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
Thursday, February 23, 2012
Clinical Trials: The Missing Data
Thanks to The Clinical Trial Gurus for their support and Sara Siegler for her excellent reporting work!
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