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The Burzynski Clinic is a clinic in Texas, United States founded in 1976 and offering unproven cancer treatment. The clinic is best known for the controversy surrounding its "antineoplaston therapy", a chemotherapy using compounds it calls antineoplastons, devised by the clinic's founder Stanislaw Burzynski in the 1970s.
The clinic has been the focus of much criticism due to the way its unproven antineoplaston therapy is promoted, the costs for cancer sufferers participating in "trials" of antineoplastons, significant problems with the way these trials are run, legal cases brought as a result of the sale of the therapy without board approval, and for other causes.
There is a scientific consensus that antineoplaston therapy is unproven and of little promise in treating cancer. Clinical trials initiated in 1993 and sponsored by the National Cancer Institute were closed due to inability to recruit qualifying patients, and a Mayo Clinic study found no benefit from antineoplaston treatment. Some sixty phase 2 clinical trials and one Phase 3 trial have been registered by Burzynski since the mid-1990s, but no results have been published. The Memorial Sloan-Kettering Cancer Center has stated: "Bottom Line: There is no clear evidence to support the anticancer effects of antineoplastons in humans."
Since 1998 Burzynski has only been been permitted to prescribe his antineoplastons as part of a registered clinical trial. Over sixty trials have been registered, only one has completed and that has not been published. The trials have been described by Burzynski's former lawyer as a "joke" and an "artifice". Trials were paused (no new patients allowed) following FDA inspections which found (for the third consecutive time) significant issues with his Institutional Review Board, and, according to papers published in November 2013, substantial issues with the conduct of both the clinic and Stanislaw Burzynski as principal investigator.
Since 2011, the clinic has also been offering "personalised gene targeted cancer therapy" and Burzynski claims to have originated the field. However, the use of chemotherapuetic agents by the clinic has been characterised 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 the Texas Medical Board. Burzynski was acquitted because he had not personally written the prescriptions.
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 [...]."
He was born on January 23, 1943 in Lublin, Poland. On graduating at age 24 from the Medical Academy in Lublin, he had published fourteen papers. The following year he earned a Ph.D. in biochemistry.
Burzynski immigrated to the United States in 1970, working at Baylor College 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, immediately opening himself up to "charges of unethical conduct and to the suspicion he had become a merchant of false hope".
Having effectively exiled himself from mainstream medicine, Burzynski pursued a course of promoting his offerings using publicity, and "aggressively [seeking] out ... terminally ill cancer patients", leading to several instances of media controversy.
Antineoplaston is a name coined by Stanislaw Burzynski for a group of peptides, peptide derivatives, and mixtures that he uses as an alternative cancer treatment. The word is derived from neoplasm.
Antineoplaston therapy has been offered in the US since 1984 but is not approved for general use due to lack of clinical evidence. The compounds are not licensed as drugs but are instead sold and administered as part of clinical trials at the Burzynski Clinic and the Burzynski Research Institute. Although Burzynski and his associates claim success in the use of antineoplaston combinations for the treatment of various diseases, there is no evidence of clinical efficacy of these methods. Oncologists have described Burzynski's studies as flawed, with one doctor stating that they are "scientific nonsense". In particular, independent scientists have been unable to reproduce the positive results reported in Burzynski's studies.
There is no convincing evidence from any randomized controlled trial that antineoplastons are useful for the treatment of cancer. The U.S. Food and Drug Administration (FDA) has not approved antineoplastons for the treatment of any disease. The American Cancer Society has found no evidence that antineoplastons have any beneficial effects in cancer, and it has recommended that people not spend money on antineoplaston treatments. A 2004 medical review described this treatment as a "disproven therapy".
Burzynski stated that he began investigating the use of antineoplastons after detecting what he considered significant differences in peptides between the blood of cancer patients and a control group. Burzynski first identified antineoplastons from human blood. Since similar peptides had been isolated from urine, early batches of Burzynski's treatment were isolated from urine collected in a Texas park. Since 1980 he has been reproducing his compounds synthetically.
The first active peptide fraction identified was called antineoplaston A-10 (3-phenylacetylamino-2,6-piperidinedione). From A-10, antineoplaston AS2-1, a 4:1 mixture of phenylacetic acid and phenylacetylglutamine, was derived. The website of the Burzynski clinic states that the active ingredient of antineoplaston A10-I is phenylacetylglutamine.
In November 2013 the FDA released the observational notes from an inspection of Stanislaw 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 is no way for the FDA to verify either initial tumor sizes or any effect that the antineoplastons might have had.
Burzynski has published a few trials claiming effectiveness for antineoplastons, although reviewers have criticized these trials as being "of a rather unclear design," and the National Cancer Institute reports that no randomized, controlled trials showing the effectiveness of antineoplastons have been published in peer-reviewed scientific journals. Independent researchers have failed to reproduce the benefits reported by Burzynski. The evidence for use of antineoplaston therapy as a treatment for cancer is still, after more than 35 years, "inconclusive".
A Phase II trial in patients with anaplastic astrocytoma or glioblastoma multiforme was conducted under the auspices of the National Cancer Institute. Due to recruitment criteria imposed by Burzynski, over the period of two years only nine patients were accrued, six of whom were evaluated for response. All six showed evidence of tumor progression after treatment durations of between 16 to 66 days, and five of the six suffered neurologic side effects caused by the antineoplastons. All nine patients died, eight due to tumor progression. The study authors concluded: "The efficacy of antineoplastons A10 and AS2-1 remains uncertain. We were unable to document efficacy in any of six assessable patients."
Since Burzynski was forced to administer the treatment only as part of a registered trial, some sixty Phase II trials have been registered with clinicaltrials.gov. No results of any of these trials have been published.
In December 2010, a planned Phase III trial was registered but it subsequently did not open for patient recruitment.
The consensus among the professional community, as represented by the American Cancer Society and Cancer Research UK among others, is that antineoplaston therapy is unproven, the Burzynski clinic is expensive, and the overall probability of the treatment turning out to be as claimed is low due to lack of credible mechanisms and the poor state of research after more than 35 years of investigation. While the antineoplaston therapy is marketed as a non-toxic alternative to chemotherapy, it is, according to David Gorski, a form of chemotherapy with significant known side effects.
The clinical efficacy of antineoplaston combinations for various diseases has been the subject of many such trials by Burzynski and his associates, but these have not produced any clear evidence of efficacy. There is no convincing evidence from randomized controlled trials in the scientific literature that antineoplastons are useful treatments of cancer, and the U.S. Food and Drug Administration (FDA) has not approved these products for the treatment of any disease. The American Cancer Society has stated since 1983 that there is no evidence that antineoplastons have any beneficial effects in cancer and recommended that people do not buy these products since there could be serious health consequences to patients who use this therapy. A 2004 medical review described antioneoplaston treatment as a "disproven therapy."
In 1998, three prominent oncologists were enlisted by the weekly Washington newsletter The Cancer Letter to conduct independent reviews of Burzynski's clinical trial research on antineoplastons. They concluded that the studies were poorly designed, not interpretable, and "so flawed that it cannot be determined whether it really works". One of them characterized the research as "scientific nonsense". In addition to questioning Burzynski's research methods, the oncologists found significant and possibly life-threatening toxicity in some patients treated with antineoplastons.
Independent scientists have been unable to reproduce the positive results reported in Burzynski's studies: the National Cancer Institute has observed that researchers other than Burzynski and his associates have not been successful in duplicating his results, and Cancer Research UK states that "available scientific evidence does not support claims that antineoplaston therapy is effective in treating or preventing cancer."
Prior to 1997, patients on antineoplastons had simply been treated by the clinic without external monitoring. Following an agreement with FDA that limited Burzynski to administering antineoplastons only to patients in clinical trials, Burzynski designed a large clinical trial that incorporated all of his current patients into a large single trial, as described by his lawyer, Richard Jaffe:
[W]e decided to hit the FDA with everything at the same time. All of his current patients would be covered in a single clinical trial which Burzynski called "CAN-1." As far as clinical trials go, it was a joke. Clinical trials are supposed to be designed to test the safety or efficacy of a drug for a disease. It is almost always the case that clinical trials treat one disease.
The CAN-1 protocol had almost two hundred patients in it and there were at least a dozen different types of cancers being treated. And since all the patients were already on treatment, there could not be any possibility of meaningful data coming out of the so-called clinical trial. It was all an artifice, a vehicle we and the FDA created to legally give the patients Burzynski’s treatment. The FDA wanted all of Burzynski’s patients to be on an IND, so that's what we did.
Jaffe further reports that in order to "make sure Burzynski could treat new patients",
[...] Burzynski personally put together seventy-two protocols to treat every type of cancer the clinic had treated and everything Burzynski wanted to treat in the future. [...] We heard that the FDA had to put together a fifty-person task force to review all of the protocols Burzynski submitted.
Of these trials, only one has been completed, and this has no published or posted results.
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:
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 1 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).
— FDA enforcement letter, Original
The letter requires cessation of noncompliant promotional activities, including use of testimonials and promotional interviews with Burzynski himself.
The November 2013 release of the FDA documents from an inspection Jan-March 2013 reveal
You failed to comply with protocol requirements related to the primary outcome, therapeutic response, for Studies (redacted) for 18 of 27 (67%) of study subjects reviewed during the inspection.
You failed to assure that all subjects met the inclusion and did not meet exclusion criteria of the study protocols...
Protocol (redacted) Section 22.214.171.124, required arrangements to be made, prior to entering the patient in the study, for a physician in the patient's local area to provide continuing medical care and collect and report the data required in the protocol.
You failed to comply with Study (redacted) requirements for discontinuation of study treatment.
Not all Adverse Events (AE) experienced by study subjects during their participation in the studies were reported to the sponsor as required by the study protocols.
You failed to protect the rights, safety, and welfare of subjects under your care. Forty-eight (48) subjects experienced 102 investigational overdoses between January I, 2005 and February 22, 2013.
Failure to prepare or maintain adequate case histories with respect to observations and data pertinent to the investigation. Your MRI tumor measurements initially recorded on worksheets at baseline and on-treatment MRI studies for all study subjects were destroyed and are not available for FDA inspectional review. You did not adequately and accurately capture all source and case report Adverse Events (AEs) experienced by study subjects during their participation in study (redacted).
Failure to report promptly to the IRB all unanticipated problems involving risk to human subjects or others.
The informed consent document did not include a statement of any additional costs to the subject that might result from participation in the research, as appropriate.
Legally effective informed consent was not obtained from a subject or the subject's legally authorized representative, and the situation did not meet the criteria in 21 CFR 50.23 - 50.24 for exception.
Investigational drug disposition records are not adequate with respect to quantity and use by subjects.
— FDA Inspection Letter Original
In Burzynski's written response to the 2013 FDA investigation he states they '"complied with all criteria for evaluation of response and made accurate assessments for tumor response."' And that his staff works hard to train families for the patients treatment at home, sometimes that inexperience might result in overdoses which Burzynski states should only make the patient sleepy.
In December 2013, the FDA issued two warning letters, one to the Burzynski Institutional Review Board and one to Stanislaw 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 that with respect to the pediatric patient whose death, identified by USA Today as Josiah Cotto, whose death apparently initiated the investigation.
The records BRI submitted to FDA on […] were not in the files that you provided regarding [Josia Cotto] during the inspection. However, during the inspection, you provided other Case Report Forms for this patient, with the same titles and for the same visit date as noted above, but containing information that differed from that which BRI submitted to FDA.”
As a result, the FDA ruled: "Failure to maintain and retain accurate case histories raises concerns about subject safety and data integrity, as well as concerns about the adequacy of safeguards in place at your site to protect patients being treated under expanded access." The Clinic was given 15 days to respond to these findings.
In 1994, a court found against Burzynski in a case of insurance fraud. According to the SMU Law Review, Burzynski was found to have defrauded an ERISA health insurance fund by billing it for unapproved "treatment" with antineoplastons, in violation of the terms of the health plan it covered.
In 2010, the Texas State Board of Medical Examiners filed a multi-count complaint against Burzynski for failure to meet state medical standards. An appeal against the advertising restrictions on the grounds of free speech was denied on the basis that this was commercial speech promoting an unlawful activity. In December 2010, the Texas State Board of Medical Examiners filed a multi-count complaint against Burzynski for failure to meet state medical standards. This suit was eventually withdrawn in November 2012 after the judge allowed Burzynski to repudiate responsibility for the actions of staff at the clinic.
In January 2012, Lola Quinlan, an elderly, stage IV cancer patient, sued Dr 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.
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. Cory Doctorow of Boing Boing summarized Stephens' threats and referred to the Streisand Effect.
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 (e.g. a satellite image of Morgan's home), 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.
On November 15, 2013, USA Today accused Burzynski of selling "false hope to families" for years. They state: "There are many reasons why Burzynski has been able to stay in business so long. He has benefited from state laws that limit the Texas Medical Board's authority to remove his license, as well as the ability of terminally ill patients to collect damages. His devoted followers are willing to fight for him. He also has exploited the public's growing fascination with alternative medicine and suspicion of the medical establishment." According to reporter Szabo, because the Texas Medical Board is unable to cancel his licence, and because his son Gregory Burzynski (who is also a medical doctor) can take over the clinic should anything happen to his father, the FDA has no way to put Burzynski out of business.
According to those consulted by USA Today, Burzynski relies on "anecdotes" to tell his story. People who think they were healed may not have been. The possibility of misdiagnosis, people receiving radiation and chemotherapy before starting at the clinic, and the difficulty of diagnosing brain tumors, have all been raised. Burzynski has responded to his critics in interviews by calling them "competitors who want to put us out of business", "hooligans", and "hired assassins". Szabo states:
As for criticism from former patients, Burzynski says, "We see patients from various walks of life. We see great people. We see crooks. We have prostitutes. We have thieves. We have mafia bosses. We have Secret Service agents. Many people are coming to us, OK? Not all of them are the greatest people in the world. And many of them would like to get money from us. They pretend they got sick and they would like to extort money from us."
History will vindicate him, Burzynski says, just as it has vindicated other persecuted medical "pioneers," such as Louis Pasteur. In the future, Burzynski says, everyone will use his therapies, and the cancer treatments used today — such as surgery, chemotherapy and radiation — will be regarded as barbaric. "There will be a time when people will see the light," he says, "and our treatments will be used by everyone."
The 2010 film, Burzynski, Cancer is Serious Business, directed, written, edited, and narrated by Eric Merola, an art director of television commercials, describes Burzynski's use of antineoplastons and his legal clashes with government agencies and regulators. The Village Voice commented that the 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 review concluded that "despite its infotainment look, Burzynski ultimately proves convincing." Prior to the debut of "Burzynski", Houston Press correspondent Craig Malisow mocked the film's lack of objectivity, characterizing it as "a puff-piece paean that cherrypicks facts and ignores any criticism", and criticized the project for presenting only Burzynski's side of the story.
A follow-up movie to Cancer is Serious Business was released in March 2013. Based on analysis of pre-release trailers, and comments made by filmmaker Eric Merola on a video blog, David Gorski, MD, PhD, FACS – Associate Professor of Surgery at the Wayne State University School of Medicine, and surgical oncologist at the Barbara Ann Karmanos Cancer Institute  – opined that the new film will focus on "[t]estimonials (or anecdotes)...of 'success stories'"; "'conversion stories' of oncologists who have become Burzynski believers"; attacks on critics and skeptics of Burzynski; attempting to justify Burzynski's "enormous bills for his antineoplaston therapy and criticism that he's making clinical trial subjects pay" to be in such trials; and "vindication", through an as-yet unpublished clinical trial claimed by Dr. Hideaki Tsuda, an anesthesiologist at Kurume University Hospital in Japan, who asserts efficacy of antineoplastons in metastatic colorectal cancer.
A showing of Burzynski by CPT12 – a Denver television station which has previously aired documentaries of "conspiracy theories surrounding 9/11 and claiming taxes are unlawful" – only generated a handful of complaints to the PBS Ombudsman. These mostly concurred with earlier reviewers of the film, who complained that the movie displays a serious lack of objectivity. Some CPT staffers were also criticized for failing to ask Eric Merola any hard-hitting questions.
In June 2013, 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 do so as part of a clinical trial, so the drug does not need a licence" for twenty years. According to Watford Observer, the mother of Luna Petagine, a young girl with a brain tumor, "cast doubt" on Burzynski's "expensive treatment." The Reading Post said, the "Panorama investigation shown on Monday questioned whether the Burzynski Clinic was 'selling hope' to families" which doubted the statistics provided by the Burzynski Clinic. The clinic complained to the Office of Communications (Ofcom) about the documentary, but the complaint was not upheld.