Stanislaw Burzynski
Encyclopedia
Stanislaw Rajmund Burzynski (born January 23, 1943 in Lublin
, Poland
) is a biochemist
and a physician
. He is founder, president and chairman of Burzynski Research Institute Inc. , based in Houston and Stafford
, Texas
. Since December 1976, Burzynski has administered peptide
s and their metabolite
s, which he calls antineoplaston
s, as treatments with alleged anti-cancer
activity.
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. The American Cancer Society
has stated that there is no evidence that antineoplastons have any beneficial effects in cancer and recommended that people do not buy these products. A 2004 medical review described antioneoplaston treatment as a "disproven therapy". Oncologists
have described Burzynski's research on antineoplastons as "flawed" and "scientific nonsense", and independent scientists have been unable to reproduce
the positive results reported in Burzynski's studies.
Burzynski’s use and advertising of antineoplastons as an unapproved cancer therapy were deemed to be unlawful by the U.S. Food and Drug Administration
(FDA) and the Texas Attorney General
, and limits on the sale and advertising of the treatment were imposed as a result. In 1994, Burzynski was found guilty of insurance fraud
for filing a claim for reimbursement by a health insurer for an illegally administered cancer treatment. In 2010, the Texas State Board of Medical Examiners filed a multi-count complaint against Burzynski for failure to meet state medical standards.
, with an M.D. degree with distinction. In 1968, he received his doctorate, D.Msc. He was licensed to practice medicine in the United States in 1973 by the Texas State Board of Medical Examiners.
From 1970 to 1972, Burzynski was employed as a research associate
at Baylor College of Medicine
in Houston, Texas. In 1972, he was named assistant professor of medicine at Baylor and remained in this position until 1977.
In May 1977 Burzynski founded the Burzynski Clinic in West Houston, Texas, where he treats his patients. He founded the Burzynski Research Institute in 1984. Burzynski has authored various research publications on antineoplastons and holds US patents on the treatments..
s", that he runs at his own establishments, the Burzynski Clinic and the Burzynski Research Institute in Houston, Texas. The clinical efficacy
of antineoplaston combinations for various diseases has been the subject of many such trials by Burzynski and his associates, but these have not produced any clear evidence of efficacy. Oncologists have described these studies as flawed, with one doctor stating that they are "scientific nonsense". In particular, independent scientists have been unable to reproduce
the positive results reported in Burzynski's studies: the National Cancer Institute
has observed that researchers other than Burzynski and his associates have not been successful in duplicating his results, and Cancer Research UK
states that “available scientific evidence does not support claims that antineoplaston therapy is effective in treating or preventing cancer.”
(FDA) and for selling antineoplastons in interstate commerce. In 1998 the Texas Attorney General
, Dan Morales
, placed limits on his advertising of antineoplastons and ordered him to cease and desist
selling his products, without FDA supervised clinical trials. Burzynski had appealed the limitations on his advertising on the grounds of free speech, but the appeal court upheld the decision, stating that "Burzynski's commercial speech
does not concern a lawful activity." Burzynski was also found guilty of fraud in 1994, as he claimed reimbursement from a health insurer for an illegally administered cancer treatment.
In 2009, the 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 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.
In 2010, the Texas State Board of Medical Examiners filed a complaint against Burzynski consisting of ten separate charges . These included (1) a failure to practice medicine in an acceptable professional manner consistent with public health and welfare; (2) a failure to meet the standard of care; negligence in performing medical services; (3) a failure to use professional diligence; (4) a failure to safeguard against potential complications; (5) a failure to disclose reasonably foreseeable side effects of a procedure or treatment; (6) a failure to disclose reasonable alternative treatments to a proposed procedure or treatment; (7) a 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; (8) 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 Food 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; (9) unprofessional or dishonorable conduct that is likely to deceive or defraud the public or injure the public; (10) 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” in this context means the billing statement is false, fraudulent, misrepresents services provided, or otherwise does not meet professional standards.
of television commercials, describes Burzynski's use of antineoplastons and his legal clashes with government agencies and regulators. The film was panned by various reviewers as being biased, poorly produced propaganda for Burzynski's treatments. The Village Voice
commented that the 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". Variety
described the film has 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". Houston Press
mocked the film’s lack of objectivity, calling it "a puff-piece
paean that cherrypicks facts and ignores any criticism", and criticizing it for presenting only Burzynski's side of the story.
sought help raising £200,000 to have his 4-year-old niece, who was diagnosed with glioma, treated at the Burzynski Clinic. 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. 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. One of the bloggers who received threatening e-mails from Stephens was Rhys Morgan, a 17-year old high school student from the United Kingdom previously noted for exposing the Miracle Mineral Supplement
; another was Andy Lewis, a skeptic and publisher of the Quackometer blog. Cory Doctorow
summarized Stephens' threats and referred to the Streisand Effect
.
Following the publicity fallout resulting from the legal threats made by Stephens against the bloggers, the Burzynski Clinic issued a press release on Novermber 29, 2011 confirming that the Clinic had hired Stephens “to provide web optimization services and to attempt to stop the dissemination of false and inaccurate information concerning Dr. Burzynski and the Clinic”,, apologizing for comments made by Stephens to bloggers and for the posting of personal information (a map showing the location of Rhys Morgan’s residence), and announcing that Stephens “no longer has a professional relationship with the Burzynski Clinic.”
Lublin
Lublin is the ninth largest city in Poland. It is the capital of Lublin Voivodeship with a population of 350,392 . Lublin is also the largest Polish city east of the Vistula river...
, Poland
Poland
Poland , officially the Republic of Poland , is a country in Central Europe bordered by Germany to the west; the Czech Republic and Slovakia to the south; Ukraine, Belarus and Lithuania to the east; and the Baltic Sea and Kaliningrad Oblast, a Russian exclave, to the north...
) is a biochemist
Biochemist
Biochemists are scientists who are trained in biochemistry. Typical biochemists study chemical processes and chemical transformations in living organisms. The prefix of "bio" in "biochemist" can be understood as a fusion of "biological chemist."-Role:...
and a physician
Physician
A physician is a health care provider who practices the profession of medicine, which is concerned with promoting, maintaining or restoring human health through the study, diagnosis, and treatment of disease, injury and other physical and mental impairments...
. He is founder, president and chairman of Burzynski Research Institute Inc. , based in Houston and Stafford
Stafford, Texas
Stafford is a city in the U.S. state of Texas within the Houston–Sugar Land–Baytown metropolitan area. The city is mostly in Fort Bend County with a small portion in Harris County. As of the 2000 U.S. Census, Stafford's population was 15,681....
, Texas
Texas
Texas is the second largest U.S. state by both area and population, and the largest state by area in the contiguous United States.The name, based on the Caddo word "Tejas" meaning "friends" or "allies", was applied by the Spanish to the Caddo themselves and to the region of their settlement in...
. Since December 1976, Burzynski has administered peptide
Peptide
Peptides are short polymers of amino acid monomers linked by peptide bonds. They are distinguished from proteins on the basis of size, typically containing less than 50 monomer units. The shortest peptides are dipeptides, consisting of two amino acids joined by a single peptide bond...
s and their metabolite
Metabolite
Metabolites are the intermediates and products of metabolism. The term metabolite is usually restricted to small molecules. A primary metabolite is directly involved in normal growth, development, and reproduction. Alcohol is an example of a primary metabolite produced in large-scale by industrial...
s, which he calls antineoplaston
Antineoplaston
Antineoplaston , a word derived from neoplasm, is a name coined by Stanislaw Burzynski for a group of peptides, derivatives, and mixtures that he uses as an alternative cancer treatment...
s, as treatments with alleged anti-cancer
Cancer
Cancer , known medically as a malignant neoplasm, is a large group of different diseases, all involving unregulated cell growth. In cancer, cells divide and grow uncontrollably, forming malignant tumors, and invade nearby parts of the body. The cancer may also spread to more distant parts of the...
activity.
There is no convincing evidence from randomized controlled trial
Randomized controlled trial
A randomized controlled trial is a type of scientific experiment - a form of clinical trial - most commonly used in testing the safety and efficacy or effectiveness of healthcare services or health technologies A randomized controlled trial (RCT) is a type of scientific experiment - a form of...
s in the scientific literature
Scientific literature
Scientific literature comprises scientific publications that report original empirical and theoretical work in the natural and social sciences, and within a scientific field is often abbreviated as the literature. Academic publishing is the process of placing the results of one's research into the...
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. The American Cancer Society
American Cancer Society
The American Cancer Society is the "nationwide community-based voluntary health organization" dedicated, in their own words, "to eliminating cancer as a major health problem by preventing cancer, saving lives, and diminishing suffering from cancer, through research, education, advocacy, and...
has stated that there is no evidence that antineoplastons have any beneficial effects in cancer and recommended that people do not buy these products. A 2004 medical review described antioneoplaston treatment as a "disproven therapy". Oncologists
Oncology
Oncology is a branch of medicine that deals with cancer...
have described Burzynski's research on antineoplastons as "flawed" and "scientific nonsense", and independent scientists have been unable to reproduce
Reproducibility
Reproducibility is the ability of an experiment or study to be accurately reproduced, or replicated, by someone else working independently...
the positive results reported in Burzynski's studies.
Burzynski’s use and advertising of antineoplastons as an unapproved cancer therapy were deemed to be unlawful by the U.S. Food and Drug Administration
Food and Drug Administration
The Food and Drug Administration is an agency of the United States Department of Health and Human Services, one of the United States federal executive departments...
(FDA) and the Texas Attorney General
State Attorney General
The state attorney general in each of the 50 U.S. states and territories is the chief legal advisor to the state government and the state's chief law enforcement officer. In some states, the attorney general serves as the head of a state department of justice, with responsibilities similar to those...
, and limits on the sale and advertising of the treatment were imposed as a result. In 1994, Burzynski was found guilty of insurance fraud
Insurance fraud
Insurance fraud is any act committed with the intent to fraudulently obtain payment from an insurer.Insurance fraud has existed ever since the beginning of insurance as a commercial enterprise. Fraudulent claims account for a significant portion of all claims received by insurers, and cost billions...
for filing a claim for reimbursement by a health insurer for an illegally administered cancer treatment. In 2010, the Texas State Board of Medical Examiners filed a multi-count complaint against Burzynski for failure to meet state medical standards.
Background
In 1967, at age 24, Burzynski graduated from the Medical Academy in Lublin, PolandMedical University of Lublin
Medical University of Lublin has its origins in the year 1944 in Lublin, Poland. The University gained its autonomy in 1950. As the years passed, new departments were added such as the Department of Dentistry in 1973....
, with an M.D. degree with distinction. In 1968, he received his doctorate, D.Msc. He was licensed to practice medicine in the United States in 1973 by the Texas State Board of Medical Examiners.
From 1970 to 1972, Burzynski was employed as a research associate
Research associate
The title of research associate is used to denote an academic research position at a university or similar institution. A research associate usually conducts research under the supervision of a principal investigator. In contrast to a research assistant or research officer, a research associate...
at Baylor College of Medicine
Baylor College of Medicine
Baylor College of Medicine, located in the Texas Medical Center in Houston, Texas, USA, is a highly regarded medical school and leading center for biomedical research and clinical care...
in Houston, Texas. In 1972, he was named assistant professor of medicine at Baylor and remained in this position until 1977.
In May 1977 Burzynski founded the Burzynski Clinic in West Houston, Texas, where he treats his patients. He founded the Burzynski Research Institute in 1984. Burzynski has authored various research publications on antineoplastons and holds US patents on the treatments..
Antineoplaston therapy
Antineoplaston is a name coined by Burzynski for a group of peptides, derivatives, and mixtures that he uses as an alternative cancer treatment. These compounds are not licensed as drugs but are instead sold and administered by Burzynski as part of what he calls "clinical trialClinical trial
Clinical trials are a set of procedures in medical research and drug development that are conducted to allow safety and efficacy data to be collected for health interventions...
s", that he runs at his own establishments, the Burzynski Clinic and the Burzynski Research Institute in Houston, Texas. The clinical efficacy
Efficacy
Efficacy is the capacity to produce an effect. It has different specific meanings in different fields. In medicine, it is the ability of an intervention or drug to reproduce a desired effect in expert hands and under ideal circumstances.- Healthcare :...
of antineoplaston combinations for various diseases has been the subject of many such trials by Burzynski and his associates, but these have not produced any clear evidence of efficacy. Oncologists have described these studies as flawed, with one doctor stating that they are "scientific nonsense". In particular, independent scientists have been unable to reproduce
Reproducibility
Reproducibility is the ability of an experiment or study to be accurately reproduced, or replicated, by someone else working independently...
the positive results reported in Burzynski's studies: the National Cancer Institute
National Cancer Institute
The National Cancer Institute is part of the National Institutes of Health , which is one of 11 agencies that are part of the U.S. Department of Health and Human Services. The NCI coordinates the U.S...
has observed that researchers other than Burzynski and his associates have not been successful in duplicating his results, and Cancer Research UK
Cancer Research UK
Cancer Research UK is a cancer research and awareness charity in the United Kingdom, formed on 4 February 2002 by the merger of The Cancer Research Campaign and the Imperial Cancer Research Fund. Its aim is to reduce the number of deaths from cancer. As the world's largest independent cancer...
states that “available scientific evidence does not support claims that antineoplaston therapy is effective in treating or preventing cancer.”
Legal issues
In 1993, Burzynski was brought to court in Texas for treating patients with a treatment not approved by the Food and Drug AdministrationFood and Drug Administration
The Food and Drug Administration is an agency of the United States Department of Health and Human Services, one of the United States federal executive departments...
(FDA) and for selling antineoplastons in interstate commerce. In 1998 the Texas Attorney General
State Attorney General
The state attorney general in each of the 50 U.S. states and territories is the chief legal advisor to the state government and the state's chief law enforcement officer. In some states, the attorney general serves as the head of a state department of justice, with responsibilities similar to those...
, Dan Morales
Dan Morales
Daniel C. "Dan" Morales served as the 48th Texas Attorney General from January 15, 1991 through January 13, 1999, during the administrations of Governors Ann Richards and George W. Bush. As attorney general, Morales reached a $17 billion settlement with big tobacco companies. He also authored...
, placed limits on his advertising of antineoplastons and ordered him to cease and desist
Cease and desist
A cease and desist is an order or request to halt an activity and not to take it up again later or else face legal action. The recipient of the cease-and-desist may be an individual or an organization....
selling his products, without FDA supervised clinical trials. Burzynski had appealed the limitations on his advertising on the grounds of free speech, but the appeal court upheld the decision, stating that "Burzynski's commercial speech
Commercial speech
Commercial Speech is speech done on behalf of a company or individual for the intent of making a profit. It is economic in nature and usually has the intent of convincing the audience to partake in a particular action, often purchasing a specific product...
does not concern a lawful activity." Burzynski was also found guilty of fraud in 1994, as he claimed reimbursement from a health insurer for an illegally administered cancer treatment.
In 2009, the FDA issued a warning letter
FDA Warning Letter
The United States Food and Drug Adminstration defines a Warning Letter as "...a correspondence that notifies regulated industry about violations that FDA has documented during its inspections or investigations...
to the Burzynski Research Institute, stating that an investigation had determined the Burzynski Institutional Review Board
Institutional review board
An institutional review board , also known as an independent ethics committee or ethical review board , is a committee that has been formally designated to approve, monitor, and review biomedical and behavioral research involving humans with the aim to protect the rights and welfare of the...
(IRB) "did not adhere to the applicable statutory requirements and FDA regulations governing the 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.
In 2010, the Texas State Board of Medical Examiners filed a complaint against Burzynski consisting of ten separate charges . These included (1) a failure to practice medicine in an acceptable professional manner consistent with public health and welfare; (2) a failure to meet the standard of care; negligence in performing medical services; (3) a failure to use professional diligence; (4) a failure to safeguard against potential complications; (5) a failure to disclose reasonably foreseeable side effects of a procedure or treatment; (6) a failure to disclose reasonable alternative treatments to a proposed procedure or treatment; (7) a 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; (8) 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 Food 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; (9) unprofessional or dishonorable conduct that is likely to deceive or defraud the public or injure the public; (10) 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” in this context means the billing statement is false, fraudulent, misrepresents services provided, or otherwise does not meet professional standards.
2010 film, Burzynski - Cancer is Serious Business
The 2010 film, Burzynski, Cancer is Serious Business, directed, written, edited, and narrated by Eric Merola, an art directorArt director
The art director is a person who supervise the creative process of a design.The term 'art director' is a blanket title for a variety of similar job functions in advertising, publishing, film and television, the Internet, and video games....
of television commercials, describes Burzynski's use of antineoplastons and his legal clashes with government agencies and regulators. The film was panned by various reviewers as being biased, poorly produced propaganda for Burzynski's treatments. The Village Voice
The Village Voice
The Village Voice is a free weekly newspaper and news and features website in New York City that features investigative articles, analysis of current affairs and culture, arts and music coverage, and events listings for New York City...
commented that the 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". Variety
Variety (magazine)
Variety is an American weekly entertainment-trade magazine founded in New York City, New York, in 1905 by Sime Silverman. With the rise of the importance of the motion-picture industry, Daily Variety, a daily edition based in Los Angeles, California, was founded by Silverman in 1933. In 1998, the...
described the film has having the qualities of a "paranoid conspiracy theory
Conspiracy theory
A conspiracy theory explains an event as being the result of an alleged plot by a covert group or organization or, more broadly, the idea that important political, social or economic events are the products of secret plots that are largely unknown to the general public.-Usage:The term "conspiracy...
" and likened it to the National Enquirer, adding that the film’s explanatory diagrams are "simplistic to the point of idiocy". Houston Press
Houston Press
The Houston Press is an alternative weekly newspaper published in Houston, Texas, United States. It is headquartered in Downtown Houston....
mocked the film’s lack of objectivity, calling it "a puff-piece
Puffery
Puffery as a legal term refers to promotional statements and claims that express subjective rather than objective views, which no "reasonable person" would take literally...
paean that cherrypicks facts and ignores any criticism", and criticizing it for presenting only Burzynski's side of the story.
Burzynski Clinic's legal threats to online critics
In November 2011, a music writer and editor for the British newspaper The ObserverThe Observer
The Observer is a British newspaper, published on Sundays. In the same place on the political spectrum as its daily sister paper The Guardian, which acquired it in 1993, it takes a liberal or social democratic line on most issues. It is the world's oldest Sunday newspaper.-Origins:The first issue,...
sought help raising £200,000 to have his 4-year-old niece, who was diagnosed with glioma, treated at the Burzynski Clinic. 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. 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. One of the bloggers who received threatening e-mails from Stephens was Rhys Morgan, a 17-year old high school student from the United Kingdom previously noted for exposing the Miracle Mineral Supplement
Miracle Mineral Supplement
Miracle Mineral Supplement, often referred to as Miracle Mineral Solution or MMS, is the colloquial product name for an aqueous solution of 28% sodium chlorite, a toxic chemical known to cause fatal renal failure, in distilled water...
; another was Andy Lewis, a skeptic and publisher of the Quackometer blog. Cory Doctorow
Cory Doctorow
Cory Efram Doctorow is a Canadian-British blogger, journalist, and science fiction author who serves as co-editor of the blog Boing Boing. He is an activist in favour of liberalising copyright laws and a proponent of the Creative Commons organization, using some of their licences for his books...
summarized Stephens' threats and referred to the Streisand Effect
Streisand effect
The Streisand effect is a primarily online phenomenon in which an attempt to hide or remove a piece of information has the unintended consequence of publicizing the information more widely...
.
Following the publicity fallout resulting from the legal threats made by Stephens against the bloggers, the Burzynski Clinic issued a press release on Novermber 29, 2011 confirming that the Clinic had hired Stephens “to provide web optimization services and to attempt to stop the dissemination of false and inaccurate information concerning Dr. Burzynski and the Clinic”,, apologizing for comments made by Stephens to bloggers and for the posting of personal information (a map showing the location of Rhys Morgan’s residence), and announcing that Stephens “no longer has a professional relationship with the Burzynski Clinic.”
External links
- American Cancer Society report on Antineoplaston Therapy
- Quackwatch on Burzynski
- Burzynski Clinic
- 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.