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Burzynski Clinic

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Stanislaw Rajmund Burzynski (born 1943 in Lublin, Poland), MD, PhD, is an American of Polish origin. A biochemist and physician, Burzynski has sold and administers chemicals with alleged anti-cancer activity and which he calls "antineoplastons" since 1986; clinical efficacy of these treatments has not been be demonstrated and several fatal side effects have occurred. The practice is considered quackery by critics.

Background

In 1967, at age 24, Burzynski graduated from the Medical Academy in Lublin, Poland, with a M.D. degree with distinction, finishing first in his class of 250. During the same year he identified naturally occurring metabolites and peptides in POOO POO

Antineoplaston therapy

In 1996 Dr. Burzynski was brought to court in Texas for treating patients with a treatment not approved by the federal Food and Drug Administration (FDA) and introducing antineoplastons into interstate commerce. 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. In 1998 the Texas Attorney General placed limits on his advertising of antineoplastons. 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. Despite years of clinical trials the efficiency of his therapy against cancer has never been demonstrated.

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.

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

References

  1. "Burzynski probe finds unflattering picture". NCRHI News. 21 (5). 1998.
  2. Goldberg P (1998). "The Antineoplaston Anomaly: How a Drug Was Used for Decades in Thousands of Patients, With No Safety, Efficacy Data". The Cancer Letter. 24 (36): –.
  3. Texas Attorney General's Office (1998-02-10). "Limits Placed on Burzynski's Cancer Treatment". Retrieved 2007-05-10.]
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