Burzynski Scam

Is Our Story Unique? Hardly.

Control+F (“Find”) will open a search bar inside any of the webpages linked below. If you then type “Burzynski” in the search box, it will take you to every occurrence within the page. We have included some excerpts below, but please, visit each link and read everything, then DECIDE FOR YOURSELF.

Scienceblogs.com
“Andy picked up on the story of two charity concerts by Peter Kay to raise money for a four-year-old girl named Billie Bainbridge, who, tragically, has a very rare brain tumor known as Diffuse Intrinsic Pontine Glioma (DIPG). It’s also inoperable. As if that weren’t bad enough, unfortunately the parents have fallen for the blandishments of one Stanislaw Burzynski and the Burzynski Clinic in Texas that Billie’s cancer can be cured using Burzynski’s methods–oh, and, not coincidentally, £200,000, which is the sum these charity concerts are being used to raise. Given that Burzynski has promoted a scientifically unproven cancer treatment called “anti-neoplastons,” which are in reality merely amino acids and peptides isolated from the urine, Andy was, quite understandably, concerned and outraged and expressed his concern and outrage in a post a few days ago entitled The False Hope of the Burzynski Clinic, in which he nicely summarized the history and evidence about anti-neoplastons, pointing out that there is no convincing evidence that they have activity against cancer, much less that they offer hope to a patient like Billie, and no research group other than Burzynski’s has ever reported positive results. I fully agree with his analysis. As a result, the legal thuggery began a couple of days later.”

Scienceblogs.com
“…Dr. Burzynski first gained fame for his antineoplastons back in 1988, when Sally Jesse Raphael featured four “miracle” patients of Burzynski, who, according to her, had had incurable cancer and failed conventional therapies but were then cancer-free, thanks to Dr. Burzynski. Unfortunately, four years later in 1992, Inside Edition followed up these four patients: In 1992, “Inside Edition” reported that two of the four patients had died and a third was having a recurrence of her cancer. (The fourth patient had bladder cancer, which has a good prognosis.) The widow of one of Raphael’s guests stated that her husband and five others from the same city had sought treatment after learning about Burzynski from a television broadcast — and that all had died of their disease. In 1995, a federal grand jury indicted Burzynski for mail fraud and marketing an unapproved drug. The indictment charged that he had billed insurance companies using procedure codes for chemotherapy, even though his treatment was not chemotherapy. He was tried in 1997 but not convicted.”

Cancer.org
“Some patients claim to have been helped by antineoplaston therapy, but these anecdotal reports are not considered evidence of effectiveness by the medical community, either for this or for any other type of therapy. Some promising results for the use of antineoplaston therapy have been reported in small studies. Most of these studies were directed by Dr. Burzynski himself. Results from a few small studies conducted by one group of researchers in Japan have also been published. However, the available clinical evidence consists of early-phase clinical trials and best case series.”

Nytimes.com
“Dr. Green reviewed Dr. Burzynski’s claims under a grant from the National Cancer Institute and later consulted for a law firm representing Aetna Insurance Company in a continuing suit against Dr. Burzynski. He said in an interview that the theory and chemistry behind antineoplastons are “gobbledygook.” First, he said “there is no evidence that the body has a natural biochemical surveillance system against cancer, AIDS, and other diseases.” Beyond that, he added, Dr. Burzynski’s chemistry “makes no sense” and antineoplastons are not even peptides, as Dr. Burzynksi claims.”

Courts.gov
“Today we write the latest chapter in a medical iconoclast’s long history of litigation over an unorthodox cancer treatment. The district court granted summary judgment for the plaintiff/appellee, the Northwest Laundry and Dry Cleaners Health & Welfare Trust Fund, an ERISA health insurance fund, after finding that the defendant/appellant, Dr. Stanislaw R. Burzynski, had defrauded the plaintiff and violated the terms of the health plan. We agree that the defendant may not trick the plaintiff into paying for an unlawful, unapproved drug. We AFFIRM. A. The Prior Litigation and Injunction – Dr. Stanislaw R. Burzynski is a Houston physician who developed an unorthodox treatment for cancer called “antineoplastons”.1 The antineoplastons treatment has never been approved by the Food and Drug Administration (“FDA”) or the Texas Department of Health. Dr. Burzynski’s antineoplastons treatment has been the subject of frequent litigation.”

Wikipedia.com
“The clinical efficacy of antineoplastons combinations for various diseases have been the subject of many such trials by Burzynski and his associates, but these have not produced any clear evidence of efficacy. Oncologists have described these 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 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 that there is no evidence that these products have any beneficial effects in cancer and have recommended that people do not buy these products. A 2004 medical review described this treatment as a ‘disproven therapy.’”

Bbrilliant.com
“From my experience as his care provider the Burzynski Clinic is a total bunko treatment. Killing for payment to those who are willing to take a chance, to fight and can afford a spin of the chance wheel of health. Burzynski is a fraud, I am sorry to say. If you are seeing this training video Please do not help or support any Burzynski work.

We were all so hopeful. It is hard not to want to try to do something. I only suggest try something else. This treatment advanced his tumor growth and would have killed him in one month instead of the medical suggested 4 months. I am will to share any of my experience. The truth is this treatment does harm not help. I think the heads of the clinic know it and that makes it a fraud.”

Ratbags.com
“Dr Burzynski is very welcome to enter the Millenium Project’s Cancer 100 Challenge, and nobody would be more pleased than I to see him nominated for a Nobel Prize. Only if he can cure cancer, of course.”

Cancerforums.net
“So a friend of ours recently recommended that we try to to get some information about this institute for treatment. However, the website seems kind of vague and I don’t even know if they treat small cell lung cancer outside of trials or not… Upon further research I noticed that they have been doing the antineoplastins trials for years now and nobody can really confirm or deny that it is working. The COST of treatment is INSANE. Of course, I know that any form of cancer treatment and medicine is a bit out there… but they ask for $500 just to look at your records, $1000 for the consult, then a DEPOSIT of $10,000 for ‘treatment’, and $5000 – $10,000 for medicine deposits.. as well as a monthly fee of a few thousand.”

Quackwatch.org
“‘Perhaps the most unfortunate result of Dr. Burzynski’s practice over the past two decades is that he has administered antineoplastons to several thousand patients without, for the most part, gathering enough information to determine whether the product is safe or actually works,’ the statement said. ‘That situation does not help patients, and it does not advance medical science.’”

Quackwatch.org
“In November 1982, consultants to the Ontario (Canada) Ministry of Health visited Burzynski’s clinical and research facilities in Houston for the purpose of providing information to the Ministry of Health about the treatment because some Ontario residents had sought reimbursement under the Ontario Health Insurance Plan (79). After reviewing Burzynski’s published papers and viewing the clinic and laboratories, the consultants, Martin Blackstein and Daniel Bergsagel, asked Burzynski to select examples of patients who he believed had had a good response to Antineoplaston treatment. They specified that each case had to satisfy the following conditions to be considered: 1) proven histologic diagnosis of cancer; 2) complete record of all cancer treatment before Antineoplastons (some of which might be responsible for a delayed response); 3) complete record of additional treatment; and 4) original X-rays, CT, or isotope scans used to document a response.

Burzynski presented them with about 12 cases at the clinic, and sent them additional cases afterward. According to the report, there were original X-rays for only one case; for two others, selected CT scans were available. The case with X-ray evidence was a patient with metastatic nodules in the lung from a colon cancer, which, from his history, appeared to be a slowly progressing disease. The consultants concluded that the X-rays showed no documentable change, though there were difficulties in interpretation because the films were reportedly taken on different machines with different magnifications. They also concluded that the two patients for whom some CT scans were available showed no definite response to Antineoplaston treatment. In those cases, they believed that the views on the scans were not the same, making direct comparison impossible.
“

Quackwatch.org
“Texas Attorney General Dan Morales announced that Texas has obtained a court agreement that requires a Houston physician to stop soliciting cancer patients for treatments with unapproved drugs he calls “antineoplastons.z” Morales has obtained a Final Judgment against Houston physician Stanislaw R. Burzynski and his corporation Burzynski Research Institute (BRI), which was filed Tuesday in State District Court in Travis County. Under the agreement, Burzynski and BRI agree to abide by probation terms he was placed under by the Texas State Board of Medical Examiners.

Specifically, the agreement stipulates that Burzynski:
        – Cannot distribute unapproved drugs in Texas
        – Can distribute “antineoplastons” only to patients enrolled in FDA approved clinical trials, unless or until FDA approves his drugs for sale
        – Cannot advertise “antineoplastons” for the treatment of cancer
        – Must place a disclaimer to his website, promotional material and ads stating that the safety and effectiveness of “antineoplastons” have not been established

Burzynski claimed in the late 1970s that he had isolated certain peptides in human urine which could reverse cancer activity in cells. He set up a clinic in Houston, Texas and began treating patients and distributing the drug, without FDA approval.”

Saulgreen.blogspot.com
“A Houston physician who claims he is the victim of a retaliation campaign by the Food and Drug administration was indicted yesterday on 75 counts of mail fraud and violation of federal medical regulations.

U.S. Attorney Gaynelle Griffin Jones said that Stanislaw R. Burzynski and the Burzynski Research Institute introduced an unapproved anti-cancer drug into Interstate commerce, submitted false and misleading claims to health insurers for payment, and violated a federal court order prohibiting interstate trade in the drug without following FDA regulations.

The FDA has never certified Burzynski’s drug, which he calls ‘antineoplastins,’ as safe or effective. Trading insuch unapproved drugs across state lines violates federal law. Byrzynski’s critics say that he is playing on the fears of desperate cancer and AIDS patietns, and that he charged those patients $40 million for antineoplastons from 1998 to 1994.”

Villagevoice.com
“Eric Merola, a former art director of commercials, is either unusually credulous, or doesn’t understand the difference between a documentary and an advertisement, or has an undisclosed relationship with the subject of his allegedly nonfiction first film. Consciously or not, Merola is shilling madly for Dr. Stanislaw Burzynski, a Polish-born physician who has run afoul of federal authorities and shown up on several quackometers for his claim to have cured scores of patients of a lethal brain cancer with a treatment derived from human urine.”

Inspire.com
“There is a lot on line that portrays Burzynski as a victimized, brilliant man who has been all but ruined by the FDA. However, there are just as many people, maybe more, that consider him to be little more than a scam artist. There are arguments on both sides. Burzynski himself seems to have contributed to his being shunned by the medical community as he’s quite good at setting up so-called research studies, but they don’t comply with regular scientific protocol, There isn’t any peer review, nor any other assurance of quality other than Burzynski’s say-so. In researching be wary of anything connected to Burzynski that is being called a “clinical trial” because often it is just Burzynski’s version of one. These treatments can be very expensive costing many, many thousands…sometimes as much as $100,000. I believe the FDA is currently allowing him to work on some patients provided they are terminal or have already failed chemo and radiation. I think the one FDA approved study is to see if Burzynski’s antineoplastons prolonge survival. One of his products was found to be a mild NF inhibitor and I believe at one time his name came up in connection with CTF but where that information has gone now I could say nor can I find it. I know of at least one person who tried it and basically got nothing out of it whatsoever. We have to remember too that NF gliomas tend to have a more indolent course than non NF tumors. 1 out of 5 NF kids will have them but a much smaller percentage will require chemo. Gliomas can remain stable indefinitely or can grow and then go through permanent stabilization. NF gliomas have even been known to entirely regress on their own which makes the assessing the affect of any product difficult unless a significant number of patients are studied under formal clinical trial. At this point there has been so much mud slinging, controversy, and poor scientific practice that its virtually impossible to say where the truth lies. Frankly, I’m actually a big fan of alternative therapies but when it comes to this one I’m very skeptical.”

“Of course, if you have loads of money and you aren’t risking your son’s sight I see nothing wrong in trying it as the only thing that comes up as a potential side effect, even amongst the nay-sayers, seems to be that the treatments may cause false hope.”

LifeBookStories YouTube Channel
“I am angry Kenne died. I saw how the ‘treatment’ beat him up. It took? quality of life from him and he almost died from doing this treatment. I watched others in our group suffer from the treatment and die. I wish it had and would work but I have real life experience saying no. Yes, Burzynski may believe it but many of the others in his group do not. This is hard work and watching people die is hard. I am so sorry I wish it worked.”

Circare.org
“Stanislau R. Burzynski, M.D., Ph.D. Following reversal and appeal Dr. Burzynski’s license was put on probation for ten years for failure to comply with federal regulations for investigational new drug studies and the Texas Food and Drug Act. The order of the Texas State Board of Medical Examiners was cleared on 2004-08-20 when the period of probation ended.”

Article from usnews.com
“According to the FDA’s analysis of the data, the therapy contributed to the deaths of at least seven people through its most common side effect, hypernatremia–a potentially life-threatening condition associated with high levels of sodium in the therapy. The FDA reported that 65 percent of Burzynski’s patients had hypernatremia, a finding seemingly at odds with Burzynski’s claim on his Web site that his drugs are ‘normally free from serious side effects.’ Burzynski contends the patients died of other causes and when there was hypernatremia, it was ‘due to the fact that the patient wasn’t drinking fluids.’”

Fda.gov
“Between December 3 and 10, 2008, Mr. Patrick D. Stone, representing the Food and Drug Administration (FDA), inspected the Burzynski Research Institute (BRI) Institutional Review Board (IRB). The purpose of this inspection was to determine whether the IRB procedures for the protection of human subjects complied with Title 21 of the Code of Federal Regulations (CFR), Parts 50 and 56. These regulations apply to clinical studies of products regulated by FDA. We are aware that at the conclusion of the inspection, our investigator presented and discussed with you, a Form FDA 483, Inspectional Observations. From our review of the establishment inspection report, the documents submitted with that report, and your April 2, 2009 written response to Form FDA 483, we conclude that the IRB did not adhere to the applicable statutory requirements and FDA regulations governing the protection of human subjects.”

Paulsbattle.org
“After further consultations and research, Paul decided to try the antineoplastons treatment offered by Dr. Burzynski at Houston , TX clinic. Paul and Ewa moved in with their friends that lived near the clinic, to attempt in saving his life. After two months of enduring a horrendous ordeal of the treatment, the only change that Paul got, was now more swollen body due to the steroids that prevented swelling of his brain. In addition his kidney’s and bladder were put under extra stress by overreacting from the un-natural intake of fluids. The additional side affect, which Paul experienced due to this treatment, was the blood clot in his right arm, which was extremely painful and very dangerous to his life. The blood clot could cause immediate death, if it would get to his lungs. His tumor continued to grow, and the side affects of the disease were more apparent from day to day. Paul was having trouble walking as well. Seeing that Burzynski’s treatment failed to help, we have decided to go to MD Anderson clinic located in Houston , TX to seek help.”

Lazymanandmoney.com
“The Burzynski Clinic is a cancer clinic in Texas started by Dr. Stanislaw R. Burzynski in 1977. This “doctor” came up with some alternative method of treating cancer. (I put “doctor” in quotes Stanislaw Burzynski may not actually be a doctor.) The thing is that it hasn’t been shown to work. In fact,there are articles that suggest that it has been shown not to work. No other scientists or doctors seem to be able to replicate some of early results he claimed.

You might ask how this clinic is allowed to operate if it doesn’t work. Glad you asked. Turns out that for decades Burzynski has been using a loophole – conducting clinical trials in hopes of getting FDA approval. Since the 90′s he’s done 61 trials that are of the phase II variety (most with “unknown” status – only one “completed”) and only 1 that is phase III. At this point, he should get all the necessary trials done by around 2468… that is if any of them actually show any positive results.

So why do care about these trials? It turns out that price for a treatment at the clinic (i.e. to be a victim participant in one of the clinical trials) is around $120,000 a year. Though one recent trial’s cost was pegged at $312,000. Insurances won’t cover it, because the treatment is considered somewhere between “unproven” and “disproven” depending on who you talk to.”

Sciencebasedmedicine.org
“If you peruse ClinicalTrials.gov for Burzynski’s current clinical trials, you’ll find that pretty much all of them use antineoplastons AS-2.1 and A-10; i.e., phenylacetic acid (PA) and phenyl acetyl glutamine (PAG). But wait! you might say.Why does this matter? PA and PAG are not sodium phenylbutyrate! True enough. However, right there, in one of the e-mails from Renée Trimble, PR flack from the Burzynski Clinic. I had asked her in an e-mail how the Burzynski Clinic did its “personalized gene-targeted cancer therapy,” and she responded:

‘The combination contains drugs which have synergistic activity which permits reduction of doses. The combination proven ineffective by prior data, is not used. Antineoplastons and their prodrug, phenyl butyrate, are important ingredients of the combination because they cover the spectrum of approximately 100 genes. Two articles in peer reviewed journals have been published by our group recently and are attached.’

I’ve discussed the fallacy of the “100 to 200 genes” before in parts I and II of this series. However, what caught my eye was the statement that phenylbutyrate is a prodrug for these antineoplastons. For those who are not familiar with basic pharmacology, a prodrug is a drug that is metabolized into something else, and it is that something else that is the actual active molecule that produces a therapeutic effect. In other words, a prodrug must undergo a chemical conversion in the body before it is active. It is also interesting to note that the complaint against Dr. Burzynski from the Texas Medical Board also mentions phenylbutyrate.”

JosephineJones.wordpress.com
“Yet it appears Dr Burzynski does actually treat his patients with chemotherapy drugs – at inflated prices. Evidence of this is to be found on patients’ blogs, including that of Wayne and Lisa Merritt linked below. It also transpires that ‘antineoplastons’ are by-products of the metabolism of sodium phenylbutyrate…”

James Randi Educational Foundation Forums
This forum contains many links, opinions, and facts related to Dr. Burzynski’s research.

Other Helpful Links

The following is a list of items, articles, supplements, etc. that we’ve found helpful in our fight. Obviously there’s not guarantee that any of the following will increase a cancer patient’s chances of survival. That said, we are convinced that they helped us tremendously.