Burzynski Patient Brandon B.’s Story
Brandon was in third grade when he started having headaches and vomiting in early April 1994. According to a Feb 22, 1996 report in the local paper, the Martinez Record (CA), he was an avid baseball player. During a game on April 28, 1994, one of his eyes shut involuntarily while he was pitching. He didn’t tell anyone because he did not want to be taken out of the game.
The next day, the article goes on, Brandon received a diagnosis of a brain tumor. This was successfully removed surgically, but in November of 1995, doctors found 3 brain tumors, one on either side of his head, just above the ears, and another near his spine. The family started Brandon on chemotherapy around Christmas 1995, but it made Brandon sick. Concerned for his quality of life, Brandon’s parents looked for alternatives to chemotherapy, and they settled on Burzynski’s antineoplaston chemotherapy after “a parent of another cancer patient recommended a doctor in Houston who treated patients with an experimental drug.” One wonders if we detect the dark hand of the Burzynski Patient Group (or its predecessor) guiding Brandon’s family to Burzynski.
According to the timeline in the Record article, the family arrived in Houston at some point in late January, 1996. Brandon would have had a catheter installed in his chest to receive the near-continuous stream of ANP. They would probably have spent a couple of weeks at the Clinic in Houston learning how to administer the ANP, and the article seems to be from after they returned home.
It’s sort of baffling that at the same time that the family is going to Burzynski, the future of his treatment was very much while in doubt, as according to the Record article:
This week, a Houston judge is due to decide whether Brandon’s doctor, Stanislaw Burzynski, will be allowed to continue administering antineoplaston to non-Texans.
The judge was Sim Lake. The reason that Burzynski might not be allowed to continue giving ANP to out-of-state patients was because he was facing dozens of federal charges related to his practice. The infuriating tragedy here is that Brandon’s family’s desperation is being used to generate support for Burzynski:
Currently, the drug cannot be mailed across state lines, though Burzynski is allowed to mail it to patients in other countries such as Brazil, Australia and Canada.
So for now, [Brandon’s family] must fly to Houston whenever Brandon’s medicine needs to be replenished. Their next trip is scheduled for early next month.
However, the [family] fear[s] the Food and Drug Administration is attempting to shut down Burzynski’s practice completely.
The travel and expense involved in Brandon’s treatment takes its toll, they admit.
And to someone who did not know about Burzynski’s behavior, this might be a compelling argument: “Why, if Burzynski can peddle his experimental therapy abroad, why not in the US?” Though the reason is simple (the US FDA is not there to protect people abroad and regulates the commercial distribution of drugs between states), the appeal that the family is making to their community, as so often happens, is met with staggering generosity:
Beginning with Brandon’s classmates and the faculty at Morello Park and extending to other community groups such as Brandon’s youth baseball league and the Martinez Kiwanis Club, an outpouring of emotional and financial assistance has overwhelmed [Brandon’s family]. […]
Terri’s and Steve’s coworkers have also pitched in. Terri’s fellow employees at Walnut Country Preschool in Concord have provided meals for the [family], who sometimes lack the time and energy to prepare them.
Perhaps most impressive, though, are the sacrifices Steve’s coworkers at Piedmont Lumber are making. So far, they’ve donated 11 weeks of vacation to Steve to use as he accompanies Brandon to Houston, where Brandon picks up his medicine. “You know, we’re teamsters. We’re supposed to be these tough guys who show no emotion,” says Steve. “But they understand what we’re going through and that I need to talk about it.”
Burzynski has thrived too long on this generosity and goodwill.
The ruling, by the way, that led to the mess that we are currently seeing in Texas, as Burzynski faces renewed charges from the Texas Medical Board, was that Burzynski could only administer ANP to patients on FDA-approved clinical trials. According to Burzynski’s lawyer:
[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. (emphasis added)
And a host of other trials were opened as well. Burzynski opened over 60 “to treat every type of cancer the clinic had treated and everything Burzynski wanted to treat in the future,” said his lawyer. Notice he does not say, “every type of cancer that seemed promising” or “could be helped.” Nope. He wanted to treat these cancers and he did, charging patients tens upon tens of thousands of dollars to participate in his “trials.” Not a single damned one of them has ended in a credible publication, and the trust of every patient who participated in the trials expecting their suffering and money to go into useful research has since been betrayed.
In an article on the front page of the San Jose Mercury News on 30 September 1996, we learn something of the course of Brandon’s treatment:
The results, [Brandon’s mom] said, led to temporary shrinkage of Brandon’s two tumors. But five months later, the family was forced to reduce the dose of Burzynski’s treatment after Brandon developed metabolism problems, apparently related to the drug. As a result, the two tumors grew and he developed more brain tumors. He has since returned to conventional treatment.
Nevertheless, the family was impressed with Burzynski’s therapy, which totaled $20,000, including travel costs and the treatment. Like other families, [they] were able to raise the money from the community.
“If something will show it won’t damage your child’s life, it’s not going to hurt them and it has a chance of helping or curing them, then any amount of money is worth it,” said [Brandon’s mom], a preschool teacher. “You do what you have to do.”
While he cannot explain the shrinkage, Brandon’s pediatric oncologist, Dr. W. Byron Smith, remains uncertain about Burzynski’s treatment.
“I think the medicine may work in a small percentage of patients with brain tumors, but in truth, I don’t really know that,” said Smith. “The only way to resolve the question is with a head-to-head clinical trial in which you randomize patients between his drug vs. the standard therapy that’s been done.”
A few notes about this passage. First, it’s unclear what the “metabolism problems” are that that are mentioned, but there is a good chance that the antineoplastons, which are the metabolic derivatives of an orphaned urea cycle drug (which Burzynski also conveniently produces), may have messed with Brandon’s sodium levels. Antineoplastons are notorious for raising patients’ sodium levels to dangerous heights, and this side effect likely contributed to the death of Josia C., which was chronicled in a USA Today investigation of the Burzynski Clinic:
In a report sent to the FDA after the [Josia’s] death, Burzynski’s staff acknowledged that his last blood sample, taken the day he passed away,showed a blood sodium level of 205 millimoles per liter, a level that is typically fatal. Burzynski’s staff blamed that reading on a “false laboratory report based on a contaminated sample.”
Yet hypernatremia is one of antineoplastons’ most common side effects, known to doctors for two decades.
One of Burzynski’s own informed consent documents — the form that patients sign before they begin treatment — put the risk at 21%.
The typical sodium level is between 135 and 145. This may or may not have been what caused Brandon to get pulled off of the treatment. But what about the shrinkage reported? Surely that’s slam dunk evidence?
Sadly, no. There are a number of reasons that a patient might appear to have regression. One is actual response. It’s a possibility. However, one must also consider the chemotherapy that Brandon had prior to the ANP treatment. Pseudoprogression can occur when a tumor swells as an initial response to a treatment but then returns to baseline. How do we know it was not that? What type/dose of steroids was Brandon on? Burzynski’s use of anti-inflammatories has made his results difficult to interpret, possibly, as the FDA found, he had patients on huge doses of corticosteroids:
However, for all of the subjects listed above as having been classified as a Complete Response despite being on corticosteroids, their corticosteroid doses were well beyond those needed to maintain physiologic levels. Specifically, these subjects were on doses of Decadron (dexamethasone, a corticosteroid) that ranged from 4 mg/day to 16 mg/day, while the physiologic-replacement equivalent of Decadron is in the range of 0.25 mg/day to 0.75 mg/day.
That’s 64 times the dose that other physicians would expect. Burzynski is also notoriously bad at classifying his own outcomes, as the FDA noted two years ago. How do we know shrinkage wasn’t due to something in Brandon’s diet or environment, if it was there at all? So, there are numerous reasons that Dr. Smith hedges a little before giving Burzynski credit. Indeed, the statement that Smith “cannot explain the shrinkage” is unfair and irrelevant, as it is never anyone’s job but Burzynski’s to provide evidence that ANP works, and the only way to do that is in a randomized trial. This has not yet happened.
Even though the Mercury News story suggests that ANP treatment terminated before the end of September, the next month, in an article in the Pleasant Hill Record on 3 Oct 1996, money is still being raised to pay Burzynski:
The Martinez Community Foundation has given the family of cancer patient Brandon Borman $3,100 from a trust fund created earlier by the foundation.
Foundation officials said that they left some funds in the account at WestAmerica Bank in hopes that others in the community would also contribute.
Brandon’s experimental therapy requires monthly trips to Houston, Texas. Neither the therapy nor the airline expenses are covered by the family’s medical insurance.
On 5 April 1997, we hear in an article from the Contra Costa Times that a ball field has been named after Brandon, but that he is not well:
The cancer has spread now from his brain to his spinal cord, and he takes morphine to control the pain of headaches. But he still plays baseball, and was there for the River Dogs’ season opener March 29.
According to the 1 May edition of the Martinez Record, Brandon threw the first pitch at the season opener at the field named for him.
In the 6 June edition of the Contra Costa Times, we hear that Brandon had been with his family at a camp for kids with cancer over Memorial Day Weekend, when he started running a fever and having seizures. On June 3, Brandon died:
“In typical Brandon fashion, he held on for two hours longer than the doctor said he would,” [Brandon’s father] said. “We think he waited until everyone had left and it was just us. We crawled into bed with him and held him. The last time it’d been just the three of us, in a hospital bed at John Muir, was when Brandon was born.
“He took his last breath and he was gone.”
Burzynski is standing before judges in Houston next month, and we can expect a parade of witnesses who think they have been helped by Burzynski will testify passionately on his behalf. Many of them have defended him in previous trials. For every patient that appears in front of Roy Scudday and Catherine Egan, I hope they remember that each live witness represents hundreds of dead patients (Burzynski claims to have treated more than 8000). Burzynski, it seems, is willing to take credit for outliers, which is, to employ a word the TMB lawyer used in his opening statement, cheating.