Burzynski Patient Ryan W.’s Story

*An appeal to encourage Congress to investigate this follows Ryan’s story*

In August 1989, Ryan W. was diagnosed with a thalamic glioblastoma, a grade IV tumor right in the middle of the brain. His prognosis was grim; his doctors estimated 6-9 months, perhaps, maybe a year with the standard therapy. (When patients exceed these estimates on Burzynski’s treatment, they are often touted by supporters as “successful treatment”, however the actual speed of progression falls on a bell curve, and outliers are to be expected.)

Beginning in October, Ryan was treated with 5 weeks of radiation. That treatment seems to have not had any effect on the tumor, at least according to an MRI in January. At the beginning of the new year, we learn that Ryan seems to be undergoing another trial of radiation and has had some complications, according to an announcement in a regional paper:

1/3/1990

MIDDLETOWN
The Fred Villari Studio of Self-Defense will hold a “kick-a-thon” Friday to raise money for the family of a 10-year-old Marlboro child diagnosed in August with a malignant brain tumor.
Students at the Route 35 studio as well as the Morganville branch are encouraged to attend with family members and friends, according to Anthony Russo, chief instructor at the Middletown studio. The goal is to perform the self-defense style kicks 100 times, and everyone participating is encouraged to solicit pledges of at least 10 cents a kick. Pledges will be recorded on a tally sheet provided for each participant.
Proceeds go to the Ryan [W] Fund and will assist the Werthwein family with medical expenses for their son, an identical twin who is currently undergoing a six-week radiation therapy treatment.
Complications from a surgical procedure caused Ryan to lapse into a coma lasting two days, and although he regained consciousness, he suffers from short-term memory loss, according to information prepared by the studio.
The surgical procedure, I am told by Ryan’s mother, was a biopsy, not meant to treat the tumor. In Richard Walters’ 1993, Options: The Alternative Cancer Therapy Bookwhich slathers unearned praise on Burzynski’s antineoplaston treatment and is the most complete record of Ryan’s treatment, Ryan’s mother describes what can be the severe effects of radiation on the developing brain:
“The radiation burnt out most of Ryan’s pituitary gland, stunted his growth, and hurt his mental functioning,” according to Sharon [W.], the boy’s mother.”
He was significantly shorter than his identical twin brother. If the radiation had such a profound effect on Ryan’s development, I’m at a loss as to how explain how/why the tumor would be unaffected. According to Walters:
After reading up extensively on alternative therapies, Ryan’s parents decided to forego chemotherapy and take their son to Houston for treatment by Dr. Burzynski. “The doctors really beat us up over not doing chemo. We were discouraged at every turn from pursuing a safe, nontoxic alternative. They also told us Burzynski was a quack,” recalls Sharon.
Antineoplastons are neither safe nor non-toxic, nor can you really consider them to be alternative therapies to chemotherapy, as they are basically derivatives of sodium phenylbutyrate and are chemotherapy by any reasonable definition.
The known toxicities can be found on this recent patient consent form, a central part of any research protocol:
consent1consent2consent3
A recent inspection found that toxic events have often been reported by Burzynski’s patients, but that the Clinic has been slow to act on that information. For instance:
  1. Patients who had Grade 3 or 4 [severe or life-threatening] toxic effects were supposed to be removed from treatment. One patient had 3 Grade 3 events followed by 3 Grade 4 events. Another patient had 7 disqualifying toxic events before he was removed from the study.
  2. Burzynski did not report all adverse events as required by his study protocols. One patient had 12 events of hypernatremia (high sodium), none of which was reported. There are several similar patients.
  3. 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, according to the [trial number redacted] List of Hospitalizations/SAE (serious adverse events) [redacted]/ Overdose [redacted]/Catheter Infection report. Overdose incidents have been reported to you [….] There is no documentation to show that you have implemented corrective actions during this time period to ensure the safety and welfare of subjects.” [emphasis added] Further, patient records show that there were many more overdoses that were not included in the Hospitalization/SAE/Overdose list.
 Ryan’s mother reported at the onset of treatment:
“The American Cancer Society said they have an arrangement with the Hilton to keep rooms available for cancer patients’ families, but when we mentioned Dr. Burzynski’s name, they said to ‘forget it.’ The Corporate Angel Network, which boasts in TV ads how it flies young cancer patients around the country for free, refused to fly our son because the National Cancer Institute won’t let them fly Burzynski’s patients. The system is a disgrace.”
For at least 23 years, top cancer charities in the country have refused to participate in what is happening in Houston. More recently, Burzynski patient Kassidy M. was similarly denied a place to stay at Ronald McDonald House because of her intended course of treatment.
According to Walters’ book, Ryan began antineoplastons in mid-April 1990.
One month after the intravenous infusions were started, there was a major breakdown of the tumor mass, and from then on, it steadily shrank as the therapy continued. “It felt as if a miracle had occurred,” says Sharon. An MRI scan of the brain on May 15-after four weeks of treatment-showed only barely visible tumor remnants.
In June, they are fundraising for Burzynski:
RyanW
What is endlessly frustrating is that these drugs were called “experimental” in 1990 and are still “experimental” 23 years later. A major red flag, especially when Burzynski’s lawyer said of Burzynski’s first trial:

[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.

Walters reports:
On November 1, 1990, Ryan displayed complete remission.
Yet, in 1993, when Walters publishes his book, for some reason, Ryan
continues to receive antineoplaston treatment, but the dosage is gradually being reduced. He wears a miniature infusion pump, carried in a waist pack, that injects antineoplastons through a catheter in his chest twenty-four hours a day. There is no pain or discomfort.
It seems after his remission, he went back on ANP, at least according to his mother. It’s hard to say what caused the initial remission, because there were at least two interventions that would have affected the tumor before Burzynski was in the picture, a biopsy and radiation. Ryan died in 1994 at the age of 14. This was 20 years ago. Antineoplaston treatment is still considered experimental.
Usually, this is where we would put an appeal to donate to St. Jude’s. You may still do that, if you like, but we are now actively campaigning for an investigation into how the FDA decided to allow Burzynski not only to continue his ridiculous trials, but to actually get a phase III trial after a decade of abominable site visits. Go to thehoustoncancerquack.com and you will find the resources you need to put primary documents–the FDA inspection notes–into the hands of your representatives so they can conduct an investigation. All appeals to understand this made to the FDA have failed, so now we need to press the issue onto the committees that oversee the FDA. Please help us uncover what went wrong so we can fix it and so this never happens again.