (9432 Katy Road, Suite 200, Houston, TX 77055) is the Delaware corporation of Stanislaw R. Burzynski, M.D., D.Msc., which is registered to conduct business in Texas, located in Houston, Texas.

The results of the operations of the Burzynski Research Institute, Inc. are summarized as follows:[8]

Research and development costs were approximately $4,780,000 and $4,480,000 for the fiscal years ended February 28, 2011 and 2010, respectively. The increase of $300,000 or 7% was due to an increase in personnel cost of $395,000, an increase in consulting and quality control costs of $28,000, and an increase in other research and development costs of $8,000, offset by a decrease in material costs of $101,000 and a decrease in facility and equipment costs of $30,000.

General and administrative expenses were approximately $250,000 and $349,000 for the fiscal years ended February 28, 2011 and 2010, respectively. The decrease of $99,000 or 28% was due to a decrease in legal and professional fees of $56,000, and a decrease in other general and administrative expenses of $43,000.

The Company had net losses of approximately $5,031,000 and $4,831,000 for the fiscal years ended February 28, 2011 and 2010, respectively. The increase in the net loss from 2010 to 2011 was primarily due to an overall increase in research and development cost offset by an overall decrease in general and administrative expenses of the Company described above. As of February 28, 2011, the Company had a total stockholders’ deficit of $(51,000).

The directors and executive officers of The Burzynski Research Institute, Inc. are provided in the following table pursuant to SEC filings:[9]

Name

Age

Office

Stanislaw R. Burzynski, M.D., D.Msc.[10]

68

Director, President, Secretary, and Treasurer

Barbara Burzynski, M.D.

70

Director

Michael H. Driscoll, J.D.

65

Director

Carlton Hazlewood, Ph.D.

75

Director

The Burzynski Research Institute utilizes its own internal Institutional Review Board, hereinafter “IRB,” to oversee the research. A 2009 warning letter from the federal Food and Drug Administration, hereinafter “FDA,” issued to the Burzynski Research Institute concluded that “the IRB did not adhere to the applicable statutory requirements and FDA regulations governing the protection of human subjects.”[11]

The Burzynski Research Institute reported the following research and development costs as well as net losses pursuant to Security and Exchange Commission, hereinafter “SEC,” filings:[12]

Research and development costs for the fiscal year that ended February 28, 2011

$4,780,000.00

Research and development costs for the fiscal year that ended February 28, 2010

$4,480,000.00

Net loss for the fiscal year that ended February 28, 2011

$5,031,000.00

Net loss for the fiscal year that ended February 28, 2010

$4,831,000.00

C. The Southern Family Pharmacy, Inc.:[13]

The Southern Family Pharmacy, Inc. (12707 Trinity Drive, Stafford, TX 77477) is the pharmacy owned by Stanislaw R. Burzynski, M.D., D.Msc.

II. FACTS

A. Antineoplastons (“ANP”) [14],[15],[16],[17],[18],[19],[20]

Antineoplastons,[21] or the group of chemical compounds and mixtures used by Stanislaw R. Burzynski, M.D., D.Msc. for which he claims anti-cancer activity,[22] are not approved by the federal FDA for the treatment or prevention of any disease.[23]

A table classifying antineoplastons, of which the first eight are or have been utilized by Burzynski, follows:[24]

Antineoplaston

Comments

A-1

Fraction derived from human urine

A-2

Fraction derived from human urine; antineoplaston from which antineoplaston A-10 is derived

A-3

Fraction derived from human urine

A-4

Fraction derived from human urine

A-5

Fraction derived from human urine

A-10[25]

3-N-phenylacetylamino piperidine 2,6-dione (“PAPD”) treated with alkali to make it soluble, although its solubility is debatable, that is not normally found in human urine; Burzynski’s so-called “anti-cancer” peptide that is derived from antineoplaston A-2;[26] A-10 is one component of Burzynski’s “current treatment regimen;” C13H14N2 O3

A.S.-2.5

Phenylacetyl glutamine (“PAG”) that is excreted in human urine; a soluble product created by treating A-10 with alkali

A.S.-2.1

A naturally occurring mixture of phenylacetic acid (“PA”) and phenylacetyl glutamine (“PAG”); a product created by treating with A.S.-2.5 with alkali; A.S.-2.1 is the second component of Burzynski’s “current treatment regimen”

Bextarotene (Targretin)[27]

4-[1-(3,5,5,8,8-pentamethyltetralin-2-yl)ethenyl]

benzoic acid; antineoplaston, which is not one of Buzynski’s 8 antineoplastons, that has been shown to reverse Alzheimers in murine models; [28],[29],[30],[31] C24H28O2 ; M.F. U.S. Patent 5,780,676 (1998)[32]

The American Cancer Society provides the following antineoplaston information:[33]

Antineoplastons are given orally or by injection into a vein. The duration of treatment usually ranges from eight to twelve months. A year of treatment can cost from $30,000 to $60,000, depending on the type of treatment, number of consultations, and the need for surgery to implant a catheter for drug delivery.

Antineoplaston therapy was developed by Stanislaw Burzynski, MD, PhD. Initial treatments are given over the course of one to three weeks at a clinic in Houston, founded by Dr. Burzynski. (Other U.S. centers are participating in studies to evaluate this treatment, as well as some centers in other countries.) Further treatments may be given "at home," but require monthly visits to a doctor, either at the Houston clinic or elsewhere with one of Dr. Burzynski's research colleagues. In the past, many of the patients who received antineoplaston treatment also were treated with surgery, radiation, chemotherapy, or combinations of these standard treatments at other centers, and some received chemotherapy prescribed by Dr. Burzynski. Currently, antineoplaston treatment is available in the United States only through participation in clinical trials led by Dr. Burzynski and his colleagues. To be eligible for these clinical studies, patients must have cancer that is growing despite conventional treatments. Patients cannot receive conventional anticancer treatments while they are participating in these antineoplaston studies.

The active components of antineoplastons, as are currently administered by The Burzynski Clinic, are actually known pharmacological compounds. That is, they are licensed drugs called [sodium] phenylbutyrate,[34] which is sold as Buphenyl[35],[36] in the US and Ammonaps[37],[38] in the UK, as well as phenylacetate,[39] which is sold as Ammonul[40] in both the US and the UK.

A chemical called phenylacetylglutamine is also given as a component of antineoplastons. This is essentially a breakdown product but does not appear to have any biological efficacy. Quoting Wikipedia,[41]

Phenylacetylglutamine is a product formed by the conjugation of phenylacetate and glutamine. It is a common metabolite that can be found in human urine.

The presumable application for phenylacetylglutamine within the context of antineoplastons is that it may function as a replacement for urea in terms of its role as a vehicle for waste nitrogen excretion.[42]

Burzynski, et al.[43] describes the mechanism of action of antineoplastons as follows:[44]

Phenylacetic acid (PN; the active ingredient of Antineoplaston AS2-1) inhibits farnesylation of protein p21 of the RAS oncogene, inhibits RAS and BCL-2, and activates the tumor suppressor genes TP53 and p21 through demethylation of their promoters.

Phenylacetylglutamine (PG; the main ingredient of Antineoplaston A10 I) restores global methylation of DNA, inhibits the oncogenes AKT2 and MYCC, activates the tumor suppressor genes PTEN and MAD, and restores activity of the mutated INI1 protein through normalization of nuclear transport.

Both PN and PG promote apoptosis: PN through inhibition of BCL-2 and PG through deamidation of the BCL-XL protein.

As was set forth in the foregoing antineoplaston table, Burzynski’s current “treatment regimen” involves antineoplaston A-10 and antineoplaston A.S.-2.1,[45] but the drug company Sigma-Tau Pharmaceuticals could not duplicate the claims made by Burzynski for antineoplaston A.S.-2.1 and antineoplaston A-10.[46]

According to the National Cancer Institute, hereinafter “NCI,” as of February 10, 2012, there are 42 closed clinical trials involving antineoplaston A-10 and antineoplaston A.S.-2.1,[47] and there are 11 active antineoplaston A-10 and antineoplaston A.S.-2.1 cancer clinical trials.[48] Also as of February 10, 2012, clinicaltrials.gov listed 61 antineoplaston clinical trials,[49] and of said 61 trials, 11 were listed as open, not yet recruiting or unknown status, which means that the status of the protocol has not been verified in more than two years.[50],[51]

Pursuant to SEC filings, The Burzynski Research Institute, Inc. conducts Phase II and Phase III clinical trials, which are sponsored by The Burzynski Research Institute, using antineoplaston A-10 and antineoplaston A.S.-2.1 in addition to conducting antineoplaston laboratory research.[52] Orphan drug status, which allows for expedited clinical trials for neglected disease, under the Orphan Drug Act of 1983 was awarded to antineoplastons on September 7, 2004.[53]

Burzynski’s Phase II antineoplaston clinical trials that are reported as completed as of May 1, 2011 are as follows:[54]

Protocol Number

Title

Number of Enrolled Patients

Number of Evaluable Patients

BT-07

Study of antineoplastons A-10 and A.S.-2.1 in patients with glioblastoma multiforme, not treated with radiation therapy or chemotherapy

40

24

BT-08

Study of antineoplastons A-10 and A.S.-2.1 in patients with anaplastic astrocytoma

19

14

BT-09

Study of antineoplastons A-10 and A.S.-2.1 in patients with brain tumors

40

26

BT-11

Study of antineoplastons A-10 and A.S.-2.1 in patients with brainstem glioma

40

28

BT-12

Study of antineoplastons A-10 and A.S.-2.1 in children with primitive neuroectodermal tumors

13

11

BT-13

Study of antineoplastons A-10 and A.S.-2.1 in children with low grade astrocytoma

11

9

BT-15

Study of antineoplastons A-10 and A.S.-2.1 in adults with anaplastic astrocytoma

27

20

BT-18

Study of antineoplastons A-10 and A.S.-2.1 in treatment of “mixed glioma”

20

13

BT-20

Study of antineoplastons A-10 and A.S.-2.1 in patients with gliobastoma multiforme, which recurred after standard radiation and/or chemotherapy

40

22

BT-21

Study of antineoplastons A-10 and A.S.-2.1 in adults with primary malignant brain tumors

40

23

BT-23

Study of antineoplastons A-10 and A.S.-2.1 in children with visual pathway glioma

12

8

Burzynski’s Phase II antineoplaston clinical trials that are open to patient enrollment are as follows:[55]

Protocol Number

Title

Number of Enrolled Patients as of May 1, 2011

BT-10

Children with brain tumors

25

BT-22

Children with primary malignant brain tumors

7

Pursuant to SEC filings, The Burzynski Research Institute in agreement with Cycle Solutions, Inc. has plans to conduct a Phase III trial comparing antineoplaston therapy alone to antineoplaston therapy in conjunction with radiation therapy in patients with diffuse, intrinsic brainstem glioma.[56]

Burzynski claims, pursuant to SEC filings, to have developed a total of 12 antineoplastons, and of said twelve antineoplastons, six formulations are of natural antineoplastons and six formulations are of synthetic antineoplastons.[57] Naturally occurring substances do not constitute patentable subject matter under Title 35 of the United States Code. Association for Molecular Pathology v. U.S. Patent and Trademark Office, No. 09-cv-4515, 94 USPQ2d 1683 (S.D.N.Y. March 29, 2010).[58] [59] Methods of production, however, may be patentable, and Burzynski has obtained a patent on a method for sodium phenylbutyrate production. [60], [61]

The Burzynski Research Institute holds eight patents in the United States, of which three are active, 4 Canadian patents as well as one Mexican patent. The eight aforementioned American patents of the The Burzynski Research Institute are as follows pursuant to SEC filings:[62]

Patent Details

Comments

Determination of antineoplastons in body tissue or fluid as a cancer diagnostic procedure

Expired

Processes for antineoplaston purified fraction preparation from human urine

Expired

Processes for the production of synthetic antineoplastons and methods of treating neoplastic disease

Expired

Antineoplaston administration to humans

Expired

Methods for antineoplaston A-10 synthesis

Expired January 11, 2009

Liposomal antineoplaston therapies

Expires May 14, 2017

Treatment regimen for the administration of phenylacetylgluatamine, phenylacetylisoglutamine and/or phenylacetate

Expires July 23, 2018

Division application - treatment regimen for the administration of phenylacetylgluatamine, phenylacetylisoglutamine and/or phenylacetate

Expires July 31, 2018

B. Previous Litigation/Complaints/Investigations/News Releases/Warnings Involving Burzynski, et al.:[63]

Case Citation

Link

United States Congressional Office of Technology Assessment (OTA) Investigation of Burzynski’s Antineoplaston Patients (1980s)[64]

See Chapter 5: http://www.cancertreatmentwatch.org/reports/ota.pdf[65]

United States of America v. Burzynski Cancer Research Institute, et al. (5th Cir. 1987) 819 F.2d 1301

http://law.justia.com/cases/federal/appellate-courts/F2/819/1301/245292/

Burzynski, et al. v. Aetna Life Insurance Company, et al. (5th Cir. 1992) 967 F.2d 1063

www.ca5.uscourts.gov/opinions%5Cpub%5C91/91-2385.0.wpd.pdf

In re Stanislaw R. Burzynski, M.D., and Burzynski Research

Institute Inc. (5th Cir. 1993) 989 F.2d 733

http://openjurist.org/989/f2d/733/in-re-stanislaw-r-burzynski

Trustees of the Northwest Laundry v. Burzynski (5th Cir. 1994) 27 F.3d 153, 155

ftp://www.ca5.uscourts.gov/pub/93/93-02071.CV0.wpd.pdf

Texas Medical Board Complaint (Docket Number 503-92-529; 1994)

http://www.casewatch.org/board/med/burzynski/order_1994.pdf

Limits Placed on Burzynski's Cancer Treatment from the Texas Attorney General's Office (News Release, February 10, 1998)

http://www.quackwatch.org/04ConsumerEducation/News/burzynski.html

Texas Medical Board Complaint (SOAH Docket Number 503-11-1669)

http://www.ministryoftruth.me.uk/wp-content/uploads/2011/11/tmbvsburzynski.pdf

FDA Warning Letter to Stanislaw R. Burzynski, M.D. (October 5, 2009) - Burzynski Research Institute and Institutional Review Board (“IRB”)

http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/ucm192711.htm

Quinlin v. Burzynski, et al. (Docket Number 2012-03429; Texas District Court - Harris County)

http://www.courthousenews.com/2012/01/19/Cancer.pdf

The following conclusion was presented within chapter 5 of the aforementioned OTA report with regard to Burzynski and his antineoplastons:[66]

Unfortunately, despite a substantial number of preliminary clinical studies presented by Burzynski and his associates describing outcomes among the patients he treated with Antineoplastons, and an attempt at a "best case" review, there is still a lack of valid information to judge whether this treatment is likely to be beneficial to cancer patients. Thus far, prospective, controlled clinical studies of Antineoplastons, which could yield valid information on efficacy, have not been conducted.

The limits placed on the research and “treatment” administered by Burzynski from the Texas Attorney General's Office’s news release dated February 10, 1998[67] are as follows:

1. Burzynski cannot distribute unapproved drugs in Texas;

2. Burzynski can distribute "antineoplastons" only to patients enrolled in FDA approved clinical trials, unless or until FDA approves his drugs for sale;

3. Burzynski cannot advertise "antineoplastons" for the treatment of cancer;

4. Burzynski must place a disclaimer to his website, promotional material and ads stating that the safety and effectiveness of "antineoplastons" have not been established.

The claims against Burzynski, et al. taken from the complaint document[68] from the pending Quinlin v. Burzynski, et al. (Docket Number 2012-03429; Texas District Court - Harris County) case, which is pending, are as follows:

1. Negligence;

2. Negligent misrepresntation;

3. Fraud;

4. Deceptive Trade Practices Act (“DTPA”) Violation;

5. Conspiracy;

6. Respondeat Superior [Tort];

7. Alter Ego.

C. Burzynski’s Publications

The Burzynski Clinic website[69] provides the following publications of Burzynski, et al.:

Citation

Link

Comments

Available via PubMed?

PubMed Link

Burzynski, S.R, Weaver, R.A., Janicki, T.J., Burzynski, G.S., Szymkowski, B., Acelar, S.S. OT-15. Preliminary results of a phase II study of antineoplastons A10 and AS2-1 (ANP) in adult patients with recurrent mixed gliomas. Neuro-Oncology 2010;12(Suppl. 4):iv72

Unable to Locate Following Preliminary Search

No

Patil, S., Burzynski, S.R, Mrowczynski, E., Grela, K. CB-15. Targeting microRNAs in glioma cells with antineoplastons. Neuro-Oncology 2010;12(Suppl. 4):iv10

Unable to Locate Following Preliminary Search

No

Burzynski, S.R, Weaver, R.A., Janicki, T., E, Szymkowski, B., Acelar, S.S., Burzynski, G.S. A phase II study of antineoplaston A10 and AS2-1 injections in children with low-grade astrocytomas. Neuro-Oncology 2010;12(6):ii95

http://www.burzynskiclinic.com/images/Pub_SRB_2004_Phase_II_study_of_ANP_A10_and_As2_1_in_children_with_multicentric_glioma.pdf

No

Patil, S., Burzynski, S.R, Mrowczynski, E., Grela, K. Antineoplastons initiate caspase induced apoptosis by suppressing survivin expression in U87 glioblastoma cells. Neuro-Oncology 2010;12(6):ii87

Unable to Locate Following Preliminary Search

No

Weaver, R.A., Szymkowski, B., Burzynski, S.R. Over a 10-year survival and complete response of a patient with diffuse intrinsic brainstem glioma (DBSG) treated with antineoplastons (ANP). Neuro-Oncology 2009;11:923

http://www.burzynskiclinic.com/images/Pub%20SRB_2007_Brainstem%20Glioma_%20Cancer%20Therapy.pdf

No

Burzynski, S.R., Janicki, T.J., Weaver, R.A., Szymkowski, B., Burzynski, G.S. Phase II study of antineoplastons A10 and AS2-1 in patients with brainstem glioma: Protocol BC-BT-11. Neuro-Oncology 2009;11:951

Unable to Locate Following Preliminary Search

No

Burzynski, S.R. The coming pandemic of liver cancer: In search of genomic solutions. In: American Academy of Anti-Aging Medicine (A4M) Anti-Aging Therapeutics, Volume XI;2009

http://www.aminocare.com/assets/pdf/The-coming-pandemic-of-liver-cancer-Volume-XI.pdf

No

Burzynski, S.R. Practical application of gene silencing theory of aging. Life extension in animal testing and human clinical trials. In: American Academy of Anti-Aging Medicine (A4M) Anti-Aging Therapeutics, Volume XI;2009

http://www.aminocare.com/assets/pdf/Practical-application-of-gene-silencing-Volume-XI.pdf

No

Patil, S., Burzynski, S., Chittur, S., Mrowczynski, E., Grela, K. The ingredients of antineoplaston AS2-1 down-regulate glycolysis pathways in glioblastoma cells. Neuro-Oncology 2008;10:1148.

No

Burzynski, S., Weaver, R., Janicki, T., Szymkowski, B., Burzynski, G. Phase II study of antineoplastons A10 and AS2-1 infusions (ANP) in patients with recurrent anaplastic astrocytoma. Neuro-Oncology 2008;10:1067

No

Patil, S., Burzynski, S., Chittur, S., Mrowczynski, E., Grela, K. Antineoplaston AS2-1 affects cell cycle checkpoints, leading to apoptosis in human glioblastoma cells. Neuro-Oncology 2008;10:786

No

Burzynski, S., Weaver, R., Janicki, T., Burzynski, G., Samuel, S., Szymkowski, B. Phase II study of antineoplastons A10 and AS2-1 (ANP) in patients with newly diagnosed anaplastic astrocytoma: A preliminary report. Neuro-Oncology 2008; 10:821

No

Burzynski, S.R., Weaver, R., Janicki, T., Walczak, M., Szymkowski, B., Samuel, S. Phase II study of antineoplastons A10 and AS2-1 (ANP) in children with optic pathway glioma: A preliminary report. Neuro-Oncology 2008;10:450

No

Burzynski, S.R. The genes of life. Farmapress Publishers, 2008

Unable to Locate Following Preliminary Search

No

Burzynski, S.R. Genomic approach to cancer treatment. In: American Academy of Anti-Aging Medicine (A4M) Anti-Aging Therapeutics, Volume X; 2008;37-44

http://www.aminocare.com/assets/pdf/The-Genetic-Approach-to-Cancer-Treatment-2008.pdf

No

Burzynski, S.R. Recent clinical trials in diffuse intrinsic brainstem glioma. Cancer Therapy 2007;5, 379-390

http://www.cancer-therapy.org/CT/v5/B/PDF/42._Burzynski,_379-390.pdf; http://www.burzynskiclinic.com/images/Pub%20SRB_2007_Brainstem%20Glioma_%20Cancer%20Therapy.pdf

No

Burzynski, S.R., Weaver, R., Szymkowski, B. A case report of a complete response and 20-year survival of a patient with a recurrent diffuse intrinsic brainstem anaplastic astrocytoma. Neuro-Oncology 2007;9:536

Unable to Locate Following Preliminary Search

No

Patil, S., Burzynski, S.R., Mrowczynski, E., Grela, K. Phenylacetylglutamine (PG) and phenylacetate (PN) interact additively to produce detachment-induced apoptosis/anoikis in glioblastoma cells. Neuro-Oncology 2007;9:482

Unable to Locate Following Preliminary Search

No

Burzynski, S.R. The Genetic Solution for Anti-Aging. In: American Academy of Anti-Aging Medicine (A4M) Anti-Aging Therapeutics, Volume IX; 2007;63-70

http://www.aminocare.com/assets/pdf/Publication_chapt%2010_AA%20Therapt%20Vol%20IX_2007.pdf

Questionable Peer Review Status

No

Burzynski, S.R. Genetics of Brain Aging (I). Gene Silencing in Neurons. In: American Academy of Anti-Aging Medicine (A4M) Anti-Aging Therapeutics, Volume IX; 2007;71-78

http://www.aminocare.com/assets/pdf/Publication_chapt%2011_AA%20Therapt%20Vol%20IX_2007.pdf

Questionable Peer Review Status

No

Burzynski, S.R. Genetics of Brain Aging (II). Genetic Mechanisms in Encoding and Consolidation of Memory. In: American Academy of Anti-Aging Medicine (A4M) Anti-Aging Therapeutics, Volume IX; 2007;79-88

http://www.aminocare.com/assets/pdf/Publication_chapt%2012_AA%20Therapt%20Vol%20IX_2007.pdf

Questionable Peer Review Status

No

Burzynski, S.R., Weaver, R.A., Janicki, T.J., Jurida, G.F., Szymkowski, B.G., Kubove, E. Phase II studies of Antineoplastons A10 and AS 2-1 (ANP) in children with newly diagnosed diffuse, intrinsic brainstem gliomas. Neuro-Oncology 2007;9:206

No

Burzynski, S.R. The breakthrough in therapy and prevention in medicine of 21st century (5). Genes and aging of the neurons. Geny a starzenie neuronow. Czasopismo Aptekarskie 2007; Nr 3 (159) 27-38

Unable to Locate Following Preliminary Search

No

Burzynski, S.R. The breakthrough in therapy and prevention in medicine of 21st century (4). Time factor in biology and medicine. Czynnik czasu w biologii i medycynie. Czasopismo Aptekarskie 2007; Nr 2 (158) 27-36

Unable to Locate Following Preliminary Search

No

Burzynski, S.R. The breakthrough in therapy and prevention in medicine of 21st century (3). The medicine of aging population. Medycyna starzejacego sie spoleczenstwa. Czasopismo Aptekarskie 2007; Nr 1 (157) 39-48

Unable to Locate Following Preliminary Search

No

Burzynski, S.R. Targeted Therapy for Brain Tumors. Columbus F, ed. Brain Cancer Therapy and Surgical Interventions. New York (NY); Nova Science Publishers, Inc. 2006;77-111

No

Burzynski, S.R. The breakthrough in therapy and prevention in medicine of 21st century (2). Epigenome and gene silencing. Epigenom i wyciszanie genow. Czasopismo Aptekarskie 2006;Nr 12 (156) 29-36

Unable to Locate Following Preliminary Search

No

Burzynski, S.R. The breakthrough in therapy and prevention in medicine of 21st century (1). The medicine of genome an epigenome. Medycyna genomu i epigenomu. Czasopismo Aptekarskie 2006;Nr 11 (155) 45-52

Unable to Locate Following Preliminary Search

No

Burzynski, S.R. Age Management Treatments Which Target Silenced Genes. Redberry GW, ed. Gene Silencing: New Research. Nova Science Publishers, Inc. 2006

Unable to Locate Following Preliminary Search

No

Burzynski, S.R., Janicki, T.J., Weaver, R.A., Szymkowski, B.G., Khan, M.I., Dolgopolov, V. Treatment of multicentric brainstem gliomas with antineoplastons (ANP) A10 and AS2-1. Neuro-Oncology. 2006;10:466

No

Burzynski, S.R., Weaver, R.A., Szymkowski, B., Janicki, T.J., Khan, M.I., Dolgopolov, V. Complete response of a diffuse intrinsic brainstem tumor and von Hippel Lindau (VHL) disease to antineoplastons A10 and AS2-1 (ANP): a case report. Neuro-Oncology. 2006;10:439

No

Burzynski, S.R. Treatments for Astrocytic Tumors in Children: Current and Emerging Strategies. Pediatric Drugs 2006;8:167-178

http://issuufree.com/drkandrew/docs/antineoplastons-for-astrocytic-tumours-pediatrics/1

Yes

http://www.ncbi.nlm.nih.gov/pubmed/16774296

Burzynski, S.R., Janicki, T.J., Weaver, R.A., Burzynski, B. Targeted therapy with Antineoplastons A10 and AS2-1 of high grade, recurrent, and progressive brainstem glioma. Integrative Cancer Therapies 2006; 5(1):40-47

http://www.ncbi.nlm.nih.gov/pubmed/16484713; http://www.burzynskiclinic.com/images/Pub_SRB_2006_Targeted_Therapy_with_ANP_of_high_grade_brainstem_glioma.pdf

Yes

http://www.ncbi.nlm.nih.gov/pubmed/16484713

Burzynski, S.R., Weaver, R.A., Janicki, T.J., Szymkowski, B.G., Jurida, G.F., Burzynski, B. Phase II studies of antineoplastons A10 and AS2-1 (ANP) in patients with recurrent, diffuse intrinsic brain stem gliomas. Neuro-Oncology 2006;10:346

http://lib.bioinfo.pl/pmid:12718563

Need to check link - does the date on the citation match that on the publication?

No

Burzynski, S.R. Master Clock of Life (II). How to Turn the Clock Back. In: American Academy of Anti-Aging Medicine. American Academy of Anti-Aging Medicine (A4M) Anti-Aging Therapeutics;Volume VIII 2006

http://www.aminocare.com/assets/pdf/Publication_Master%20Clock%20II_AA%20Therapt%20Vol%20VIII_2006.pdf

Questionable Peer Review Status

No

Burzynski, S.R. Master Clock of Life (I). "Junk DNA." and Promoters Regions as Major Components of the Clock. American Academy of Anti-Aging Medicine (A4M) Anti-Aging Therapeutics;Volume VIII 2006

http://www.aminocare.com/assets/pdf/Publication_Master%20Clock%20I_AA%20Therapt%20Vol%20VIII_2006.pdf

Questionable Peer Review Status

No

Burzynski, S. R. Gene silencing theory of aging: the clinical trial supporting the theory. Anti-Aging Therapeutics 2005;Vol VII:39-46

No

Burzynski, S.R., Weaver, R.A., Janicki, T.J., Burzynski, B., Jurida, G. Targeted therapy with ANP in children less than 4 years old with inoperable brain stem gliomas. Neuro-Oncology 2005;7:300

No

Weaver, R.A., Burzynski, S.R., Janicki, T.J., Burzynski, B., Jurida, G., Szymkowski, B. Long-term survival in patients with glioblastoma multiforme treated in phase II studies with ANP. Neuro-Oncology 2005;7:299

No

Burzynski, S.R., Weaver, R.A., Janicki, T., Szymkowski, B., Jurida, G., Khan, M., Dolgopolov, V. Long-term survival of high-risk pediatric patients with primitive neuroectodermal tumors treated with Antineoplastons A10 AS2-1. Integrative Cancer Therapies 2005;4(2):168-177

http://www.ncbi.nlm.nih.gov/pubmed/15911929

Yes

http://www.ncbi.nlm.nih.gov/pubmed/15911929

Burzynski, S.R. Aging: Gene silencing or gene activation? Med Hypoth 2005; 64, 201-208

http://www.aminocare.com/assets/pdf/Publication_Gene%20Silencing%20or%20Gene%20Activation_Med%20Hypoth%202005.pdf

Yes

http://www.ncbi.nlm.nih.gov/pubmed/15533642

Burzynski, S.R. Mechanizmy i profilaktyka genetycznego starzenia. Mechanisms and prevention of genetic aging. Neurologia I Psychiatria 2004;4:1-8

Unable to Locate Following Preliminary Search

No

Burzynski, S.R., Ilkowska-Musial, E., Klimczak M.W., Musial, L. Antineoplastons In Dairy Products. Journal of Applied Nutrition 2004;54;1-8

Unable to Locate Following Preliminary Search

No

Burzynski, S.R., Weaver, R. Bestak. M., Lewy, R.I., Janicki, T., Jurida, G., Szymkowski, B., Khan, M., Dolgopolov, V. Long-term survivals in phase II studies of Antineoplastons A10 and AS2-1 (ANP) in patients with diffuse intrinsic brain stem glioma. Neuro-Oncology 2004;6:386

No

Weaver, R.A., Burzynski, S.R., Bestak, M., Lewy, R.I., Janicki, T.J., Szymkowski, B., Jurida, G., Khan, M.I., Dolgopolov, V. Phase II study of Antineoplastons A10 and AS2-1 (ANP) in recurrent glioblastoma multiforme. Neuro-Oncology 2004;6:384

No

Burzynski, S.R., Weaver, R. Bestak. M., Janicki, T., Szymkowski, B., Jurida, G., Khan, M., Dolgopolov, V. Treatment of primitive neuroectodermal tumors (PNET) with antineoplastons A10 and AS2-1 (ANP). Preliminary results of phase II studies. Neuro-Oncology 2004;6:428

No

Burzynski, S.R., Weaver, R. Bestak. M., Janicki, T., Jurida, G., Szymkowski, B., Khan, M., Dolgopolov, V. Phase II studies of antineoplastons A10 and AS2-1 (ANP) in children with atypical teratoid/rhabdoid tumors (AT/RT) of the central nervous system. A preliminary report. Neuro-Oncology 2004;6:427

No

Burzynski, S.R., Lewy, R.I., Weaver, R., Janicki, T., Jurida, G., Khan, M., Larisma, C.B., Paszkowiak, J., Szymkowski, B. Long-term survival and complete response of a patient with recurrent diffuse intrinsic brain stem glioblastoma multiforme. Integrative Cancer Therapies 2004;3:257-261

http://www.ncbi.nlm.nih.gov/pubmed/15312271

Yes

http://www.ncbi.nlm.nih.gov/pubmed/15312271

Burzynski, S.R., Weaver, R., Lewy, R., Janicki, T. Jurida, G., Szymkowski, B., Khan, M., Bestak, M. Phase II study of antineoplaston A10 and AS2-1 in children with recurrent and progressive multicentric glioma. A Preliminary Report. Drugs R&D 2004;5(6):315-326

http://www.ncbi.nlm.nih.gov/pubmed/15563234

Yes

http://www.ncbi.nlm.nih.gov/pubmed/15563234

Burzynski, S.R. The Present State of Antineoplaston Research. Integrative Cancer Therapies 2004;3:47-58

http://www.burzynskiclinic.com/images/Pub_SRB_2004_Present_State_of_ANP_Research.pdf

Yes

http://www.ncbi.nlm.nih.gov/pubmed/15035876

Burzynski, S.R., Lewy, R.I., Weaver, R.A., Axler, M.L., Janicki, T.J., Jurida, G.F., Paszkowiak, J.K., Szymkowski, B.G., Khan, M.I., Bestak, M. Phase II Study of Antineoplastons A10 and AS2-1 in Patients with Recurrent Diffuse Intrinsic Brain Stem Glioma (Preliminary Report). Drugs in R&D 2003;4:91-101

http://www.ncbi.nlm.nih.gov/pubmed/12718563

Yes

http://www.ncbi.nlm.nih.gov/pubmed/12718563

Waldbillig R, Burzynski SR. Mechanism of action, uptake, and gene array studies on the antineoplastic agent phenylacetylglutamine (PG) in human glioma cells U-87. Neuro-Oncology 2003;10:309

No

Burzynski, S.R., Weaver, R.A., Bestak, M., Lewy, R.I., Janicki, T.J., Jurida, G.F., Paszkowiak, J.K., Szymkowski, B.G., Khan, M.I. Phase II study of Antineoplastons A10 and AS2-1 (ANP) in children with recurrent and progressive multicentric glioma. A preliminary report. Neuro-Oncology 2003;10:358

http://adisonline.com/drugsrd/Abstract/2004/05060/Phase_II_Study_of_Antineoplaston_A10_and_AS2_1_in.2.aspx

No

Burzynski, S.R. The Methylation Control of Gene Activation and Silencing Theory. The Basic Principles and Practice of Anti-Aging Medicine & Age Management for the Aesthetic Surgeon and Physician. Vincent C. Giampapa (Ed.) 2003;33-4

No

Burzynski, S.R., Maxwell L. Axler, Robert I. Lewy, Tomasz Janicki, Elwira Ilkowska-Musial, Anna Baranowska, M.Sc. Amino Acid Supplementation in Treatment of Cancer-Related Symptoms. Journal of Applied Nutrition 2003; 53:52-60

No

Burzynski, S. R. Gene Silencing - A New Theory of Aging. Med Hypoth 2003; 60:578-583

http://www.ncbi.nlm.nih.gov/pubmed/12615527

Yes

http://www.ncbi.nlm.nih.gov/pubmed/12615527

Burzynski, S.R. Antineoplaston Therapy. Chapter in Integrative Oncology - Conventional and Complementary Strategies. Urban & Fischer; 2002

No

Burzynski, S.R. Antineoplastons. In: Clinician's Complete Reference To Complementary/Alternative Medicine, Novey, D. W. (Ed.). Mosby 2000;496-507, St.Louis, USA

No

Burzynski, S.R. The Best of Alternative Medicine. Townsend Letter for Doctors 2000;200:32

No

Burzynski, S.R., Conde, A.B., Peters, A., Saling B., Ellithorpe, R., Daugherty, J.P., and Nacht C.H. A Retrospective Study of Antineoplastons A10 and AS2-1 in Primary Brain Tumors. Clin. Drug Invest 1999;18:1-10

No

Burzynski, S.R. Efficacy of Antineoplastons A10 and AS2-1. Mayo Clin. Proc 1999;74:641-643

http://www.ncbi.nlm.nih.gov/pubmed/10377942

Yes

http://www.ncbi.nlm.nih.gov/pubmed/10377942

Burzynski, S.R. Antineoplastons in the treatment of malignant brain tumors. Anti-Aging Medical Terapeutics, vol. 2. Klatz RM., Goldman R. (Ed), Health Quest Publications 1998;28-34, Marina del Rey, Ca, USA

No

Burzynski, S.R. Antineoplastons, oncogenes and cancer. Anti-Aging Medical Therapeutics, Vol.1. Klatz RM, Goldman R. (Ed), Health Quest Publication 1997; Marina del Rey, CA, USA

No

Burzynski, S.R. Potential of antineoplastons in diseases of old age. Drugs & Aging 1995;7:157-167

http://www.ncbi.nlm.nih.gov/pubmed/8535046

Yes

http://www.ncbi.nlm.nih.gov/pubmed/8535046

Soltysiak-Pawluczuk, D., Burzynski, S.R., Feldo, M., Majewska, B., Kleinrok, Z. Cellular accumulation of antineoplaston AS2-1 in human hepatoma cells. Cancer Letters 88 (1995);88:107-112

http://www.sciencedirect.com/science/article/pii/030438359403621O

Yes

http://www.ncbi.nlm.nih.gov/pubmed/7850766

Juszkiewicz, M., Chodkowska, A., Burzynski, S.R., Mlynarczyk, M., Kleinrok, Z. The influence of antineoplaston A5 on particular subtypes of central dopaminergic receptors. Drugs Exptl Clin Res 1995;21:153-156

http://www.ncbi.nlm.nih.gov/pubmed/8529528

Yes

http://www.ncbi.nlm.nih.gov/pubmed/8529528

Juszkiewicz, M., Chodkowska, A., Burzynski, S.R., Feldo, M., Majewska, B., Kleinrok, Z. The influence of antineoplaston A5 on the central dopaminergic structures. Drugs Exptl Clin Res 1994;20:161-167

http://www.ncbi.nlm.nih.gov/pubmed/7813388

Yes

http://www.ncbi.nlm.nih.gov/pubmed/7813388

Burzynski, S.R. Immunosurveillance versus chemosurveillance. Post Nauk Med 1993;6:260-262

Unable to Locate Following Preliminary Search

No

Burzynski, S.R. Antineoplastons, An Investigational Cancer Therapy. Townsend Letter for Doctors 1993;3,150-15

No

Burzynski, S.R. Novel differentiation inducers. Recent Advances in Chemotherapy. Adam D. (Ed), Futuramed Publishers. 1992; Munich, Germany

No

Liau, M.C., Liau, C.P., Burzynski, S.R. Potentiation of induced terminal differentiation by phenylacetic acid and related chemicals. Internat J Exptl Clin Chemother 1992;5:9-17

No

Liau, M.C., Luong, Y., Liau, C.P., Burzynski, S.R. Prevention of drug induced DNA hypermethylation by antineoplaston components. Internat J Exptl Clin Chemother 1992;5:19-27

No

Lee, S.S., Burzynski, S.R. Synergistic Effect of Antineoplaston A5 and Retinoic Acid on the Induction of Human Promyelocytic Leukemia line HL-60. Recent Advances in Chemotherapy. Adam D. (Ed), Futuramed Publishers. 1992: Munich, Germany

No

Liau, M.C., Luong, Y., Liau, C.P., Burzynski, S.R. Prevention of drug-induced DNA hypermethylation by antineoplastons. Recent Advances in Chemotherapy. Adam D. (Ed), Futuramed Publishers. 1992; Munich, Germany

No

Burzynski, S.R, Kubove, E., Burzynski, B. Phase II clinical trials of antineoplastons A10 and AS2-1 infusions in astrocytoma. Recent Advances in Chemotherapy. Adam D. (Ed), Futuramed Publishers. 1992; Munich, Germany

No

Lee, S.S., Burzynski, S.R. Antineoplaston A5: A growth inhibitor for cancerous cells and growth stimulator for normal cells. Internat J Exptl Clin Chemother 1991;4:63-65

No

Kampalath, B.N., Liau, M.C., Burzynski, B., Burzynski, S.R. Protective effect of antineoplaston A10 in hepatocarcinogenesis induced by aflatoxin B1. Internat J Tissue Reactions 1990;12 (suppl):43-50

No

Liau, M.C., Lee, S.S., Burzynski, S.R. Modulation of cancer methylation complex isoenzymes as a decisive factor in the induction of terminal differentiation mediated by antineoplaston A5. Internat J Tissue Reactions 1990; 12 (suppl): 27-36

No

Lee, S.S., Burzynski, S.R. Inducibility of HL-60 leukemic cells to undergo terminal differentiation after repeated treatment with antineoplaston A5. Internat J Exptl Clin Chemother 1990;3:125-128

No

Lee, S.S., Burzynski, S.R. Induction of differentiation of HL-60 human promyelocytic leukemic cell by antineoplaston A5. Internat J Tissue Reactions 1990;12(suppl):37-42

No

Liau, M.C., Ashraf, A.Q., Lee, S.S., Hendry, L.B., Burzynski, S.R. Riboflavin as a minor active anticancer component of antineoplaston A2 and A5. Internat J Tissue Reactions 1990;12:19-26

No

Liau, M.C., Lee, S.S., Burzynski, S.R. Separation of active anticancer components of antineoplaston A2, A3, and A5. Internat J Tissue Reactions 1990; 12 (suppl): 1-17

No

Burzynski, S.R., Kubove, E., Burzynski, B. Treatment of hormonally refractory cancer of the prostate with antineoplaston AS2-1. Drugs Exptl Clin Res 1990;16: 361-36

http://www.ncbi.nlm.nih.gov/pubmed/2152694

Yes

http://www.ncbi.nlm.nih.gov/pubmed/2152694

Burzynski, S.R. Isolation, purification and synthesis of antineoplastons. Internat J Exptl Clin Chemother 1989;2:63-69

No

Liau, M.C., Lee, S.S., Burzynski, S.R. Hypomethylation of nucleic acids: A key to the induction of terminal differentiation. Internat J Exptl Clin Chemother 1989;2:187-199

No

Hendry, L.B., Muldoon, T.G., Burzynski, S.R. Modeling studies suggest the modified dipeptide analog phenylacetylamino-2, 6-piperidinedione may interact with DNA. Adv Exptl Clin Chemother. 1988; 2: 11-13

No

Burzynski, S.R. Antineoplastons: Basic research and clinical applications. Adv Exptl Clin Chemother. 1988; 2: 1-9

No

Burzynski, S.R. Isolation, purification and synthesis of antineoplastons. Adv Exptl Clin Chemother. 1988; 6: 1-7

No

Liau, M.C., Lee, S.S, Burzynski, S.R. Differentiation inducing components of antineoplaston A5. Adv Exptl Clin Chemother. 1988; 6: 9-25

No

Lee, S.S., Burzynski, S.R. Terminal differentiation of HL-60 human promyelocytic leukemia cells induced by antineoplaston A2. Adv Exptl Clin Chemother 1988;6:27-31

No

Burzynski, S.R. Treatment of bladder cancer with antineoplaston formulations. Adv Exptl Clin Chemother. 1988. 2: 37-46

No

Burzynski, S.R., Kubove, E., Burzynski, B. Phase I clinical studies of oral formulation of antineoplaston AS2-1. Adv Exptl Clin Chemother 1988;2:29-36

No

Burzynski, S.R. Treatment of malignant brain tumors with antineoplastons. Adv Exptl Clin Chemother 1988;6:45-56

No

Ashraf, A.Q., Kampalath, B.N., Burzynski, S.R. Pharmacokinetic analysis of antineoplaston A10 injections following intravenous administration in rats. Adv Exptl Clin Chemother 1988;6:33-39

http://www.ncbi.nlm.nih.gov/pubmed/3569015

Yes

http://www.ncbi.nlm.nih.gov/pubmed/3569015

Ashraf, A.Q., Burzynski, S.R. Comparative study of antineoplaston A10 levels in plasma of healthy people and cancer patients. Adv Exptl Clin Chemother 1988;2: 19-28

No

Lee, S.S., Burzynski, S.R. Tissue culture and animal toxicity studies of antineoplaston A5. Drugs Exptl Clin Res 1987;13 (suppl 1):31-35

http://www.ncbi.nlm.nih.gov/pubmed/3569013

Yes

http://www.ncbi.nlm.nih.gov/pubmed/3569013

Kampalath, B.N., Liau, M.C., Burzynski, B., Burzynski, S.R. Chemoprevention by antineoplaston A10 of benzo (a) pyrene-induced pulmonary neoplasia. Drugs Exptl Clin Res 1987;13 (suppl 1):51-55

http://www.ncbi.nlm.nih.gov/pubmed/3569016

Yes

http://www.ncbi.nlm.nih.gov/pubmed/3569016

Liau, M.C., Szopa, M., Burzynski, B., Burzynski, S.R. Chemosurveillance: A novel concept of the natural defense mechanism against cancer. Drugs Exptl Clin Res 1987;13 (suppl 1):71-76

http://www.ncbi.nlm.nih.gov/pubmed/3569019

Yes

http://www.ncbi.nlm.nih.gov/pubmed/3569019

Lee, S.S., Mohabbat, M.O., Burzynski, S.R. In vitro cancer growth inhibition and animal toxicity studies of antineoplaston A3. Drugs Exptl Clin Res 1987;13 (suppl 1):13-16

http://www.ncbi.nlm.nih.gov/pubmed/3569011

Yes

http://www.ncbi.nlm.nih.gov/pubmed/3569011

Khalid, M., Burzynski, S.R. N,N'-disubstituted L-isoglutamines as novel cancer chemotherapeutic agents. Drugs Exptl Clin Res 1987;13 (suppl 1):57-60

http://www.ncbi.nlm.nih.gov/pubmed/3569017

Yes

http://www.ncbi.nlm.nih.gov/pubmed/3569017

Hendry, L.B., Muldoon, T.G., Burzynski, S.R., Copland, J.A., Lehner, A.F. Stereochemical modeling studies of the interaction of antineoplaston A10 with DNA. Drugs Exptl Clin Res 1987;13 (suppl 1):77-81

http://www.ncbi.nlm.nih.gov/pubmed/3569020

Yes

http://www.ncbi.nlm.nih.gov/pubmed/3569020

Burzynski, S.R., Kubove, E. Initial clinical study with antineoplaston A2 injections in cancer patients with five years follow-up. Drugs Exptl Clin Res 1987;13 (suppl 1):1-12

http://www.ncbi.nlm.nih.gov/pubmed/3569010

Yes

http://www.ncbi.nlm.nih.gov/pubmed/3569010

Burzynski, S.R., Kubove, E. Phase I clinical studies of antineoplaston A3 injections. Drugs Exptl Clin Res 1987;13 (suppl 1):17-29

http://www.ncbi.nlm.nih.gov/pubmed/3569012

Yes

http://www.ncbi.nlm.nih.gov/pubmed/3569012

Burzynski, S.R., Kubove, E., Burzynski, B. Phase I clinical studies of antineoplaston A5 injections. Drugs Exptl. Clin Res 1987;13 (suppl 1):37-43

http://www.ncbi.nlm.nih.gov/pubmed/3569014

Yes

http://www.ncbi.nlm.nih.gov/pubmed/3569014

Liau, M.C., Szopa, M., Burzynski, B., Burzynski, S.R. Quantitative assay of plasma and urinary peptides as an aid for the evaluation of cancer patients undergoing antineoplaston therapy. Drugs Exptl Clin Res 1987;13 (suppl 1):61-70

http://www.ncbi.nlm.nih.gov/pubmed/3569018

Yes

http://www.ncbi.nlm.nih.gov/pubmed/3569018

Ashraf, A.Q., Liau, M.C., Kampalath, B.N., Burzynski, S.R. Pharmacokinetic study of radioactive antineoplaston A10 following oral administration in rats. Drugs Exptl Clin Res 1987;13 (suppl 1):45-50

Burzynski, S.R., Mohabbat. M.O. Chronic animal toxicity studies of antineoplaston A2. Drugs Exptl Clin Res 1986;12 (suppl 1):73-75

http://www.ncbi.nlm.nih.gov/pubmed/3743382

Yes

http://www.ncbi.nlm.nih.gov/pubmed/3743382

Ashraf, A.Q., Liau, M.C., Mohabbat, M.O., Burzynski, S.R. Preclinical studies of antineoplaston A10 injections. Drugs Exptl Clin Res 1986;12 (suppl 1):37-45

http://www.ncbi.nlm.nih.gov/pubmed/3743379

Yes

http://www.ncbi.nlm.nih.gov/pubmed/3743379

Burzynski, S.R., Mohabbat, M.O., Lee, S.S. Preclinical studies of antineoplaston AS2-1 and antineoplaston AS2-5. Drugs Exptl Clin Res 1986;12 (suppl 1):11-16

No

Burzynski, S.R. Antineoplaston A3. Drugs of the Future 1986;11:551-552

No

Burzynski, S.R. Antineoplastons - History of the research (I). Drugs Exptl Clin Res 1986;12 (suppl 1):1-9

http://www.ncbi.nlm.nih.gov/pubmed/3527634

Yes

http://www.ncbi.nlm.nih.gov/pubmed/3527634

Burzynski, S.R. Antineoplaston AS2-5. Annual Drug Data Report 1986;8:319

No

Burzynski, S.R. Antineoplaston AS2-1. Annual Drug Data Report 1986;8:320

No

Burzynski, S.R., Khalid, M. Antineoplaston AS2-5. Drugs of the Future 1986;11:364-365

No

Burzynski, S.R. Antineoplaston A10 injections. Annual Drug Data Report 1986;8:597

No

Burzynski, S.R. Antineoplaston A3. Annual Drug Data Report 1986;8:412

No

Burzynski, S.R. Antineoplaston A2. Annual Drug Data Report 1986;8:504

No

Burzynski, S.R., Khalid, M. Antineoplaston AS2-1. Drugs of the Future 1986; 11: 361-363

No

Burzynski, S.R. Antineoplaston A2. Drugs of the Future 1986;11:549-550

No

Burzynski, S.R. Antineoplaston A5. Annual Drug Data Report 1986;8:869

No

Burzynski, S.R. Antineoplaston A5. Drugs of the Future 1986;11:824-825

No

Burzynski, S.R. Synthetic antineoplastons and analogs. Drugs of the Future 1986;11: 679-688

No

Liau, M.C., Burzynski, S.R. Altered methylation complex isoenzymes as selective targets for cancer chemotherapy. Drugs Exptl Clin Res 1986;12 (suppl 1):77-86

http://www.ncbi.nlm.nih.gov/pubmed/3743383

Yes

http://www.ncbi.nlm.nih.gov/pubmed/3743383

Lehner, A.F., Burzynski, S.R., Hendry, L.B. 3-phenylacetylamino-2, 6-piperidinedione, a naturally occurring peptide analog with apparent antineoplastic activity may bind to DNA. Drugs Exptl Clin Res 1986;12 (suppl 1):57-72

http://www.ncbi.nlm.nih.gov/pubmed/3743381

Yes

http://www.ncbi.nlm.nih.gov/pubmed/3743381

Burzynski, S.R., Kubove, E. Toxicology studies of antineoplaston A10 injections in cancer patients. Drugs Exptl Clin Res 1986;12 (suppl 1):47-55

http://www.ncbi.nlm.nih.gov/pubmed/3743380

Yes

http://www.ncbi.nlm.nih.gov/pubmed/3743380

Burzynski, S.R. Toxicology studies of antineoplaston AS2-5 injections in cancer patients. Drugs Exptl Clin Res 1986;12 (suppl 1):17-24

http://www.ncbi.nlm.nih.gov/pubmed/3743377

Yes

http://www.ncbi.nlm.nih.gov/pubmed/3743377

Burzynski, S.R., Burzynski, B., Mohabbat, M.O. Toxicology studies of antineoplaston AS2-1 injections in cancer patients. Drugs Exptl Clin Res 1986;12 (suppl 1):25-35

http://www.ncbi.nlm.nih.gov/pubmed/3743378

Yes

http://www.ncbi.nlm.nih.gov/pubmed/3743378

Burzynski, S., Mohabbar. M., Lee, S. Preclinical studies of antineoplaston AS2-1 in mice with oral administration. Drugs Exptl Clin Res 1986;132

http://www.ncbi.nlm.nih.gov/pubmed/3743376

Title per PubMed: “Preclinical studies on antineoplaston AS2-1 and antineoplaston AS2-5”

Yes - Title per PubMed: “Preclinical studies on antineoplaston AS2-1 and antineoplaston AS2-5”

http://www.ncbi.nlm.nih.gov/pubmed/3743376

Lee, S.S., Mohabbat, M.O., Burzynski, S.R. Tissue culture and acute animal toxicity studies of antineoplaston A2. Future Trends in Chemotherapy 1985;6:481-484

No

Burzynski, S.R., Hai TT. Antineoplaston A10. Drugs of the Future 1985;10:103-105

No

Burzynski, S.R. Phase I clinical studies of antineoplaston AS2-5 injections. Recent Advances in Chemotherapy. Ishigami J. (Ed), University of Tokyo Press. 1985; Tokyo, Japan

No

Burzynski, S.R., Mohabbat, M.O., Burzynski, B. Toxicology studies on oral formulation of antineoplaston A10 in cancer patients. Future Trends in Chemotherapy 1985;6:485-493

No

Burzynski, S.R., Mohabbat MO, Burzynski B. Animal toxicology studies on oral formulation of antineoplaston A10. Drugs Exptl Clin Res 1984;10:113-118

No

Lee, S.S., Mohabbat, M.O., Burzynski, S.R. Tissue culture and animal toxicity studies of antineoplaston A2. Drugs Exptl Clin Res 1984;10:607-610

No

Burzynski, S.R. Antineoplaston A10. Annual Drug Data Report 1984;6:124

No

Burzynski, S.R., Mohabbat, M.O., Burzynski, B. Human toxicology studies on oral formulation of antineoplaston A10. Drugs Exptl Clin Res 1984;10:891-909

No

Burzynski, S.R., Mohabbat, M.O., Burzynski, B. Toxicology studies on oral formulation of antineoplaston A10 in cancer patients. Drugs Exptl Clin Res 1984;10:611-619

No

Beall, P., Szopa, B., Burzynski, S.R., Hazlewood, C.F. Polypeptides that inhibit human breast cancer cell division. Cancer Biochem Biophys 1979;3:93-96

http://www.ncbi.nlm.nih.gov/pubmed/552902

Yes

http://www.ncbi.nlm.nih.gov/pubmed/552902

Burzynski, S.R. Antyneoplastony. Przeglad Lekarski 1978;6:583-586

http://www.ncbi.nlm.nih.gov/pubmed/694049

Yes

http://www.ncbi.nlm.nih.gov/pubmed/694049

Gross S, Galicka N, Grabarczyk M, Giannini M, Burzynski SR, Stolzmann Z. Urinary peptides inhibit DNA synthesis in vitro in certain cultured neoplastic cells. Clin Chem 1977;23:148-149

No

Burzynski, S.R., Stolzmann, Z., Szopa, B., Stolzmann, E., Kaltenberg, O.P. Antineoplaston A in cancer therapy (I). Physiol Chem Phys 1977;9:485-500

No

Burzynski, S.R., Stolzmann, Z., Szopa, B., Stolzmann, E., Kaltenberg, O.P. Antineoplaston A in cancer therapy (I). Physiol Chem Phys 1977;9:485-500

http://www.ncbi.nlm.nih.gov/pubmed/275868

Yes

http://www.ncbi.nlm.nih.gov/pubmed/275868

Burzynski, S.R. Antineoplastons: Biochemical defense against cancer. Physiol Chem Phys 1976;8:275-279

http://www.ncbi.nlm.nih.gov/pubmed/1013179

Yes

http://www.ncbi.nlm.nih.gov/pubmed/1013179

Gross, S., Galicka, N., Burzynski, S.R., Stolzmann, A. Urinary peptides in muscular dystrophy. Physiol Chem Phys 1976;8:161-166

http://www.ncbi.nlm.nih.gov/pubmed/988599

Yes

http://www.ncbi.nlm.nih.gov/pubmed/988599

Burzynski, S.R. Sequential analysis in subnanomolar amounts of peptides; Determination of the structure of a habituation-induced brain peptide (ameletin). Anal Biochem 1976;70:359-365

http://www.ncbi.nlm.nih.gov/pubmed/1267130

Yes

http://www.ncbi.nlm.nih.gov/pubmed/1267130

Burzynski, S.R., Loo, T.L., Ho, D.H., Rao, P.N., Georgiades, J., Kratzenstein, H. Biologically active peptides in human urine: III. Inhibitors of the growth of leukemia, osteosarcoma and HeLa cells. Physiol Chem Phys 1976;8:13-22

http://www.ncbi.nlm.nih.gov/pubmed/1066715

Yes

http://www.ncbi.nlm.nih.gov/pubmed/1066715

Burzynski, S.R., Rao, P.N., Gross, S., Stolzman, Z. Inhibition of the Growth of HeLa Cells by the Peptide Isolated from Normal Human Urine. Fed Proc 1976;35:623

No

Burzynski. S.R. Quantitative analysis of amino acids and peptides in the femtomolar range. Anal Biochem 1975;65:93-99

http://www.ncbi.nlm.nih.gov/pubmed/1130705

Yes

http://www.ncbi.nlm.nih.gov/pubmed/1130705

Burzynski, S.R., Ungar, G. Brain Peptides Associated with Habituation to a Sound Stimulus. Neuroscience Abstracts 1975;1:329

No

Ungar, G., Burzynski, S.R., Tate, D.L. Learning-induced Brain Peptides. Peptides: Chemistry, structure and biology. Walter, R., Meienhofer, J. (Ed), Ann Arbor Science; 1975; Ann Arbor, Michigan, USA

No

Burzynski, S.R., Ungar, A.L., Lubanski, E. Biologically active peptides in human urine: II. Effect on intestinal smooth muscle and heart. Physiol Chem Phys 1974;6:457-468

http://www.ncbi.nlm.nih.gov/pubmed/4548759

Yes

http://www.ncbi.nlm.nih.gov/pubmed/4548759

Burzynski, S.R., Ungar, A.L., Lubanski, E. Effect of Urinary Peptides on Smooth Muscle and Heart. Fed Proc 1974;33:547

No

Burzynski, S.R. Biologically active peptides in human urine: I. Isolation of a group of medium-sized peptides. Physiol Chem Phys 1973;5:437-447

http://www.ncbi.nlm.nih.gov/pubmed/4775589

Yes

http://www.ncbi.nlm.nih.gov/pubmed/4775589

Burzynski, S.R., Georgiades, J. Effect of Urinary Peptides on DNA, RNA and Protein Synthesis in Normal and Neoplastic Cells. Fed Proc 1973;32:766

No

Ungar, G., Burzynski, S.R. Isolation and Purification of a Habituation-inducing Peptide from Trained Rat Brain. Fed Proc 1973;32:367

No

Burzynski, S., Czerniak, Z. A simple method for the separation of free and bound amino acids and its application to the identification of bound amino acids in human blood serum. Chem Anal 1970;15:223-225

No

Szajner-Milart, J., Burzynski, S.R., Paczos-Chadyma, E., Czerniak, Z. Free amino acids in serum of obese children. Endokr Pol 1970;21:611-617

http://www.ncbi.nlm.nih.gov/pubmed/5531748

Yes

http://www.ncbi.nlm.nih.gov/pubmed/5531748

Krzeczkowska, I., Czerniak, Z., Burzynski, S. Quantitative determinations of carbohydrates and their statistical analysis, I. Results obtained in various conditions using paper and thin-layer chromatography. Chem Anal 1969;13:1221-1228

No

Burzynski, S. Investigations on unknown ninhydrin-reacting substances in human blood serum I. Attempts at identification of three such substances. Experientia 1969;25:490-491

http://www.ncbi.nlm.nih.gov/pubmed/5796158

Yes

http://www.ncbi.nlm.nih.gov/pubmed/5796158

Burzynski, S. Bound amino acids in serum of patients with chronic renal insufficiency. Clin Chim Acta 1969;25:231-237

http://www.sciencedirect.com/science/article/pii/0009898169902599

Yes

http://www.ncbi.nlm.nih.gov/pubmed/5801388

Czerniak, Z., Burzynski, S. Free amino acids in serum of patients with chronic renal insufficiency. Clin Chim Acta 1969;24:367-372

http://www.ncbi.nlm.nih.gov/pubmed/5797414

Yes

http://www.ncbi.nlm.nih.gov/pubmed/5797414

Burzynski, S., Czerniak, Z. A simple method for free and bound amino acid separation. Folia Soc Sci Lub 1969/70;Sec. A-D 9/10 (suppl):143-144

No

Burzynski, S., Czerniak, Z. Quantitative determination of amino acids using photometry of negative printed chromatograms. Modification of the method and its application for amino acid analysis in blood serum. Chem Anal 1969;14:667-671

http://www.ncbi.nlm.nih.gov/pubmed/5996246

Yes

http://www.ncbi.nlm.nih.gov/pubmed/5996246

Czerniak, Z., Burzynski, S. Qualitative analysis of amino acids using the multiple development of chromatograms in different eluents. Chem Anal 1969;14:673-676

No

Krzeczkowska, I., Czerniak, Z., Burzynski, S. Quantitative determinations of free amino acids in human blood with the use of our own method and Beckman amino acid analyzer. Pol Arch Med Wewn 1968;40:223-228

http://www.ncbi.nlm.nih.gov/pubmed/5669683

Yes

http://www.ncbi.nlm.nih.gov/pubmed/5669683

Krzeczkowska, I., Czerniak, Z., Burzynski, S. Quantitative determinations of free amino acids in the blood of patients with myocardial infarction using a new method of photometry of the negative printed chromatograms. Pol Arch Med Wewn 1968;41:361-368

No

Krzeczkowska, I., Czerniak, Z., Burzynski, S. Quantitative determinations of carbohydrates and their statistical analysis, II. Analysis of variance for four-crossed classification and Tukey confidence intervals. Chem Anal 1968;13:1229-1238

No

Burzynski, S. Investigations on amino acids and peptides in blood serum of healthy people and patients with chronic renal insufficiency. 1968; Lublin, Poland: 274 pp (doctoral dissertation)

No

Krzeczkowska, I., Burzynski, S. Czerniak Z. Quantitative determination of amino acids using photometry of negative printed chromatograms. Ann Univ MC Sklodowska 1966;21:125-134

No

Krzeczkowska, I., Czerniak, Z., Burzynski, S. The application of the negative printed chromatograms for quantitative determination of free amino acids in the blood of healthy people. Ann Univ MC Sklodowska 1966;21:313-322

Unable to Locate Following Preliminary Search

No

Krzeczkowska, I., Burzynski, S., Czerniak, Z. Investigations on the possibility of the determination of mushroom species on the basis of the composition of their amino acids. Ann Univ MC Sklodowska 1965;20:221-229

Unable to Locate Following Preliminary Search

Title per PubMed: “[Studies on the possibility of determination of mushroom species according to the composition of their amino acids]”

Yes - Title per PubMed: “[Studies on the possibility of determination of mushroom species according to the composition of their amino acids]”

http://www.ncbi.nlm.nih.gov/pubmed/5896094

Krzeczkowska, I., Czerniak, Z., Burzynski, S. Free and bound amino acids of some edible mushrooms. Ann Univ MC Sklodowska 1965;20:303-312

Unable to Locate Following Preliminary Search

Title per PubMed: “[Free and bound amino acids in some edible mushrooms. 3. Determination of content of free and bound amino acids in edible mushrooms: Cantharellus cibarius Fr., Armillaria mellea Vahl and Agaricus campestris Fr]”

Yes - Title per PubMed: “[Free and bound amino acids in some edible mushrooms. 3. Determination of content of free and bound amino acids in edible mushrooms: Cantharellus cibarius Fr., Armillaria mellea Vahl and Agaricus campestris Fr]”

http://www.ncbi.nlm.nih.gov/pubmed/5896096

Krzeczkowska, I., Czerniak, Z., Burzynski, S. Bound amino acids of some edible mushrooms. Ann Univ MC Sklodowska 1964;19:329-336

Unable to Locate Following Preliminary Search

Yes

http://www.ncbi.nlm.nih.gov/pubmed/5893108

Krzeczkowska, I., Burzynski, S., Czerniak, Z. Free amino acids of some edible mushrooms. Ann Univ MC Sklodowska 1964;19:321-328

Unable to Locate Following Preliminary Search

Yes

http://www.ncbi.nlm.nih.gov/pubmed/5893107

The following two citations were listed on PubMed but do not appear on the publication list on The Burzynski Clinic website:

Citation

Link

Comments

Burzynski, S. Antineoplastons: the controversy continues. JAMA. 1993 Jan 27;269(4):475

http://www.ncbi.nlm.nih.gov/pubmed/8419664

Not on PubMed

Burzynski, S. Joint ownership not always best answer. Mich Med. 1979 Jun;78(17):338, 344

http://www.ncbi.nlm.nih.gov/pubmed/449738

Not on PubMed

D. Expanded Access Statutes

The federal statutes that govern the expanded access to unproven therapies are as follows:

Statute

Link

Comments

21 Code of Federal Regulation Part 312

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRsearch.cfm?CFRPart=312

Investigational new drug application

21 Code of Federal Regulation Part 316

http://ecfr.gpoaccess.gov/cgi/t/text/text-idx?c=ecfr&tpl=/ecfrbrowse/Title21/21cfr316_main_02.tpl

Orphan drugs;[70] see also Orphan Drug Act of 1983

Food, Drug and Cosmetic Act § 561 (21 United States Code § 360bbb)

http://www.fda.gov/RegulatoryInformation/Legislation/FederalFoodDrugandCosmeticActFDCAct/FDCActChapterVDrugsandDevices/ucm110713.htm

Expanded access to unapproved therapies and diagnostics

Food and Drug Modernization Act of 1997 § 402 (21 United States Code § 301 et seq.)

http://www.fda.gov/RegulatoryInformation/Legislation/FederalFoodDrugandCosmeticActFDCAct/SignificantAmendmentstotheFDCAct/FDAMA/FullTextofFDAMAlaw/default.htm

Expanded access to experimental drugs and devices

E. Informed Consent Statutes

The federal codes that govern informed consent are as follows:

Code

Link

Comments

21 Code of Federal Regulations Part 50

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?CFRPart=50

Protection of human subjects; elements of informed consent; See http://www.fda.gov/downloads/RegulatoryInformation/Guidances/UCM291085.pdf?source=govdelivery

42 Code of Federal Regulations § 441.257

http://ecfr.gpoaccess.gov/cgi/t/text/text-idx?c=ecfr&tpl=/ecfrbrowse/Title42/42cfr441_main_02.tpl

Informed consent

45 Code of Federal Regulations § 46.116

http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.html

General requirements for informed consent

45 Code of Federal Regulations § 46.117

http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.html

Documentation for informed consent

III. QUESTIONS/ISSUES PRESENTED FOR CERTIORARI

A. Possible Legal Issues[71]

Personal injury claims as well as tort claims under the federal Tort Claims Act may be brought by persons whom underwent “treatment” at The Burzynski Clinic. Additionally, taking the allegations in the Quinlin complaint as true and in favor of the plaintiff, the statutes governing the electronic transfer of monies, such as the Electronic Funds Transfer Act, or 15 United States Code § 1693, may also be applicable here, and the Seventh Amendment of the Constitution governs jury trials in civil matters in which the amount in controversy exceeds $20.00. Legal action may be brought by the United Staes under 28 United States Code § 1345.

Again, taking the allegations in the Quinlin complaint as true and in favor of the plaintiff, the alleged inflation of the price of antineoplastons as distributed by The Southern Family Pharmacy, Inc. may violate the federal Anti-Kickback statute, which is codified as 42 United States Code § 1328 , state false claims statutes and the federal False Claims Act, which is codified as 31 United States Code §§ 3729–3733.[72]

The aforementioned Quinlin complaint alleges that unauthorized charges were made on her credit card with regard to antineoplaston therapy, and the Fair Debt Collection Act is codified as 15 United States Code § 1692.

In order to obtain antineoplastons from Burzynski, patients travel to The Burzynski Clinic in Texas.[73] With regard to the Constitutional “Commerce Clause,” which governs interstate commerce and also provides the authority for the Lanham Act that is codified as 15 United States Code § 1051 et seq.,[74] [75]quoting Trustees of the Northwest Laundry v. Burzynski (5th Cir. 1994) 27 F.3d 153, 155,[76] “Dr. Burzynski was on notice that interstate use of antineoplastons violated federal law.” Any persons involved in commerce activities are subject to the Federal Trade Commission Act,[77] hereinafter “FTCA,” which is codified as 15 United States Code § 45, and § 5 of said FTCA governs unfair or deceptive acts or practices as were alleged in Quinlin v. Burzynski, et al. (Docket Number 2012-03429; Texas District Court - Harris County). As was previously set forth herein, ANTINEOPLASTON® is a registered trademark.[78]

As was also previously set forth herein, naturally occurring substances do not constitute patentable subject matter under Title 35 of the United States Code. Association for Molecular Pathology v. U.S. Patent and Trademark Office, No. 09-cv-4515, 94 USPQ2d 1683 (S.D.N.Y. March 29, 2010).[79] [80] Methods of production, however, may be patentable, and Burzynski, for example, has obtained a patent on a method for sodium phenylbutyrate production.[81] [82] The eight aforementioned American patents of the The Burzynski Research Institute are as follows pursuant to SEC filings:[83]

Patent Details

Comments

Determination of antineoplastons in body tissue or fluid as a cancer diagnostic procedure

Expired

Processes for antineoplaston purified fraction preparation from human urine

Expired

Processes for the production of synthetic antineoplastons and methods of treating neoplastic disease

Expired

Antineoplaston administration to humans

Expired

Methods for antineoplaston A-10 synthesis

Expired January 11, 2009

Liposomal antineoplaston therapies

Expires May 14, 2017

Treatment regimen for the administration of phenylacetylgluatamine, phenylacetylisoglutamine and/or phenylacetate

Expires July 23, 2018

Division application - treatment regimen for the administration of phenylacetylgluatamine, phenylacetylisoglutamine and/or phenylacetate

Expires July 31, 2018

35 United States Code § 292 constitutes the False Patent Marking statute, and it contains both a civil fine within § (a) as well as qui tam provision, or § (b), that gives any person the right to sue for said penalty.

As was previously incorporated herein, the federal statutes that govern expanded access to unproven therapies, such as antineoplastons, are as follows:

Statute

Link

Comments

21 Code of Federal Regulation Part 312

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRsearch.cfm?CFRPart=312

Investigational new drug application

21 Code of Federal Regulation Part 316

http://ecfr.gpoaccess.gov/cgi/t/text/text-idx?c=ecfr&tpl=/ecfrbrowse/Title21/21cfr316_main_02.tpl

Orphan drugs;[84] see also the Orphan Drug Act of 1983

Food, Drug and Cosmetic Act § 561 (21 United States Code § 360bbb)

http://www.fda.gov/RegulatoryInformation/Legislation/FederalFoodDrugandCosmeticActFDCAct/FDCActChapterVDrugsandDevices/ucm110713.htm

Expanded access to unapproved therapies and diagnostics

Food and Drug Modernization Act of 1997 § 402 (21 United States Code § 301 et seq.)

http://www.fda.gov/RegulatoryInformation/Legislation/FederalFoodDrugandCosmeticActFDCAct/SignificantAmendmentstotheFDCAct/FDAMA/FullTextofFDAMAlaw/default.htm

Expanded access to experimental drugs and devices

Potential legal issues also exist with regard to informed consent, or a lack thereof, as was alleged within the complaint document filed by attorneys on behalf of Ms. Quinlin. See Quinlin v. Burzynski, et al. (Docket Number 2012-03429; Texas District Court - Harris County).[85] As was also previously incorporated herein, the federal codes that govern informed consent are as follows:

Code

Link

Comments

21 Code of Federal Regulations Part 50

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?CFRPart=50

Protection of human subjects; elements of informed consent; See http://www.fda.gov/downloads/RegulatoryInformation/Guidances/UCM291085.pdf?source=govdelivery

42 Code of Federal Regulations § 441.257

http://ecfr.gpoaccess.gov/cgi/t/text/text-idx?c=ecfr&tpl=/ecfrbrowse/Title42/42cfr441_main_02.tpl

Informed consent

45 Code of Federal Regulations § 46.116

http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.html

General requirements for informed consent

45 Code of Federal Regulations § 46.117

http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.html

Documentation for informed consent

See also the FDA document released on February 9, 2012 intended for small entities titled Guidance For Sponsors, Investigators, and Institutional Review Boards – Questions and Answers on Informed Consent Elements, 21 CFR § 50.25(c).

Burzynski’s representation of the use of antineoplastons as “gene therapy,”[86] which is defined as an experimental technique that utilizes genes in the treatment or prevention of disease,[87] may constitute unfair or deceptive practices under § 5 of the federal Trade Commission Act, which is codified as 15 United States Code § 45, as said code applies to everyone involved in commerce. Consumer Protection Act violations may also be considered. Quoting http://ghr.nlm.nih.gov/handbook/therapy/procedures, the gene therapy process is as follows:[88]

A gene that is inserted directly into a cell usually does not function. Instead, a carrier called a vector is genetically engineered to deliver the gene. Certain viruses are often used as vectors because they can deliver the new gene by infecting the cell. The viruses are modified so they can’t cause disease when used in people. Some types of virus, such as retroviruses, integrate their genetic material (including the new gene) into a chromosome in the human cell. Other viruses, such as adenoviruses, introduce their DNA into the nucleus of the cell, but the DNA is not integrated into a chromosome.

Antineoplastons do not constitute “gene therapy” despite the claims made by Burzynski on his website, where he represents the use of antineoplastons as “[i]nnovative and cutting-edge Personalized Gene Targeted Cancer Therapy.”[89] The website also includes the following:[90]

Gene-targeted medications are drugs that selectively block the growth and spread of cancer without affecting the healthy cells. Targeted therapies interfere with cancer cell growth differently than cytotoxic chemotherapy and at various points during the development, growth, and spread of cancer. By switching off the signals that make cancer cells grow and divide uncontrollably, targeted cancer therapies can help stop the growth of cancer cells.

Targeted medications have shown to be tolerated easier than standard chemotherapy and radiation with no side effects or minimal adverse reactions noted.

There are currently close to 30 targeted therapeutics approved by the FDA (as of January 2011). This number grows rapidly with the advancement of the research in genomics. All of the FDA approved gene-targeted medications are available for treatment at the Burzynski Clinic. The combination of targeted medications is customized for each patient and determined by the type of oncogenes involved in patient's cancer (Personalized Treatment).

Within this context, the deceptive misrepresentation of antineoplastons, which obtained orphan drug status in 2004 under the Orphan Drug Act of 1983 as was previously set forth herein, as “gene therapy” may be sufficient to bring suit against Burzynski, et al. in federal court.

Patient protection violations may also exist under the Health Information Technology for Economic and Clinical Health Act as well as under the not yet implemented Patient Protection and Affordable Care Act, which is the subject of a lawsuit by author Sara Elizabeth Siegler.

IV. CONCLUSION/CORRECTIVE ACTIONS

Having no authority to act upon any of the information provided herein, the authors of this report, whose services were provided pro bono, reserve this section of the report for the responsible agencies/entities.

________________

[1] adam@cappsie.com

[2] See Quinlin v. Burzynski, et al. (Docket Number 2012-03429; Texas District Court - Harris County): http://www.courthousenews.com/2012/01/19/Cancer.pdf

[3] www.burzynskiclinic.com/images/.../CV_DrB-2010-CURRENT.pdf

[4] http://www.quackwatch.org/01QuackeryRelatedTopics/Cancer/burzynski1.html

[5] According to Saul Green, Ph.D., Stanislaw Burzynski did not earn his Ph.D., although he represents himself as an M.D., Ph.D. See: http://www.quackwatch.org/01QuackeryRelatedTopics/Cancer/burzynski1.html

[6] See Quinlin v. Burzynski, et al. (Docket Number 2012-03429; Texas District Court - Harris County): http://www.courthousenews.com/2012/01/19/Cancer.pdf

[7]http://www.faqs.org/sec-filings/110531/BURZYNSKI-RESEARCH-INSTITUTE-INC_10-K/#b

[8] http://www.faqs.org/sec-filings/110531/BURZYNSKI-RESEARCH-INSTITUTE-INC_10-K/#b

[9]http://www.faqs.org/sec-filings/110531/BURZYNSKI-RESEARCH-INSTITUTE-INC_10-K/

[10]http://www.faqs.org/sec-filings/111017/BURZYNSKI-RESEARCH-INSTITUTE-INC_10-Q/a11-25973_1ex32d1.htm#b

[11] http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/ucm192711.htm

[12]http://www.faqs.org/sec-filings/110531/BURZYNSKI-RESEARCH-INSTITUTE-INC_10-K/

[13] See Quinlin v. Burzynski, et al. (Docket Number 2012-03429; Texas District Court - Harris County): http://www.courthousenews.com/2012/01/19/Cancer.pdf

[14] http://www.skepticalhealth.com/2011/11/28/antineoplastons/

[15] http://www.cancer.gov/cancertopics/pdq/cam/antineoplastons/healthprofessional

[16] http://www.cancer.gov/cancertopics/pdq/cam/antineoplastons/patient/

[17]http://www.cancer.org/Treatment/TreatmentsandSideEffects/ComplementaryandAlternativeMedicine/PharmacologicalandBiologicalTreatment/antineoplaston-therapy

[18] http://www.quackwatch.org/01QuackeryRelatedTopics/Cancer/burzynski2.html

[19]http://www.burzynskiclinic.com/images/stories/ANP_chemical_formulas.pdf

[20]http://www.burzynskiclinic.com/images/stories/ANP_mechamism_of_activity.pdf

[21]ANTINEOPLASTON® is a trademark registered with the U.S. Patent and Trademark Office

pursuant to http://www.faqs.org/sec-filings/110531/BURZYNSKI-RESEARCH-INSTITUTE-INC_10-K/#TableOfContents

[22]http://www.chemeurope.com/en/encyclopedia/Antineoplaston.html

[23]http://www.cancer.gov/cancertopics/pdq/cam/antineoplastons/healthprofessional

[24]http://www.quackwatch.org/01QuackeryRelatedTopics/Cancer/burzynski1.html

[25]Insoluble A-10 is 3-N-phenylacetylamino piperidine 2,6-dione (“PAPD”), whereas “soluble” A-10 is composed of phenylacetic acid (“PA”) and phenylacetyl glutamine (“PAG”) per http://www.quackwatch.org/01QuackeryRelatedTopics/Cancer/burzynski1.html.

[26] According to Burzyski, A-10 is the anticancer peptide common to all of his urine fractions per Saul Green, Ph.D. (http://www.quackwatch.org/01QuackeryRelatedTopics/Cancer/burzynski1.html).

[27]http://en.wikipedia.org/wiki/Bexarotene

[28]http://www.cbsnews.com/8301-504763_162-57374685-10391704/cancer-drug-reverses-alzheimers-disease-in-mice-hope-for-humans/

[29]http://www.express.co.uk/posts/view/301201/Drug-to-cure-Alzheimer-s

[30]Cramer PE, et al. ApoE-directed therapeutics rapidly clear β-amyloid and reverse deficits in AD mouse models. (9 February 2012). Science Express. doi:10.1126/science.1217697 (http://www.sciencemag.org/content/early/2012/02/08/science.1217697.abstract).

[31] http://online.wsj.com/article/SB10001424052970204642604577215382600942356.html

[32]M.F. Boehm, R.A. Heyman, L. Zhi, C.K. Hwang, S. White, A. Nadzan, U.S. Patent 5,780,676 (1998) via http://en.wikipedia.org/wiki/Bexarotene

[33]http://www.cancer.org/Treatment/TreatmentsandSideEffects/ComplementaryandAlternativeMedicine/PharmacologicalandBiologicalTreatment/antineoplaston-therapy

[34] http://en.wikipedia.org/wiki/Sodium_phenylbutyrate

[35] http://dailymed.nlm.nih.gov/dailymed/archives/fdaDrugInfo.cfm?archiveid=3849

[36] US20080171792.pdf

[37]http://www.medicines.org.uk/emc/medicine/21412/SPC/ammonaps%20500%20mg%20tablets/ ; http://www.sobi.com/en/Healthcare-Professionals/Products-alphabetical-list/Ammonaps-sodium-phenylbutyrate/

[38] US20080171792.pdf

[39] http://clinicaltrials.gov/ct2/show/NCT00597909

[40] http://www.drugs.com/pro/ammonul.html

[41]http://en.wikipedia.org/wiki/Phenylacetylglutamine

[42] Brusilow SW. Phenylacetylglutamine may replace urea as a vehicle for waste nitrogen excretion. Pediatr Res. 1991 Feb;29(2):147-50. (http://www.ncbi.nlm.nih.gov/pubmed/2014149)

[43]Burzynski, S.R., Janicki, T.J., Weaver, R.A., Burzynski, B. Targeted Therapy with Antineoplastons A10 and AS2-1 of High-Grade, Recurrent and Progressive Brainstem Glioma. Integrative Cancer Therapies, 2006; 40-47 (http://www.burzynskiclinic.com/images/Pub_SRB_2006_Targeted_Therapy_with_ANP_of_high_grade_brainstem_glioma.pdf).

[44]http://www.burzynskiclinic.com/images/stories/ANP_mechamism_of_activity.pdf

[45] http://www.quackwatch.org/01QuackeryRelatedTopics/Cancer/burzynski1.html

[46]http://www.quackwatch.org/01QuackeryRelatedTopics/Cancer/burzynski1.html

[47]http://www.cancer.gov/clinicaltrials/search/results?protocolsearchid=10124447

[48]http://www.cancer.gov/clinicaltrials/search/results?protocolsearchid=10124449

[49]http://clinicaltrials.gov/ct2/results?term=antineoplaston&show_down=Y#down

[50]http://clinicaltrials.gov/ct2/results?term=antineoplaston&recr=Open&show_down=Y

[51]http://www.quackwatch.org/01QuackeryRelatedTopics/Cancer/burzynski2.html

[52]http://www.faqs.org/sec-filings/110531/BURZYNSKI-RESEARCH-INSTITUTE-INC_10-K/#b

[53]http://www.faqs.org/sec-filings/110531/BURZYNSKI-RESEARCH-INSTITUTE-INC_10-K/#b

[54]http://www.faqs.org/sec-filings/110531/BURZYNSKI-RESEARCH-INSTITUTE-INC_10-K/#b

[55]http://www.faqs.org/sec-filings/110531/BURZYNSKI-RESEARCH-INSTITUTE-INC_10-K/

[56]http://www.faqs.org/sec-filings/110531/BURZYNSKI-RESEARCH-INSTITUTE-INC_10-K/

[57]http://www.faqs.org/sec-filings/110531/BURZYNSKI-RESEARCH-INSTITUTE-INC_10-K/

[58] http://www.aclu.org/files/assets/2010-3-29-AMPvUSPTO-Opinion.pdf

[59]This case is also referred to as the myriad gene patent litigation.

[60]http://www.freshpatents.com/Use-of-highly-concentrated-formulations-of-4-phenylbutyrate-for-treatment-of-certain-disorders-dt20080717ptan20080171792.php ; http://images2.freshpatents.com/pdf/US20080171792A1.pdf

[61]http://www.freshpatents.com/Process-for-preparation-of-liquid-dosage-form-containing-sodium-4-phenylbutyrate-dt20070104ptan20070004805.php; http://images2.freshpatents.com/pdf/US20070004805A1.pdf

[62]http://www.faqs.org/sec-filings/110531/BURZYNSKI-RESEARCH-INSTITUTE-INC_10-K/#b

[63]See also: Schiff v. Prados, 112 Cal. Rptr. 2d 171 - Cal: Court of Appeal, 1st Appellate Dist., 4th Div. 2001 (http://www.quackwatch.org/01QuackeryRelatedTopics/Cancer/prados.pdf).

[64] http://www.skepticalhealth.com/2011/11/28/antineoplastons/

[65]Chapter 5: http://www.quackwatch.org/01QuackeryRelatedTopics/OTA/ota05.html

[66]http://www.quackwatch.org/01QuackeryRelatedTopics/OTA/ota05.html

[67]http://www.quackwatch.org/04ConsumerEducation/News/burzynski.html

[68]http://www.courthousenews.com/2012/01/19/Cancer.pdf

[69]http://www.burzynskiclinic.com/publications.html

[70]https://docs.google.com/viewer?url=http%3A%2F%2Foig.hhs.gov%2Foei%2Freports%2Foei-09-00-00380.pdf

[71]Federal Cause of Action guide courtesy of the United States District Court for the Southern District of Ohio: http://www.ohsd.uscourts.gov/cmecf/ecftraining/Atty%20Guide%20Appx%20A.pdf

[72]31 United States Code § 3731 governs fraud, and injunctions against fraud may be obtained under 18 United States Code § 1345.

[73]http://www.burzynskiclinic.com/images/stories/PatientTravelInfoBrochure.pdf

[74] http://www.law.cornell.edu/wex/Lanham_Act

[75] The definition of the Lanham Act provided by Nolo’s Plain-English Law Dictionary is as follows,

The federal statute that governs trademarks, service marks, and unfair competition. The Lanham Act covers matters that include the procedures for federally registering trademarks, when owners of trademarks may be entitled to federal judicial protection against infringement, and other guidelines and remedies for trademark owners.

[76] ftp://www.ca5.uscourts.gov/pub/93/93-02071.CV0.wpd.pdf

[77] http://www.federalreserve.gov/boarddocs/supmanual/cch/ftca.pdf

[78]http://www.faqs.org/sec-filings/110531/BURZYNSKI-RESEARCH-INSTITUTE-INC_10-K/

[79] http://www.aclu.org/files/assets/2010-3-29-AMPvUSPTO-Opinion.pdf

[80]This case is also referred to as the myriad gene patent litigation.

[81]http://www.freshpatents.com/Use-of-highly-concentrated-formulations-of-4-phenylbutyrate-for-treatment-of-certain-disorders-dt20080717ptan20080171792.php ; http://images2.freshpatents.com/pdf/US20080171792A1.pdf

[82]http://www.freshpatents.com/Process-for-preparation-of-liquid-dosage-form-containing-sodium-4-phenylbutyrate-dt20070104ptan20070004805.php; http://images2.freshpatents.com/pdf/US20070004805A1.pdf

[83]http://www.faqs.org/sec-filings/110531/BURZYNSKI-RESEARCH-INSTITUTE-INC_10-K/

[84]https://docs.google.com/viewer?url=http%3A%2F%2Foig.hhs.gov%2Foei%2Freports%2Foei-09-00-00380.pdf

[85]http://www.courthousenews.com/2012/01/19/Cancer.pdf

[86]http://www.ornl.gov/sci/techresources/Human_Genome/medicine/genetherapy.shtml

[87]http://ghr.nlm.nih.gov/handbook/therapy/genetherapy

[88]http://ghr.nlm.nih.gov/handbook/therapy/procedures

[89]http://www.burzynskiclinic.com/

[90]http://www.burzynskiclinic.com/treatment-options.html

Clinical Trials: The Missing Data

Thanks to The Clinical Trial Gurus for their support and Sara Siegler for her excellent reporting work!
View the vlog here. You can grab the formatted, linked PDF containing publicly available "information" on the Burzynski clinic here. I say "information" but there is a distinct lack of publication in such respected journals such as PubMed.

Why I became a skeptic

Why I became a skeptic.

It all started many years ago. I was christened, baptised and confirmed Catholic; I followed the faith for years without question. Things like God never answering prayers, or all the bad things happening in the world, due to "free will", never occurred to me to question.

Gradually, as if I were someone slowly waking from a deep slumber and being inexorably drawn to the truth, I literally, mentally woke up. This didn't happen over night.

I realised that there were too many unanswered questions, perhaps answerable only by way of anecdote, opinion or apocryphal story. This just wasn't good enough. I needed to know more. I needed to dig deeper. I needed the truth about everything.

More recently I began thinking. I started to question everything: I questioned religion; I questioned people; I questioned life. I investigated Atheism and Agnosticism, and the reasons people apostatise. I became a big fan of James Randi, Penn & Teller, Houdini, Richard Dawkins and the late Christopher Hitchens. I read as much as I could, still do. In fact, my story is so involved and long running I won't go into it here, at least with regard to the religious aspects of my "enlightenment". Rather, and moving forward to the almost-present day, this is how I became a skeptic.

It was Sunday 20 November 2011 that an interesting story appeared in the Guardian (website in this case), written by Luke Bainbridge and entitled "The worst year of my life: cancer has my family in its grip".

Luke wrote: "My four-year-old niece Billie has an inoperable brain tumour. Her mother, my sister-in-law, has breast cancer." In fact, Billie had Diffuse Intrinsic Pontine Glioma (DIPG).
Being an incredibly rare illness with only about 40 children diagnosed with it every year in Britain, the odds were against her.

Luke then goes on to explain about "a pioneering treatment at the Burzynski Clinic in Texas for children with DIPG".
"The estimated cost is £200,000. It is not available in this country, it is new and there are no guarantees. When you are faced with a decision like that, what can you do? It's like Monopoly money and when we realised we would have to raise this amount, it seemed ridiculous. Especially as there's only a slight chance that the treatment might work."

This seemed a simple plea for help (and money). Celebrity influence, in the form of British comedian Peter Kay and British band Badly Drawn Boy, was also drawn in to raise money. I wondered if there was anything to this claim, after all £200,000 is a substantial amount of money to simply (and blithely) hand over without a little proof.
As the news of this story spread like wildfire, the blogosphere came alive and, what can really only be described as a war, broke out as people began asking for efficacy of this clinic's trial-treatment. The "war" comprised of bloggers and tweeters asking for evidence, while hotly defending the lack of evidence were the patients, the support groups and in general, the apologists. At one point the Burzynski Clinic directly attacked Rhys Morgan, a 17-year-old Welsh schoolboy, with libel threats.

I believe this excerpt is the most poignant both to libel law as well as science:"[Plaintiffs] cannot, by simply filing suit and crying 'character assassination!', silence those who hold divergent views, no matter how adverse those views may be to plaintiffs' interests. Scientific controversies must be settled by the methods of science rather than by the methods of litigation. … More papers, more discussion, better data, and more satisfactory models – not larger awards of damages – mark the path towards superior understanding of the world around us." – US Chief Justice Frank Easterbrook, Underwager v Salter 22 Fed. 3d 730 (1994)

The more I read, the more I needed to know and the more I had to get to the bottom of it all. I lived and breathed "Burzynski"; I still do, although I have cooled a little pending the outcome of a report I complied with the help of Sara Siegler - a whistle blower and Dan Sfera - of the Clinical Trial Gurus fame.

As it turns out, there is so little information published as to the effectiveness of this "treatment", that no one can really say whether it works or not. There is no imperical evidence to support the efficacy of Antineoplaston treatment the clinic offers; at least nothing beyond anecdote and conference reference.However, Laura of the Hope for Laura charity, reports some 77% tumour shrinkage. You can read her blog here. That blog also secured celebrity endorsement in the form of British comedian Rufus Hound. The MRIs and the medical notes are not publicly available for impartial, statistical and medical scrutiny; these details being crucial and key to finding the truth.

We are encouraged to take the blog, and its reports, as gospel. Faced with such 'obvious' evidence, on the surface, it is difficult to refute, but the plural of 'anecdote' is not 'data', and it is the data which is the qualifier. Just because I tell someone I can fly, that anecdote does not make it so.
The question still remains: if Dr Burzynski has indeed found a cure -- or at the least an efficacious treatment -- for even a single type of cancer, then we all want to know about it. We all want to be rid of this cancerous [no pun intended] blot on mankind and the sooner the better. So why not publish the results and trial data in respected journals? Why not shout it from the rooftops? Why instead, go about your business, shrouded in secrecy, refusing to answer the call of the skeptic? The easiest way to hush the skeptic is with good old fashioned evidence.

For the record: It is not my intention to directly attack the patients themselves. I did originally donate £10 to Laura's cause as was mentioned on Twitter and I'm happy to put my hands up to that. She was (and still is at time of writing this blog) ill and in need of help from the public, to which she, the charity and several celebrities appealed.
At the time, I simply wasn't aware of the bigger picture, including the history surrounding the clinic and 'treatment'. If anything, I suppose you could say "I was suckedered in with the rest of 'em." However, I am far more informed now, and I am asking the right questions, but that doesn't make me evil or bad, nor does it detract from teh truth I seek.

I wish Laura well as with all of the patients engaging or attending with The Burznyski Clinic.

Believe it or not, skeptics do have the patients' best interests at heart when we ask for the evidence, though is rarely well received as is often their last hope, and usually when all conventional medicine has failed.
Skeptics feel that charlatans peddling false hope and preying on vulnerable and desperate people for a quick profit should be challenged and stopped. It's true that no one should stop anyone from making their own decisions, but personally speaking, I would rather the potential patient was fully aware of everything -- a total transparency if you will -- before signing lots of money over to a quack and their Snake Oil.

In this video, Dr Ben Goldacre explains why clinical trials are important, what they involve and who can take part in one. He also describes common concerns patients might have and gives tips on what questions to ask before taking part in any research.

This is what The James Randi Educational Foundation wrote about The Burzynski Clinic.

It's worth mentioning that Chemotherapy is what The Burzynski Clinc administers. I'm not quite sure how the "it's not Chemotherapy" suggestion came about but the NHS asserts: Chemotherapy is a type of treatment for cancer where medicine is used to kill cancer cells. It can be given either as a tablet, or as an injection or infusion directly into a vein. So despite what Laura's understanding is, it's not quite correct according to what is accepted as "chemotherapy".

So moving forward: by simply asking for the clinical trial data, which would prove or disprove the efficacy of the clinic's treatment, I have been subjected to an argumentum ad hominem in which my personal life -- regardless of it being completely irrelevant to my question -- was dragged into Twitter. I was a little disappointed to have been personally attacked by Laura here considering my original and early feelings toward cancer and charity.The proverb states one should not bite the hand that feeds you. I couldn't help feeling that, despite my original, well-intentioned gesture, this was being thrown back into my face, and for simply asking a question about the clinic, and it wasn't even directed at Laura!

I have noted several Burzynski apologists, though there is little point in listing them here (I'm sure you can find them if you've a mind to), take so much pleasure in attacking skeptics to a level that might be considered imprudent.

And on to the present. The report I helped compiled, is now with the FDA, FBI, NCI, NIH and the Inspector General of DHHS. We have also completed a FOIA request in an attempt to release the data. You can read the PDF report here.

I particularly like this quote as it does epitomise what I'm trying to do but does explain why others feel the need to vilify the skeptics:
"The idea is to try and give all the information to help others to judge the value of your contribution; not just the information that leads to judgment in one particular direction or another."
-- Richard P. Feynman