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Purveyor of unproven cancer treatments

The Burzynski Clinic is a clinic selling an unproven cancer treatment, which has been characterized as harmful quackery. In 1967, Burzynski graduated from the Medical Academy in Lublin, Poland. In 1968, he received another degree. Burzynski claims this degree was a Ph. D. in biochemistry, but cancer researcher Saul Green found evidence indicating he received a D. Msc (Doctor of Medical Science) after a one year project and passing a test. Burzynski moved to the United States in 1970, working at Baylor College of Medicine until 1977 when he established the Burzynski Research Laboratory where he administered antineoplaston therapy, initially to 21 patients but then more widely as "experimental" treatment. This opened him up to "charges of unethical conduct and to the suspicion he had become a merchant of false hope", which led to several instances of media controversy. Reviewers of his scientific papers have disputed the design of the trials and scientific validity of the published results. In February 2017, following lengthy hearings the Texas Medical Board recommended Burzynski's medical license be revoked, with the revocation suspended, and a fine of $360,000 for billing irregularities and other violations. Burzynski was married to another medical doctor Barbara Burzynski until her death in 2021. They had three children, including Gregory Burzynski, who is also a medical doctor. Both Gregory and Barbara became board members of the Burzynski Research Institute and worked at the Burzynski Clinic. The word is derived from neoplasm. A Reuters fact check concluded that "Online claims that the drugs are a cancer 'cure' and that any of them has been FDA approved, are misleading." Although the therapy is promoted as natural and benign, it is in reality a form of chemotherapy with harmful side effects including severe neurotoxicity. He first identified antineoplastons from human blood. Since similar peptides had been isolated from urine, early batches of Burzynski's treatment were isolated from urine. The first active peptide fraction identified was called antineoplaston A 10 (3 phenylacetylamino 2,6 piperidinedione). From A 10, antineoplaston AS2 1 was derived – a 4:1 mixture of phenylacetic acid and phenylacetylglutamine. The Burzynski Clinic website states that the active ingredient of antineoplaston A10 I is phenylacetylglutamine. According to Gorski, a research oncologist, it appears unlikely that the Burzynski clinic would indeed be able to actually personalise gene targeting therapies, i. e., "identify who would benefit from specific targeted therapies simply from blood tests," as Burzynski claims, since there are no proven methods to achieve this. the Clinic refreshed the branding of its offering to include the word "immunotherapy" in an attempt to leverage the popular excitement around cancer immunotherapy. The treatment however remains the same, using antineoplastons.

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." 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.

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.

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.

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".

In 2010, Eric Merola, an art director of television commercials, released a film titled Burzynski: Cancer is Serious Business, that promotes the Clinic's claims and describes Burzynski's use of antineoplastons and his legal clashes with government agencies and regulators. In March 2013, Merola released a follow up movie to Cancer is Serious Business. The Village Voice commented that the first movie "violates every basic rule of ethical filmmaking" and that by interviewing only Burzynski's supporters, the film's producer "is either unusually credulous, or doesn't understand the difference between a documentary and an advertisement". Variety described the film as having the qualities of a "paranoid conspiracy theory" and likened it to the National Enquirer, adding that the film's explanatory diagrams are "simplistic to the point of idiocy". The Variety review concluded that "despite its infotainment look, Burzynski ultimately proves convincing." In April 2013, Burzynski received the Pigasus Award, which is bestowed each April Fool's Day by the James Randi Educational Foundation (JREF) to "honor the five worst offenders who are intentionally or unintentionally peddling harmful paranormal and pseudoscientific nonsense." The Foundation cited as the basis for the award the high cost of antineoplaston treatments, the lack of controlled trials demonstrating efficacy, the lack of FDA approval on the treatments, the lack of published final results of any single clinical trial, and the existence of FDA warning letters concerning research method safety and possible rules violations impacting patient safety. In June 2013, the BBC's Panorama explored Burzynski in a documentary titled Curing cancer or 'selling hope' to the vulnerable? and argued "Burzynski exploits a legal loophole" by treating patients with antineoplastons "as part of a clinical trial, so the drug does not need a licence" for twenty years. The clinic complained to the Office of Communications (Ofcom) about the documentary, but the complaint was not upheld. In November 2013, an investigative report in USA Today by Liz Szabo accused Burzynski of selling "false hope to families" for years. In August 2015, Burzynski was listed by the Houston Press as number 8 on a list of The 10 Most Embarrassing Houstonians accusing him of being "Truly an embarrassment to such a medical city where some of the best cancer medicine in the world is performed."