Burzynski Clinic
The Burzynski Clinic is a clinic in Texas, United States founded in 1976 and offering unproven cancer treatment. The clinic is best known for the controversy surrounding its "antineoplaston therapy", a chemotherapy using compounds it calls antineoplastons, devised by the clinic's founderStanislaw Burzynski in the 1970s.
The clinic has been the focus of criticism due to the way its antineoplaston therapy is promoted, the costs for cancer sufferers participating in "trials" of antineoplastons, problems with the way these trials are run, legal cases brought as a result of the sale of the therapy without board approval, and for other causes.
There is a scientific consensus that antineoplaston therapy is unproven and has little promise in treating cancer. Clinical trials initiated in 1993 and sponsored by the National Cancer Institute were closed due to inability to recruit qualifying patients, and a Mayo Clinic study found no benefit from antineoplaston treatment.[1] Some sixty phase 2 clinical trials and one Phase 3 trial have been registered by Burzynski since the mid-1990s, but no results have been published. The Memorial Sloan-Kettering Cancer Center has stated: "Bottom Line: There is no clear evidence to support the anticancer effects of antineoplastons in humans."[1]
Since 1998 Burzynski has been permitted to prescribe his antineoplastons only as part of a registered clinical trial. Over sixty trials have been registered, although just one has completed and the results have not been published. The trials have been described by Burzynski's former lawyer as a "joke" and an "artifice".[2] Trials were paused (no new patients allowed) following FDA inspections which found (for the third consecutive time) significant issues with his Institutional Review Board, and, according to papers published in November 2013, substantial issues with the conduct of both the clinic and Stanislaw Burzynski as principal investigator.[3]
Since 2011, the clinic has also offered "personalised gene targeted cancer therapy" that Burzynski claims to have originated. However, the use ofchemotherapuetic 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 the Texas Medical Board. Burzynski was acquitted because he had not personally written the prescriptions.[3]
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...."
