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| title | chunk | source | category | tags | date_saved | instance |
|---|---|---|---|---|---|---|
| Burzynski Clinic | 2/6 | https://en.wikipedia.org/wiki/Burzynski_Clinic | reference | science, encyclopedia | 2026-05-05T09:17:44.243805+00:00 | kb-cron |
According to the National Cancer Institute, as of August 2019, "no phase III randomized, controlled trials of antineoplastons as a treatment for cancer have been conducted. Publications have taken the form of case reports, phase I clinical trials, toxicity studies, and phase II clinical trials", and "for the most part, these publications have been authored by the developer of the therapy, Dr. Burzynski, in conjunction with his associates at the Burzynski Clinic. Although these studies often report remissions, other investigators have not been successful in duplicating these results." From 1991 to 1995, the NCI initiated multiple phase II trials of antineoplastons. In 1995, after over $1 million had been spent on these trials, they were stopped due to fundamental conflicts between NCI investigators and Burzynski and his employees, notably around Burzynski's insistence on approving all protocols in the NCI trial. Since the mid-1990s, Burzynski registered some sixty clinical trials of antineoplastons and, in December 2010, a Phase III trial that did not open for patient recruitment. The results of these trials are seldom published in reputable journals, and the few that have been do not confirm the worth of the clinic's treatments. The aim of registering so many trials, according to the 2008 book of long-time Burzynski lawyer Richard Jaffe, was to allow for treating any cancer Burzynski might want to treat. The largest trial Burzynski registered was called CAN-1 and aimed to cover all clinic patients at that time. Jaffe wrote that CAN-1 was "a joke" of a clinical trial and explained the legal maneuvering:
The CAN-1 protocol had almost two hundred patients in it and there were at least a dozen different types of cancers being treated. And since all the patients were already on treatment, there could not be any possibility of meaningful data coming out of the so-called clinical trial. It was all an artifice, a vehicle we and the FDA created to legally give the patients Burzynski's treatment. The FDA wanted all of Burzynski's patients to be on an IND [Investigational New Drug (IND) Application], so that's what we did. All trials were paused (no new patients allowed) following a 2013 FDA inspection which found (for the third consecutive time) significant issues with his Institutional Review Board, and, according to reporting published in November 2013, substantial issues with the conduct of both the clinic and Burzynski as principal investigator.
=== Efficacy === Although Burzynski and his associates claim success in the use of antineoplaston combinations for the treatment of various diseases, and some of the clinic's patients say they have been helped, there is no clinical evidence of the efficacy of these methods. The consensus among the professional community, as represented by the American Cancer Society and Cancer Research UK is that antineoplaston therapy is unproven, and the overall probability of the treatment turning out to be as claimed is low due to lack of credible mechanisms and the poor state of research after more than 35 years of investigation. Antineoplaston treatments have significant known side effects including severe neurotoxicity. Hypernatremia is also a significant risk given the high levels of sodium in antineoplaston infusions. Independent scientists have been unable to reproduce the positive results reported in Burzynski's studies: NCI observed that researchers other than Burzynski and his associates have not been successful in duplicating his results, and Cancer Research UK states that "available scientific evidence does not support claims that antineoplaston therapy is effective in treating or preventing cancer." There is no convincing evidence from randomized controlled trials in the scientific literature that antineoplastons are useful treatments of cancer, and the U.S. Food and Drug Administration (FDA) has not approved these products for the treatment of any disease. The American Cancer Society has stated since 1983 that there is no evidence that antineoplastons have any beneficial effects on cancer and recommended that people not buy these products since there could be serious health consequences. A 2004 medical review described antineoplaston treatment as a "disproven therapy". In 1998, three oncologists were enlisted by the weekly Washington newsletter The Cancer Letter to conduct independent reviews of Burzynski's clinical trial research on antineoplastons. They concluded that the studies were poorly designed, not interpretable, and "so flawed that it cannot be determined whether it really works". One of them characterized the research as "scientific nonsense". In addition to questioning Burzynski's research methods, the oncologists found significant and possibly life-threatening toxicity in some patients treated with antineoplastons. In 2018 an article in The Lancet Oncology said "This quackery has continued for 40 years and caused serious harm to desperate patients. Enough is enough!".
=== Cost === According to the American Cancer Society, "Treatment can cost from $7,000 to $9,500 per month or more, depending on the type of treatment, number of consultations, and the need for surgery to implant a catheter for drug delivery. Available information suggests that health insurance plans often do not reimburse costs linked to this treatment." As of March 2015, the Burzynski Clinic required patients to provide a deposit before treatment starts, and their website informed patients that "Since we are classified as 'out of network' we are unable to accept Medicare, Medicaid and any HMO insurance." Recent criticism has focused on the use of crowdfunding to raise the costs of quack treatments, including specifically hundreds of thousands of dollars in the case of the Burzynski Clinic.
== Legal issues ==