Stanisław Burzyński

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 the human body which he concluded control cancer growth. He found that there is a marked deficiency of these peptides in cancer patients. The following year, 1968, he earned his Ph.D. in biochemistry as one of the youngest candidates in Poland ever to hold both an M.D. and Ph.D. His Ph.D. title has been questioned.

From 1970 to 1977, while a researcher and Assistant Professor 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, Dr. Burzynski received a Certificate of Appreciation from Baylor College of Medicine, commending him for completing five years of dedicated service and acknowledging his contributions made to the “Advancement of Medical Education, Research, and Health Care”.

In May 1977 Burzynski founded his clinic in Houston where he's since treated over 8,000 patients. He is also the president of the Burzynski Research Institute, where he continues research on antineoplastons. Dr. Burzynski is a member of several medical associations and the author or co-author of more than 250 publications, including 37 scientific publications about antineoplastons and numerous not peer reviewed abstracts at medical conferences. Currently Dr. Burzynski holds 212 patents and 28 trademarks in 35 countries for his treatments and inventions (data as of January 2007).

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.