Burzynski Clinic

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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 controversial "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 criticism primarily due to the way its antineoplaston therapy is promoted, the costs for cancer sufferers participating in "trials" of antineoplastons, problems with the way these trials are run, and legal cases brought as a result of the sale of the therapy without board approval. Additionally, there is no scientifically acceptable evidence of clinical efficacy of antineoplaston combinations for various diseases.

Stanislaw Burzynski

Stanislaw Rajmund Burzynski is the founder, president and chairman of the controversial Burzynski Research Institute Inc. (OTCQBBZYR), based in Houston and Stafford, Texas.

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.[1][2] The following year he earned a Ph.D. in biochemistry.[3]

Burzynski moved 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".[4] which lead to several instances of media controversy.[4]

Burzynski founded the Burzynski Research Institute in 1984.[5] He has authored various research publications on antineoplastons[6] and holds American patents on the treatments.[7]

In 2013, Burzynski was awarded the James Randi Educational Foundation's Pigasus Award, which is bestowed each April Fool's Day on frauds.[8]

Publications

Burzynski has published around a dozen academic papers,[9] primarily case reports and reports of his trials where he claims effectiveness for antineoplastons. The papers frequently caused academic controversy, with reviewers disputing the design of the trials and scientific validity of the published results.[10][11][12]

Antineoplaston therapy

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.[13] The word is derived from neoplasm.[14]

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.[15][16][17]

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.[18] 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.[19] 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.[20] The website of the Burzynski clinic states that the active ingredient of antineoplaston A10-I is phenylacetylglutamine.[17]

Since 2011, the clinic has also marketed antineoplastons as "personalised gene-targeted cancer therapy" which stirred further controversy as the treatment bears no relationship to gene-targeted therapy and only superficially incorporates elements of personalized medicine.[21]

Clinical trials

For definitions of clinical trial phases, see clinical trial.

Clinical trials initiated in 1993 and sponsored by the National Cancer Institute were closed due to inability to recruit qualifying patients.

In 1994–1997, a Phase II trial in patients with anaplastic astrocytoma or glioblastoma multiforme was conducted under the auspices of the National Cancer Institute.[22] Due to strict recruitment criteria insisted upon by Burzynski, over the period of two years only nine patients were accrued, six of whom were evaluated for response. According to study authors, "the small sample size precludes definitive conclusions about treatment efficacy",[22] however all six showed evidence of tumor progression after treatment durations of between 16 to 66 days.[10][22] All nine patients died, eight due to tumor progression.[10][22] The study authors concluded that "The efficacy of antineoplastons A10 and AS2-1 remains uncertain. We were unable to document efficacy in any of six assessable patients."[22]

Prior to 1997, patients on antineoplastons had simply been treated by the clinic without external monitoring. Since 1998, following an agreement with FDA, Burzynski has been permitted to prescribe his antineoplastons only as an investigational new drug (IND) undergoing a registered clinical trial. Therefore, Burzynski designed a new clinical trial that incorporated all of his current patients, 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.[23]

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.[23]

Since the mid-1990s, Burzynski registered some sixty clinical trials of antineoplastons and, in December 2010, a Phase III trial which did not open for patient recruitment.[24] None of the trials have published results, and all were paused (no new patients allowed) following a 2013 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.[25]

Efficacy

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. The consensus among the professional community, as represented by the American Cancer Society[26] and Cancer Research UK[27] among others, is that antineoplaston therapy is unproven 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.[21]

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,[28] and Cancer Research UK states that "available scientific evidence does not support claims that antineoplaston therapy is effective in treating or preventing cancer."[27]

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.[15] 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.[29][26] A 2004 medical review described antioneoplaston treatment as a "disproven therapy."[10]

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".[30] In addition to questioning Burzynski's research methods, the oncologists found significant and possibly life-threatening toxicity in some patients treated with antineoplastons.[31]

The Memorial Sloan-Kettering Cancer Center has stated: "Bottom Line: There is no clear evidence to support the anticancer effects of antineoplastons in humans."[32]

Legal issues

FDA warnings

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,[33][34] 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.[35]

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.[36]

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...."[25]

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.[25][37][38][39]

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."' 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.[25]

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 serious problems with patient medical files with respect to a pediatric patient whose died while treated by Burzynski[40] and whose death apparently initiated the investigation.[41]

On March 23, 2014, USA Today reported that the FDA had decided to permit "a handful" of cancer patients to receive Doctor Burzynski's treatment provided that the patients did not receive the treatment directly from him.[42]

Texas Medical Board

In July 2014, the Texas Medical Board filed a 202-page complaint against Burzynski to the Texas state office of administrative hearings.[43][44] The complaint addresses allegations by the Board including misleading patients into paying exorbitant charges,[43]:2 misrepresenting unlicensed persons to patients as licensed medical doctors,[43]:2,4-6,28-31,50-53 and misleading patients into accepting care from providers without significant education or training related to cancer treatment.[43]:2 Citing examples of problems with 29 patients, which are listed in the document, the board said that "unapproved combinations of highly toxic chemotherapy" were prescribed "in ways that caused harm to several patients."[45]

The use of chemotherapuetic 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 the Texas Medical Board. Burzynski was acquitted because he had not personally written the prescriptions.[25]

Lawsuits

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.[46]

In 2010, the Texas State Board of Medical Examiners filed a multi-count complaint against Burzynski for failure to meet state medical standards.[47] 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.[47] This suit was eventually withdrawn in November 2012 after the judge allowed Burzynski to repudiate responsibility for the actions of staff at the clinic.[48]

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.[49]

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.[50] 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.[51][52] 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.[53] One of the bloggers who received threatening e-mails from Stephens was Rhys Morgan,[54][55][56][57] a 17-year old sixth-form student from Cardiff, Wales, at the time, previously noted for exposing the Miracle Mineral Supplement.[58][59] Another was Andy Lewis, a skeptic and publisher of the Quackometer blog.[60][61][62] Cory Doctorow of Boing Boing summarized Stephens' threats and referred to the Streisand Effect.[63]

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",[64] 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.[65]

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 revealed the aggressive actions by Burzynski's supporters toward the critics, including contacting their employers, lodging complain 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'. [66]

USA Today investigation

On November 15, 2013, USA Today accused Burzynski of selling "false hope to families" for years. It was stated: "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.[25]

In an interview with Reporting on Health[67] USA Today reporter Liz Szabo explained why she was so keen on writing this article. She stated the following:

As part of my routine reporting, I emailed Burzynski for a response to the book, which was not flattering to him. I expected Burzynski to ignore me or decline the interview. Instead, I got an 8-page response from his attorneys, warning us of the dangers of writing about their client. That was a first. I’ve never in my life gotten a legal warning about a story before I’ve even written a word. It was a red flag. Also, it was hard to believe that his lawyer could really whip up a letter like this in 24 hours. It seemed more likely that the lawyer had it on file and was perhaps in the habit of sending legal warnings to journalists. That bugged me. Whenever someone works that hard to keep a story from being published, it’s a pretty good sign that you need to write it.

Liz Szabo located the parents of a 6-year-old New Jersey child who died just before the FDA clinical hold was issued due to a “serious adverse event” in June 2012. It became clear that the child's death had prompted the clinical hold, a fact unknown to the parents. This news was not published until it appeared in the Burzynski Research Institute’s annual report to the Securities and Exchange Commission, filed on May 29, 2013. In the same interview Szabo stated: "... it’s just inexcusable to leave out the 36 years of controversy surrounding this guy, which can be found with a few seconds of Web searching."[68]

According to those consulted by Szabo, 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",[69] "hooligans", and "hired assassins".[25] 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."[25]

Burzynski – Cancer is Serious Business

Two propaganda films have been made promoting the Clinic's claims. Both were written, directed, edited, and narrated by Eric Merola, an art director of television commercials.

Part 1 - 2010

The 2010 film, Burzynski, Cancer is Serious Business describes Burzynski's use of antineoplastons and his legal clashes with government agencies and regulators.[70] 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".[71] 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."[72] 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.[73]

Part 2 - 2013

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 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 [74][75] – opined[76] 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.[77]

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"[78] – 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.[79]

BBC Panorama documentary

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 do so as part of a clinical trial, so the drug does not need a licence" for twenty years.[80] According to Watford Observer, the mother of Luna Petagine, a young girl with a brain tumor, "cast doubt" on Burzynski's "expensive treatment."[81] 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.[82] The clinic complained to the Office of Communications (Ofcom) about the documentary, but the complaint was not upheld.[83]

See also

References

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  20. ^ NCI Drug Dictionary, Definitions of antineoplastons A10 and AS2-1
  21. ^ a b Dr. Stanislaw Burzynski's "personalized gene-targeted cancer therapy": Can he do what he claims for cancer?, David Gorski, Science Based Medicine
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  33. ^ Texas State Board of Medical Examiners, Appellant v. Stanislaw R. Burzynski, M.D., Ph.D., Appellee Court judgement
  34. ^ 819 F.2d 1301 1987 judgment
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  39. ^ FDA Inspection Letter [1]
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  43. ^ a b c d Hearing Conducted by the Texas State Office of Administrative hearings, Texas Medical Board, July 10, 2014  SOAH Docket No. 503-12-1342
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