Antineoplaston - Revision history

WikiSysop at 19:17, 4 November 2015

2015-11-04T19:17:07Z

Halbmond: /* Legal Issues */

2014-12-17T10:48:20Z

Legal Issues

Halbmond at 09:41, 17 December 2014

2014-12-17T09:41:42Z

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Heimdall at 21:34, 30 November 2011

2011-11-30T21:34:19Z

Heimdall at 21:33, 30 November 2011

2011-11-30T21:33:34Z

Heimdall at 21:31, 30 November 2011

2011-11-30T21:31:36Z

Heimdall at 21:21, 30 November 2011

2011-11-30T21:21:35Z

Heimdall: More info

2011-11-30T21:14:17Z

More info

Heimdall at 16:33, 30 November 2011

2011-11-30T16:33:32Z

Halbmond at 15:30, 30 November 2011

2011-11-30T15:30:08Z

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 ==References==
 <references/>
-[[category:Miracle Therapy]]
+[[category:Miracle Therapy Cancer]]

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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.
-The Texas Medical board summoned Burzyński 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>
+The Texas Medical board summoned Burzyński 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> FDA had put a partial clinical hold on his clinical trials for pediatric patients which even was extended to all clinical trials six months later. FDA inspections of both Burzynski Clinic and Burzynski Research Institute followed in early 2013. However, FDA lifted these bans again in June 2013, despite damning inspection results establishing a rather sweeping non-compliance with FDA constraints by Burzynski. Meanwhile, the Texas Medical Board is again taking action against Burzynski. One of the latest additions to the list of trangressions, the TMB added the use of health care providers with little or no education or skill and representing them to patients as being doctors.<ref>http://www.sciencebasedmedicine.org/the-texas-medical-board-vs-stanislaw-burzynski-2014-edition/ </ref>
 ==Clinical Trials==

@@ Line 44: / Line 44: @@
 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>
-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>
+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>[http://www.cancer.gov/cancertopics/pdq/cam/antineoplastons/healthprofessional/page5 Antineoplastons - Human/Clinical Studies], National Cancer Institute, August 24, 2011</ref>
 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>

@@ Line 44: / Line 44: @@
 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>
-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>
+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>
 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>

@@ Line 24: / Line 24: @@
 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>
 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 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>
+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>
 *failure to practice medicine in an acceptable professional manner consistent with public health and welfare;

@@ Line 1: / Line 1: @@
 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 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>
+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 what is claimed to be 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==

@@ Line 1: / Line 1: @@
 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>
+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==
@@ Line 7: / Line 7: @@
 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.
 ==Composition of Antineoplastons==
@@ Line 22: / Line 20: @@
 ==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>
 ==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>
-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>
+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>
-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>.
+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>
-The products are not approved by FDA and may only be used as part of clinical studies.
+The products are not approved by FDA and may only be used as part of clinical trials.
 ==The movie "Burzynski - Cancer is Serious Business"==