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. 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. Another warning issued in October 2012 notes that the Burzynski Clinic is advertising investigational drugs as being "safe and effective", noting: The letter requires cessation of noncompliant promotional activities, including 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