The Burzynski Clinic is a controversial clinic offering unproven cancer treatments. The company was founded in 1976 and located in Texas, USA. It is best known for the controversial "antineoplastone therapy", using compounds called antineoplastons, designed by clinical founder Stanislaw Burzynski in the 1970s. There is no scientific evidence received about the benefits of combining antineoplastone for various diseases.
Clinics have been the focus of criticism primarily because of the way antineoplastone therapy is promoted, the cost for people with cancer who participate in antineoplastons "trials", problems with the way these tests are run, and legal cases brought as a result of the sale of therapy without consent state council.
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Stanislaw Burzynski
Burzynski was born on January 23, 1943 in Lublin, Poland. He graduated from the Medical Academy in Lublin. The following year he earned his Ph.D. in biochemistry.
Burzynski moved to the United States in 1970, working at Baylor College until 1977, when he founded the Burzynski Research Laboratory where he administered antineoplastone therapy, initially to 21 patients but later on more widely as a "trial treatment". It opens itself up to "allegations of unethical behavior and suspicion that it has been a false hope trader", which led to several examples of media controversy.
Burzynski founded the Burzynski Research Institute in 1984. His scientific work has led to academic controversy, with reviewers questioning the design of trials and the scientific validity of the published results.
In February 2017 after a lengthy trial, the Texas Medical Board recommended a Burzynski medical license revoked, with suspended retraction, and a $ 360,000 fine for billing irregularities and other violations.
Maps Burzynski Clinic
Antineoplastone therapy
Antineoplaston is a name created by Burzynski for a group of peptides, peptide derivatives, and a mixture that he uses as an alternative cancer treatment. The word comes from neoplasms .
Antineoplastone therapy has been offered in the US since 1984 but is not approved for general use. This compound is not licensed as a drug but is sold and administered as part of clinical trials at the Burzynski Clinic and the Burzynski Research Institute.
Burzynski stated that he began to investigate the use of antineoplastons after detecting what he considered to be a significant difference in the presence of peptides between the blood of cancer patients and the control group. He first identified antineoplastons from human blood. Because the same peptide has been isolated from the urine, Burzynski's early batch treatment was isolated from urine. Burzynski has since produced these compounds synthetically.
The first active peptide fraction identified is called antineoplastone A-10 (3-phenylacetylamino-2,6-piperidinedione). From A-10, AS2-1 antineoplastone is lowered - a mixture of phenylacetic and phenylacetylglutamine 4: 1. The Burzynski Clinic website states that the active ingredient of antineoplastone A10-I is phenylacetylglutamine.
Since 2011, the clinic has marketed itself as offering "targeted cancer therapy with a personalized gene", which has sparked further controversy, as it has no connection to gene-targeted therapy and only superficially incorporates personalized drug elements. The clinical version of the drug is personified with little resemblance to targeted cancer therapy, as clinics including chemotherapy drugs and antineoplastons are part of this treatment.
Clinical test
According to the National Cancer Institute, in April 2013, "no randomized III phases, controlled trials of antineoplastons as a treatment for cancer have been performed • Publications have taken the form of case reports, phase I clinical trials, toxicity studies and phases Clinical trials II" , and "for the most part, this publication has been written by therapy developer, Dr. Burzynski, along with colleagues at the Burzynski Clinic.Although these studies often report remission, other researchers have not succeeded in duplicating these results."
From 1991 to 1995, NCI initiated several phase II trials of antineoplastons. In 1995, after more than $ 1 million was spent on this experiment, they were discontinued before the effectiveness of antineoplastons could be determined.
Since the mid-1990s, Burzynski enrolled sixty clinical trials of antineoplastons and, in December 2010, a phase III trial not open to patient recruitment. Burzynski has not published the full results for all of this. According to his lawyer, Richard Jaffe:
[...] Burzynski personally composed seventy-two protocols to treat every type of cancer treated by the clinic and all that Burzynski wants to treat in the future. [...] We heard that the FDA must collect fifty-man task forces to review all of Burzynski's proposed protocols.
All trials were suspended (no new patients allowed) after the 2013 FDA inspection found (for the third time in a row) a significant issue with its Institutional Review Board, and, according to a paper published in November 2013, a substantial issue with behavior both clinics and Burzynski as principal investigators.
Benefits
Although Burzynski and his colleagues claim to be successful in the use of a combination of antineoplastone for the treatment of various diseases, and some clinical patients say they have been assisted, there is no evidence of the clinical efficacy of this method. Consensus among the professional community, as represented by the American Cancer Society and Cancer Research UK, among others, is that antineoplastone therapy is not proven and the overall probability of treatment turns out to be as low claimed because of the lack of credible and poor research mechanisms after more than 35 years of inquiry. While antineoplastone therapy is marketed as a non-toxic alternative to chemotherapy, it is a form of chemotherapy with significant adverse effects that are known to include severe neurotoxicity.
Independent scientists can not reproduce the positive results reported in Burzynski's research: NCI observes that researchers other than Burzynski and colleagues have not succeeded in duplicating the results, and Cancer Research UK states that "available scientific evidence does not support the claim that antineoplastone therapy is effective in treating or preventing cancer. "
There is no convincing evidence from randomized controlled trials in the scientific literature that antineoplastone is a useful cancer treatment, and the US Food and Drug Administration (FDA) has not approved this product for the treatment of any disease. The American Cancer Society has stated since 1983 that there is no evidence that antineoplastons have a beneficial effect on cancer and advise people not to buy this product because there may be serious health consequences. A medical review in 2004 described antineoplastone treatment as an "unproven therapy".
In 1998, three oncologists were registered by the weekly Washington newspaper The Cancer Letter to conduct an independent review of Burzynski's clinical trial research on antineoplastons. They concluded that the research was poorly designed, uninterpretable, and "so flawed that it could not be determined whether it actually worked". One of them marked the study as "scientific bullshit". In addition to questioning Burzynski's research methods, oncologists have found significant toxicity and may be life-threatening in some patients treated with antineoplastons.
The Memorial Sloan-Kettering Cancer Center has stated: "Bottom Line: There is no clear evidence to support the anticancer effects of antineoplastons in humans."
Cost
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, the number of consultations, and the need for surgery to implant a catheter for drug delivery.Visible information indicates that health insurance plans often do not replace the cost associated with this treatment. "In March 2015, the Burzynski Clinic required patients to deposit before treatment began and their website told patients that" Because we were classified as "off the network" we were unable to receive Medicare, Medicaid and insurance Any HMO ".
Legal issues
FDA warning
The use of Burzynski and ad antineoplastons as an unapproved cancer therapy is considered unlawful by the US FDA and the Attorney General of Texas, and limits the sale and treatment advertisements imposed as a result.
In 2009, the FDA issued a warning letter to the Burzynski Research Institute, which stated that the investigation has determined the Burzynski Institutional Review Board (IRB) "does not comply with applicable legal requirements and FDA regulations governing the protection of human subjects." It identifies a number of specific findings, among them that the IRB has approved the study without ensuring the risk to the patient is minimized, has failed to prepare the necessary written procedures or maintain the necessary documentation, and has failed to undertake the necessary studies for the study, among others. The Institute is given fifteen days to identify the steps needed to prevent future violations.
Another warning issued in October 2012 notes that the Burzynski Clinic advertises the drug under study as "safe and effective", noting:
Promotion of the new drug under study is prohibited under FDA regulations at 21 CFR 312.7 (a), stating, "Sponsors or investigators, or anyone acting on behalf of 1 sponsor or researcher, shall not represent in the promotional context that the new drug investigated is safe or effective for the purpose under investigation or promoting the drug. This provision is not intended to limit the full exchange of scientific information about the drug, including the dissemination of scientific findings in scientific or lay media.Instead, the aim is to limit the claims of the promotion of safety or the effectiveness of the drug for the use under investigation and to prevent drug commercialization before being approved for commercial distribution. "
Websites, including press releases posted and embedded videos, contain such claims as promoting Antineoplastons as safe and/or effective for purposes under investigation or promoting drugs. [...] Since Antineoplastons is a new drug under study, product indications, warnings, precautions, adverse reactions, and dosages 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 being investigated, by making representations as mentioned above, violates 21 CFR 312.7 (a).
The letter requires discontinuation of non-compliant promotional activities, including the use of testimonials and promotional interviews with Burzynski himself.
In June 2012, trials of antineoplastone were suspended after the death of a pediatric patient. In January and February 2013, the FDA inspected Burzynski and his IRB in Houston. In December 2013, the FDA issued its findings in a warning letter to Burzynski, stating "concerns about subject security and data integrity, as well as concerns about the adequacy of existing protections on your site to protect patients...."
In November 2013 the FDA released an observational record from Burzynski's examination 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 main results, therapeutic response [...], to 67% of the study subjects examined during the examination, "admitted patients who failed to meet inclusion criteria, failed to stop treatment when patients had severe toxic reactions to antineoplastons, and failure to report any side effects. Furthermore, the FDA told Burzynski, "You failed to protect the right, security, and welfare of the subject under your care.Fourty eight (48) subjects experienced 102 overdoses investigated between 1 January 2005 and 22 February 2013 [...] No there is documentation indicating that you have applied corrective action during this time period to ensure the safety and well being of the subject. "The FDA also observed that Burzynski has denied patient consent by not informing them of the extra costs they may be having during the treatment and that he can not be held accountable stock of the drug under study. Finally, the FDA observes: "Measurement of tumors [...] You were originally recorded on the worksheet at the start and the study [...] study treatment for all study subjects was destroyed and not available for an FDA inspectional review", meaning that there is no way for the FDA to verify the size of the initial tumor or the effects that antineoplastons may have.
In Burzynski's written response to the FDA's 2013 investigation he stated that the researchers "met all criteria for response evaluation and made accurate assessments for tumor response."
In December 2013, the FDA issued two warning letters, one to the Institute for Institutional Review of Burzynski and one for Burzynski, the subject of an investigation in February. The FDA found that Burzynski and IRB had failed to address the problems identified in the initial observation report. The letter to Burzynski noted a serious problem with the patient's medical file in connection with a pediatric patient who died while being treated by Burzynski and whose death appears to be initiating an investigation.
On March 23, 2014, USA Today reported that the FDA had decided to allow "a handful" of cancer patients to receive Burzynski treatment provided the patient did not receive immediate treatment from him.
David Gorski writes in 2014 that for four decades the FDA and state medical agencies can not shut down the Burzynkski business that sells unproven care - "these organizations should protect people from practitioners like Burzynski, but too often they fail on their allegations. , in this case is spectacular. "
The Burzynski clinic also makes use of the exceptions of compassionate use. According to an investigative report by STAT News published in August 2016, the clinic benefited from the political lobby of Burzynski supporters, including the patient's family with terminal diagnosis. According to the FDA document obtained by STAT, "From 2011 to 2016, 37 members of Congress wrote to the FDA on Burzynski. [...] Most MPs asked the agency to provide a constituency of 'loving use liberation' so they could try a drug that not approved, or to allow his clinical trials to continue. "According to Burzynski," intervention by MPs is helpful. "
However, appeals to the FDA using the dedication exceptions are not always successful. In one case, "Burzynski said he was using Texas state law to avoid agents and start treatment." Critics argue that "congressional advocacy poses a risk to give sickly families and false hopes to their families, while also giving a measure of legitimacy to him that many believe he is inappropriate."
Texas Medical Agency
In December 2010, the use of chemotherapy agents by clinics has been characterized as "random" and its use from an unapproved combination "with no known but obviously detrimental benefit" by the Texas Medical Board, which regulates and licenses doctors in the state of Texas. , causing the case against Burzynski by the council. Burzynski was released because he did not personally write the recipe.
In July 2014, the council filed a 202 page complaint against Burzynski to the Texas State Administration Administration Office. The complaint was responded to by the Council's allegations including misleading patients for exorbitant fees, misrepresenting unlicensed persons to patients as licensed medical doctors, and misleading patients to receive treatment from providers without significant education or training related to cancer treatment. Citing examples of problems with 29 patients, listed in the document, the board said that "unapproved combinations of highly toxic chemotherapy" are prescribed "in ways that cause damage to some patients." In July 2015, Burzynski's lawyer, Richard Jaffe, resigned from a case citing the potential for a conflict of interest, a result of Jaffe's pursuit of action against Burzynski in bankruptcy court. With the addition of a replacement advisor, the trial will begin in November 2015.
In November 2015, Texas Medical Board brought Burzynski to court in Houston, Texas. Burzynski is accused of bait-and-switch tactics, improperly burdening patients, not telling patients that he has a pharmacy they should use to fill in their drugs, and prescribe illegal drugs. Former Burzynski lawyer, Richard Jaffe, has filed a lawsuit in the Federal Court by claiming an unpaid legal fee of over $ 250,000. Burzynski through a lawyer at this time denied all allegations.
On March 3, 2017, Texas Medical Agency sanctioned Burzynski, placed him on probation and fined him $ 40,000. Staff recommendations are more punitive. Trial periods include additional medical training, Board disclosure decisions to patients and medical facilities, and monitoring of patient records.
Legal threats to online criticism
In November 2011, a music writer and editor for the British newspaper The Observer sought help to collect Ã, Â £ 200,000 to get his 4-year-old nephew, who was diagnosed with glioma, treated at the Burzynski Clinic. Some bloggers report another case of patients who have spent the same amount of money on care, and have died, and challenged the validity of Burzynski's treatment. Marc Stephens, identified himself as a representative of the Burzynski Clinic, sent an email accusing them of defamation and demanded that Burzynski's coverage be removed from their site. One blogger who received a threatening email from Stephens was Rhys Morgan, a 17-year-old seventh-grade student from Cardiff, Wales, at the time, previously known for exposing the Miracle Mineral Supplement. Others are Andy Lewis, a skeptic and Quackometer blog publisher.
After the publication resulting from legal threats made by Stephens against bloggers, the Burzynski Clinic issued a press release on November 29, 2011 confirming that the Clinic has hired Stephens "to provide web optimization services and to try to stop misleading and inaccurate information about Dr. Burzynski and the Clinic ", apologized for Stephens' comments to bloggers and to post personal information, and announced that Stephens" no longer has a professional relationship with the Burzynski Clinic. "
His stories, including threats to bloggers, were covered by BMJ (formerly the
Source of the article : Wikipedia
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