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 patient medical files with respect to a pediatric patient who died while treated by Burzynski and whose death apparently initiated the investigation. 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