'Antineoplastons' Given by Cancer Clinic Called 'False Hope'

Zosia Chustecka

November 21, 2013

A controversial doctor who has been using "antineoplastons" derived from urine to treat a variety of cancers for many years is featured in an extensive special report in USA Today. Medical experts interviewed by the newspaper say that he is "selling false hope" to cancer patients.

Why the special report has appeared now — when Dr. Burzynski has been using these controversial therapies for decades — is unclear, but it is an extensive investigation, with several articles, video clips, and graphics.

Perhaps coincidentally, the US Food and Drug Administration (FDA) has just released a full report from a clinic inspection, which is highly critical of the way that patients have been treated. In addition, the Texas Medical Board is due to hold a hearing on the treatment of one such patient in early 2014.

The doctor at the center of the controversy is Stanislaw Burzynski, MD, PhD, who graduated from medical school in Poland, was at Baylor Medical School in Houston, and then in 1997 opened up his own clinic in Houston. He has been treating cancer patients with antineoplastons for decades, supposedly in clinical trials, but the products have never been approved. Patients pay for this alternative therapy out of their own pockets, often fundraising to meet the cost of treatment, which can mount up to $250,000.

In a video clip on the USA Today special report, Peter Adamson, MD, professor of pediatrics at the University of Pennsylvania School of Medicine in Philadelphia, and chair of the Children's Oncology Group, said the reason that antineoplastons have not reached the market and have not been used elsewhere is that they do not work. "And if they don't work, why are they still being used?" he asked.

Dr. Adamson also questioned the costs involved. For other experimental therapies being tested in clinical trials, patients do not pay because the cost of the experimental therapy is borne by the developer of the product.

Another issue is that the diagnosis may not have been correct in the first place, suggested Jan Buckner, professor and chair of oncology at the Mayo Clinic in Rochester, Minnesota. Many of the patients for whom the therapy is claimed to have been successful have had brain tumors, but it can be very difficult to differentiate between a benign and a malignant brain tumor. "If the diagnosis wasn't right to start with, it doesn't matter what the treatment was," he said.

"Probably the saddest part of this decades-old saga is that we don't have clear answers," Dr. Adamson commented. "There are certainly reports of side effects, and so we know there is harm," but there is no clear evidence of benefit, he said.

Benefit has been reported in individual case histories and anecdotes. There are 5 patients' success stories posted on the Burzynski Clinic Web site, and some have been featured in newspapers and featured on television shows.

However, for every patient who claims to have been cured, there could be many more who are not around to speak up, because they died or were harmed, pointed out Arthur Caplan, PhD, professor and head of the division of bioethics at NYU Langone Medical Center in New York City.

In fact, the success stories prompted one blogger to put together a list of "the other Burzynski patients," created by tracing cancer patients who had publicly asked for donations to fund treatment at the Burzynski Clinic. The blogger found 50 such patients, and found that they all died of their disease. The Web site warns patients against these therapies, pointing out that Dr. Burzynski "has had over 35 years to produce that single piece of good evidence and has utterly failed to do so."

FDA Puts Trials on Hold

According to a timeline in the USA Today report, Dr. Burzynski started treating patients with antineoplastons in 1977 when he set up his own clinic.

In 1995, a grand jury indicted him on 75 felony charges, including mail fraud, violations of the Food Drug and Cosmetics Act, and contempt of court. The charge led to 2 trials; in 1997, one ended in a hung jury and the other in acquittal.

In 1996, he filed Investigational New Drug Applications to conduct clinical trials with antineoplastons. More recently, in 2009, he applied and received the go-ahead for a phase 3 randomized controlled clinical trial.

In 2004, the FDA granted orphan drug status to antineoplastons.

However, the FDA has had concerns about patient safety since 2001, the newspaper reports, and has now put a clinical hold on all trials with antineoplastons.

Further details are outlined by David Gorski, MD, on his Respectful Insolence blog. "We know that last year a child suffered a severe adverse reaction to antineoplaston therapy, which led to the FDA putting a clinical hold on antineoplastons for children [in July 2012]. Then, in January apparently, the clinical hold was placed on antineoplastons for adults as well, although apparently patients already receiving them could continue to do so," he wrote earlier this year.

Dr. Gorski is a breast cancer surgeon at the Wayne State University School of Medicine in Detroit, and managing editor of the Science-Based Medicine blog, the Web site that has long poured scorn on the whole concept of antineoplastons and other treatments offered to cancer patients by Dr. Burzynski (which include treatment that is described as gene-targeted, but in fact comprises of a cocktail of chemotherapy).

In September 2012, the FDA issued a warning letter to the Burzynski Research Institute and, last week, the FDA released its clinic inspection notes.

The FDA told Dr. Burzynski that he had "failed to protect the rights, safety, and welfare of subjects under your care." During the clinic inspection, the agency found failure to comply with protocol requirements for the reporting of therapeutic outcomes, failure to discontinue the experimental treatment when patients showed serious adverse events, failure to report promptly all serious adverse events (including hospital admissions for pneumonia, cranial bleeds, and others), instances of investigational overdosing, and failure to inform patients of the costs that they would incur when participating in the studies.

"The findings are very disturbing and paint a picture of a clinic that fails to follow even basic practices to protect patients," comments a Forbes report. "If true, these observations show a clinic taking money from patients improperly and performing experimental treatments on them without many of the required safety measures."

According to another news report, in January 2014, Dr. Burzynski is due to go before the Texas Medical Board as a result of a complaint by the parent of a patient. The board panel will hear the case and decide if disciplinary action is appropriate.

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