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| title | chunk | source | category | tags | date_saved | instance |
|---|---|---|---|---|---|---|
| Burzynski Clinic | 4/6 | https://en.wikipedia.org/wiki/Burzynski_Clinic | reference | science, encyclopedia | 2026-05-05T09:17:44.243805+00:00 | kb-cron |
Another warning issued in October 2012 notes that the Burzynski Clinic is advertising investigational drugs as being "safe and effective", noting: Promotion of an investigational new drug is prohibited under FDA regulations at 21 CFR 312.7(a), which states, "A sponsor or investigator, or any person acting on behalf of a sponsor or investigator, shall not represent in a promotional context that an investigational new drug is safe or effective for the purposes for which it is under investigation or otherwise promote the drug. This provision is not intended to restrict the full exchange of scientific information concerning the drug, including dissemination of scientific findings in scientific or lay media. Rather, its intent is to restrict promotional claims of safety or effectiveness of the drug for a use for which it is under investigation and to preclude commercialization of the drug before it is approved for commercial distribution."The websites, including the posted press releases and embedded videos, contain claims such as the following that promote Antineoplastons as safe and/or effective for the purposes for which they are being investigated or otherwise promote the drugs. [...] Since Antineoplastons are investigational new drugs, the products' indication(s), warnings, precautions, adverse reactions, and dosage and administration have not been established and are unknown at this time. Promoting Antineoplastons as safe and effective for the purposes for which they are under investigation, by making representations such as those noted above, is in violation of 21 CFR 312.7(a). The letter requires cessation of non-compliant promotional activities, including the use of testimonials and promotional interviews with Burzynski himself. 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...." In November 2013 the FDA released the observational notes from an inspection of Burzynski as a principal investigator that took place between January and March 2013. Among the findings were "[failure] to comply with protocol requirements related to the primary outcome, therapeutic response [...], for 67% of study subjects reviewed during the inspection", admitting patients who failed to meet inclusion criteria, failing to stop treatment when patients had severe toxic reactions to antineoplastons, and failure to report all adverse events. Further, the FDA told Burzynski, "You failed to protect the rights, safety, and welfare of subjects under your care. Forty-eight (48) subjects experienced 102 investigational overdoses between January 1, 2005 and February 22, 2013 [...] There is no documentation to show that you have implemented corrective actions during this time period to ensure the safety and welfare of subjects." The FDA also observed that Burzynski had denied patients informed consent by not informing them of extra costs that they might incur during treatment and that he could not account for his stock of the investigational drug. Lastly, the FDA observed: "Your [...] tumor measurements initially recorded on worksheets at baseline and on-study treatment [...] studies for all study subjects were destroyed and are not available for FDA inspectional review", meaning that there was no way for the FDA to verify either initial tumor sizes or effects that the antineoplastons may have had. In Burzynski's written response to the 2013 FDA investigation, he states that the investigators '"complied with all criteria for evaluation of response and made accurate assessments for tumor response."' In December 2013, the FDA issued two warning letters, one to the Burzynski Institutional Review Board and one to Burzynski, the subjects of the investigations in February. The FDA found that Burzynski and the IRB had largely failed to address the concerns identified in the initial observation reports. The letter to Burzynski noted serious problems with medical files with respect to 6-year-old Josia Cotto, a young brain tumor patient who died while being treated by Burzynski with the sodium-rich antineoplastons and whose death apparently initiated the investigation. USA Today reported that Cotto's blood sodium was measured before his death at "a level that is typically fatal", but the Burzynski Clinic claimed that the measurement was erroneous. On March 23, 2014, USA Today reported that the FDA had decided to permit "a handful" of cancer patients to receive Burzynski's treatment provided that the patients did not receive the treatment directly from him. David Gorski wrote in 2014 that over four decades the FDA and state medical boards have been unable to shut down Burzynkski's business selling unproven treatments – "these organizations are supposed to protect the public from practitioners like Burzynski, but all too often they fail at their charges, in this case spectacularly." The Burzynski Clinic has also made use of expanded access petitions, also known as compassionate use exemptions. According to an investigative report by STAT News published in August 2016, the clinic has benefited by politicians who lobbied the FDA to allow Burzynski to sell antineoplastons to families of patients with terminal diagnoses. According to FDA documents obtained by STAT, "From 2011 to 2016, 37 members of Congress wrote to the FDA about Burzynski. [...] Most of the lawmakers asked the agency to grant constituents 'compassionate use exemptions' so that they could try his unapproved drugs, or to allow his clinical trials to proceed." According to Burzynski, "interventions by lawmakers were helpful." According to STAT, critics state that "the congressional advocacy risks giving the terminally ill and their families a false sense of hope, while also conferring a measure of legitimacy on him that many believe he does not deserve." However, FDA expanded access petitions were not always granted. Burzynski attempted to avoid FDA oversight by recruiting patients under Texas's "Right to try" law, which was passed in 2015.