14 lines
1.6 KiB
Markdown
14 lines
1.6 KiB
Markdown
---
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title: "Burzynski Clinic"
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chunk: 3/6
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source: "https://en.wikipedia.org/wiki/Burzynski_Clinic"
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category: "reference"
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tags: "science, encyclopedia"
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date_saved: "2026-05-05T09:17:44.243805+00:00"
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instance: "kb-cron"
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---
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=== FDA warnings ===
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In 1978, FDA representatives warned Burzynski that he was violating federal law because he was not administering antineoplastons in the context of a clinical trial. In 1981, FDA wrote in a letter, "the FDA advises persons who inquire about Burzynski's alleged cure that we do not believe the drug is fit for administration to humans and that there is no reason to believe Dr. Burzynski has discovered an effective cure for cancer."
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In 1996, Burzynski's use and advertising of antineoplastons as an unapproved cancer therapy were deemed to be unlawful by the U.S. FDA and the Texas Attorney General, and limits on the sale and advertising of the treatment were imposed as a result.
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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. |