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The '''Antineoplaston-Therapy''' (ANP) according to Stanislaw Burzynski is an [[unconventional cancer treatments|unconventional cancer treatment]] using so-called „antineoplaston remedies“. Burzynski invented the name for a group of peptides. The [[pseudomedicine|pseudomedical]] therapy is known in US since 1977, evidence for efficacy is not available as of yet. Several fatalities are associated with the therapy.<ref>http://www.ncahf.org/nl/1998/9-10.html</ref>, it is regarded as inappropriate for the treatment of cancer.<ref>Goldberg P, The Antineoplaston Anomaly: How a Drug Was Used for Decades in Thousands of Patients, With No Safety, Efficacy Data, The Cancer Letter 1998 vol 24, 36</ref><ref>http://www.quackwatch.com/01QuackeryRelatedTopics/Cancer/burzynski2.html</ref>  

The '''Antineoplaston-Therapy''' (ANP) according to Stanisław Burzyński is an [[unconventional cancer treatments|unconventional cancer treatment]] using so-called „antineoplaston remedies“. Burzyński invented the name for a group of peptides. The [[pseudomedicine|pseudomedical]] therapy is known in US since 1977, evidence for efficacy is not available as of yet. Several fatalities are associated with the therapy.<ref>http://www.ncahf.org/nl/1998/9-10.html</ref>, it is regarded as inappropriate for the treatment of cancer.<ref>Goldberg P, The Antineoplaston Anomaly: How a Drug Was Used for Decades in Thousands of Patients, With No Safety, Efficacy Data, The Cancer Letter 1998 vol 24, 36</ref><ref>http://www.quackwatch.com/01QuackeryRelatedTopics/Cancer/burzynski2.html</ref>  

Critics of the method must expect threats by marketers or users of this method.<ref>[http://www.quackometer.net/blog/2011/11/the-burzynski-clinic-threatens-my-family.html The Burzynski Clinic Threatens My Family.], Quackometer, 24. November 2011</ref>

Critics of the method must expect threats by marketers or users of this method.<ref>[http://www.quackometer.net/blog/2011/11/the-burzynski-clinic-threatens-my-family.html The Burzynski Clinic Threatens My Family.], Quackometer, 24. November 2011</ref>

==Stanislaw Burzynski==

==Stanisław Burzyński==

[[image:burzynski.jpg|Stanislaw Burzynski|right]]

[[image:burzynski.jpg|Stanisław Burzyński|right]]

Inventor is the physician Stanislaw Rajmund Burzynski (born January 23, 1943 in Lublin, Poland) living in Houston, Texas.<ref>[http://www.cancercontrolsociety.com/bio2002/burzynski.html Short biography Stanislaw Burzynski], accessed November 25, 2011</ref>). Burzynski claims to have achieved both M.D. and Ph.D. degrees in medicine in Lublin in 1967. These claims are dubitable since that university does not have a doctoral program. Additionally, his dissertation cannot be traced.<ref>[http://www.quackwatch.com/01QuackeryRelatedTopics/Cancer/burzynski1.html Stanislaw Burzynski and "Antineoplastons"], Saul Green, Ph.D., Quackwatch</ref><ref>[http://www.ratbags.com/rsoles/comment/burzynski.htm Comment and Opinion, Burzynski Research Institute], The Millenium Project, Peter Bowditch</ref>

Inventor is the physician Stanisław Rajmund Burzyński (born January 23, 1943 in Lublin, Poland) living in Houston, Texas.<ref>[http://www.cancercontrolsociety.com/bio2002/burzynski.html Short biography Stanisław Burzyński], accessed November 25, 2011</ref>). Burzyński claims to have achieved both M.D. and Ph.D. degrees in medicine in Lublin in 1967. These claims are dubitable since that university does not have a doctoral program. Additionally, his dissertation cannot be traced.<ref>[http://www.quackwatch.com/01QuackeryRelatedTopics/Cancer/burzynski1.html Stanisław Burzyński and "Antineoplastons"], Saul Green, Ph.D., Quackwatch</ref><ref>[http://www.ratbags.com/rsoles/comment/burzynski.htm Comment and Opinion, Burzynski Research Institute], The Millenium Project, Peter Bowditch</ref>

Burzynski migrated to the United States in 1970 and was employed at Baylor University in Houston, isolating peptides from rat brains for three years. He received a licence to practice medicine in USA in 1973 and was awarded a three-year grant to study the effects of urinary peptides as an assistant professor. When the grant was not renewed, Burzynski founded his own clinic in Houston.

Burzyński migrated to the United States in 1970 and was employed at Baylor University in Houston, isolating peptides from rat brains for three years. He received a licence to practice medicine in USA in 1973 and was awarded a three-year grant to study the effects of urinary peptides as an assistant professor. When the grant was not renewed, Burzyński founded his own clinic in Houston.

In 1994 Burzynski was convicted for tax insurance fraud.<ref>[ftp://www.ca5.uscourts.gov/pub/93/93-02071.CV0.wpd.pdf United States Court of Appeals, Fifth Circuit summary judgment], July 28, 1994</ref> The Texas Medical board summoned him for a hearing on April, 11 2012 which will debate the revocation of his medical licence.<ref>http://www.burzynskimovie.com/index.php?option=com_content&view=article&id=126 Burzynski moviesite, accessed November 26, 2011</ref>

In 1994 Burzyński was convicted for tax insurance fraud.<ref>[ftp://www.ca5.uscourts.gov/pub/93/93-02071.CV0.wpd.pdf United States Court of Appeals, Fifth Circuit summary judgment], July 28, 1994</ref> The Texas Medical board summoned him for a hearing on April, 11 2012 which will debate the revocation of his medical licence.<ref>http://www.burzynskimovie.com/index.php?option=com_content&view=article&id=126 Burzyński moviesite, accessed November 26, 2011</ref>

==Composition of Antineoplastons==

==Composition of Antineoplastons==

Antineoplastons are a group of organic chemical compounds which are usually found in urine and blood. They consist mostly of amino acids, the building blocks of proteins and peptides, compounds made of two or more amino acids.  

Antineoplastons are a group of organic chemical compounds which are usually found in urine and blood. They consist mostly of amino acids, the building blocks of proteins and peptides, compounds made of two or more amino acids.  

In 1985 he presented peptides which he called A1, A2, A3, A4 and A5. He detected that A2 had the highest effects on tumor cells and named its active ingredient A10. Chemically speaking, A10 is 3-N-phenylacetyl-amino-piperidine-2,6-dione. He developed the products AS&nbsp;2.5 and AS&nbsp;2.1 from this peptide. Burzynski first prepared them from human blood, later from human urine. He developed and patented a manufacturing process for the peptides allowing him to produce them without taking them from human urine. This method is based on synthesis of glutamine and phenylacetyl chloride. Since 1980, the preparation can thus be manufactured synthetically using inexpensive substances commercially available.<ref>ISBN 1-881025-09-8, Ralph Moss, "The Cancer Industry", 1996</ref><ref>[http://www.cancer.gov/cancertopics/pdq/cam/antineoplastons/patient/page2 Questions and Answers About Antineoplastons], National Cancer Institute</ref>

In 1985 he presented peptides which he called A1, A2, A3, A4 and A5. He detected that A2 had the highest effects on tumor cells and named its active ingredient A10. Chemically speaking, A10 is 3-N-phenylacetyl-amino-piperidine-2,6-dione. He developed the products AS&nbsp;2.5 and AS&nbsp;2.1 from this peptide. Burzyński first prepared them from human blood, later from human urine. He developed and patented a manufacturing process for the peptides allowing him to produce them without taking them from human urine. This method is based on synthesis of glutamine and phenylacetyl chloride. Since 1980, the preparation can thus be manufactured synthetically using inexpensive substances commercially available.<ref>ISBN 1-881025-09-8, Ralph Moss, "The Cancer Industry", 1996</ref><ref>[http://www.cancer.gov/cancertopics/pdq/cam/antineoplastons/patient/page2 Questions and Answers About Antineoplastons], National Cancer Institute</ref>

In alternative medicine, tributyrat PA and PB are known as a kind of preliminary version of Burzynski's antineoplastons.

In alternative medicine, tributyrat PA and PB are known as a kind of preliminary version of Burzyński's antineoplastons.

==The Therapy==

==The Therapy==

The therapy is available only from Burzynski at the "Burzynski Clinic" in West Houston, Texas. He offers the treatment as part of studies, since the compounds used are not approved. In order to qualify, a patient must have been non-respondent to standard therapies, or the tumour must have been rated incurable. The compound is either injected or taken orally. If a patient's condition improves due to intravenous adminstration, patients may switch to oral administration. During intravenous administration, antineoplastones must be given constantly, thus requiring a programmable pump which patients carry on them.

The therapy is available only from Burzyński at the "Burzynski Clinic" in West Houston, Texas. He offers the treatment as part of studies, since the compounds used are not approved. In order to qualify, a patient must have been non-respondent to standard therapies, or the tumour must have been rated incurable. The compound is either injected or taken orally. If a patient's condition improves due to intravenous adminstration, patients may switch to oral administration. During intravenous administration, antineoplastones must be given constantly, thus requiring a programmable pump which patients carry on them.

==Costs==

==Costs==

==Clinical Trials==

==Clinical Trials==

Burzynski and his assistants tried to prove clinical efficacy of antineoplastons with several clinical studies. The U.S. government register of clinical trials displays 60 entries (as of November 2011) by Burzynski's Research Institute.<ref>[http://clinicaltrials.gov/ct2/results?spons=%22Burzynski+Research+Institute%22&spons_ex=Y Overview: clinical surveys of Burzynski Research Institute]</ref> The studies are criticized by oncologists due to "flawed research methods" and rated "scientific nonsense".<ref>[http://www.highbeam.com/doc/1P1-19476029.html Oncologists criticize methods of controversial cancer treatment], Terri Langford, Associated Press, Oktober 1, 1998</ref><ref>[http://www.ncbi.nlm.nih.gov/pubmed/15061600 Alternative cancer cures: "unproven" or "disproven"?], Vickers A., PubMed</ref> Randomized, controlled surveys could not replicate the Burzynski's results. Between 1991 and 1995, more than a million dollars were spent on independent studies at Mayo Clinic and Memorial Sloan Kettering.<ref>[http://ict.sagepub.com/content/3/1/59.abstract Managing Social Conflict in Complementary and Alternative Medicine Research: The Case of Antineoplastons], Mitchell R. Hammer, PhD, Wayne B. Jonas, MD, doi: 10.1177/1534735404263448, Integr. Cancer Therapies March 2004 vol. 3 no. 1 59-65</ref><ref name="HoustonPress" /> The studies were cancelled prematurely for ethical reasons because of the method's poor efficacy.<ref>Burzynski SR, Efficacy of antineoplastons A10 and AS2-1, 1999 Mayo Clin. Proc., vol 74 6 Seiten 641-2 PMID 10377942</ref><ref>Buckner JC, Malkin MG, Reed E, Cascino TL, Reid JM, Maes MM, Tong WPY, LIM S, Figg WD: Phase II study of Antineoplaston A10 (NSC 648539) and AS 2-1 (NSC 620261) in patients with recurrent glioma. Mayo Clin Proc, 74, 137-145, 1999</ref>  

Burzyński and his assistants tried to prove clinical efficacy of antineoplastons with several clinical studies. The U.S. government register of clinical trials displays 60 entries (as of November 2011) by Burzynski Research Institute.<ref>[http://clinicaltrials.gov/ct2/results?spons=%22Burzynski+Research+Institute%22&spons_ex=Y Overview: clinical surveys of Burzynski Research Institute]</ref> The studies are criticized by oncologists due to "flawed research methods" and rated "scientific nonsense".<ref>[http://www.highbeam.com/doc/1P1-19476029.html Oncologists criticize methods of controversial cancer treatment], Terri Langford, Associated Press, Oktober 1, 1998</ref><ref>[http://www.ncbi.nlm.nih.gov/pubmed/15061600 Alternative cancer cures: "unproven" or "disproven"?], Vickers A., PubMed</ref> Randomized, controlled surveys could not replicate the Burzyński's results. Between 1991 and 1995, more than a million dollars were spent on independent studies at Mayo Clinic and Memorial Sloan Kettering.<ref>[http://ict.sagepub.com/content/3/1/59.abstract Managing Social Conflict in Complementary and Alternative Medicine Research: The Case of Antineoplastons], Mitchell R. Hammer, PhD, Wayne B. Jonas, MD, doi: 10.1177/1534735404263448, Integr. Cancer Therapies March 2004 vol. 3 no. 1 59-65</ref><ref name="HoustonPress" /> The studies were cancelled prematurely for ethical reasons because of the method's poor efficacy.<ref>Burzynski SR, Efficacy of antineoplastons A10 and AS2-1, 1999 Mayo Clin. Proc., vol 74 6 Seiten 641-2 PMID 10377942</ref><ref>Buckner JC, Malkin MG, Reed E, Cascino TL, Reid JM, Maes MM, Tong WPY, LIM S, Figg WD: Phase II study of Antineoplaston A10 (NSC 648539) and AS 2-1 (NSC 620261) in patients with recurrent glioma. Mayo Clin Proc, 74, 137-145, 1999</ref>  

In December 2007, FDA granted https://en.wikipedia.org/wiki/Orphan_drug orphan drug] status to Burzynski's concoctions for the treatment of gliomas, a group of brain tumors hard to treat.<ref name="HoustonPress">http://www.houstonpress.com/2009-01-01/news/cancer-doctor-stanislaw-burzynski-sees-himself-as-a-crusading-researcher-not-a-quack/</ref> In 2009, FDA issued a caution against the institute due to violations of regulations for the protection of patients.<ref>[http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/ucm192711.htm Warning letter FDA - Burzynski Research Institute / IRB]</ref>

In December 2007, FDA granted https://en.wikipedia.org/wiki/Orphan_drug orphan drug] status to Burzyński's concoctions for the treatment of gliomas, a group of brain tumors hard to treat.<ref name="HoustonPress">http://www.houstonpress.com/2009-01-01/news/cancer-doctor-stanislaw-burzynski-sees-himself-as-a-crusading-researcher-not-a-quack/</ref> In 2009, FDA issued a caution against the institute due to violations of regulations for the protection of patients.<ref>[http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/ucm192711.htm Warning letter FDA - Burzynski Research Institute / IRB]</ref>

An independent review by American Cancer Society also arrived at negative results and recommended  patients not to spend money on antineoplaston treatments since there is no evidence of positive effects in treatment of cancer. A 2004 medical review described this treatment as a "disproven therapy".<ref name="acs">[http://caonline.amcancersoc.org/cgi/reprint/33/1/57.pdf Antineoplastons] - American Cancer Society on Antineoplastons ''CA Cancer J Clin'' 1983;33;57-59, DOI: 10.3322/canjclin.33.1.57</ref>.

An independent review by American Cancer Society also arrived at negative results and recommended  patients not to spend money on antineoplaston treatments since there is no evidence of positive effects in treatment of cancer. A 2004 medical review described this treatment as a "disproven therapy".<ref name="acs">[http://caonline.amcancersoc.org/cgi/reprint/33/1/57.pdf Antineoplastons] - American Cancer Society on Antineoplastons ''CA Cancer J Clin'' 1983;33;57-59, DOI: 10.3322/canjclin.33.1.57</ref>.

==The movie "Burzynski - Cancer is Serious Business"==

==The movie "Burzynski - Cancer is Serious Business"==

In 2010, Eric Merola (a former director of TV commercials) did a movie "Burzynski - Cancer is Serious Business" which dealt with Burzynski's conflicts with authorities. Critics panned the film as one-sided, poorly produced propaganda promoting Burzynski's treatment. Village Voice commented:

In 2010, Eric Merola (a former director of TV commercials) did a movie "Burzynski - Cancer is Serious Business" which dealt with Burzyński's conflicts with authorities. Critics panned the film as one-sided, poorly produced propaganda promoting Burzyński's treatment. Village Voice commented:

:''violates every basic rule of ethical filmmaking: Merola interviews only Burzynski's supporters, produces no patient records other than the doctor's own, and offers no credible proof of the drug's success and no data about its side effects, even as he slams chemotherapy and radiation.''<ref>[http://www.villagevoice.com/2010-06-01/film/quack-quack-goes-burzynski/ QUACK-QUACK Goes Burzynski], Village Voice, June 1, 2010, accessed November 25, 2011</ref>  

:''violates every basic rule of ethical filmmaking: Merola interviews only Burzynski's supporters, produces no patient records other than the doctor's own, and offers no credible proof of the drug's success and no data about its side effects, even as he slams chemotherapy and radiation.''<ref>[http://www.villagevoice.com/2010-06-01/film/quack-quack-goes-burzynski/ QUACK-QUACK Goes Burzynski], Village Voice, June 1, 2010, accessed November 25, 2011</ref>