FDA warnings 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 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. 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 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."'
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."
Texas Medical Board In December 2010, the use of
chemotherapeutic agents by the clinic has been characterized as "random" and their use of unapproved combinations "with no known benefits but clear harms" by the
Texas Medical Board, which regulates and licenses physicians in the state of Texas, led to a case against Burzynski by that board. Burzynski was acquitted because he had not personally written the prescriptions. The complaint addressed allegations by the Board including misleading patients into paying exorbitant charges, In July 2015, Burzynski's counsel, Richard Jaffe, withdrew from the case citing a potential conflict of interest, a result of Jaffe's pursuing actions against Burzynski in bankruptcy court. With the addition of replacement counsel, the hearing was set to begin in November 2015. In November 2015, the Texas Medical Board took Burzynski to court in Houston, Texas. Burzynski was accused of
bait-and-switch tactics, improperly charging patients, not informing patients that he owns the pharmacy they were required to use to fill their medications, and of
off-label prescribing of drugs. Burzynski's former attorney Richard Jaffe has filed suit in Federal Court claiming unpaid legal fees of over $250,000. Burzynski through his current attorney denied all charges. On March 3, 2017, the Texas Medical Board sanctioned Burzynski, placing him on probation and fining him $40,000. After being sanctioned for over 130 violations, he was allowed to keep his medical license and to continue to practice. Staff recommendations had been more punitive. Probation terms included additional medical training, disclosure of the Board's ruling to patients and medical facilities, and monitoring of his patient records.
Lawsuits In 1983, a federal court issued an injunction against Burzynski, barring him from shipping antineoplastons in
interstate commerce without FDA approval. Burzynski continued to use antineoplastons and was charged with 75 federal counts of mail fraud and violations of federal drug laws. In 1994, a 20-day trial resulted in the dismissal of the 34 counts of mail fraud. On the other 41 counts, the jury deadlocked, failing to come to a verdict. In a separate
administrative proceeding, the Texas State Board of Medical Examiners charged Burzynski with violations of Texas state law relating to his use of antineoplastons. An
administrative law judge ruled that Burzynski violated a section of the Texas Health and Safety Code dealing with prescriptions for unapproved drugs. The
Texas Court of Appeals ultimately upheld this determination in a 1996 decision. In 1998, a federal judge ordered that Burzynski repay an insurance company over $200,000 he charged six patients for his unapproved treatments. The judge concluded that Burzynski was "unjustly enriched" by the insurance payments, but that the violations did not rise to fraud or misrepresentation. In 1998, the parents of a 10-year-old girl with brain cancer sued Burzynski for fraud, saying he had misled them about the efficacy of his treatments. The girl, Christina Bedient, died of cancer after being treated with antineoplastons in 1996. Burzynski settled the suit by refunding some of the family's expenses. In December 2010, the Texas State Board of Medical Examiners filed a multi-count complaint in the
Texas State Office of Administrative Hearings against Burzynski for failure to meet state medical standards. In November 2012, a Texas State Office of Administrative Hearings administrative law judge ruled that Burzynski was not
vicariously liable under Texas administrative law for the actions of staff at the clinic. In January 2012, Lola Quinlan, an elderly, stage IV cancer patient, sued Burzynski for using false and misleading tactics to "swindle her out of $100,000". She also sued his companies, The Burzynski Clinic, the Burzynski Research Institute, and Southern Family Pharmacy, in Harris County Court. She sued for negligence, negligent misrepresentation, fraud, deceptive trade and conspiracy. The case was dismissed after Quinlan died.
Legal threats to online critics In November 2011, a music writer and editor for the British newspaper
The Observer sought help raising £200,000 to have his 4-year-old niece, who was diagnosed with
glioma, treated at the Burzynski Clinic. Several bloggers reported other cases of patients who had spent similar amounts of money on the treatment, and had died, and challenged the validity of Burzynski's treatments. Marc Stephens, identifying himself as a representative of the Burzynski Clinic, sent emails accusing them of libel and demanding that coverage of Burzynski be removed from their sites. One of the bloggers who received threatening e-mails from Stephens was
Rhys Morgan, a 17-year-old
sixth-form student from Cardiff, Wales, at the time, previously noted for exposing the
Miracle Mineral Supplement. Another was Andy Lewis, a skeptic and publisher of the Quackometer blog. Following the publicity fallout resulting from the legal threats made by Stephens against the bloggers, the Burzynski Clinic issued a press release on November 29, 2011, confirming that the Clinic had hired Stephens "to provide
web optimization services and to attempt to stop the dissemination of false and inaccurate information concerning Dr. Burzynski and the Clinic", apologizing for comments made by Stephens to bloggers and for the posting of personal information, and announcing that Stephens "no longer has a professional relationship with the Burzynski Clinic." The story, including the threats against the bloggers, was covered by the
BMJ (formerly the
British Medical Journal). The chief clinician at
Cancer Research UK expressed his concern at the treatment offered, and Andy Lewis of Quackometer and science writer
Simon Singh, who had previously been sued by the
British Chiropractic Association, said that
English libel law harms public discussion of science and medicine, and thus public health. In an article in
Skeptical Inquirer published in March 2014, skeptic Robert Blaskiewicz chronicled the activities by skeptics to investigate and challenge Burzynski's claim of cancer treatments. He claimed aggressive actions by Burzynski's supporters toward the critics, including contacting their employers, lodging complaints to state licensing boards and defamation. Blaskiewicz pointedly indicated that, although Burzynski had dismissed Marc Stephens, his clinic has not retracted the warnings of the possibility of lawsuits against critics, that it is "a threat that hangs over all of these activists every day". == Media and commentary ==