View source for Burzynski Clinic

{{Short description|Purveyor of unproven cancer treatments}}
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{{Infobox hospital
| name                  = Burzynski Clinic
| org/group             = 
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| image                 = 
| image_size            = 225 
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| coordinates           = <!-- {{coord|LAT|LON|type:landmark|display=inline,title}} -->
| location              = [[Houston]]
| region                = 
| state                 = Texas
| country               = USA
| healthcare            = <!-- UK: NHS; AU/CA: Medicare; ELSE free-form text, e.g. Private -->
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| affiliation           = 
| speciality            = Alternative cancer treatment
| opened                = 1976
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}}
The '''Burzynski Clinic''' is a clinic offering an unproven [[cancer treatment]], which has been characterized as harmful [[quackery]],<ref name=quackery/> and long-time Burzynski lawyer [[Richard Jaffe]] described a [[clinical trial]] as "a joke".<ref name="jaffe-book" /> It was founded in 1976 and is located in [[Houston]], Texas, in the United States. It offers a form of [[chemotherapy]] called "antineoplaston therapy" devised by the clinic's founder Stanislaw Burzynski in the 1970s. ''Antineoplaston'' is Burzynski's term for a group of urine-derived peptides, peptide derivatives, and mixtures. There is no accepted scientific evidence of benefit from antineoplaston combinations for various diseases.

The clinic has been the focus of criticism primarily due to the way its antineoplaston therapy is promoted, the costs for people with cancer participating in trials of antineoplastons and problems with the way these trials are run. Legal cases have been brought as a result of the sale of the therapy without regulatory approval.

Burzynski is also the president and founder of a pharmaceutical company, the '''Burzynski Research Institute''', which manufactures his antineoplaston drugs.<ref name="malisow-2008"/><ref name="sec-2011"/>

==Stanislaw Burzynski==
{{Infobox person
| name               = Stanislaw Burzynski
| image              = 
| alt                = 
| caption            = 
| birth_name         = Stanislaw Rajmund Burzynski
| birth_date         = {{Birth year and age |1943}}
| birth_place        = 
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| education          = {{Unbulleted|Medical Academy in Lublin, Poland (1967)|Ph.D. in biochemistry (1968)}}
| occupation         = 
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| notable_works      = 
| spouse             = {{marriage |Barbara Burzynski ||end=d. 2021}}
| children           = 3; Dr. Gregory Burzynski
}}

Stanislaw Rajmund Burzynski was born in 1943.<ref name="TMB-2023">{{cite web |title=Stanislaw Burzynski Physician profile |url=https://profile.tmb.state.tx.us/ |website=Texas Medical Board |access-date=13 January 2023}}</ref> In 1967, Burzynski graduated from the [[Medical University of Lublin|Medical Academy in Lublin]], Poland.<ref name="Smith1992">{{cite journal|journal=The Canadian Journal of Sociology|title=The Burzynski Controversy in the United States and in Canada: A Comparative Case Study in the Sociology of Alternative Medicine|first=Murray E. G.|last=Smith|year=1992|doi=10.2307/3341192|volume=17|issue=2|pages=133–160|jstor=3341192}}</ref><ref>{{Cite journal|doi=10.3322/canjclin.33.1.57|title=Unproven Methods of Cancer Management — Antineoplastons|journal=CA: A Cancer Journal for Clinicians|volume=33|issue=1|pages=57–59|year=1983|pmid=6401577|doi-access=free}}</ref> In 1968, he received another degree. Burzynski claims this degree was a Ph.D. in biochemistry, but cancer researcher Saul Green found evidence indicating he received a D.Msc (Doctor of Medical Science) after a one-year project and passing a test.<ref name="green-1992">{{cite journal |last1=Green |first1=Saul |title='Antineoplastons': An Unproved Cancer Therapy |journal=JAMA |date=3 June 1992 |volume=267 |issue=21 |pages=2924–2928 |doi=10.1001/jama.267.21.2924|pmid=1583762 }}</ref><ref name="green-quackwatch">{{cite web |last1=Green |first1=Saul |title=Stanislaw Burzynski and "Antineoplastons" |url=https://quackwatch.org/related/Cancer/burzynski1/ |website=Quackwatch |access-date=16 January 2023 |date=19 January 2013}}</ref><ref>Smith, p. 136 "He earned his Ph.D. in biochemistry with a thesis entitled 'Investigations on amino acids and peptides in blood serum of healthy people and patients with chronic renal insufficiency'."</ref>

Burzynski moved to the [[United States]] in 1970, working at [[Baylor College of Medicine]] until 1977 when he established the Burzynski Research Laboratory where he administered antineoplaston therapy, initially to 21 patients but then more widely as "experimental" treatment. This opened him up to "charges of unethical conduct and to the suspicion he had become a merchant of false hope", which led to several instances of media controversy.<ref name="Smith1992"/>{{rp|138}}

Burzynski incorporated his pharmaceutical company, the Burzynski Research Institute in 1984.<ref name="malisow-2008">{{cite news |last1=Malisow |first1=Craig |title=Cancer Doctor Stanislaw Burzynski Sees Himself as a Crusading Researcher, Not a Quack |url=http://www.houstonpress.com/2009-01-01/news/cancer-doctor-stanislaw-burzynski-sees-himself-as-a-crusading-researcher-not-a-quack/full/ |work=Houston Press |date=31 December 2008|archive-url=https://web.archive.org/web/20130512041636/http://www.houstonpress.com/2009-01-01/news/cancer-doctor-stanislaw-burzynski-sees-himself-as-a-crusading-researcher-not-a-quack/full/ |archive-date=2013-05-12 }}</ref><ref name="sec-2011">{{cite web |title=10K filing for the fiscal year ended February 28, 2011 |url=https://www.sec.gov/Archives/edgar/data/724445/000110465911032257/a11-13213_110k.htm |website=US Security and Exchange Commission |publisher=Burzynski Research Institute |access-date=9 January 2023}}</ref> Reviewers of his scientific papers have disputed the design of the trials and scientific validity of the published results.<ref name="vickers"/><ref name=rocco>{{cite journal|last=Di Rocco|first=C|date=December 2014|volume=30|issue=12|page=2063|title=Main editor's comment to the paper: the response and survival of children with recurrent diffuse intrinsic pontine glioma based on phase II study of antineoplastons A10 and AS2-1 in patients with brainstem glioma. Stanislaw R. Burzynski, Tomasz J. Janicki, Gregory S. Burzynski, Ania Marszalek.|doi=10.1007/s00381-014-2513-5|pmid=25096071|journal=Childs Nerv Syst|doi-access=free}}</ref><ref>{{cite journal|last=Blaskiewicz|first=Robert|url=http://www.brainlife.org/fulltext/2014/Blaskiewicz_R140822.pdf|date=24 July 2014|title=Comment to the paper: The response and survival of children with recurrent diffuse intrinsic pontine glioma based on phase II study of antineoplastons A10 and AS2-1 in patients with brainstem glioma|doi=10.1007/s00381-014-2514-4|pmid=25146834|volume=30|issue=12|journal=Childs Nerv Syst|pages=2067–8|s2cid=37195241|access-date=11 February 2015|archive-url=https://web.archive.org/web/20150211034505/http://www.brainlife.org/fulltext/2014/Blaskiewicz_R140822.pdf|archive-date=11 February 2015|url-status=dead}}</ref>

In February 2017, following lengthy hearings the Texas Medical Board recommended Burzynski's medical license be revoked, with the revocation suspended, and a fine of $360,000 for billing irregularities and other violations.<ref>{{Cite news|url=http://www.houstonpress.com/news/unorthodox-doc-stanislaw-burzynski-faces-360-000-fine-and-probation-9206755|title=Unorthodox Doc Stanislaw Burzynski Faces $360,000 Fine and Probation|last=Malisow|first=Craig|newspaper=[[Houston Press]]|date=17 February 2017}}</ref>

Burzynski was married to another medical doctor Barbara Burzynski until her death in 2021.<ref name="barbara-obit">{{cite news |author1=Burzynski family |title=Barbara Burzynski Obituary |url=https://www.legacy.com/us/obituaries/houstonchronicle/name/barbara-burzynski-obituary?id=17355429 |work=Legacy.com |agency=Houston Chronicle |date=28 August 2021}}</ref> They had three children, including Gregory Burzynski, who is also a medical doctor. Both Gregory and Barbara became board members of the Burzynski Research Institute and worked at the Burzynski Clinic.<ref name="sec-2021">{{cite web |author1=Burzynski Research Institute |title=10K filing for the fiscal year ended February 28, 2021 |url=https://www.sec.gov/Archives/edgar/data/724445/000110465921071200/tm2111726-1_10k.htm |website=US Security and Exchange Commission}}</ref><ref name="barbara-obit"/>

==Antineoplaston therapy==

''Antineoplaston'' is a name coined by Burzynski for a group of [[peptides]], peptide derivatives, and mixtures that he uses as an [[alternative cancer treatment]].<ref>{{cite journal|last1=Block|first1=Keith I.|title=Antineoplastons and the Challenges of Research in Integrative Care|journal=Integrative Cancer Therapies|volume=3|issue=1|pages=3–4|year=2004|pmid=15035867|doi=10.1177/1534735404263274|doi-access=free }}</ref> The word is derived from ''[[neoplasm]]''.<ref name="trials">{{cite journal|first1=Shannon|last1=Brownlee|first2=Gary|last2=Cohen|title=Trials of a Cancer Doc: Experimental drugs and a 20-year fight with the FDA|journal=U.S. News & World Report|pmid=10186429|url=https://www.usnews.com/usnews/news/articles/981005/archive_004873.htm|year=1998|volume=125|issue=13|pages=28–35}}</ref>

Although the therapy is promoted as natural and benign, it is in reality a form of [[chemotherapy]] with harmful side effects including severe [[neurotoxicity]].<ref name=quackery/>

Though Burzynski first injected patients with his peptides in 1977, antineoplastons have never been approved for general use. The compounds are not licensed as drugs but are instead sold and administered as part of clinical trials at the Burzynski Clinic and the Burzynski Research Institute.<ref>{{cite journal|pmid=9091754|year=1997|title=Lessons from antineoplaston|volume=349|issue=9054|page=741|journal=Lancet|doi=10.1016/S0140-6736(97)21011-1|last1=The Lancet|s2cid=54234406 |doi-access=free}}</ref><ref name="pmid16484713 ">{{Cite journal|last1=Burzynski|first1=S. R.|last2=Janicki|first2=T. J.|last3=Weaver|first3=R. A.|last4=Burzynski|first4=B.|title=Targeted Therapy with Antineoplastons A10 and AS2-1 of High-Grade, Recurrent, and Progressive Brainstem Glioma|doi=10.1177/1534735405285380|journal=Integrative Cancer Therapies|volume=5|issue=1|pages=40–47|year=2006|pmid=16484713|doi-access=free}}</ref><ref name="green-1992" />

Burzynski stated that he began investigating the use of antineoplastons after detecting what he considered significant differences in the presence of peptides between the blood of cancer patients and a control group.<ref name=Burzy1986>{{cite journal|last1=Burzynski|first1=SR|title=Antineoplastons: history of the research (I)|journal=Drugs Under Experimental and Clinical Research|volume=12|issue=Suppl 1|pages=1–9|year=1986|pmid=3527634}}</ref> He first identified antineoplastons from human blood. Since similar peptides had been isolated from urine, early batches of Burzynski's treatment were isolated from urine.<ref name=Burzy1986/> Burzynski has since produced the compounds synthetically.<ref>{{cite journal|last1=Marshall|first1=Eliot|title=The Politics of Alternative Medicine|journal=Science|volume=265|issue=5181|pages=2000–2002|year=1994|pmid=8091220|doi=10.1126/science.8091220|bibcode=1994Sci...265.2000M}}</ref>

The first active peptide fraction identified was called antineoplaston A-10 (3-phenylacetylamino-2,6-piperidinedione). From A-10, antineoplaston AS2-1 was derived – a 4:1 mixture of [[phenylacetic acid]] and [[phenylacetylglutamine]].<ref>NCI Drug Dictionary, [http://cancer.gov/Templates/drugdictionary.aspx?searchTxt=antineoplaston Definitions of antineoplastons A10 and AS2-1]</ref> The Burzynski Clinic website states that the active ingredient of antineoplaston A10-I is phenylacetylglutamine.<ref name="pmid16484713"/>

Since 2011, the clinic has marketed itself as offering "personalized gene-targeted cancer therapy", which has stirred further controversy. David Gorski argues that the concept of "personalised cancer therapy" is "more of a marketing term than a scientifically meaningful description".<ref name="SBM1">[http://www.sciencebasedmedicine.org/index.php/stanislaw-burzynskis-personalized-gene-targeted-cancer-therapy/ Dr. Stanislaw Burzynski's "personalized gene-targeted cancer therapy": Can he do what he claims for cancer?], David Gorski, Science Based Medicine</ref> According to Gorski, it appears unlikely that the Burzynski clinic would indeed be able to actually personalise gene-targeting therapies, i.e., "identify who would benefit from specific targeted therapies simply from blood tests," as Burzynski claims, since there are no proven methods to achieve this.<ref name="SBM1" /> Consequently, many reject Burzynski's claim of offering [[personalized medicine]], because in reality his patients are administered untested combinations of various approved and unapproved medications, without a sound rationale for a given combination and without "any concern for potential adverse reactions".<ref>David Gorski for Science-Based Medicine. December 12, 2011 [http://www.sciencebasedmedicine.org/stanislaw-burzynski-antineoplastons-and-the-orphan-drug-sodium-phenyl-butyrate/ Dr. Stanislaw Burzynski, antineoplastons, and the selling of an orphan drug as a cancer cure] Quote: " it’s not the concept of "personalized gene-targeted therapy" to which I object. It’s how Burzynski does it and how he corrupts the very concept through his "everything but the kitchen sink" approach to throwing "targeted" therapies at cancer patients willy-nilly without a systematic rationale for picking them or, it seems, any concern for potential adverse reactions due to combining drugs that have not been tested adequately in combination."</ref><ref>Sharon Hill for The Skeptical Inquirer. January 10, 2014 [http://www.csicop.org/specialarticles/show/burzynski_clinic_a_scientifical_year_of_fail/ Burzynski Clinic: A Scientifical Year Of Fail]</ref>

{{asof|2023}} the Clinic refreshed the branding of its offering to include the word 'immunotherapy' in an attempt to leverage the popular excitement around [[cancer immunotherapy]]. The treatment however remains the same, bogus, one using antineoplastons.<ref name=quack2023>{{cite web |vauthors=Gorski DH |publication=[[Science-Based Medicine]] |title=TCancer quack Stanislaw Burzynski continues to prey on cancer patients in 2023 |url=https://sciencebasedmedicine.org/cancer-quack-stanislaw-burzynski-continues-to-prey-on-cancer-patients-in-2023/ |date=18 September 2023}}</ref>

===Clinical trials===

{{For|definitions of clinical trial phases|clinical trial}}
According to the [[National Cancer Institute]], as of April 2013, "no phase III randomized, controlled trials of antineoplastons as a treatment for cancer have been conducted. Publications have taken the form of case reports, phase I clinical trials, toxicity studies, and phase II clinical trials",<ref>National Cancer Institute. [http://www.cancer.gov/cancertopics/pdq/cam/antineoplastons/healthprofessional/Page5#_47 Information for Professionals: Antineoplastons (PDQ®): Human/Clinical Studies] Updated: April 9, 2013. Page accessed March 14, 2015.</ref> and "for the most part, these publications have been authored by the developer of the therapy, Dr. Burzynski, in conjunction with his associates at the Burzynski Clinic. Although these studies often report remissions, other investigators have not been successful in duplicating these results."<ref name=NCIsummary>National Cancer Institute. [http://www.cancer.gov/cancertopics/pdq/cam/antineoplastons/healthprofessional/page7 Information for Professionals: Antineoplastons (PDQ®): Summary of the Evidence] Updated: April 9, 2013. Page accessed March 14, 2015.</ref>

From 1991 to 1995, the NCI initiated multiple phase II trials of antineoplastons. In 1995, after over $1&nbsp;million had been spent on these trials, they were stopped due to fundamental conflicts between NCI investigators and Burzynski and his employees, notably around Burzynski's insistence on approving all protocols in the NCI trial.<ref>{{cite journal|last1=Hammer|first1=Mitchell R.|last2=Jonas|first2=Wayne B.|title=Managing Social Conflict in Complementary and Alternative Medicine Research: The Case of Antineoplastons|journal=Integrative Cancer Therapies|date=March 2004|volume=3|issue=1|pages=59–65|doi=10.1177/1534735404263448|pmid=15035877|doi-access=free}}</ref>

Since the mid-1990s, Burzynski registered some sixty clinical trials of antineoplastons and, in December 2010, a Phase III trial that did not open for patient recruitment. The results of these trials are seldom published in reputable journals, and the few that have been do not cofirm the worth of the clinic's treatments.<ref>{{cite web |vauthors=Gorski DH |publisher=[[Science-Based Medicine]] |title=The Texas Medical Board lets Stanislaw Burzynski off lightly: A cautionary tale of the failure of regulating medicine |url=https://sciencebasedmedicine.org/texas-medical-board-lets-off-stanislaw-burzynski-lightly/ |date=6 March 2017}}</ref> The aim of registering so many trials, according to the 2008 book of long-time Burzynski lawyer Richard Jaffe, was to allow for treating any cancer Burzynski might want to treat.<ref name="jaffe-book"/>

The largest trial Burzynski registered was called CAN-1 and aimed to cover all clinic patients at that time. Jaffe wrote that CAN-1 was "a joke" of a clinical trial and explained the legal maneuvering:
{{quotation|The CAN-1 protocol had almost two hundred patients in it and there were at least a dozen different types of cancers being treated. And since all the patients were already on treatment, there could not be any possibility of meaningful data coming out of the so-called clinical trial. It was all an artifice, a vehicle we and the FDA created to legally give the patients Burzynski's treatment. The FDA wanted all of Burzynski's patients to be on an IND [Investigational New Drug (IND) Application], so that's what we did.<ref name="jaffe-book">{{cite book|last=Jaffe|first=Richard|title=Galileo's Lawyer: Courtroom Battles in Alternative Health, Complementary Medicine and Experimental Treatments|year=2008|publisher=Thumbs UP|location=Houston TX|isbn=978-0980118308|page=[https://archive.org/details/galileoslawyerco00jaff/page/107 107]|url-access=registration|url=https://archive.org/details/galileoslawyerco00jaff/page/107}}</ref><ref name="Szabo_11/15/2013" />}}

All trials were paused (no new patients allowed) following a 2013 FDA inspection which found (for the third consecutive time) significant issues with his Institutional Review Board, and, according to reporting published in November 2013, substantial issues with the conduct of both the clinic and Burzynski as principal investigator.<ref name="Szabo_11/15/2013">{{cite web | last=Szabo | first=Liz | title=Doctor accused of selling false hope to families | website=[[USA Today]] | date=November 15, 2013 | url=https://www.usatoday.com/story/news/nation/2013/11/15/stanislaw-burzynski-cancer-controversy/2994561/ | access-date=March 14, 2023}}</ref>

===Efficacy===

Although Burzynski and his associates claim success in the use of antineoplaston combinations for the treatment of various diseases, and some of the clinic's patients say they have been helped,<ref name=ACS1 /> there is no [[clinical trial|clinical evidence]] of the [[efficacy]] of these methods. The consensus among the professional community, as represented by the [[American Cancer Society]]<ref name=ACS1/> and [[Cancer Research UK]]<ref name="cancer-uk"/> is that antineoplaston therapy is unproven, and the overall probability of the treatment turning out to be as claimed is low due to lack of credible mechanisms and the poor state of research after more than 35 years of investigation. Antineoplaston treatments have significant known side effects including severe [[neurotoxicity]].<ref>National Cancer Institute. [http://www.cancer.gov/cancertopics/pdq/cam/antineoplastons/healthprofessional/page1 Information for Professionals: Antineoplastons (PDQ®): Overview] Updated: April 9, 2013. Page accessed March 14, 2015.</ref><ref name="gorski-four-decades"/>

Independent scientists have been [[reproducibility|unable to reproduce]] the positive results reported in Burzynski's studies: NCI observed that researchers other than Burzynski and his associates have not been successful in duplicating his results,<ref name=NCIsummary/> and Cancer Research UK states that "available scientific evidence does not support claims that antineoplaston therapy is effective in treating or preventing cancer."<ref name="cancer-uk">{{cite web|publisher=[[Cancer Research UK]]|title=Antineoplaston therapy|url=https://www.cancerresearchuk.org/about-cancer/treatment/complementary-alternative-therapies/individual-therapies/antineoplaston-therapy|access-date=February 12, 2023}}</ref>

There is no convincing evidence from [[randomized controlled trial]]s in the [[scientific literature]] that antineoplastons are useful treatments of cancer, and the U.S. [[Food and Drug Administration]] (FDA) has not approved these products for the treatment of any disease.<ref>{{cite web |publisher=National Cancer Institute |url=https://www.cancer.gov/about-cancer/treatment/cam/patient/antineoplastons-pdq|title=Antineoplastons (PDQ®) |type=Patient Version |date=15 August 2019 }}</ref> The American Cancer Society has stated since 1983 that there is no evidence that antineoplastons have any beneficial effects on cancer and recommended that people not buy these products since there could be serious health consequences.<ref name=ACS1>{{cite web|url=http://www.cancer.org/treatment/treatmentsandsideeffects/complementaryandalternativemedicine/pharmacologicalandbiologicaltreatment/antineoplaston-therapy|archive-url=https://web.archive.org/web/20100721031005/http://www.cancer.org/Treatment/TreatmentsandSideEffects/ComplementaryandAlternativeMedicine/PharmacologicalandBiologicalTreatment/antineoplaston-therapy|archive-date=July 21, 2010|url-status=dead|title=Antineoplaston Therapy|date=November 2008|access-date=September 5, 2016|publisher=American Cancer Society}}</ref><ref>{{cite journal|title=Antineoplastons|journal=CA|volume=33|issue=1|pages=57–9|year=1983|pmid=6401577|doi=10.3322/canjclin.33.1.57|doi-access=free}}</ref> A 2004 medical review described antineoplaston treatment as a "disproven therapy".<ref name="vickers">{{cite journal|last1=Vickers|first1=A.|title=Alternative Cancer Cures: 'Unproven' or 'Disproven'?|journal=CA|volume=54|issue=2|pages=110–8|year=2004|doi=10.3322/canjclin.54.2.110|pmid=15061600|citeseerx=10.1.1.521.2180|s2cid=35124492}}</ref>

In 1998, three [[oncology|oncologists]] were enlisted by the weekly Washington newsletter ''The Cancer Letter'' to conduct independent reviews of Burzynski's clinical trial research on antineoplastons. They concluded that the studies were poorly designed, not interpretable, and "so flawed that it cannot be determined whether it really works". One of them characterized the research as "scientific nonsense".<ref>{{cite news|first=Terri|last=Langford|date=October 1, 1998|url=http://www.highbeam.com/doc/1P1-19476338.html|archive-url=https://web.archive.org/web/20140611030012/http://www.highbeam.com/doc/1P1-19476338.html|url-status=dead|archive-date=June 11, 2014|title=Oncologists criticize methods of controversial cancer treatment|agency=Associated Press}}</ref> In addition to questioning Burzynski's research methods, the oncologists found significant and possibly life-threatening toxicity in some patients treated with antineoplastons.<ref>{{cite news|title=The Antineoplaston Anomaly: How a Drug Was Used for Decades in Thousands of Patients, With No Safety, Efficacy Data|url=http://www.quackwatch.org/01QuackeryRelatedTopics/Cancer/burzynski2.html|access-date=August 26, 2012|newspaper=The Cancer Letter|date=September 25, 1998}}</ref>

In 2018 an article in ''[[The Lancet Oncology]]'' said "This quackery has continued for 40 years and caused serious harm to desperate patients. Enough is enough!".<ref name=quackery>{{cite journal |vauthors=Figg WD |title=Antineoplastons: when is enough enough? |journal=Lancet Oncol |volume=19 |issue=6 |pages=733–734 |date=June 2018 |pmid=29893248 |doi=10.1016/S1470-2045(18)30338-3 |s2cid=48359789 |url=}}</ref>

===Cost===

According to the American Cancer Society, "Treatment can cost from $7,000 to $9,500 per month or more, depending on the type of treatment, number of consultations, and the need for surgery to implant a catheter for drug delivery. Available information suggests that health insurance plans often do not reimburse costs linked to this treatment."<ref name=ACS1/> As of March 2015, the Burzynski Clinic required patients to provide a deposit before treatment starts, and their website informed patients that "Since we are classified as 'out of network' we are unable to accept Medicare, Medicaid and any HMO insurance."<ref>Burzynski Clinic [http://www.burzynskiclinic.com/preparing-for-your-appointment.html Preparing for your appointment] Page accessed March 15, 2014</ref>

Recent criticism has focused on the use of [[crowdfunding]] to raise the costs of quack treatments, including specifically hundreds of thousands of dollars in the case of the Burzynski Clinic.<ref>{{cite web|last1=Cara|first1=Ed|title=Crowdfunding Sites Are Putting Money in the Pockets of Cancer Quacks, Report Finds|url=https://gizmodo.com/crowdfunding-sites-are-putting-money-in-the-pockets-of-1829004277 |website=Gizmodo|date=12 September 2018 |access-date=10 December 2018}}</ref><ref>{{Cite journal|last=Newman|first=Melanie|date=12 September 2018|title=Is cancer fundraising fuelling quackery?|url=https://www.bmj.com/content/362/bmj.k3829|journal=BMJ|volume=362|page=k3829|doi=10.1136/bmj.k3829|s2cid=52193362|issn=1756-1833}}</ref><ref>{{Cite web|url=https://sciencebasedmedicine.org/crowdfunding-the-fuel-for-cancer-quackery/|title=Crowdfunding: The fuel for cancer quackery|date=17 September 2018|website=Science-Based Medicine|access-date=12 January 2019}}</ref><ref>{{Cite web|url=https://arstechnica.com/science/2018/09/crowdfunding-raises-millions-for-quack-cancer-remedies-like-coffee-enemas/|title=Crowdfunding raises millions for quack cancer remedies, like coffee enemas|last=Mole|first=Beth|date=20 September 2018|website=Ars Technica|access-date=12 January 2019}}</ref>

== Legal issues ==

===FDA warnings===

In 1978, FDA representatives warned Burzynski that he was violating federal law because he was not administering antineoplastons in the context of a clinical trial.<ref name="malisow-2008"/> In 1981, FDA wrote in a letter, "the FDA advises persons who inquire about Burzynski’s alleged cure that we do not believe the drug is fit for administration to humans and that there is no reason to believe Dr. Burzynski has discovered an effective cure for cancer."<ref name="macleans-1982">{{cite news |last1=Carlos |first1=Jackie |title=An unproven treatment with a high cost |publisher=Macleans |date=27 December 1982 |url=https://archive.macleans.ca/article/1982/12/27/an-unproven-treatment-with-a-high-cost|archive-url=https://archive.today/20221226213715/https://archive.macleans.ca/article/1982/12/27/an-unproven-treatment-with-a-high-cost |archive-date=26 December 2022 |location=Ontario, Canada}}</ref>

In 1996, Burzynski's use and advertising of antineoplastons as an unapproved cancer therapy were deemed to be unlawful by the U.S. FDA and the [[Texas Attorney General]],<ref>[http://www.3rdcoa.courts.state.tx.us/opinions/HTMLopinion.asp?OpinionID=847 Texas State Board of Medical Examiners, Appellant v. Stanislaw R. Burzynski, M.D., Ph.D., Appellee]{{webarchive|url=https://web.archive.org/web/20110928111650/http://www.3rdcoa.courts.state.tx.us/opinions/HTMLopinion.asp?OpinionID=847|date=September 28, 2011}} Court judgment</ref><ref>[http://openjurist.org/819/f2d/1301/united-states-v-burzynski-cancer-research-institute-r 819 F.2d 1301] 1987 judgment</ref> and limits on the sale and advertising of the treatment were imposed as a result.

In 2009, the [[FDA Warning Letter|FDA issued a warning letter]] to the Burzynski Research Institute, stating that an investigation had determined the Burzynski [[Institutional Review Board]] (IRB) "did not adhere to the applicable statutory requirements and FDA regulations governing the [[Human subject research|protection of human subjects]]." It identified a number of specific findings, among them that the IRB had approved research without ensuring risk to patients was minimized, had failed to prepare required written procedures or retain required documentation, and had failed to conduct required continuing reviews for studies, among others. The institute was given fifteen days to identify the steps it would take to prevent future violations.<ref>{{cite web|title=2009 Burzynski Research Institute Warning Letter |publisher=U.S. Food and Drug Administration|url=https://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2009/ucm192711.htm|access-date=November 22, 2011}}</ref>

Another warning issued in October 2012 notes that the Burzynski Clinic is advertising investigational drugs as being "safe and effective", noting: {{quotation|Promotion of an investigational new drug is prohibited under FDA regulations at 21 CFR 312.7(a), which states, "A sponsor or investigator, or any person acting on behalf of a sponsor or investigator, shall not represent in a promotional context that an investigational new drug is safe or effective for the purposes for which it is under investigation or otherwise promote the drug. This provision is not intended to restrict the full exchange of scientific information concerning the drug, including dissemination of scientific findings in scientific or lay media. Rather, its intent is to restrict promotional claims of safety or effectiveness of the drug for a use for which it is under investigation and to preclude commercialization of the drug before it is approved for commercial distribution."<br /><br />The websites, including the posted press releases and embedded videos, contain claims such as the following that promote Antineoplastons as safe and/or effective for the purposes for which they are being investigated or otherwise promote the drugs. [...] Since Antineoplastons are investigational new drugs, the products' indication(s), warnings, precautions, adverse reactions, and dosage and administration have not been established and are unknown at this time. Promoting Antineoplastons as safe and effective for the purposes for which they are under investigation, by making representations such as those noted above, is in violation of 21 CFR 312.7(a).|FDA enforcement letter|[https://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/EnforcementActivitiesbyFDA/WarningLettersandNoticeofViolationLetterstoPharmaceuticalCompanies/UCM326631.pdf Original]}}

The letter requires cessation of non-compliant promotional activities, including the use of testimonials and promotional interviews with Burzynski himself.<ref>[http://scienceblogs.com/insolence/2012/11/07/stanislaw-burzynski-slapped-down-by-the-fda-once-again/ Respectful Insolence], ScienceBlogs, November 7, 2012</ref>

In June 2012, antineoplaston trials were paused following the death of a child patient. In January and February 2013, the FDA inspected Burzynski and his IRB in Houston. In December 2013, the FDA issued its findings in warning letters to Burzynski, expressing "concerns about subject safety and data integrity, as well as concerns about the adequacy of safeguards in place at your site to protect patients...."<ref name="Szabo_12/11/2013">{{cite web | last=Szabo | first=Liz | title=FDA issues warning to controversial Houston cancer doctor | website=[[USA Today]] | date=December 11, 2013 | url=https://www.usatoday.com/story/news/nation/2013/12/11/fda-issues-warning-to-controversial-houston-cancer-doctor/3990623/ | access-date=March 14, 2023}}</ref>

In November 2013 the FDA released the observational notes from an inspection of Burzynski as a principal investigator that took place between January and March 2013. Among the findings were "[failure] to comply with protocol requirements related to the primary outcome, therapeutic response [...], for 67% of study subjects reviewed during the inspection", admitting patients who failed to meet inclusion criteria, failing to stop treatment when patients had severe toxic reactions to antineoplastons, and failure to report all adverse events. Further, the FDA told Burzynski, "You failed to protect the rights, safety, and welfare of subjects under your care. Forty-eight (48) subjects experienced 102 investigational overdoses between January 1, 2005 and February 22, 2013 [...] There is no documentation to show that you have implemented corrective actions during this time period to ensure the safety and welfare of subjects.” The FDA also observed that Burzynski had denied patients informed consent by not informing them of extra costs that they might incur during treatment and that he could not account for his stock of the investigational drug. Lastly, the FDA observed: "Your [...] tumor measurements initially recorded on worksheets at baseline and on-study treatment [...] studies for all study subjects were destroyed and are not available for FDA inspectional review", meaning that there was no way for the FDA to verify either initial tumor sizes or effects that the antineoplastons may have had.<ref name="Szabo_11/15/2013" /><ref>{{cite news|last=Lipson|first=Peter|title=FDA Documents Paint Disturbing Picture of Burzynski Cancer Clinic|url=https://www.forbes.com/sites/peterlipson/2013/11/11/fda-documents-paint-disturbing-picture-of-burzynski-cancer-clinic/|work=[[Forbes]]|access-date=November 14, 2013}}</ref><ref>{{cite web|last=Gorski|first=David|title=Revealed by the FDA: The results of the most recent inspection of the Burzynski Clinic|url=http://www.sciencebasedmedicine.org/revealed-by-the-fda-the-results-of-the-most-recent-inspection-of-the-burzynski-clinic/|publisher=Science Based Medicine|access-date=14 November 2013|date=11 November 2013}}</ref><ref>{{Cite web|url=https://www.fda.gov/downloads/AboutFDA/CentersOffices/OfficeofGlobalRegulatoryOperationsandPolicy/ORA/ORAElectronicReadingRoom/UCM373967.pdf|title=FDA Inspection Letter|website=[[Food and Drug Administration]]}}</ref>

In Burzynski's written response to the 2013 FDA investigation, he states that the investigators '"complied with all criteria for evaluation of response and made accurate assessments for tumor response."'<ref name="Szabo_11/15/2013" />

In December 2013, the FDA issued two warning letters, one to the Burzynski Institutional Review Board and one to Burzynski, the subjects of the investigations in February. The FDA found that Burzynski and the IRB had largely failed to address the concerns identified in the initial observation reports. The letter to Burzynski noted serious problems with patient medical files with respect to a pediatric patient who died while treated by Burzynski<ref name="Szabo_12/11/2013" /> and whose death apparently initiated the investigation.<ref>{{cite web|title=Inspections, Compliance, Enforcement, and Criminal Investigations|url=https://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2013/ucm378237.htm|publisher=FDA|access-date=December 12, 2013}}</ref>

On March 23, 2014, ''USA Today'' reported that the FDA had decided to permit "a handful" of cancer patients to receive Burzynski's treatment provided that the patients did not receive the treatment directly from him.<ref>{{cite news|title=FDA agrees to let patients get controversial drug|url=https://www.usatoday.com/story/news/nation/2014/03/21/burzynski-cancer-patients-fda-drug/6711697/|work=USA Today|first1=Liz|last1=Szabo|date=March 21, 2014}}</ref>

[[David Gorski]] wrote in 2014 that over four decades the FDA and state medical boards have been unable to shut down Burzynkski's business selling unproven treatments – "these organizations are supposed to protect the public from practitioners like Burzynski, but all too often they fail at their charges, in this case spectacularly."<ref name="gorski-four-decades">{{cite journal|title=Stanislaw Burzynski: four decades of an unproven cancer cure|author=Gorski D.|author-link=David Gorski|journal=Skeptical Inquirer|year=2014|volume=38|issue=2|page=36|url=https://skepticalinquirer.org/2014/03/stanislaw-burzynski-four-decades-of-an-unproven-cancer-cure/}}</ref>

The Burzynski Clinic has also made use of [[Expanded access|expanded access petitions]], also known as compassionate use exemptions. According to an investigative report by STAT News published in August 2016, the clinic has benefited by politicians who lobbied the FDA to allow Burzynski to sell antineoplastons to families of patients with terminal diagnoses. According to FDA documents obtained by STAT, "From 2011 to 2016, 37 members of Congress wrote to the FDA about Burzynski. [...] Most of the lawmakers asked the agency to grant constituents 'compassionate use exemptions' so that they could try his unapproved drugs, or to allow his clinical trials to proceed."<ref name="statnews-2016">{{cite news|title=To help cancer patients, lawmakers pushed access to a controversial doctor|url=https://www.statnews.com/2016/08/29/stanislaw-burzynski-cancer-treatment-congress/|last=Kaplan|first=Sheila|date=August 29, 2016|work=STAT News|publisher=[[Boston Globe Media]]}}</ref> According to Burzynski, "interventions by lawmakers were helpful."<ref name="statnews-2016"/> According to STAT, critics state that "the congressional advocacy risks giving the terminally ill and their families a false sense of hope, while also conferring a measure of legitimacy on him that many believe he does not deserve."<ref name="statnews-2016"/>

However, FDA expanded access petitions were not always granted. Burzynski attempted to avoid FDA oversight by recruiting patients under Texas's [[Right-to-try law|"Right to try" law]], which was passed in 2015.<ref name="statnews-2016"/><ref name=quackery/><ref name="raps-2017">{{cite news |last1=Brennan |first1=Zachary |title=Who's Actually Using 'Right-To-Try' Laws? A Texas Oncologist Explains his Experience |url=https://www.raps.org/regulatory-focus%E2%84%A2/news-articles/2017/8/who-s-actually-using-right-to-try-laws-a-texas-oncologist-explains-his-experience |access-date=11 January 2023 |work=Regulatory Focus |publisher=Regulatory Affairs Professionals Society |date=4 August 2017}}</ref>

===Texas Medical Board===

In December 2010, the use of [[chemotherapy|chemotherapeutic agents]] by the clinic has been characterized as "random" and their use of unapproved combinations "with no known benefits but clear harms" by the [[Texas Medical Board]], which regulates and licenses physicians in the state of Texas, led to a case against Burzynski by that board. Burzynski was acquitted because he had not personally written the prescriptions.<ref name="Szabo_11/15/2013" />

In July 2014, the board filed a 202-page complaint against Burzynski to the Texas State Office of Administrative Hearings.<ref name="tmb-2014">{{citation|title=Hearing Conducted by the Texas State Office of Administrative hearings|url=https://www.scribd.com/embeds/234000288/content|publisher=Texas Medical Board|date=July 10, 2014}} SOAH Docket No. 503-12-1342</ref><ref>{{cite news|title=Texas Medical Board files 202-page complaint against cancer "cure" being used in NH|last=Brooks|first=David|url=http://www.nashuatelegraph.com/granitegeek/1041667-468/texas-medical-board-files-202-page-complain-against.html|date=July 14, 2014|work=Nashua Telegraph|access-date=July 20, 2014}}</ref> The complaint addressed allegations by the Board including misleading patients into paying exorbitant charges,<ref name="tmb-2014"/>{{rp|2}} misrepresenting unlicensed persons to patients as licensed medical doctors,<ref name="tmb-2014"/>{{rp|2,4–6,28–31,50–53}} and misleading patients into accepting care from providers without significant education or training related to cancer treatment.<ref name="tmb-2014"/>{{rp|2}} Citing examples of problems with 29 patients, which were listed in the document, the board said that "unapproved combinations of highly toxic chemotherapy" were prescribed "in ways that caused harm to several patients."<ref>{{cite news|last=Szabo|first=Liz|title=Texas medical board charges controversial cancer doctor|publisher=USA Today|date=July 24, 2014|url=https://www.usatoday.com/story/news/nation/2014/07/24/new-charges-for-burzynski/13111483/|access-date=July 24, 2014}}</ref> In July 2015, Burzynski's counsel, Richard Jaffe, withdrew from the case citing a potential conflict of interest,<ref>{{citation|title=Order no. 26 – Finding mandatory basis for attorney withdrawal|url=https://www.scribd.com/doc/288010171/Order-No-26-Finding-Mandatory-Basis-for-Attorney-Withdrawal|date=August 26, 2015|publisher=[Texas] State Office of Administrative Hearings}} SOAH Docket No. 503-14-1342.MD</ref> a result of Jaffe's pursuing actions against Burzynski in bankruptcy court.<ref>{{citation|title=Board staff response to respondent's motion for continuance of hearing on the merits and to modify order no. 27|url=https://www.scribd.com/doc/288010206/Board-Staff-Response-to-Respondent-s-Motion-for-Continuance-of-Hearing-on-the-Merits-and-to-Modify-Order-No-27|date=October 23, 2015|publisher=State Office of Administrative Hearings}} SOAH Docket No. 503-14-1342.MD</ref> With the addition of replacement counsel, the hearing was set to begin in November 2015.<ref>{{citation|title=Order no. 27 – Summarizing August 26. 2015 prehearing conference and modifying the dates for the hearing on the merits|url=https://www.scribd.com/doc/288010191/Order-No-27-Summarizing-August-26-2015-Prehearing-Conference-and-Modifying-the-Dates-for-the-hearing-on-the-Merits|date=September 2, 2015|publisher=[Texas] State Office of Administrative Hearings}} SOAH Docket No. 503-14-1342.MD</ref>

In November 2015, the Texas Medical Board took Burzynski to court in Houston, Texas. Burzynski was accused of [[bait-and-switch]] tactics, improperly charging patients, not informing patients that he owns the pharmacy they were required to use to fill their medications, and of [[off-label use|off-label prescribing]] of drugs. Burzynski's former attorney Richard Jaffe has filed suit in Federal Court claiming unpaid legal fees of over $250,000. Burzynski through his current attorney denied all charges.<ref>{{cite news|last1=Szabo|first1=Liz|title=Controversial Texas doctor Stanislaw Burzynski goes before disciplinary board|url=https://www.usatoday.com/story/news/2015/11/19/controversial-texas-doctor-stanislaw-burzynski-goes-before-disciplinary-board/76006572/|work=USA Today|date=19 November 2015|access-date=29 November 2015}}</ref>

On March 3, 2017, the Texas Medical Board sanctioned Burzynski, placing him on probation and fining him $40,000.<ref name="Chang2017a">{{cite news|last1=Chang|first1=Julie|title=Texas Medical Board sanctions controversial cancer doctor Burzynski|url=http://www.mystatesman.com/news/texas-medical-board-sanctions-controversial-cancer-doctor-burzynski/L9lDsfNTbBOuaWWqLEDBUI/|access-date=1 April 2017|work=[[Austin American-Statesman]]|date=3 March 2017}}</ref> After being sanctioned for over 130 violations, he was allowed to keep his medical license and to continue to practice.<ref>{{cite journal|last1=Blaskiewicz|first1=Robert|title=Burzynski Sanctioned by Texas Medical Board|journal=[[Skeptical Inquirer]]|date=2017|volume=41|issue=4|pages=7–8}}</ref> Staff recommendations had been more punitive.<ref name="Chang2017a"/><ref name="TMB_2/15/2017">{{cite news | author=Texas Medical Board | title=In the Matter of the Complaint Against Stanislaw Rajmund Burzynski, M.D. SOAH Docket No, 503-14-1342, MD | newspaper=[[Houston Press]] | date=February 15, 2017 | url=http://houstonpress.com/media/pdf/232_final_order.pdf | access-date=March 14, 2023 | archive-url=https://web.archive.org/web/20220128125158/http://houstonpress.com/media/pdf/232_final_order.pdf | archive-date=January 28, 2022 | url-status=dead}}</ref> Probation terms included additional medical training, disclosure of the Board's ruling to patients and medical facilities, and monitoring of his patient records.<ref>{{cite news|last1=Chang|first1=Julie|title=Texas Medical Board sanctions controversial cancer doctor Burzynski|url=http://www.statesman.com/news/texas-medical-board-sanctions-controversial-cancer-doctor-burzynski/sxUP7GZ8XbYR4KzPTH5aCJ/|access-date=1 April 2017|work=[[Austin American-Statesman]]|date=3 March 2017}}</ref>

===Lawsuits===

In 1983, a federal court issued an injunction against Burzynski, barring him from shipping antineoplastons in [[interstate commerce]] without FDA approval. Burzynski continued to use antineoplastons and was charged with 75 federal counts of mail fraud and violations of federal drug laws. In 1994, a 20-day trial resulted in the dismissal of the 34 counts of mail fraud. On the other 41 counts, the jury deadlocked, failing to come to a verdict.<ref name="MaxwellMayo">Larry A. "Max" Maxwell & Thomas Win. Mayo, [https://scholar.smu.edu/cgi/viewcontent.cgi?article=1600&context=smulr Health Care Law], ''SMU Law Review'', Vol. 50, issue 2 (Annual Survey of Texas Law), pp. 1291–92.</ref> In a separate [[Administrative law|administrative proceeding]], the Texas State Board of Medical Examiners charged Burzynski with violations of Texas state law relating to his use of antineoplastons. An [[administrative law judge]] ruled that Burzynski violated a section of the Texas Health and Safety Code dealing with prescriptions for unapproved drugs. The [[Texas Court of Appeals]] ultimately upheld this determination in a 1996 decision.<ref name="MaxwellMayo"/>

In 1994, the United States Court of Appeals for the Fifth Circuit affirmed a lower court decision that Burzynski had defrauded a health insurance fund into reimbursing about $90,000 for antineoplaston treatment. The appeals court ruled that Burzynski "may not trick the plaintiff into paying for an unlawful, unapproved drug."<ref>{{cite court |litigants=Trustees of the Northwest Laundry & Dry Cleaners Health & Welfare Trust Fund v. Stanislaw R. Burzynski |opinion=93-2071. |court= 5th Cir.|date=28 July 1994 |url=http://www.ca5.uscourts.gov/Opinions/pub/93/93-02071.CV0.wpd.pdf |website=US Courts |quote= |postscript= }}</ref><ref name="houston-chronicle-1995-04-18">{{cite news |last1=Sorelle |first1=Ruth |last2=Deborah |first2=Tedford |title=Grand jury panel hears controversial physician |work=Houston Chronicle |date=18 April 1995}}</ref>

In 1998, a federal judge ordered that Burzynski repay an insurance company over $200,000 he charged six patients for his unapproved treatments. The judge concluded that Burzynski was "unjustly enriched" by the insurance payments, but that the violations did not rise to fraud or misrepresentation.<ref name="AP-1998-04-11">{{cite news |title=Judge orders Burzynski to reimburse insurance carrier |agency=Associated Press Newswires |date=11 August 1998}}</ref><ref>{{cite court |litigants=Provident Life & Accident Insurance Company v. Stanislaw R. Burzynski, M.D., and Burzynski Research Institute, Inc. |vol= |reporter= |opinion= |pinpoint= |court=S.D. Tex. |date=7 Aug 1998 |quote=Provident has failed to show that Burzynski committed fraud or engaged in actionable negligent misrepresentation with respect to Medow, McKeeby, or Hadley, due to a lack of justifiable reliance on the part of Provident. It has, however, shown that Burzynski was unjustly enriched by the payments made to him for the treatment of these patients. Accordingly, Provident is entitled to restitution for its payments made to Burzynski on behalf Medow, McKeeby, and Hadley.}}</ref>

In 1998, the parents of a 10-year-old girl with brain cancer sued Burzynski for fraud, saying he had misled them about the efficacy of his treatments. The girl, Christina Bedient, died of cancer after being treated with antineoplastons in 1996.<ref name="trials"/><ref name="family-sues">{{cite news |last1=Nissimov |first1=Ron |title=Family sues Burzynski in girl's cancer death |work=Houston Chronicle |date=11 July 1998}}</ref> Burzynski settled the suit by refunding some of the family's expenses.<ref name="sec-2000">{{cite web |author1=Burzynski Research Institute |title=Form 10KSB For the fiscal years ended February 28, 1998, February 28, 1999 and February 29, 2000 |url=https://www.sec.gov/Archives/edgar/data/724445/000091205701512202/a2046803z10ksb.txt |website=US Security and Exchange Commission |date=2 May 2001}}</ref>

In December 2010, the Texas State Board of Medical Examiners filed a multi-count complaint in the [[Texas State Office of Administrative Hearings]] against Burzynski for failure to meet state medical standards.<ref>[http://www.ministryoftruth.me.uk/wp-content/uploads/2011/11/tmbvsburzynski.pdf TMB v. Burzynski]</ref> In November 2012, a Texas State Office of Administrative Hearings administrative law judge ruled that Burzynski was not [[Vicarious liability|vicariously liable]] under Texas administrative law for the actions of staff at the clinic.<ref>Texas State Office of Administrative Hearings via [http://scienceblogs.com/insolence/2012/11/26/significance-of-the-tmb-dismissal-case-against-burzynski/ Stanislaw Burzynski gets off on a technicality], [[National Geographic Society|National Geographic]] ScienceBlogs</ref>

In January 2012, Lola Quinlan, an elderly, stage IV cancer patient, sued Burzynski for using false and misleading tactics to "swindle her out of $100,000". She also sued his companies, The Burzynski Clinic, the Burzynski Research Institute, and Southern Family Pharmacy, in Harris County Court. She sued for negligence, negligent misrepresentation, fraud, deceptive trade and conspiracy.<ref>Cameron Langford. [https://www.courthousenews.com/cancer-patient-says-doc-used-her-as-atm/ "Cancer Patient Says Doc Used Her as ATM."] ''[[Courthouse News Service]]'', January 19, 2012</ref> The case was dismissed after Quinlan died.<ref>{{Cite web|date=July 16, 2012|title=201203429 - QUINLAN, LOLA vs. BURZYNSKI, STANISLAW (M D) (Court 269)|url=https://www.hcdistrictclerk.com/edocs/public/CaseDetails.aspx?Get=2N4YAfs6WoSfXzc35CRM+F3Hphklu8we11CDohih6p4LX3KFvnXu+qvqLR1VY4EA+GEBGHisvsIhLJLnRNHlY/mFduG/VseUjwczyYNR/5Q=|access-date=2022-02-14|website=www.hcdistrictclerk.com|quote="Judgment For: DISMISSED ON PLAINTIFF'S MOTION"}}</ref><ref>{{cite web |title=Lola Quinlan Obituary |url=https://www.legacy.com/obituaries/name/lola-quinlan-obituary?pid=178821120 |website=Legacy.com |access-date=15 February 2022 |language=en |date=24 March 2016}}</ref>

=== Legal threats to online critics ===

In November 2011, a music writer and editor for the British newspaper ''[[The Observer]]'' sought help raising £200,000 to have his 4-year-old niece, who was diagnosed with [[glioma]], treated at the Burzynski Clinic.<ref>{{cite news|author=Luke Bainbridge|url=https://www.theguardian.com/theobserver/2011/nov/20/a-family-gripped-by-cancer?INTCMP=SRCH|title="The worst year of my life: cancer has my family in its grip" Luke Bainbridge. 20 November 2011|publisher=Guardian|date= November 20, 2011|access-date=July 19, 2013 |location=London}}</ref> Several bloggers reported other cases of patients who had spent similar amounts of money on the treatment, and had died, and challenged the validity of Burzynski's treatments.<ref>[http://skepticalhumanities.com/2011/11/26/stanislaw-burzynskis-public-record/ Stanislaw Burzynski's public record], Skeptical Humanities</ref><ref>[http://freethoughtblogs.com/pharyngula/2011/11/28/burzynski-clinic-the-domain-of-scoundrels-and-quacks/ Burzynski clinic the domain of scoundrels and quacks], ''Pharyngula'' ([[PZ Myers]])</ref> Marc Stephens, identifying himself as a representative of the Burzynski Clinic, sent emails accusing them of libel and demanding that coverage of Burzynski be removed from their sites.<ref>{{cite web|url=http://www.skepticnorth.com/2011/11/burzynski-clinic-meet-the-streisand-effect/|title=Burzynski Clinic? Meet the Streisand Effect|access-date=November 28, 2011}}</ref> One of the bloggers who received threatening e-mails from Stephens was [[Rhys Morgan]],<ref>{{cite news|last=Sample|first=Ian|title=The schoolboy blogger who took on a US clinic|url=https://www.theguardian.com/world/2011/nov/29/schoolboy-blogger-us-clinic|access-date=November 29, 2011|newspaper=[[The Guardian]]|date=November 29, 2011|location=London}}</ref><ref>{{cite news|last=Malisow|first=Craig|title=Burzynski Fanatic Threatens Bloggers 'Round the World|url=http://blogs.houstonpress.com/hairballs/2011/11/burzynski_fanatic_threatens_bloggers.php|access-date=November 29, 2011|newspaper=[[Houston Press]]|date=November 29, 2011}}</ref><ref>{{cite news|last=Plait|first=Phil|title="Alternative" cancer clinic threatens to sue high school blogger|url=http://blogs.discovermagazine.com/badastronomy/2011/11/28/alternative-cancer-clinic-threatens-to-sue-high-school-blogger/|access-date=November 29, 2011|newspaper=[[Discover Magazine]]|date=November 28, 2011}}</ref><ref>{{cite news|last=Morgan|first=Rhys|title=The Burzynski Clinic is using libel laws to silence critics of its cancer treatment|url=https://www.theguardian.com/commentisfree/cifamerica/2011/nov/30/burzynski-clinic-cancer-libel-laws|access-date=November 20, 2011|newspaper=The Guardian|date=November 20, 2011|location=London}}</ref> a 17-year-old [[Sixth form|sixth-form]] student from Cardiff, Wales, at the time, previously noted for exposing the [[Miracle Mineral Supplement]].<ref>{{cite news|last=Robbins|first=Martin|title=The man who encourages the sick and dying to drink industrial bleach|url=https://www.theguardian.com/science/2010/sep/15/miracle-mineral-solutions-mms-bleach|access-date=December 1, 2011|newspaper=The Guardian|date=September 15, 2010|location=London}}</ref><ref>{{cite news|title=The man who encourages the sick and dying to drink industrial bleach|url=http://richarddawkins.net/articles/534614-praise-for-rhys-morgan-15-over-miracle-cure-alert |access-date=December 1, 2011 |newspaper=[[The Richard Dawkins Foundation for Reason and Science]] |date=October 17, 2010 |url-status=dead |archive-url=https://web.archive.org/web/20120401213135/http://richarddawkins.net/articles/534614-praise-for-rhys-morgan-15-over-miracle-cure-alert|archive-date=April 1, 2012}}</ref> Another was Andy Lewis, a skeptic and publisher of the Quackometer blog.<ref>[http://theness.com/neurologicablog/index.php/the-burzynski-clinic-another-crank-tries-to-intimidate-a-blogger/ The Burzynski clinic: another crank tries to intimidate a blogger], [[Steve Novella]]</ref><ref>{{Cite web|url=http://rhysmorgan.co/2011/11/threats-from-the-burzynski-clinic/|title=Threats From The Burzynski Clinic}}</ref><ref>[http://www.quackometer.net/blog/2011/11/the-burzynski-clinic-threatens-my-family.html Burzynski clinic threatens my family], The Quackometer</ref>

Following the publicity fallout resulting from the legal threats made by Stephens against the bloggers, the Burzynski Clinic issued a press release on November 29, 2011, confirming that the Clinic had hired Stephens "to provide [[Search engine optimization|web optimization]] services and to attempt to stop the dissemination of false and inaccurate information concerning Dr. Burzynski and the Clinic",<ref>{{cite web|title=Press Release|url=https://docs.google.com/viewer?a=v&pid=explorer&chrome=true&srcid=0BzijOpjuex1bMjE4N2JjOGItZGFlOS00NDE0LTk2YzktMThkYjFiOTU2YjNl&hl=en_US|publisher=Burzynski Clinic|access-date=November 29, 2011}}</ref> apologizing for comments made by Stephens to bloggers and for the posting of personal information, and announcing that Stephens "no longer has a professional relationship with the Burzynski Clinic."

The story, including the threats against the bloggers, was covered by the ''[[BMJ]]'' (formerly the ''British Medical Journal''). The chief clinician at [[Cancer Research UK]] expressed his concern at the treatment offered, and Andy Lewis of Quackometer and science writer [[Simon Singh]], who had previously been sued by the [[British Chiropractic Association]], said that [[English defamation law|English libel law]] harms public discussion of science and medicine, and thus public health.<ref>{{cite journal|doi=10.1136/bmj.d7865|url=http://www.bmj.com/content/343/bmj.d7865|title=Texan clinic threatens UK bloggers with legal action over criticisms of its treatments|year=2011|last1=McCartney|first1=M.|journal=BMJ|volume=343|pages=d7865|pmid=22138837|s2cid=20053134}}</ref>

In an article in [[Skeptical Inquirer]] published in March 2014, skeptic Robert Blaskiewicz chronicled the activities by skeptics to investigate and challenge Burzynski's claim of cancer treatments. He claimed aggressive actions by Burzynski's supporters toward the critics, including contacting their employers, lodging complaints to state licensing boards and defamation. Blaskiewicz pointedly indicated that, although Burzynski had dismissed Marc Stephens, his clinic has not retracted the warnings of the possibility of lawsuits against critics, that it is "a threat that hangs over all of these activists every day".<ref>{{cite journal|last1= Blaskiewicz|first1=Robert|title=Skeptic Activists Fighting for Burzynski's Cancer Patients|journal=Skeptical Inquirer|volume=38.2|issue=March/April|pages=44–47|year=2014|url= http://www.csicop.org/si/show/skeptic_activists_fighting_for_burzynskis_cancer_patients/}}</ref>

== Media and commentary ==

* In 2010, Eric Merola, an [[art director]] of television commercials, released a film titled ''Burzynski: Cancer is Serious Business'', that promotes the Clinic's claims and describes Burzynski's use of antineoplastons and his legal clashes with government agencies and regulators.<ref>{{cite news|url=https://movies.nytimes.com/2010/06/04/movies/04burzynski.html|title=A Texas Doctor With a Possible Cancer Cure|date=June 4, 2010|work=New York Times|first=Jeannette|last=Catsoulis}} {{IMDb title|qid=Q108000965|title=Burzynski}}</ref> In March 2013, Merola released a follow-up movie to ''Cancer is Serious Business''.<ref>{{cite news|url=https://www.imdb.com/title/tt2908348/?ref_=nm_knf_i2|title=Burzynski< part II IMDB|date=August 21, 2013|access-date=August 29, 2015|author=IMDB|publisher=IMDB.com}}</ref> ''[[The Village Voice]]'' commented that the first movie "violates every basic rule of ethical filmmaking" and that by interviewing only Burzynski's supporters, the film's producer "is either unusually credulous, or doesn't understand the difference between a documentary and an advertisement".<ref>{{cite web|author=Ella Taylor|url=http://www.villagevoice.com/2010-06-01/film/quack-quack-goes-burzynski/|title=QUACK-QUACK Goes Burzynski – Page 1 – Movies – New York|publisher=Village Voice|date=June 1, 2010|access-date=November 25, 2011}}</ref> ''[[Variety (magazine)|Variety]]'' described the film as having the qualities of a "paranoid [[conspiracy theory]]" and likened it to the ''[[National Enquirer]]'', adding that the film's explanatory diagrams are "simplistic to the point of idiocy". The ''Variety'' review concluded that "despite its infotainment look, ''Burzynski'' ultimately proves convincing."<ref>{{cite news|last=Scheib|first=Ronnie|url=https://www.variety.com/review/VE1117942914?refcatid=31|title=Variety Reviews – Burzynski – Film Reviews – New U.S. Release – Review by Ronnie Scheib |publisher=Variety.com |date=June 3, 2010|access-date=November 25, 2011}}</ref>
* In April 2013, Burzynski received the [[Pigasus Award]], which is bestowed each [[April Fool's Day]] by the [[James Randi Educational Foundation]] (JREF) to "honor the five worst offenders who are intentionally or unintentionally peddling harmful paranormal and pseudoscientific nonsense."<ref>{{cite web|url=http://www.randi.org/site/index.php/jref-news/2074-jrefs-pigasus-awards-to-honor-dubious-peddlers-of-woo.html|title=JREF's Pigasus Awards "Honors" Dubious Peddlers of "Woo"|publisher=[[James Randi Educational Foundation]]|access-date=April 1, 2013}}</ref> The Foundation cited as the basis for the award the high cost of antineoplaston treatments, the lack of controlled trials demonstrating efficacy, the lack of FDA approval on the treatments, the lack of published final results of any single clinical trial, and the existence of FDA warning letters concerning research method safety and possible rules violations impacting patient safety.
* In June 2013, the [[BBC]]'s ''[[Panorama (TV series)|Panorama]]'' explored Burzynski in a documentary titled ''Curing cancer or 'selling hope' to the vulnerable?'' and argued "Burzynski exploits a legal loophole" by treating patients with antineoplastons "as part of a clinical trial, so the drug does not need a licence" for twenty years.<ref>{{cite news|url=https://www.bbc.co.uk/news/health-22717245|title=Curing cancer or 'selling hope' to the vulnerable?|publisher=[[Panorama (TV series)]]|date=August 22, 2013|access-date=15 June 2013|author=Richard Bilton}}</ref><ref>{{cite web|url=http://www.getreading.co.uk/news/amelia-saunders-family-mislead-burzynski-4051287|title=Amelia's family 'misled by cancer clinic'|publisher=[[Reading Post]]|date=August 22, 2013|access-date=15 June 2013}}</ref> The clinic complained to the [[OFCOM|Office of Communications]] (Ofcom) about the documentary, but the complaint was not upheld.<ref>{{citation|url=http://stakeholders.ofcom.org.uk/binaries/enforcement/broadcast-bulletins/243/obb243.pdf|title=Complaint by Johnsons Solicitors on behalf of the Burzynski Clinic|work=Ofcom Broadcast Bulletin|issue=243|date=December 2, 2013|access-date=December 2, 2013|pages=23–35}}</ref>
* In November 2013, an investigative report in ''[[USA Today]]'' by Liz Szabo accused Burzynski of selling "false hope to families" for years.<ref name="Szabo_11/15/2013" /> In an interview with Reporting on Health, Szabo said that her interest in reporting on Burzynski was sparked when she emailed him with questions asking for a response to a book critical of him, and received a legal warning letter from his attorneys in reply.<ref>{{cite web|title=Braving legal threats to investigate a medical folk hero|url=http://www.reportingonhealth.org/2014/01/12/qa-liz-szabo-braving-legal-threats-investigate-medical-folk-hero|publisher=Reporting on Health}}</ref>
* In August 2015, Burzynski was listed by the ''[[Houston Press]]'' as number 8 on a list of ''The 10 Most Embarrassing Houstonians'' accusing him of being "Truly an embarrassment to such a medical city where some of the best cancer medicine in the world is performed."<ref>{{cite news|title=The 10 Most Embarrassing Houstonians|url=http://www.houstonpress.com/news/the-10-most-embarrassing-houstonians-7681068|access-date=20 September 2015}}</ref>

==See also==

* [[Clinica 0-19]]
* [[Hallwang Clinic]]
* [[List of unproven and disproven cancer treatments]]
* [[Oasis of Hope Hospital]]
* [[Ty Bollinger]]

==References==

{{Reflist|30em}}

==Further reading==

* {{cite web|title=John Najarian, Transplant Surgeon/Stanislaw Burzynski, Cancer Researcher|url=https://dash.harvard.edu/bitstream/handle/1/9453691/mstennes.html?sequence=2&isAllowed=y|website=DASH.Harvard.edu|publisher=Harvard DASH|access-date=7 September 2020}}
* {{cite web|publisher=Science-Based Medicine|title=Burzynski: Cancer Is A Serious Business, Part 2: Like the first Burzynski movie, only more so?|author=Gorski D|author-link=David Gorski|date=14 March 2013|access-date=9 March 2015|url=http://www.sciencebasedmedicine.org/burzynski-cancer-is-a-serious-business-part-2-like-the-first-burzynski-movie-only-more-so/}}
* {{cite web|title=Stanislaw Burzynski and 'Antineoplastons'|author=Green S|publisher=Quackwatch|date=19 January 2013|access-date=9 March 2015|url=http://www.quackwatch.org/01QuackeryRelatedTopics/Cancer/burzynski1.html}}

==External links==

* [https://www.burzynskiclinic.com Burzynski Clinic]
* [https://www.sec.gov/Archives/edgar/data/724445/000110465911032257/a11-13213_110k.htm Burzynski Research Institute, Inc.] FORM 10-K For the fiscal year ended February 28, 2011. Legally-required financial statements and other filings with the Securities and Exchange Commission.

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[[Category:Alternative cancer treatments]]
[[Category:Pseudoscience]]
[[Category:Clinics in Texas]]
[[Category:Health fraud companies]]
[[Category:1976 establishments in Texas]]
[[Category:Medical and health organizations based in Texas]]