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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>  
 
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 were threatened by a marketer of the method in 2011.<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><ref>[http://rhysmorgan.co/2011/11/threats-from-the-burzynski-clinic/ Threats from The Burzynski Clinic], Blog of Rhys Morgan, November 28, 2011</ref> After a public outrage, Burzynski's Clinic issued an apology and a statement that the marketer in question was not "in a professional relationship with the Burzynski Clinic" anymore. The press release confirmed the marketer had been contracted to "stop the dissemination of false and misleading information" about the antineoplaston therapy. Bloggers will be contacted by lawyers to remove false or misleading information.<ref>[https://docs.google.com/viewer?a=v&pid=explorer&chrome=true&srcid=0BzijOpjuex1bMjE4N2JjOGItZGFlOS00NDE0LTk2YzktMThkYjFiOTU2YjNl&hl=en_US&pli=1 Press Release], Burzynski Clinic, November 29, 2011, accessed November 30, 2011</ref>
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Critics of the method were threatened by a marketer of the method in 2011.<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><ref>[http://rhysmorgan.co/2011/11/threats-from-the-burzynski-clinic/ Threats from The Burzynski Clinic], Blog of Rhys Morgan, November 28, 2011</ref> After a public outrage, Burzynski's Clinic issued an apology and a statement that the marketer in question was not "in a professional relationship with the Burzynski Clinic" anymore. The press release confirmed the marketer had been contracted to "stop the dissemination of false and misleading information" about the antineoplaston therapy. Bloggers will be contacted by lawyers to remove false or misleading information.<ref name="press_release">[https://docs.google.com/viewer?a=v&pid=explorer&chrome=true&srcid=0BzijOpjuex1bMjE4N2JjOGItZGFlOS00NDE0LTk2YzktMThkYjFiOTU2YjNl&hl=en_US&pli=1 Press Release], Burzynski Clinic, November 29, 2011, accessed November 30, 2011</ref>
    
==Stanisław Burzyński==
 
==Stanisław Burzyński==
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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.
 
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.
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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==
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==Costs==
 
==Costs==
 
An according therapy is estimated at approximately $ 100,000 per year of treatment. Patients have to pay $ 6,000 prior to the start of treatment and instalments of $ 7,500 to $ 9,000 per month. Most insurance companies consider the therapy unproven and do not reimburse costs.<ref>Aetna Clinical Policy Bulletin, [http://aetna.com/cpb/medical/data/200_299/0240.html Antineoplaston Therapy and Sodium Phenylbutyrate]</ref><ref>Blue Cross/Blue Shield Medical Policy, [http://empireblue.com/provider/noapplication/f2/s5/t9/pw_ad084920.pdf Antineoplaston Therapy]</ref><ref>[http://www.zenosblog.com/2011/11/big-business-in-texas/ Big business in Texas], Zeno's Blog, November 26, 2011</ref>
 
An according therapy is estimated at approximately $ 100,000 per year of treatment. Patients have to pay $ 6,000 prior to the start of treatment and instalments of $ 7,500 to $ 9,000 per month. Most insurance companies consider the therapy unproven and do not reimburse costs.<ref>Aetna Clinical Policy Bulletin, [http://aetna.com/cpb/medical/data/200_299/0240.html Antineoplaston Therapy and Sodium Phenylbutyrate]</ref><ref>Blue Cross/Blue Shield Medical Policy, [http://empireblue.com/provider/noapplication/f2/s5/t9/pw_ad084920.pdf Antineoplaston Therapy]</ref><ref>[http://www.zenosblog.com/2011/11/big-business-in-texas/ Big business in Texas], Zeno's Blog, November 26, 2011</ref>
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==Legal Issues==
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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>
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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>
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In 2010 the Texas State Board of Medical Examiners filed a complaint against Burzyński.<ref>[http://www.ministryoftruth.me.uk/wp-content/uploads/2011/11/tmbvsburzynski.pdf, Complaint by the Texas Medical Board], December 8, 2010</ref> The complaint contains the following charges:<ref>[http://www.ministryoftruth.me.uk/2011/11/28/texas-medical-board-vs-burzynski/ Texas Medical Board vs Burzynski], Blog: Ministry of Truth, November 28. 2011</ref>
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*failure to practice medicine in an acceptable professional manner consistent with public health and welfare;
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*failure to meet the standard of care;
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*negligence in performing medical services;
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*failure to use professional diligence;
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*failure to safeguard against potential complications;
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*failure to disclose reasonably foreseeable side effects of a procedure or treatment;
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*failure to disclose reasonable alternative treatments to a proposed procedure or treatment;
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*failure to obtain informed consent from the patient or other person authorized by law to consent to treatment on the patient’s behalf before performing tests, treatments, or procedures; and
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*prescription or administration of a drug in a manner that is not in compliance with Chapter 200 of this title (relating to Standards for Physicians Practicing Complementary and Alternative Medicine) or, that is either not approved by the  ood and Drug Administration (FDA) for use in human beings or does not meet the standards for off-label use, unless an exemption has otherwise been obtained from the FDA.
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*unprofessional or dishonorable conduct that is likely to deceive or defraud the public or injure the public;
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*providing medically unnecessary services to a patient or submitting a billing statement to a patient or a third party payer that the licensee knew or should have known was improper. “Improper” means the billing statement is false, fraudulent, misrepresents services provided, or otherwise does not meet professional standards.
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The Texas Medical board summoned him for a hearing to be held 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>
    
==Clinical Trials==
 
==Clinical Trials==
 
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>  
 
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>  
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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>
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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>  
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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><ref>[www.cancer.gov/cancertopics/pdq/cam/antineoplastons/healthprofessional/page5">Antineoplastons - Human/Clinical Studies], National Cancer Institute, August 24, 2011</ref>
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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>.
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In a November 2011 press release Bursynski Clinic listed a "number of studies since 2006" claiming to prove efficacy of the treatment.<ref name="press_release" /> None of the studies was published in a paper with a high [http://en.wikipedia.org/wiki/Impact_factor impact factor] and most have not been peer reviewed at all. 9 studies are claimed to have been printed by the Journal of Neuro-Oncology which has a good impact factor but in truth were just presented as preliminary results at conferences that were covered by the journal. Contrary to the claim in the press release, there aren’t any scientific studies supporting antineoplason treatment since 2006.<ref>[http://freethoughtblogs.com/blaghag/2011/11/a-look-at-the-burzynski-clinics-publications/ A look at the Burzynski clinic’s publications], Jen McCreight, freethoughtblogs, November 29, 2011</ref><ref>[http://freethoughtblogs.com/blaghag/2011/11/more-damning-revelations-about-burzynskis-research/ More damning revelations about Burzynski’s “research”], Jen McCreight, freethoughtblogs, November 30, 2011</ref><ref>[http://www.ministryoftruth.me.uk/2011/11/30/burzynski-the-press-release/ Burzynski – The Press Release], Blog: Ministry of Truth, November 30. 2011</ref>
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The products are not approved by FDA and may only be used as part of clinical studies.
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The products are not approved by FDA and may only be used as part of clinical trials.
    
==The movie "Burzynski - Cancer is Serious Business"==
 
==The movie "Burzynski - Cancer is Serious Business"==
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