Burzynski Clinic: Difference between revisions
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'''Stanislaw Rajmund Burzynski''' (born 1943 in [[Lublin]], [[Poland]]), MD, PhD, is an American immigrant of Polish origin. A [[biochemist]] and [[physician]], Burzynski has |
'''Stanislaw Rajmund Burzynski''' (born 1943 in [[Lublin]], [[Poland]]), MD, PhD, is an American immigrant of Polish origin. A [[biochemist]] and [[physician]], Burzynski has administered peptides and their metabolites, which he calls "[[antineoplastons]]", as treatments with claimed ''[[in vivo]]'' anti-[[cancer]] activity since December 1976. The clinical efficacy of these treatments, currently undergoing Phase II trials, has not been established by formal FDA Phase III trials and has been the subject of long running legal and medical controversies.<ref>Smith MEG. [http://links.jstor.org/sici?sici=0318-6431(199221)17%3A2%3C133%3ATBCITU%3E2.0.CO%3B2-D "The Burzynski Controversy in the United States and in Canada: A Comparative Case Study in the Sociology of Alternative Medicine,"] ''Canadian Journal of Sociology '', Vol. 17, No. 2 (Spring, 1992), pp. 133-160</ref> |
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== Background == |
== Background == |
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Revision as of 08:38, 12 February 2008
Template:Totallydisputed Stanislaw Rajmund Burzynski (born 1943 in Lublin, Poland), MD, PhD, is an American immigrant of Polish origin. A biochemist and physician, Burzynski has administered peptides and their metabolites, which he calls "antineoplastons", as treatments with claimed in vivo anti-cancer activity since December 1976. The clinical efficacy of these treatments, currently undergoing Phase II trials, has not been established by formal FDA Phase III trials and has been the subject of long running legal and medical controversies.[1]
Background
In 1967, at age 24, Burzynski graduated from the Medical Academy in Lublin, Poland, with a M.D. degree with distinction. During the same year he identified naturally occurring metabolites and peptides in blood and which he found that there is a marked deficiency of these substances in cancer patients. He suspected these compounds might control cancer growth.[2] In 1968, he received his doctorate, D.Msc, translated as the equivalent to a Ph.D., in biochemistry as one of the youngest candidates in Poland ever to hold both an M.D. and Ph.D.[3][4]
From 1970 to 1977, while a researcher and Assistant Professor[citation needed] at Baylor College of Medicine in Houston, his research was sponsored and partially funded by the National Cancer Institute. At Baylor, he authored and co-authored 16 publications, including five concerning his research on peptides and their effect on human cancer. Burzynski named these peptides "antineoplastons" due to their alleged activity in correcting and normalizing neoplastic, or cancerous, cells.
In May 1977 Burzynski founded his clinic in Houston where he has since treated over 8,000 patients. He is also the president of the Burzynski Research Institute, where he continues research on antineoplastons.[5] Burzynski is an the author or co-author of more than 250 publications, including 66 scientific publications. Burzynski holds numerous US patents for his treatments and inventions.[6]
Antineoplaston therapy
The "antineoplastons," natural peptides and metabolites, are not generally cytotoxic like many historical (and current) antineoplastic agents; rather the highest usage levels carry a very high sodium load that require careful attention to fluid and electrolyte balance. Burzynski's claims are that the "antineopalston" peptides are species and genetically specific, so that treatment success depends greatly on whether the chosen agents match the patient's disease and that most animal trials are inherently not very meaningful.
After leaving Baylor in 1977 and all through the 1990s, Burzynski faced ongoing institutional resistance at many junctures in his development and clinical experimentation with anti-neoplastons, including from the FDA, NCI, insurance companies, medical associations, the state medical board, and pharmaceutical competitors.[7] Despite having a current IND, in 1996 Dr. Burzynski was brought to court in Texas for treating patients with a treatment not approved by the Food and Drug Administration (FDA) and for introducing antineoplastons into interstate commerce, the prosecutors using a novel re-interpretation that patients going out of state constituted interstate commerce.[7]
On 1997-03-03 a U.S. District Court judge in Houston acquitted Dr. Stanislaw Burzynski on all 34 fraud charges brought against him by the FDA for lack of evidence. Another trial ended in a hung jury.[citation needed] In 1998 the Texas Attorney General, Dan Morales, placed limits on his advertising of antineoplastons.[8] After that he could administer his antineoplastons to patients only within FDA supervised clinical trials. Most of the trials (25) are currently in phase II.
In September 2004, the FDA granted orphan drug designation for antineoplastons A10 and AS2-1 for the treatment of brainstem glioma. The FDA's orphan drug program is intended to encourage research, development and approval of products for treatment of diseases that affect fewer than 200,000 patients in the United States per year and provide a significant therapeutic advantage over existing treatments. This enables the Burzynski Research Institute to apply for assistance from the Office of Orphan Product Development in guiding the drug through the regulatory approval process.
Despite a number of presentations, peer reviewed papers, and ongoing studies, to date, Burzynski has not published any clinical trial results reviewed and accepted by the FDA for completed Phase II and III drug studies. In January 2007, one of the studies, Phase II trial on brainstem glioma was officially closed for enrollment. The results of the trial will be submitted for the FDA evaluation once the patients currently in the study complete the treatment. In December 2006 the protocol for the Phase III trial on brainstem glioma was submitted for the FDA evaluation. In the letter from March 2007 the FDA requested amendments to the proposed protocol.
External links
- American Cancer Society report on Antineoplaston Therapy
- Quackwatch on Burzynski
- Burzynski Clinic
- Burzynski Research Institute
References
- ^ Smith MEG. "The Burzynski Controversy in the United States and in Canada: A Comparative Case Study in the Sociology of Alternative Medicine," Canadian Journal of Sociology , Vol. 17, No. 2 (Spring, 1992), pp. 133-160
- ^ John Robbins (1996) Reclaiming Our Health: Exploding the Medical Myth and Embracing the Source, KRAMER, H.J. ISBN-10: 0915811804 "Antineoplastons are found in profusion in the blood and urine of healthy individuals -- but are virtually absent in cancer victims. The compounds were first noted in the early 1960s by researchers at Rockefeller University, but no one linked them to cancer until Stanislaw Burzynski in 1968 noted their absence in cancer victims."
- ^ Gavin Phillips, "Interview with Dr. Burzynski (M.D., Ph.D. Biochemistry)", 12.05.2003, accessed online 31 Jan 2008
- ^ Daniel Haley, (2000) Politics in Healing: The Suppression and Manipulation of American Medicine. Washington, DC: Potomac Valley Press.
- ^ "Burzynski Research Institute Home Page". Retrieved 2007-05-10.
- ^ US Patent Office
- ^ a b Thomas D. Elias (2000) The Burzynski Breakthrough, Lexikos, ISBN-10: 0938530666
- ^ Texas Attorney General's Office (1998-02-10). "Limits Placed on Burzynski's Cancer Treatment". Retrieved 2007-05-10.]