Tagged: Burzynski cure rate
Burzynski Patient McKenzie L.’s Story
As Stanislaw Burzynski stands in front of the Texas Medical Board to answer for yet another litany of abominations, patients are no doubt gathering to protest in front of the courthouse so they can beg for their lives. Many of his supporters in the past have been then-current patients who were convinced that Burzynski is their only chance at life. Burzynski’s patients often have dismal prognoses and their prospects do not improve when they buy into his medical adventurism. In anticipation of such patients being used as human shields yet again, we are focusing on stories of people who have testified on Burzynski’s behalf, begged for their lives in courts and in the public, but who of course died anyway. These patients, so far, include Burzynski patient Elke B., Burzynski patient Douglas W., Burzynski patient Janet C., and Burzynski patient Sen. Ed G. These patients may not be testifying in the upcoming trial, but their stories are perhaps the most important and are far more eloquent and revealing.
Today we start looking at the roster of the dead and dying known as the ANP Coalition. This is the collection of patients, mostly children, who came to Burzynski’s aid when his unproven “antineoplaston” chemotherapy was taken off the market following a juvenile patient’s death. The ANP Coalition did help get the trials reinstated, as best we can tell, however, out of the nine patients who have appeared in the Coalition’s pro-Burzynski campaigns, 6 have died. Not all of the patients received ANP, but all of the patients have been used. Only one, as far as we know, is on ANP at this time.
The first patient we will examine is McKenzie L. Hers was perhaps the most extensively covered story of all the ANP Coalition’s new patients. We have some 80 files on her story. It is horrible and long and frustrating, but it’s a story that must be told because it makes staggeringly clear the real harm that sloppy journalism can cause. Everyone here tried to do the right thing, but a selective blindness is pervasive and it has truly catastrophic results.
The first evidence that something is wrong appears on McKenzie’s grandfather’s Facebook page on 28 Nov 2012:
It turns out, as we hear almost two years later that McKenzie had been walking home from school with her grandfather and
“swayed in a crooked line down the sidewalk and her eyes seemed unfocused. When he asked her what was wrong she told him she was seeing double.”
The diagnosis is Diffuse Intrinsic Pontine Glioma, a tumor in the brain stem. Almost universally fatal. It catches the fifth-grader and her family mid-stride; McKenzie had just received a stellar report card and seems to be athletically inclined, swimming and riding horses. Within two weeks, she begins a long series of visits to the hospital for conventional treatment, radiation and chemotherapy, it seems.
Right out of the gate, the traditional therapy does what it is supposed to, beat back the cancer. It is unlikely to kill off it all, but is only a stop-gap measure. We hear on Jan. 7 that double vision and walking have been a problem, but the problems are lessening. On 20 February 2013, we hear that according to their first MRI after treatment, the tumor has shrunk by 50%.
By October, however, the tumor grows back.
Burzynski first appears on the family’s timelines in January 2013, when McKenzie’s grandfather posts an article about Burzynski, one riddled with inaccuracies and conspiracy theories (get a skeptic’s take on the same Burzynski decision here). In September of 2013, however, with the family running out of options, members of the Burzynski Patient Group begin appearing in the family’s Facebook timelines, especially an enthusiastic chemtrail, New World Order, and fluoride truther.
On 2 October 2013, McKenzie L.’s family goes to Houston looking for a miracle:
By the end of the month, there seems to be devotion to the Burzynski cause. At the time, Burzynski’s antineoplaston trials were suspended after the death of a child, Josiah C., whose story was told on the cover of USA Today in November 2013, just after McKenzie’s family seems to have committed to Burzynski’s cause. Neither the Clinic nor the FDA told Josiah’s family that the clinical trial that their son was on had been shut down following his death.
Five days after the expose of Burzynski appeared on the cover of USA Today, Michael Rosenfield of WBZ-TV files a report about a petition that McKenzie’s grandfather has started to lobby the FDA for a compassionate exemption for her to receive Burzynski’s drug. At the time, the compassionate exemption seemed to be the only way that Burzynski could get patients on the drug. All of the trials were closed. The list of Burzynski’s horrific violations seemed too unthinkably long to permit him to continue. Burzynski’s response to the charges was clearly inadequate for the FDA. This is the first point where the media failed to serve the public interest. An 8-month investigation raising profound doubts about whether the “doctor in Texas,” as Rosenfield refers to him, and his “controversial drug,” as Rosenfield refers to it, was completely ignored. Indeed, the absence is conspicuous given the horror with which the article was received. We believe that Rosenfield had a journalistic obligation to report that the FDA had observed that:
- Burzynski (as investigator, the subject of the inspection) “failed to comply with protocol requirements related to the primary outcome, therapeutic response […] for 67% of study subjects reviewed during the inspection.” This means that several patients who were reported as “complete responses” did not meet the criteria defined in the investigational plan, as were patients who were reported as having a “partial response” and “stable disease.” This means that his outcomes figures for these studies are inaccurate.
- Additionally, some patients admitted failed to meet the inclusion criteria for the study.
- Even though patients needed to have a physician back home to monitor their progress prior to enrolling in a trial, the FDA found a patient who began receiving treatment before a doctor had been found.
- Patients who had Grade 3 or 4 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.
- 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.
- 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] It seems that these overdoses are related to the protocol, which requires family members to administer the drugs via programmable pump on their own. Further, patient records show that there were many more overdoses that were not included in the Hospitalization/SAE/Overdose list.
- “Your […] tumor measurements initially recorded on worksheets at baseline and on-study treatment […] studies for all study subjects were destroyed and are not available for FDA inspectional review.” This is one of the most damning statements, as without any…not a single baseline measurement…there is no way to determine any actual effect of the antineoplaston treatment. This means that Burzynski’s studies–which by last account cost $30,000 to begin and $7000 a month to maintain–are unpublishable.
- Some adverse events were not reported to the Burzynski Clinic IRB for years. (One patient had an adverse event in 1998 and the oversight board did not hear about it until 2005.)
- The FDA observed that the informed consent document did not include a statement of extra costs that might be incurred. Specifically, some informed consent documents were signed days to weeks before billing agreements, and in a couple of cases no consent form could be found.
This document was available online for anyone access to Google to see. Nonetheless, this is the doctor to whom Rosenfield unquestioningly commended young McKenzie’s eager and vulnerable family. The audience of this report was not informed about the true magnitude and nature of the controversy before the station linked to the petition, which was certainly relevant and available. Michael Rosenfield must share some of the blame for what comes.
Three days later, WMUR files a similar report about the petition. McKenzie’s grandfather, again, appears in the report. The interview with McKenzie’s grandmother is heartbreaking, but reporter Jean Macken does not put their grief and fear in context. And they link to the petition, which has already received at least 9,000 signatures following Rosenfield’s report. Jean Macken must share some of the blame for what comes. Incredibly, WMUR had already reported about a fundraiser for the antineoplaston treatment that DIPG patient Justin B. received. Sadly, Justin died.
The next day, the New Hampshire Union Leader publishes an article called, “Hope for McKenzie; A girl vs. bureaucracy.” It is wretched. For instance:
The FDA exists to improve the health of Americans. It screens and tests drugs so that unsafe ones do not reach the market. But what about people who are terminally ill? If someone is facing imminent death, who cares about possible negative side effects of an experimental drug? The FDA does.
Doctors do. For instance, a patient who is facing immanent death may forego palliative care. They risk having their remaining limited time and their savings squandered by a quack. They may get killed quicker. Their quality of life may decline. The cost of trying to deal with the side effects may escalate. They may become ineligible for trials that might actually have a chance of helping them.
Terminally ill children and adults can get unapproved drugs through a policy called “compassionate use.” But even that takes time. Patients have to apply, and the FDA has to approve the use. It is time that some patients do not have.
In emergency cases, the FDA can get approval for compassionate use or “expanded access” overnight.
McKenzie [L.] is fighting for her life. No one knows how much time she has left. We pray that it is longer than the time the FDA will take to respond to her parents’ request. If you would like to help, you can sign the online petition asking that McKenzie be allowed to take the one drug doctors say could save her life.
This last line is deceptive, making it sound like more than a tiny number of uninformed or self-interested physicians would say that ANP would be the one and only drug that could save her. In fact, as we will see, the family has a hard time even finding a physician who would be willing to administer the drugs. This is factually misleading, emotionally manipulative, and irresponsible in the extreme. The New Hampshire Union Leader’s editors must share some of the blame for what comes.
The same day, 25 Nov 2013, the Nashua Telegraph reports on the family’s attempt to get signatures for the petition and to raise money. This is in the news section, not the opinion section, and the reporter, Dean Shalhoup, does not recommend that readers support the initiative. He just reports. Nonetheless, there are some disturbing lapses in judgment that warranted a little research that was either not done or not included.
[The family was] so intrigued by Burzynski’s apparent success in raising from near zero to around 27 percent the cure rate of patients diagnosed, as was McKenzie, with an inoperable pediatric brainstem tumor that they traveled to Houston about two months ago to meet him. “The man has a success rate with this drug,” [McKenzie’s grandfather] said. “I have been in touch with (cancer) survivors who used this drug.”
Of course, Liz Szabo, by this point, had already made it abundantly clear why one should doubt the value of Burzynski’s testimonials:
Yet independent oncologists say that appearances can be deceiving, and that patients shouldn’t be too quick to credit Burzynski. Experts say there are several reasons to be skeptical of Burzynski’s claims.
• Burzynski often relies on anecdotes, which don’t tell the full story. […]
• Burzynski’s therapies are unproven. […]
• Burzynski’s patients may have been misdiagnosed. […]
• Burzynski’s patients may have been cured by previous therapy.
Also, I should mention that sometimes weird things happen. Flukes and fortune can also, rarely, lead to remissions. Next, the “apparent success” cited was easily shown by a little research to be “illusory success.” For instance, Szabo had just reported that the FDA had found that Burzynski had been:
Inflating success rates in 67% of cases, by inaccurately reporting how tumors responded to treatment.
This fact was available and relevant to Shalhoup’s story. Secondly, Burzynski had not–and has never to date–published a reputable study stemming from the 60+ clinical trials he’d opened in the 1990s. This fact checking didn’t need investigative reporting; Szabo, her colleagues, and her editors had done that. All it needed was a Google search. While this is somewhat better than other reporting on McKenzie’s case, Dean Shaloup must share some responsibility for what comes. He allowed desperate people to parrot poppycock.
The next day, on 26 Nov 2013, New Hampshire Senator Kelly Ayotte issued a press release titled:
“Ayotte Urges FDA to Consider Compassionate Use Request for 12-Year Old New Hampshire Girl Fighting Brain Cancer”
The entirely Burzynski has routinely benefited from patients who believe that he is their only hope. They go to public officials and beg for their lives, which is a bargain that politicians are not in a position to make. They beg in and outside of courts, in statehouses, and in the halls of Congress for the perversity of paying to be in a clinical trial. I don’t doubt that Sen. Ayotte wanted to do the best thing for her constituent. We ALL wanted McKenzie to live a long life. And once Sen. Ayotte had thrown in with Burzynski’s patient, well, someone in her position is in the awkward position of not being able to retract that support gracefully. I had hoped that what happened to McKenzie would lead to the Senator sponsoring radically increased funding for rare childhood brain tumor research in McKenzie’s memory. Research into these tumors is underfunded and patients deserve more options than quackery. There should never be a patient who has to say that “no other treatment options are available,” to quote Ayotte’s press release.
Of course, Shalhoup had to follow up on the story after Ayotte’s office got involved, but when he did, he included a link and instructions on how to find the change.org petition. This is not to his credit. By the 27th, the petition had received 40,000 signatures, no doubt largely from the people who had been misinformed by these reporters. Quackery thrives when reporters opt to do almost entirely uncritical human interest stories. April Guilmet reported in the Union Leader Correspondent that:
Ayotte noted, however, that there have been documented cases of patients reacting positively for the treatment, while the [L] family noted that some patients in past studies have even had their tumors shrink over time.
Burzynski “documented” cures are just as “documented” as UFO abductions and sightings of Bigfoot. This is why scientists–and the regulatory process–requires a higher standard than mere anecdote for miracle cancer claims. Woe to everyone if every nostrum-pushing quack is allowed to circumvent the regulatory process.
On January 13, Shalhoup, from the Telegraph, reports on how the community has committed to help McKenzie, as is to be expected. Strangers can be endlessly kind, but they need to be informed. They need better information than:
“The FDA recently banned the drug, prompted in large part by Burzynski’s 1995 indictment on multiple charges stemming from allegations he violated the federal Food, Drug and Cosmetic Act.”
No. He beat those charges. The FDA didn’t revisit that case. The immediate cause of the suspension appears to be Josiah C’s death and the subsequent investigation. Again, it was in the USA Today piece. While Shalhoup does give a strong half a sentence to vague, uninterviewed detractors of Burzynski, there is nothing like balance in the article, as, again, the link to the petition and info on how to donate is included.
On 28 January Carol Robidoux at the Nashua Patch published an entirely credulous snippet called, “Saving McKenzie [L]: How You Can Help.”
This article ended:
McKenzie’s grandfather […] said the FDA has proof the controversial treatment, available through a clinic in Texas, has a 33 percent cure rate, versus that of conventional cancer treatment, which has a 0 percent cure rate for the kind of cancer McKenzie is up against.
Watch the YouTube video, uploaded here, in which McKenzie and her grandfather tell their story. Then, go to change.org and sign the petition.
Then, pass it on.
Links were included throughout the original. Skeptics did contact Robidoux to try to put what was happening in context. In reply to one skeptic’s email expressing concern, she wrote:
They are going into this with open eyes.Just as people every day fly to foreign countries for treatments or surgeries that aren’t approved or legal in the U.S., this family has the right to pursue whatever treatment they would like, based on what they’ve tried and what their options are, what’s available, and what offers some shred of hope in a hopeless situation. If it is snake oil, if Burzynski is a fake, there are certainly enough local authorities and national news outlets delving into Burzynski’s claims to bear that out. I see Texas authorities have been investigating him since the 1980s. That’s a long time.If the family does nothing, McKenzie will die. What they’ve tried already, within the realm of approved treatment – also very toxic to the human body – has not netted any positive results.People make bad investments every day – in stocks, in get rich quick schemes, in religious organizations that promise healing, in New Age crystals and other remedies. Maybe Burzynski realizes he’s capitalizing on the desperation of people who truly have no other options. Maybe he believes something about his treatment has merit for some percentage of patients. I’m not a medical reporter, or even an investigative reporter, by my own or anyone’s standards.
Her standards clearly mean nothing. She’s in fact wrong about this, as conventional treatment unquestionably had abated some of her symptoms and initially shrunk the tumor as hoped. Orac called out her credulousness on the 30th, and she showed up in the comments:
As the other “credulous” reporter referenced here, I just want to reinforce that the story I wrote was one of several written about a family taking desperate measures to save a child with cancer who had run out of “conventional” treatment options. They were well aware of the quackery charges against Dr. Burzynski, yet were willing to take a calculated risk. It is not my duty as a journalist to tell them they are making a mistake – although I did discuss with the grandfather what I had learned about Burzynski in researching it on background for the story. He knew it all, and had visited the clinic himself. For the poster of this blog to persist in calling me a “credulous” reporter in the context of this blog reinforces to me that he is unable to comprehend that sometimes the elements of a story are not what the story is actually about. I cannot and will not investigate Dr. Burzynski – it was out of my realm of expertise and resources, and has already been done by other investigative health and regional reporters; I will report why a New Hampshire family is feeling so desperate that they are willing to petition the FDA for an unproven and controversial treatment. There was nothing about what I wrote that added credulity to Dr. Burzynski or his method.
The question left unanswered is how a decision can both be calculated and desperate? Robidoux’s staggering lack of self-insight to not realize that a call to “pass it on” might suggest to readers that there was something worth fighting for in Burzynski suggests she is in the wrong business.
On the 30th, we hear from April Guilmet that the family has received the support of Senator Jean Shaheen too. We hear how things were going in mid-December:
In a letter sent to Commissioner Hamburg Jan. 17, both Ayotte and Shaheen urged the FDA to communicate directly with the [L.] family.
In early December, the [L.] family was told that McKenzie would be permitted to start ANP therapy in Texas, provided the family could find a physician willing to monitor her progress locally, [a] family friend […] said.
Burzynski even offered to provide the therapy to McKenzie at no cost, according to her family. [emphasis added]
But just over a week later, further complaints against Burzynski were revealed and the FDA told the family they could no longer issue a compassion exemption.
“It’s come down to this,” said [McKenzie’s grandfather] via his cell phone as he drove on the interstate Tuesday morning. “So now I’m headed out to bang on a couple doors.They may want me to go away but I’m not backing down.”
[McKenzie’s grandfather] said he recently learned that the FDA has made more than 50 claims against Burzynski and at least one of his patients died while being treated.
And despite this, the commitment has been made. The grandfather is crashing through warning barriers that were meant to protect McKenzie and other patients
On the same day, the Skeptics for the Protection of Cancer Patients reached out to the reporter to let her know about our strong reservations about the treatment. We offered documents to substantiate our concerns and gave her contact information of patients who claimed to have been maltreated. She immediately replied that she would like permission to use portions of our letter because:
I think its important to share all sides of this story and there are so, so many.
We consented and appeared in the follow up article a few days later:
Of the Burzynski therapy, the American Cancer Society said last week: “Relying on this type of treatment alone avoiding or delaying conventional medical care for cancer may have serious health consequences.’’
Science blogger Robert Blaskiewicz of the Skeptics for the Protection of Cancer Patients group, said he’s been researching Burzynski for the past two years and is genuinely concerned for [McKenzie’s] well-being, should she ultimately be able to obtain ANP treatment.
“I’m all for patient choice,” Blaskiewicz said. “But I’m also for informed consent. Is [McKenzie’s family] aware of the stories, of the 20-year pattern of patients believing that unambiguous signs of progression are signs of success?”
Dr. David Gorski, an oncologist and the administrator of the sciencebasedmedicine.org website, has likewise devoted much of site to speaking out against Burzynski as well as the anti-vaccine movement and various forms of alternative medicine.
Contacted this week, Gorski said he believed previous trials of ANP “were designed to let Burzynski treat patients, not find answers.”
Gorski is right. We know almost nothing more about antineoplastons than we did when the trials were opened. We have detailed the unambiguous signs of progression (especially ischemic necrosis, or tumors breaking up in the middle because they have outgrown their blood supply) on this site. All we want is a reputable paper to fact-check us, because if we’re right, this is a potential medical ethics scandal that involves 8 times as many patients as the Tuskegee Experiment:
- We first noticed this pattern in the story of Amelia S.
- The family of Haley S heard this (also, see the clinic’s heartless reaction to a stroke that the child had).
- The Clinic gave the same prognosis to Justin B’s family in 2006.
- We see a similar cyst in Leslie S.’s story (2006), and it nabbed Burzynski an extra $7,500 before she died.
- We see it AGAIN–as far back as 1994!–in Cody G.’s story.
- We saw it again in the case of Samantha T.
- We saw it again in the story of Christy M.
- A similar story came from Georgia State Senator Ed G.’s story.
- In the most grotesque horror show we have ever written about, Burzynski himself tells the family of Chase S. the same thing. Poor Chase ended lying in state in his family’s front room for months.
Also in the article, we also hear about McKenzie’s grandfather’s trip to Washington, D.C.:
[He] met individually with some legislators or their staffs last week, including U.S. Sens. Kelly Ayotte, R-N.H., and Jeanne Shaheen, D-N.H., as well as Elizabeth Warren, D-Mass., Ted Cruz, R-Texas, Rand Paul, R-Ky., Ed Markey, D-Mass., Dianne Feinstein, D-Calif., and Tom Harkin, D-Iowa.
He also attended a meeting with seven FDA officials, though FDA Commissioner Margaret Hamburg was traveling and wasn’t present at the meeting.
“Basically, we told (the FDA) that it would be nice if we could get everyone sitting down at one table with them — doctors, patients and legislators,” [the grandfather said] said. “Because there hasn’t been enough communication here.”
When skeptics said that we had concerns, we were not making things up. We had warned and warned and warned everyone about what was going to happen to McKenzie if the family charged ahead and circumvented patient protections. We were concerned that if the doors were opened for one patient, then the FDA would have no justification for denying the treatment to other desperate people.
This is why we were devastated to hear on March 23rd in USA Today:
The FDA acknowledged Friday that it has agreed to allow [7 Burzynski patients] to use the experimental drug, but only if they can find a qualified, independent physician to administer the drug. Beyond infusing the drug and overseeing their care, the doctor would have to formally apply for expanded access to an “investigational new drug,” as well as get approval from an institutional review board, an independent panel that reviews safety and ethical issues involved in clinical trials.
The FDA grants an average of more than 1,000 requests a year for expanded access.
Burzynski will supply antineoplastons for free, says his attorney, Richard Jaffe. [emphasis added]
The next step is finding a doctor to administer the drug, as pointed out in the Billerica Minuteman on March 27th in an article called: “Help McKenzie [L.] Get Needed Treatments.” Again, links are included to the various petitions and projects that can really only help Burzynski and nobody else. The family is still having a hard time finding someone to sign up to work with Burzynski, as we hear in the Nashua Telegraph on 29 March:
That second hurdle, to date a seemingly insurmountable obstacle, is finding a doctor who would agree to administer the drug, called antineoplastons, or ANP, [McKenzie’s grandfather] said. “They said she can use it if we can find a qualified doctor,” he said. “But who knows what ‘qualified’ means? An oncologist? Do they want a research doctor?”
Essentially, the answer to the last question is yes. Which means, [he said] said, even if there’s a doctor out there who would take McKenzie’s case, he or she would likely have to spend lots of money and jump through a lot of hoops to become qualified.
“We can’t even find a doctor to go that far,” [he] said.
This is another red flag; when qualified researchers are unwilling to sign the papers, you have a problem.
Following a visit to Dana Farber in mid-April, according to a public Facebook page set up of McKenzie, the docs say that she “looked really good.” We don’t hear about progress getting a doctor to sign up with Burzynski until May:
This doctor is Terry Bennett, who explained his participation in the June 15 Telegraph:
The latest move came several weeks ago in the person of a Rochester physician who battled the U.S. Food and Drug Administration to get access to a similarly expensive drug that he felt confident would stem the cancer that was ravaging his body and buy him some time.
Dr. Terry Bennett said his experience prompted him to come forward when he learned the young Hudson girl and her family were beseeching the FDA to grant a compassionate exception that would allow McKenzie access to ANP treatments. […]
Bennett said it didn’t take long after he met McKenzie to agree to be her “backup” doctor in New Hampshire, as he calls his role.
“I thought, if there’s any way they can make this happen, I’m all for it,” he said.
“We have a (sick) little girl here. I will supervise what goes on here the best I can.”
Though you might think, based on the things said above (in bold), and in keeping with common research practice, that the Burzynski Clinic was going to foot the bill. Nope. The family is being charged the customary $15,000 a month in ancillary charges.
Even though the clinic is providing the medication free of charge it is still going to cost approx. $15,000.00 per month for medical supplies, consultations, & administrative fees that insurance will not cover.
While we expected Burzynski to charge out the nose for this treatment, some people thought it was going to be free including the doctor and the nurse who volunteered their services on that basis. On the same day that McKenzie’s Facebook group announced that she was starting on the ANP…
….and article by Dylan Morrill appeared at Fosters.com, which revealed in part:
Nearly two months later, Bennett and his employees spent more-than 100 hours filling out the FDA application to become the sponsoring doctor and perform the therapy using Burzynksi’s medicines.
Dye was then contacted through “a friend of a friend of a friend,” and decided to offer her nursing services for free to McKenzie. She took two trips down to Burzynski’s Houston clinic to learn about the therapy.
Both Dye and Bennett are not charging for their services, and they thought that Burzynski would also be working pro bono. In December, 2013, Burzynski wrote a letter to U.S. Sen. Kelly Ayotte’s legislative assistant Dan Auger explaining that he would provide antineoplaston therapy for free if the FDA granted the exemption.
The letter read: “This is to confirm S.R. Burzynski, manufacturer of Antineoplaston A10 and As2-1 infusions is willing to provide these agents for free and for compassionate means.”
Bennett said he was told in May during a phone conversation with Burzynski that the medicine was being donated. It was after that conversation that Bennett decided to sponsor McKenzie.
[McKenzie’s] family also believed that McKenzie’s medicine was being provided for free. But […] McKenzie’s mother, said she received an itemized bill from Burzynski showed up in her mail a few weeks ago.
The family was told that the first month will cost $28,000 and every month after that will cost $16,000.
The family received an itemized bill from Burzynski? I think the FDA would be interested in seeing it. I smell a refund!
“It meets all the criteria for a bait and switch operation,” said Bennett. [emphasis added]
The next day, Bennett appeared in another article, which reported:
Bennett said he will not withdraw his sponsorship of McKenzie, despite the cost of treatment. But he’s extremely upset over what he calls a very disturbing phone call that he received on May 28.
Bennett says a representative of the Burzynski Clinic called him on that date seeking payment for the first month of McKenzie’s therapy. Prior to that, Bennett, who is donating his services, thought Burzynski was doing the same.
Instead, said Bennett, “I’m supposed to be the bag man for all of this. They want me to collect the $30 grand for the family and send it to Burzynski.” [emphasis added]
He later said:
On the other, there’s the opinion of Dr. Terry Bennett of Rochester, who agreed to be the overseeing local physician for the treatment of Burzynski.
“This is a classic bait-and-switch operation,” Bennett said of Burzynski in a recent phone interview. “He suckered me and this family into buying into a very expensive treatment plan.”
That second article, by the way, is titled, “Dr. Feels Misled in Cancer Treatment Costs.” It sort of reminds me of the headline. “Amelia S.’s Family ‘Misled By Clinic’” It reminds me of the gouging of Denise D., who was treated so badly by the clinic. It reminds me of Supatra A’s family, who had budgeted but still found themselves in debt to the clinic. It reminds me of poor Kathy B. who said that she:
made this video [of a patient visit with Greg Burzynski] in anticipation that I would be receiving the antineoplastons. Apparently after spending over 30,000 here I found out that the Antineoplastons are only reserved for brain cancer patients who have already undergone chemo radiation. FDA put this restriction on the Burzynski Clinic, so any other cancer patients are BASICALLY ONLY GETTING THE TRADITIOINAL ALLOPATHIC TREATMENTS OF SYNTHETIC ANTINEOPLASON PILLS THAT DID NOTHING FOR ME.
All of these patients are dead. This is what we are dealing with here. This is why reporters need to do a better job of checking the public record before they endorse a shameless quack.
Registered Nurse Ariel Dye also volunteered her services to help McKenzie. She was the one who, instead of the patient, went down to Houston to learn how to use the ANP pumps and administer the drugs. I suspect that patients being trained to administer the drugs themselves may have contributed to the huge number of overdoses observed by the FDA and that this was a fix to the protocol the FDA demanded that Burzynski never got around to doing. He only had 15 years, after all. In November, we hear about Nurse Dye’s experience at the Clinic. She is scathing:
“I went out there and watched the nurse teach a layperson how to work off a central line. It was nothing,” said Dye, who is an IV-certified RN. “It was crazy to me that they charged this.”
“I got little to no instruction saying (things like) if there are major reactions, this is what you’re going to do in this case, in that case,” she said. “They made it seem like it was this big training program they put me through, but they lied and were looking to make money.”
Dr. Bennett came around fully by this point:
“His claims have no merit. He has never tested any of it realistically,” said Bennett.
On day 2 of the treatment, McKenzie feels pretty good, her grandfather reports. But not long thereafter, a few weeks after the start of ANP treatment, we learn that McKenzie is suffering from side effects of ANP:
On July 27th, we see that the disease is progressing unabated, which is what you would expect if she were put on snake-oil, and what we have seen so many times:
At about this time, Burzynski was whacked with a 200-page list of charges against him by the Texas Medical Board. This development was announced at The Amazing Meeting, the premier conference on science in the public interest:
http://www.youtube.com/watch?v=yJGIxDou9v0
In response to this action by the TMB, Fosters.com printed an article “Do Not Take Her Hope Away,” which was entirely irresponsible. For instance, they mentioned Dr. Bennett but not his opinion of the clinic. They did not mention that the tumor had continued to grow, as was to be expected. In fact, by July 31st, we hear how ineffective antineoplastons had been:
In late September, April Guilmet tells us what has happened:
The ANP treatments cost the family about $15,000 per month.“She had crippling headaches and her blood counts got very low,” [McKenzie’s grandfather] said. “At full dosage, her body just couldn’t handle it.”
[McKenzie] went off ANP in mid-August, he said. Since then, her family has been researching other treatment options. She is currently on a regimen of gene-targeted drugs prescribed by doctors at Dana Farber. The family departed for University of Chicago on Sunday, where they will meet with another team of physicians.
The tragedy of fringe medicine is that her tumor might well have been treated by something with a chance of working instead of antineoplaston. To all the reporters who wondered, “What’s the harm in in treating someone with a terminal illness with….whatever they want?” I refer them to the energy, money, and precious time squandered on this course of treatment.
By September 28th, the family is in Chicago pursuing experimental treatment, and Burzynski is, blessedly, out of the picture.
They are cutting into the brain stem which is usually a surgical no-go zone (and is why so many of Burzynski patients haven’t had biopsies to confirm radiological diagnoses).
McKenzie died at home on 23 Oct 2014. A radiant light went with her, and hundreds of people McKenzie had touched saw her off.
To think that all of these powerful people were following McKenzie’s story and for want of critical commentary of the treatment in the media, McKenzie suffered for it.
I think Telegraph reporter David Brooks offered a fair summary of McKenzie’s ordeal in his write up after the funeral, “Alternative Methods are Not Safe Bets,” and he concluded:
It’s hard for an outsider not to feel sympathy for a desperate family struggling to save a loved one.
But we should give more weight to a medical establishment that has doubled the human lifespan, that has created a huge, complicated system of peer review, double-blind tests, treatment protocols which is far from perfect but has done more for your health and mine than has a millennium of hopes and dreams.
Brooks apparently interviewed some of McKenzie’s family in the aftermath:
The treatment over the summer accomplished nothing except making McKenzie sicker for a while, and cost McKenzie’s family and supporters many thousands of dollars, even though it was stopped quickly because of side effects, said McKenzie’s grandfather […] .
But [McKenzie’s grandfather] who says the total cost was “less than $25,000,” thinks the effort was worthwhile and might have succeeded if so many obstacles hadn’t been placed in its path […].
Most frightening is the lesson that the grandfather has apparently taken away from this. According to Brooks:
If somebody else he knew was diagnosed with DIPG, he’d recommend going to Burzynski.
The lack of regret is eerily similar to sentiments of the families of Burzynski patients going back decades. For example, in 1982, The Windsor Star reported that a family member still believed in the treatment “with all my heart” but her sister-in-law Deanne had arrived too late for the six weeks of antineoplaston treatment to be effective.
I hope that when the Texas Medical Board drags Burzynski to stand before a judge in Austin on June 15 the press remembers that treating this issue as a human interest story, such as we have seen in the case of McKenzie L., perpetuates misery and magnifies suffering.
Burzynski Patient Derek W.’s story
As Stanislaw Burzynski heads to court again to answer charges made by the Texas Medical Board on behalf of a variety of patients, he is doubtlessly preparing by getting the testimony of current and former patients. In anticipation of this pony’s one trick, we are telling the stories of patients who have testified on Burzynski’s behalf over the course of his long, dubious career and see where they are now. Much of what follows is based on reporting from The Oregonian and on written testimony presented to Congress in 1996 in the same hearing in which Douglas W. testified.
Derek W. was just 7-years old but already knew what he wanted to be when he grew up: a preacher. His proud parents nicknamed him the “preacher in sneakers” and ensured he was active in their growing church congregation. Derek also enjoyed participating in his local cub scout troop.
On November 6, 1995, Derek’s parents received the devastating news that Derek had a deadly tumor in his upper brain stem. According to his dad, the news was bleak, so they scoured the country for a solution:
Without treatment he was given 3-6 weeks to live. With paliatory treatments, primarily radiation, he was given between 4 and 18 months. As any parent in our position would, we researched all known traditional and non-traditional cancer treatments.
The doctors’ recommendation of radiation was not likely to be curative. So the family decided to try Burzynski’s treatment antineoplastons because it “appeared to be based on firm scientific data.” Derek’s dad said Burzynski “felt that his success rate was as high as 20%,” but the trusting father acknowledged that the number “was not scientifically documented”.
Sadly, the data released by the Burzynski Clinic over the decades has been notoriously misleading. Indeed, the 20% survival number remains unsubstantiated even two decades later. And yet, other desperate families are still under the false impression that antineoplastons have been demonstrated to be safe and effective.
For example, the family of McKenzie L. thought she had a 27% chance of survival by being pumped full of Burzynski’s concoction. To a desperate parent, a 1-in-5 or better chance certainly sounds infinitely better than the 0% chance that brutally honest cancer doctors sometimes are required by ethics to provide.
The mother of Brendan B., who paid $10k to the Burzynski Clinic in 1991, describes the psychology in a 1996 New York Times article:
“I would have gone out and stood naked in traffic,” Mrs. [B] said. “I would have died in his place if that were possible. I would have done anything to make this child live.” Dr. Burzynski, she said, “offered us a thread to cling to.”
When she and her son Brendan were in Dr. Burzynski’s office, she said, “a very interesting thing happened.” She explained: “I got caught up in this whole thing with all these sick people, people coming and saying they were cured. I feel so stupid even talking about it because I am intelligent and educated and so is my husband.”
She believed in Dr. Burzynski, in spite of herself she said, because “this beautiful child is dying and here’s this person who may possibly have something.”
In addition to Burzynski’s treatment, Derek received radiation as recommended by his oncologists. His father is hopeful that the tumor’s lack of growth is a good sign:
We had an MRI that showed no new tumor growth since we began Dr. Burzynski’s medicine. We still feel [Derek’s] situation is shaky, and this does not mean the medicine is working for sure. It is our one and only hope. Without it, he for sure would die. With it, we still have a chance.
If only Derek’s parents had been able to speak to Mrs. B, who said, “It’s fine to say Dr. Burzynski offers hope, but you have to have hope in something that’s not ephemeral.”
And if only Derek’s parents had reviewed the results of a 1982 visit to the Burzynski Clinic by Canadian doctors. The doctors’ report contained a horrifying picture of what was happening in Houston, according to the 1996 NY Times article and a Usenet posting:
We were surprised that Dr. Burzynski would show us such questionable cases. We were left with the impression that either he knows very little about cancer and the response of different tumors to radiation and hormonal measures, or else he thinks that we are very stupid, and he has tried to hoodwink us.
As we look back over the cases were were shown, we are left with the impression that the only patients who are still alive either had slowly growing tumors, or had received effective treatment before being referred to Houston.
And the Canadians reportedly concluded:
After reviewing 20 case reports, selected by Dr. Burzynski as his best examples of clear cut responses to Antineoplastons we were unable to identify a single case in which therapeutic benefit could be attributed to Antineoplaston.
[…]
We believe that it is unethical to administer unproven agents such as Antineoplastons to patients without satisfying the requirements of the FDA and an ethics committee, that the minimum standards for human experimentation are being met. We also believe that it is immoral to charge patients for this unproven, experimental treatment.
What’s true in 1982 is still true today, since the American Cancer Society agrees that “there is no convincing evidence showing that antineoplastons actually work.” In fact, Burzynski has, according to FDA inspection records, a horrible time satisfying them that his evaluations of his trial outcomes are accurate. Indeed, the FDA recently found that his outcomes are inflated 2/3 of the time.
Derek died of his cancer on December 13, 1996, just over 11 months after his diagnosis. There is no available evidence that antineoplastons improved Derek’s survival.
Derek’s parents wanted to create a special memorial to their son. So when their church expanded to include three 40-foot crosses, they made sure one of them was dedicated in memory of him. The crosses were made of steel and shared their message at least 2 miles away.
Derek’s mom thought the memorial cross was a fitting way for her “preacher in sneakers” to continue to preach: “You want a chance to remember the person who died and to have their dreams live on. [The cross] is a testimony to our hope.”
Burzynski Patient Derek T.’s Story
Derek T. first appeared in the press in June 1993. At the time, he was suffering from a brain tumor and the community was rallying around him (and 2 other kids with cancer) to raise money for the Children’s Wish Foundation. Derek was 6 years old and had been taken to Sea World by the charity. According to his mother, who appeared in the Hamilton Spectator:
Derek’s mother […] was also overwhelmed.
“I just can’t believe how much the community is pulling for us,” she said. “People really didn’t know what to do, so they did this. It has helped the family and I think the trip to Sea World helped Derek’s health.”
Derek’s journey was chronicled by the Hamilton Spectator, so we have a pretty good record of his progress. At the time of the fundraiser for the Children’s Wish Foundation, according to an article that appeared in April of 1994, his tumor was shrinking thanks to radiation treatment. He went back to school in September but, then we hear in the issue from April 18:
But, around Christmas, his flu-like symptoms turned out to be the tumor growing again and pressing on his brain.
‘It happened very fast,’ said his aunt.
Before long, he was confined to a wheelchair. As the condition overtook him, Derek could only shake his head and move his hands to communicate.
That’s when the [family] re-mortgaged their home and decided to ignore the advice of caregivers at McMaster University Medical Centre.
They were on their way to Houston, to the Burzynski Clinic, where they have used an unproven experimental chemotherapy for nearly 40 years under the guise of clinical with no good evidence for efficacy. The Spectator is way out of its league and has basically no idea what the treatment entails as we see in April:
In Houston, he hopes to receive a new treatment involving injections of plasmalike antineoplaston cells through the chest catheter.
No, not even close. If only the Spectator had reviewed the 1982 report by Canadian physicians Blackstein and Bergsagel commissioned by the Ministry of Health in Ontario, which had some damning revelations:
We were left with the impression that either [Dr. Burzynski] knows very little about cancer and the response of different tumors to radiation and hormonal measures, or else he thinks that we are very stupid, and he has tried to hoodwink us. As we look back over the cases were were shown, we are left with the impression that the only patients who are still alive either had slowly growing tumors, or had received effective treatment before being referred to Houston.
The 1982 Canadian report concluded:
After reviewing 20 case reports, selected by Dr. Burzynski as his best examples of clear cut responses to Antineoplastons we were unable to identify a single case in which therapeutic benefit could be attributed to Antineoplaston.
And even more from the 1982 Canadian report:
We believe that it is unethical to administer unproven agents such as Antineoplastons to patients without satisfying the requirements of the FDA and an ethics committee, that the minimum standards for human experimentation are being met. We also believe that it is immoral to charge patients for this unproven, experimental treatment.
So, in April 1994, the family, facing the progressing disease ends up in Houston. Instantly, unnecessary life-threatening complications arise just trying to get Derek on treatment:
His parents […] and his five-year old sister […] flew to Texas last Thursday, when Derek was admitted to hospital for insertion of a catheter in his chest through which the new drug will be pumped. ‘They had trouble inserting the catheter because they couldn’t find a vein, then when they got him stabilized … his heart went wild and started beating 200 times a minute,’ said his aunt […] in a telephone interview yesterday. ‘He has a very low blood count and when your blood count is down you don’t heal properly,’ she added. ‘We’ve been told the next 24 hours are going to be critical.’ The child has already received one blood transfusion and may need another, she said
The doctors objected to antineoplastons for a reason. At the same time, the family is feeling the pinch:
Money, she added, is becoming a major worry for the family. ‘This hospital stay isn’t something we’d planned on,’ she said. ‘OHIP doesn’t cover any of this because it’s an experimental treatment and you pay for your Kleenex and bedpans and everything.’
This is the case at Burzynski’s clinic, though it would probably not be elsewhere. Usually, patients receive medical care in exchange for being on a clinical trials, because the developers intend to make their money when the drug goes to market. R&D is an investment in real drug trials. At the Burzynski Clinic, patients pay dearly to receive experimental treatment.
When Derek was let out of the hospital, he moved into a motel, where they hoped treatment would begin:
‘They figured on Wednesday Derek was stable enough that they could start the treatments, so what’s going to happen is that they’ll set up all the medical equipment they need in the motel so they can do the treatments there rather than having to get Derek to the clinic every day,’ said [Derek’s aunt]. ‘I think someone will be coming over every day to spend a couple of hours to get this treatment into him. ‘We’re told they may be able to come home in two to three weeks, but it could be four to six weeks before they start to see any effect from the treatments,’ she added.
The kid’s too sick to go to the Clinic.
Two days later, we hear:
They have been told the treatments could last six months, or continue indefinitely at a cost of between $3,000 and $10,000 a month. Yesterday, Derek’s aunt […] said: ‘Yesterday was a good day for him, his spirits are up and he seems to be gaining strength. ‘What they’re going to do is continue the treatments for 10 to 14 days and then see about letting him come home. His parents seem to feel better now that the treatments have started. They seem to be a little more up now.’
All the while the community is rallying around Derek to raise money for Burzynski. A few days later, Derek’s uncle returns home and talks to the press:
‘I think our little guy’s getting better,’ [Derek’s uncle] said yesterday afternoon. ‘They’re saying that if he makes it through the next month his chances will improve fantastically.’ ‘I think the next two weeks are going to tell it all,’ he added.
The child is in a pretty horrible state, almost locked in, it seems:
‘Now he’s a lot more alert and staying awake a lot longer,’ he said. ‘They’ve worked out a little sign language to communicate with Derek he looks up for yes and closes his eyes for no.
And in this interview we get a sense of the power of testimonials, which are nearly worthless as evidence of a treatment’s efficacy:
In the weeks before Derek’s parents […] decided to make one last attempt to save their son’s life, they contacted several former and current patients of the clinic to ease their natural suspicion. ‘We had a lot of suspicion before we went down,’ the uncle said. ‘We were asking ourselves should we go or should we just stay here and let Derek die in peace.’ That’s when they started talking to former patients, gathering uniform reports of miracle cures.
‘I sat there on the phone in tears talking to these people and then told John and Brenda they had to make a try,’ he said. ‘Everyone we talked to had a different story, but it was all one miracle after another.’
And that’s the hook. These patients stories are deceptive, and it’s not because the patients are lying (though they are almost certainly wrong in every case). USA Today reporter Liz Szabo documented some of the problems and practices at the Burzynski Clinic that explain the apparent “miracles” without crediting Burzynski.
On May 6, we hear that money has been pouring in for Burzynski on the back of this kid’s suffering. The uncle seems to be hearing that things are going well:
According to Derek’s uncle […], the child is improving every day. ‘He’s starting to move his arms and say things like ‘Mom’ and ‘No.” ‘They’re quite enthusiastic at the clinic about the progress he’s making. ‘Everything sounds really good so far.’
That may sound like a gain, but it also sounds… really, really slight. Almost imperceptible, and you know that the family is scanning and interpreting every grunt and motion as a reflection of what is going on with the tumor. Except the next week, on the 14th, we hear:
The Winona boy, 6, who is undergoing an experimental treatment for the brain stem cancer that threatens his life, was taken to hospital earlier this week for treatment of fatigue and because he wasn’t eating. Derek’s uncle […] said the hospital treatment was needed because the megadoses of the serum he’s receiving frequently left him too tired to eat properly. After two days, however, he was returned to the motel room where he’s staying with his parents. ‘He had a bit of a turn for the worse, but now he’s doing fine again.’
So, by the family’s account, this was a life-threatening side effect of the treatment.
But the fundraising for Burzynski has gone well. By May 25th, some $40,000 in donations have arrived for the treatment. The family is still in Houston. I wonder if he is too sick to move:
In a telephone interview yesterday, Derek’s mother said the child remains weak from the constant flow of drugs he is receiving, but she is learning to take great pleasure in small victories.
“I got really excited yesterday because I heard him laugh a little while he was watching cartoons,” she said. “That was the first time I’d heard him laugh in two months.”
When Derek was discharged from a Hamilton hospital two months ago, his parents were told there was little hope he would survive. That’s when they decided to make a last-ditch stand against the disease.
“When he got out of the hospital in Hamilton, they said his time was limited, but now we’ve celebrated another birthday and that’s got to say something,” [his mom] said. “If you saw him in the hospital when he could barely move his arms, you’d know just how far he’s come.”
Honestly, I’d be interested in seeing what type of anti-inflammatory steroid dose the kid is on. As reported by USA Today, according to an FDA warning letter from April of 2013:
In a written response to FDA inspections sent to the agency in April, Burzynski had argued that patients with brain tumors often need anti-inflammatory drugs, called corticosteroids, to restore normal levels in the body. The FDA did not accept this explanation, however, noting that Burzynski had patients on steroid doses that were five to 64 times higher than the levels that doctors would expect patients to need. [emphasis added]
This does throw into question, as the FDA noted, the reliability of Burzynski’s results. And in reality, things are not going well, as we hear on the 28th of May:
A thousand miles from home, in a tiny motel room on the outskirts of Houston, Tex., [Derek’s parents] pray for a miracle.
On the bed in front of them lies their seven-year-old son Derek, his mouth hanging open, his pale body limp. A tumor the size of a golf ball is pressing on the stem of his brain, paralyzing most of his body and causing pain no child should suffer.
[…]
The youngster can’t move his limbs, he can’t talk, and it’s a struggle to even open his eyes. But he is alive.
[…]
“As a parent, you can’t just sit there and watch your son die,” [Derek’s mom] says. “You do everything in your power to save his life. You try anything and see anyone who might be able to help because that’s all you can do. You are so desperate.”
Yes. And that’s why the FDA and the TMB need to step up and stop playing ball with predatory alt med peddlers. In the same article, we see the family is having doubts:
At the moment, the [family is] not convinced Dr. Burzynski is Derek’s miracle maker.
[…]
It’s costing the [family] as much as $1,000 a day for doctors’ visits, equipment, emergency trips to the hospital, and to keep up the steady flow of Dr. Burzynski’s concoction for their son.
[…]
“Sometimes I wonder if maybe we should just hop on a plane and go home,” [Derek’s father] says. “But then the next day we’ll see an improvement and think, this is his only chance.”
And at this point, improvement is indistinguishable from just not getting worse. In some ways, this case is reminiscent of the course of Chase S.’s story. Chase was essentially lying in state for months in his parents’ living room, while the family insisted that he was improving.
The family has been in Houston much longer than the usual 3 weeks, and they are thinking about trying to get Derek home in early June, as we hear on the 4th:
While there’s no evidence yet to show the treatment is working with Derek, [his dad] said they are eager to come home. “We’ve been here quite a while now and we are comfortable administering the medication so we could do all that at home,” he said in an interview yesterday.
There were plans to do an MRI scan on Derek to determine if the brain tumor is shrinking but he’s been too weak the last 10 days to undergo the procedure.
He’s been battling fluid in the lungs and cold-like symptoms; yesterday was his first day back on solid foods in a week.
The father says that Derek is better than when he came down, but how can that be? They plan to return to Canada with a 2-month supply of antineoplastons.
Once the family returns, the paper seems to give us a more frank assessment of Derek’s lack of progress:
“His eyes are much more alert and although he can’t talk, he’s able to communicate with us,” [Derek’s mom] said.
They don’t know for sure if the experimental treatment he received at the clinic - called antineoplastons - has shrunk the boy’s tumor; he has been too weak to undergo the scan that would determine its size.
But they believe the medication has at least stopped the tumor’s growth, based more on what they saw at the clinic than improvements in his physical condition.
“We really truly believe in that clinic,” Derek’s mother said. “We saw so many miracles down there, people coming in real bad shape and walking out of there. We are believers.”
She said seeing those people get better helped keep the two of them going during times when Derek was not doing so well.
“It made us strong and gave us hope,” she said.
“We have no regrets about going down. We’re glad we went and we hope everything works out,” [Derek’s dad] added.
If there is one regret, it’s that they didn’t discover the clinic earlier, when the tumor was smaller, [Derek’s mom] said.
The statement that they “saw so many miracles down there” is curious. It’s too bad they weren’t more explicit about the nature of those “miracles.” They even turn blame back on themselves for why they aren’t seeing improvement, that they did not get their sooner. It probably would have made no difference to anyone but Burzynski’s accounting staff if they had.
Another thing, there’s no evidence that Derek has received palliative care, which is surely indicated. And on June 21st the Spectator headline says it all:
“All we can do is hope, pray,’ says mom: No sign experimental drug is working for Derek”
On September 15th, Derek died. During the intervening time since the last update in the paper, Derek had been in the hospital a lot:
[His mom] explained Derek has been in and out of hospitals in Grimsby and Hamilton for the last five weeks suffering a variety of ailments that included a bleeding ulcer, pneumonia and urinary infections.
And in the end, the family rationalizes why the treatment did not help, as we see in the paper:
Derek’s father […] said they’d been told their son would need to get the antineoplaston treatment, delivered through a catheter inserted in his chest, for a solid six weeks in order to show any benefit.
Because of his recurring health problems, however, the longest stretch they managed was five weeks. “We got the treatment into him, but it was never as much as he needed,” [Derek’s dad] said.
This is the first time that we have heard this “six solid weeks” nonsense. As we know from any number of patient reports, nurses have claimed that it begins working immediately. It’s hard to say why in this case the family would be told this (if that is in fact accurate that they were), but it does give the Clinic an easy out when the boy arrived too sick to even make it to treatment.
Burzynski Patient Hannah H’s Story
*An appeal to encourage Congress to investigate this follows Hannah’s story*
On Oct 18, 2005, 4-year old Hannah H. began complaining of a headache after her mother took her to skating class. Her mom took her to the doctor who suggested that they go to the hospital to rule out anything serious. By the time they reached the hospital, however, Hannah was slurring her speech and was weak on one side. Very quickly it was determined that she had two brain tumors and one had started to bleed. The first tumor, a benign papaloma in the left ventricle, was removed with surgery, the other, however, was on the brain stem. According to her mom:
They had to biopsy to see what it was – they had 6 Dr.’s in the operating room and were in there for about 4 hours. She came out of surgery fine with no problems and they were able to get a piece of tumour.
It was a diffuse intrinsic pontine glioma, one of the few diagnosed via biopsy. Hannah was in the hospital through Halloween, as was reported in the Vancouver Sun on Nov 1st.
The family continues conventional therapies (timodal and nemotuzamab) for the next year, but in mid-August 2006, the family is clearly looking for new options. They reached out to Justin B’s family (Justin died in 2007):
We’ve tried the standard treatments and while things have remained reasonably stable, with a few ups and downs, we are always looking out for alternate treatments. We’re hearing lots more about Dr. Burzynski’s treatment and would like to ask you some questions about it
Hannah’s family is talking to other Burzynski patients’ families as well. On 9 Sept, on Leo D.’s page (Leo died the next month), her mother leaves a note:
We have found the same thing with Hannah and the Dexamethazone (what they call Decadron in Canada) we have found that her muscles have gotten way weaker, so her walking is really suffering and her speech has declined a great deal – we are also trying new things to get her off the dex… however we’re finding it really hard to do, we use the liquid and can get her down to .25 of a mg and then we have to go up again because we can’t understand what she’s saying… its been like that for about month now…
On Sept 22, the family announces that they will be flying down to Houston for antineoplaston therapy on the 24th and hope to start treatment on Monday:
Well, we have decided to take our daughter Hannah to Houston and have her treated at the Burzynski clinic. Of the choices offered to Hannah for treatment, this seems to offer the best hope for long term survival. The various chemo treatments had what seemed to be good results for short term survival but Antineoplastons had the better long term numbers.
We’ll be be flying down from Vancouver on Sunday morning and get started on Monday with treatment. we’re making all the necessary arrangements now and hopefully things will go smoothly.
The statement about long-term numbers is not borne out by the evidence. In fact, there is no good evidence that antineoplastons work. Over 60 trials have been started by Burzynski, but none has been satisfactorily published. These are the trials that might have established anything like survival rates, so with no finished, published studies there is no basis for anyone to assert that a “rate” exists. Of course, maybe the clinic was sharing preliminary data, but the problem with that is a recent inspection found that Burzynski (as investigator, the subject of the inspection):
“failed to comply with protocol requirements related to the primary outcome, therapeutic response […] for 67% of study subjects reviewed during the inspection.”
This means that several patients who were reported as “complete responses” did not meet the criteria defined in the investigational plan, as were patients who were reported as having a “partial response” and “stable disease.” As a result, his outcome figures for these studies are inaccurate. Furthermore, all the baseline measurements for all patients whose files were reviewed by the FDA were destroyed and not available to investigators. Basically, his results can’t be reviewed. This is part of a pattern of sloppy “research” that stretches back for at least a decade.
The family goes through the customary training period at the clinic, because Burzynski’s treatment requires patients to fend for themselves. This likely contributed to the over 100 overdoses and serious but often unreported toxic events that the FDA uncovered during their inspection. For the record, the FDA told Stanislaw 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]
This would have shut down any research institution that received government funds. We’re talking about entire universities, here, not individual studies. Yet Burzynski still treats patients.
While on treatment, Hannah experiences the overwhelming thirst that comes with ANP’s massive sodium doses, with the attendant side effect of urination, and this causes all sorts of problems and consternation:
We’ve had Hannah on the ANP treatment for almost 2 weeks. Things have been going pretty well with treatment and Hannah hasn’t shown any bad reaction to the medication yet.
We’ve had Hannah in diapers for about 3 weeks and what we’ve had a problem with is all the diaper changes and leaks when Hannah is sleeping. There doesn’t seem to be many times when we are able to get her changed at night and often during the day when she doesn’t have a really big pee and fills her diaper and then leaks. This can only get worse the the projected fluid increase as she continues on the treatment.
Ultimately the family decides to line child diapers with adult diapers. That much fluid is going through the poor little girl.
The family had just returned to Vancouver from Houston when we hear that Hannah has died. She died at the same hospital where she was diagnosed a year earlier. I see no mention of any positive results of Burzynski’s antineoplastons in Hannah’s case.
One of the lasting effects of Hannah’s experiences has been the establishment of Hannah’s Heroes, which funds legitimate cancer research and operates to this day. One of the sad facts is that the rare tumor that Hannah had is not well understood and there are not many good therapeutic options. Hannah’s Heroes are trying to fill the research gap in the area of brain stem tumors.
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.
Burzynski Patient Laurye L.’s Story
(note: quotations from the Laurye’s family’s website are translated from French)
In September 2002, 2 year old Laurye L. was taken to the optometrist, who diagnosed her as farsighted. In January, doctors carried out some visual tests on her, but it turned out that Laurye’s visual problems were not in her eyes, but in her brain. In early March 2003, her health was clearly deteriorating. On the 11th of that month, her parents received a diagnosis. It was that monster that keeps appearing on this website, the Diffuse Intrinsic Pontine Glioma, a brain stem tumor for which there is no real effective long term treatment and to which most patients succumb.
Three days later, Laurye had surgery to reduce pressure in her head, but the prognosis was the same. The family was discouraged from making Laurye suffer through chemotherapy by their doctors. They did, however, give her cortisone and started 28 radiation sessions, which seemed to slow the growth of the tumor.
The family found a real clinical trial in North Carolina (“a chemotherapy with painful side effects without promise of success”) and they found Burzynski, whose treatment, antineoplastons (ANP), they believed, gave Laurye a 50% chance of a cure. No published studies of ANP exist to substantiate that number, or any number for that matter. In fact, the FDA recently observed Burzynski (as investigator, the subject of a recent inspection):
“failed to comply with protocol requirements related to the primary outcome, therapeutic response […] for 67% of study subjects reviewed during the inspection.” This means that several patients who were reported as “complete responses” did not meet the criteria defined in the investigational plan, as were patients who were reported as having a “partial response” and “stable disease.”
This means that his outcomes figures for these studies are inaccurate. Given these findings, there is no basis for any percentage given by anyone about the efficacy of antineoplastons to be believed.
The parents describe their rationale:
“The name of the treatment is antineoplastons. [It is] nontoxic, the side effects are very minimal and do not affect the quality of life: excessive thirst which increases the volume of urine, no pain for Laurye. After many confirmations with patients who received treatments from Dr. Burzinski successfully, we chose this option believing that this is the best opportunity available to children with this type of tumor.”
Sadly, this is another case of the Burzynski Patient Group luring another person into Burzynski’s exam room. In August, the family goes on vacation, and Laurye is still well enough to learn to fish with her dad.
They outline their plan. On Nov 24, the family will leave Quebec for Houston. The intravenous treatment will cost them $7,200 for the first year and in the second year, capsules will cost $2,000/month for as long as Laurye is on treatment. Medicare does not cover the treatment, so the family sets up a foundation to fund Burzynski’s treatment.
In Houston, on the first of December, Laurye has a port installed in her chest where she will receive the antineoplastons, which will be pumped nearly continuously for months at a time. Laurye has an MRI the next day, and the family passes the next few weeks, like all other caregivers who come to Houston for ANP, learning how to administer the antineoplastons:
This practice, having patients’ families administer the drug, may have contributed to the over 100 overdoses in the last few years. It does not explain, however, this observation by the FDA:
“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)
The family returned to Quebec on December 18th. The family reports:
Since December 3, Laurye is on intravenous injection. She must wear a backpack with 2 medication bags in it 24 hours a day. A small pump, connected by a pipe to the catheter, is programmed every four hours (6 doses per day ). We have to change the bags and reprogram the pump daily. In addition, Laurye has a healthy diet to follow and an MRI every two months. The only side effects are excessive thirst, fatigue, and frequent urination.
The unquenchable thirst and urination are caused by the high sodium load that ANP patients carry. According to the FDA’s findings, one patient experienced 12 episodes of hypernatremia (high sodium), none of which was reported.
The family’s new foundation very quickly holds numerous fundraisers, mobilizing the entire community. According to the numbers on the family’s website, no fewer than 18 fundraisers were planned. Additionally, first nine raised $31,520.75 for Burzynski. It is an outrage that the immeasurable kindness and generosity of entire communities has been squandered on Burzynski’s apparently unpublishable studies.
In February (presumably), we get another update.
Her current situation is stable. Every day is an uphill battle against this deadly disease for the whole family, for friends and especially for Laurye. This unique method of treatment [demands] a exceptionally big commitment of time, energy and courage from us. Currently, Laurye is doing very well. […] The first months were difficult; before her body adjusted to the treatment, she was tired and irritable but the best is yet to come for our Laurye.
We got the results of the January 30, 2004 [MRI], encouraging news for our daughter. The tumor did not progress. She remained stable.
While this does mean that the tumor is not growing quickly, periods of tumor stability are not unexpected even without treatment.
Laurye has not had a winter like other children. We always had to be careful that she did not fall ill. Also, the pump does not react well to cold temperatures so we had to limit her outdoor activities. Laurye changed physically (weight gain and swelling) due to cortisone medication to be given in addition to the current treatment. This is to [prevent?] pain during treatment because [when] the tumor is attacked it can cause a lot of pressure in the head. After the good MRI results, we could reduce the cortisone.
This sounds a lot like a line that patients have been repeating throughout this project, that symptoms of getting worse (in this case, swelling in the brain stem) are often described by patients as if they were signs of getting better. Parents of sick children grasp anything at all that would suggest that their child is getting better, even when it is getting worse. We’ve seen a disturbing pattern of patients reporting that getting worse was getting better. We’ve seen it at least 10 times.
We don’t hear much, honestly, until 2005. A mysterious spot appears on the January MRI and disappears on the Feb 22 MRI. Another MRI is scheduled for April 5. The news is not good:
Laurye past a MRI on April 5 and the tumour increased of 3% and there are 3 spots (8mm, 4mm, 1mm).
Doctor Jurida asked [for] a pet scan to see if there is some activity in the spots. We are very worried. We are waiting for on appointment for the pet scan and with the results we will know more. But what we find weird is that in january there was a spot. Febuary it was gone and know there are 3 of them. […]
Laurye eyes restarted to cross and her legs are hurting. Can someone tell if they ever have any spots like us and what happened.
We don`t know what to think? Doctor Jurida says that as long as we have some spots we cannot disconnect Laurye? It is going to be 17 months on the I.V. treatment and Laurye is starting to be tired of it.
By May, Laurye is off ANP. On May 22nd, she goes on Temodar, which seems to be a standard treatment for this type of tumor. Laurye’s mother reports in June:
Doctor Burzynski told us that it doesn’t do any good to keep Laurye on the treatment. He is suggesting the capsules of antineoplastons all alone or another possibility, capsule of sodium phenylbutyrate (PB) with a soft chimio.
I would like to know if you heard of the sodium phenylbutyrate capsule and what do you thing of them.
Laurye is loosing her ability`s a little bit every week but the clinic can`t tell me if it is necrosis or other tumours. The only way to know would be a biopsy and it is too dangerous, so we will never know.
They do mention that her only side effects from the chemotherapy is constipation and tiredness. In the same post, we see this:
We would like to take the best decision for Laurye. We decided to start oral chemo (TEMODAR) on may 23, 2005 hoping to stop the tumours if its the case for an undetermined time because we would like to go back to the antineoplaston capsules to prevent the increasing again. What if it is not the tumour increasing and it is necroses due to radiation. She is going to have done chemo for nothing, it doesn`t take the necrosis away. the only way to stop necrosis would be hyper-bar oxygene (HBO).
There is a question i’m asking myself and 2 doctors say 2 different things. Do you think chemo increases [radiation necrosis?]
Laurye’s flame is flickering in these final months. On September 8, an update from a family friend:
A few weeks ago [Laurye] was unable to walk or stand. She was unable to do much but lay on the couch and drink through a straw. Her doctors in Canada said it was due to a bleed, but could not confirm it. Her Decadron was increased and she got up and went to school. She had a PET and we are still awaiting the results. Unfortunately, the increased Decadron dose is no longer working. Depending on the results of the PET, as to whether or not she will qualify for Hyperbaric treatment. She will have to go to a private clinic because the local MD’s have told her parents to let her go (pass away) and will not authorize any further treatment.
On September 10th, in Le Soleil, we hear:
The battle of the little Laurye [L] against the brainstem glioma, a rare and incurable cancer, is nearing completion. The girl who has awakened the sympathy of the population during two years of valiant struggle now living his last moments.
“Let yourself go, Laurye, I’m ready to let you go.” The voice full of distress, Sonia [C] courageously facing the imminent death of his daughter. “I asked her if she was ready to go to heaven. She said nodding,” tells the mother, experiencing immense pain.
Although Laurye’s awareness is intact, her physical condition has deteriorated significantly in recent days. She first stopped walking and talking and can now no longer eat.
[Her mother] [was] torn from the bedside of her 5-year old daughter for a brief press conference yesterday afternoon to announce that a few hours, maybe a few days, remained in Laurye’s life. She [thanked] all those who supported the family morally and financially throughout his illness.
In the same article, we hear what the total amount that went to the treatment:
Founded in 2003, the Laurye [L] Foundation has raised approximately $235,000. The director of the Foundation insisted that the remaining approximately $ 10,000 cash will be used to fund research on glioma or will be routed to other foundations that assist sick children.
A staggering sum.
Laurye died on September 10th.
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.
Burzynski Patient Briannah O.’s Story
At four months of age, after seizures and becoming rigid and immobile, Briannah O. was diagnosed with a exceedingly rare brain tumor, a juvenile pilocytic astrocytoma. The tumor was inoperable and eventually the size of a grapefruit. It’s typically slow growing and while usually benign, it occupies valuable real estate. In the first two months after diagnosis, Briannah had two shunts put in to relieve pressure from fluid accumulating in the brain and had a very, very brief trial with chemotherapy. According to one of Briannah’s websites, in early 2007, the family was interested in going to the Burzynski Clinic.
Almost immediately, the family started to run into troubles with the Clinic. Brianna’s mother left a post on a message board on May 10, saying that she was unable to get any of her local doctors to agree to work with the Burzynski Clinic, whereas the “B. Clinic people are making me feel very pressured like it’s my problem.”
The antineoplaston treatment can only be administered, per an agreement with the FDA in the mid-1990s, under the auspices of a clinical trial. Burzynski opened over 60 clinical trials and in the nearly two intervening decades has only finished one and published zero.
One of the problems is that after the training period of a few weeks in Houston, Burzynski shifts the burden of administering the treatments for months onto the caregivers. The fact that the administration of the treatment is in the hands of well-meaning amateurs may have contributed to a finding the FDA made earlier this year:
“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]
Because people are administering this treatment at home, they need local physicians to take over the routine tasks of blood work and other local monitoring. It is not at all surprising to see that a patient would have a difficult time finding a knowledgeable physician refusing to work with Burzynski. When she says no doctor is going to “sign any documents that legally bind them to the clinic and that legally links them to be a FDA co-investigator,” it is ironic, since according to an argument by which Burzynski managed to cling to his medical license last year:
“Respondent’s ownership of the clinic and his self-designation as the clinic’s chief physician on some forms, his ability to hire and fire everyone, and even that the forms which state that he is in “charge of treatment” (as stated in the informed consent forms for patient A) is only evidence of responsibility under vicarious liability theory, given the fact that the medical records detail exactly what doctors provided services to these two patients and who was involved in the delivery of medical care to these patients.”
It sure sounds like someone knows it’s a bad idea to take responsibility for patients at that clinic.
The same day as that previous post, Briannah’s mother posted that the “Barbara T.” at the Clinic explained that the family needed a FDA form 1572 to proceed. “Barbara T” was likely Barbara Tomaszewski, who was Burzynski’s business manager. According to Burzynski’s lawyer, during the period when Burzynski was indicted, she kept the clinic afloat:
“As the patient numbers started to decline, she came up with dozens of ways to cut costs and increase income. Some of the services that had been farmed out, like pharmacy supplies, were brought inside the clinic, and buildings were refinanced. She did whatever she had to do to squeeze or save every dollar she could.” (108)
I wonder how much of the current “everything but the squeal” business model of the clinic is a legacy of this woman?
Later that same day still, she heard the same message from Dr. Weaver. Dr. Weaver, by the way, was sanctioned in May 2014 by the Texas Medical Board for his behavior at the Burzynski Clinic, including:
Sure I could go into the problems that the FDA reported about how Burzynski’s institutional review board works, but who has the time? Luckily, there’s an entire Form 483 covered with numerous observations that suggest the board is unable to oversee a trial.
On the 17th of February, Briannah’s story hits the papers, as the family desperately scrambles for funds for Burzynski:
The [O family] and their friends and family are seeking financial help to get Briannah to Houston for the experimental therapy, which uses synthetic organic compounds called antineoplastons.
Dr. Stanislaw Burzynski originally developed the treatment more than 30 years ago, and has treated more than 3,000 patients with the intravenously injected compound, which essentially reprograms the brain tumor cells to die off and stop growing.
The procedure is considered experimental because Food and Drug Administration trials that have been ongoing since the 1990s are still under way. That also means it is a private treatment that insurance won’t reimburse. Just starting the treatment costs $20,000, and it can add up to as much as $200,000 over time.
Preliminary FDA trials show that of 226 brain tumor patients treated, 29.2 percent showed complete disappearance or more than 50 percent shrinkage of the tumor, 35.8 percent showed stabilization, while 35 percent had continued tumor growth, according to the clinic.
One wonders where these numbers came from and if they can be said to represent anything real. It’s hard to know since the FDA observed that 2/3 of the outcomes that they examined during an inspection were inaccurate, finding:
Burzynski (as investigator, the subject of the inspection) “failed to comply with protocol requirements related to the primary outcome, therapeutic response […] for 67% of study subjects reviewed during the inspection.”
This means that several patients who were reported as “complete responses” did not meet the criteria defined in the investigational plan, as were patients who were reported as having a “partial response” and “stable disease.”
At the end of April, Briannah has a shunt revision. The next week, she is up and bubbly, apparently healthy enough to travel to Houston:
The gift of little Briannah’s health comes at the perfect time, following a $22,000 anonymous donation to help start an experimental treatment at the Burzynski Clinic in Houston. Another $2,200 has been donated into an account established for Briannah.
But the struggle the [O family] began almost a year and a half ago, when their daughter was diagnosed with an inoperable and life-threatening brain tumor, is not over.
They need a local doctor to agree to be the “co-investigator” for Briannah while she is home from her treatments in Houston. And, in future months, they will need an estimated $7,600 per month to maintain the treatments.
Tammy said she is not a desperate mother grasping at straws, but a mother who has no other options for treating her baby’s condition.
The treatment is considered controversial in some medical circles.
This passage is simultaneously heartening and infuriating. The generosity of strangers is often amazing, and this is one of the biggest anonymous donations that we have seen since we started this website. Nonetheless, I am baffled that hundreds of patients have been looking for media attention to raise money for decades, and not one reporter has gotten off their backside to investigate whether or not their coverage of the issue would be a positive thing for the community until Liz Szabo put in months of legwork for her USA Today report, which appeared a few weeks ago. She and her editors should be congratulated for their brave decision to look more deeply into the Clinic, a courage that was recently honored with high praise from William Heisel on the Annenberg School blog: “Her story in USA Today, Doctor accused of selling false hope to families, is one of the best medical investigations I have read.”
On June 6th, a gallery of the family’s trip to Houston goes up.
On June 11, 2007, Briannah’s mom sent an email to a member of a now abandoned antineoplaston support group, who reposted it. The family had some connections in Houston (I think they lived there before), and after they flew down, spent some time reuniting with friends. Then they visited the Clinic. I turns out that while the staff was “delightful and helpful,” Briannah had not had the appropriate type of head scan prior to coming to Houston:
I was never told by the clinic in all the times that I spoke with them over the phone that it had to be a specific kind of MRI. I was just told that I had to have an MRI with in 2 weeks of our appointment.
At this point, I imagine that the family spends a couple of weeks learning to be independent caregivers for their daughter. Learning how to use the pump and prepare the bags. They stay with a couple who live near the clinic.
According to the local paper on 16 June:
[Briannah’s father] will return to Gilbert on Father’s Day, leaving his wife and their two other daughters in Houston for the first three weeks of the treatment, which could last an undetermined period of time.
“We don’t doubt that the medicine is going to work on her,” [her dad] said.
The treatment begins the same day that article runs. A scan posted in July shows the sheer size of this tumor. It dominates the center of the scan and is a terrifying monster. In August, the family is having a hard time keeping Briannah’s electrolytes under control. Her sodium levels are all over the place, and she’s experiencing the known side effects of antineoplastons. The Clinic claims they have never seen sodium plummet like this before.
At about the same time the Baby Briannah Foundation is incorporated.
On August 31 she had a scan. Two weeks later, the results are in:
This is the first MRI that we have had done since we started the Antineoplaston Therapy in June 2007. The report also stated that the ventricles remain dilated and have “minimally” improved since the previous study!!! […].
I am so grateful for Dr. Burzynski and his awesome discovery of the Antineoplaston Gene Therapy! I sincerely believe that because of these treatments Briannah is with us today and doing as well as she is.
One wonders how much of the improvement is due to the shunts that were fixed in April and how much this is to be expected from a slow growing tumor. There is also the question of how tumors grow–sometimes periods of stability just happen. Notice that it is not shrinking.
The local paper notes on Oct 8:
But since Briannah began experimental treatment in June in Houston, Texas, the youngest of Tammy and Mark [O]’s three daughters has experienced a lessening in the swelling and gained a lot of baby fat. For the first time, her MRI shows no growth in the tumor.
At this point, we’re going to guess that the improvement that we are seeing is related to steroids. Reduction in swelling? Gaining weight (for a baby that was failing to thrive before)? We’re guessing steroids. Burzynski’s patients are often treated with large doses of steroids, according to the FDA, and as reported in USA Today, patients were found to be on 5 to 65 times the anticipated dose of steroids. As the Clinic is basically a one-trick pony, there is no reason to suspect they changed their tune here.
Among the other revelations in this article, we learn that the treatment is costing $6,400 a month and that the little girl’s birthday in mid-October will double as a fundraiser. Also given the completely expected toxicities we saw above, the reporter still manages to open a sentence with the line: “The treatment, considered nontoxic….” I don’t think that the journalist did anything wrong, I just think that the family has a distorted view of what toxicity means.
On the 11th of December, following another MRI, we are informed that the tumor has shrunk by 9%. It’s hard to take anything the Clinic tells a patient seriously when the FDA observed two-thirds of the reported clinical trial outcomes were apparently inflated. I’m not even sure how clinically significant that would be if it is an accurate result, especially as, according to the Szabo story, experts (which Burzynski is not) will disagree 40% of the time when when interpreting rare brain tumors. These results were reported uncritically in the local paper on 28 Dec. There is something of a vicious feedback cycle here. One must be completely and totally up front about the prognosis at all points with patients. They deserve that, especially when they are as vulnerable as parents as a child with a brain tumor. They have never had good news. ANY change, even “not getting worse,” is a HUGE victory, and expectations need to be managed. Yet the family reports:
“Right now, little Briannah is going to live a normal and a full life,” said [Briannah’s dad]. “We’re just really overjoyed.”
This is, of course, what everyone wants. But is it likely? And when it is reprinted in a paper, it’s difficult to see how that hope could not be massively reinforced, making what comes later all the more devastating.
In Feb 2008, Briannah seems to be having a crisis related to her sodium levels. She may be experiencing salt wasting, which can happen when there is injury to the brain. Via a friend of the family, we learn on Feb 7th:
“Baby Briannah was moved to PICU yesterday because her sodium levels dropped dangerously low. My daughter told me last night that Briannah was on IVs and her sodium level had come up some. Tammy and her husband, Mark, have made what was a difficult decision for them; they have decided to insert a peg (g-tube) for Brianna’s feedings. She has been getting her feedings with an NG tube for about 2 years now. Providing her Sodium level rises to normal today, the Broviac (Catheter) and Peg surgeries are scheduled for 2 PM this afternoon. That will be 3 PM Texas time.”
That night, we get an update on what is happening from Briannah’s mother. The catheter needed to be replaced and a gastric tube has been put in. At the same time, when she goes off of ANP, her sodium plummets. It may be the first time that ANP has actually pushed someone’s sodium in the right direction.
This child is clearly not on the path to the full normal life that everyone hopes for. And despite this trip to the PICU, the local paper reports in May:
Since the treatment began, mom Tammy [O] said the youngest of her three daughters has been happier and healthier than ever.
“We’ve been able to enjoy this year,” [her mom] said. “It’s been wonderful. No trauma. No injuries.”
Further, and perhaps not surprisingly, Briannah’s development has been arrested, though by all accounts she is a happy little girl:
Due to the tumor and a surgery when it was first discovered, she still can’t walk but she actively interacts with her parents and sisters, kicks, sits up and speaks baby talk.
We also learn that the father is turning his DJ business into a fundraising vehicle for Burzynski’s treatment, and in early June, another fundraiser is held at a farm where guests pick peaches to raise money.
In August, we get another optimistic assessment from the local paper, as well as this description of the treatment:
Briannah’s tumor has shrunk 20 percent since she began the nontoxic gene therapy treatment at Houston’s Burzynski Clinic.
The definition of gene therapy that makes this description of antineoplastons accurate would also redefine eating a banana as gene therapy. While the family did share some scans, I can’t find any of the results of this treatment. Further, she is still having some serious issues:
While she’s beginning to briefly sit by herself, doctors don’t know how much Briannah can see, and she also has been having seizures.
It looks like the family took a two hour trip to Sedona right before Christmas.
On January 26, a post goes up on another patients’ website:
An optic glioma, the type of tumor that James has, is considered a “benign” tumor. How deceiving that word can be. Too many believe that it means that this tumor will/can do no harm. Yet, I write tonight with tears flowing and a heavy heart because sweet Baby Briannah lost her life tonight to an optic glioma.
(In fact, it looks like she may have died on the 24th.)
As the family described her passing, the family were with their pastor at Phoenix Children’s when Briannah died.
The local paper described the last hours in more detail:
The fight included shunts placed in her skull to reduce swelling in her brain and, beginning in June 2007, an experimental gene therapy in which she was administered a synthetic organic compound through a tube.
It seemed to be working. The tumor was shrinking, and the once-emaciated Briannah had reached a normal height and weight, though she was unable to walk or talk.
Everything changed last week, when Briannah’s sodium level plummeted, causing her kidneys to shut down. She went into cardiac arrest twice.
“She left her body twice, and they brought her back after 22 minutes, and the second time after 18 minutes,” [her mother] said. “That in itself is a miracle, I’m not kidding you.”
But eventually, [Briannah’s parents] had to make the decision to take her off life support. “When I got to watch Briannah’s body deteriorate, it got to the point where it was easy to let her go,” [her mother] said.
It is difficult to reconcile the idea that the treatment seemed to be working and the poor little girl’s progression and death. We can say, however, that lot of patients have celebrated their fortunes while on Burzynski’s treatment when they in fact were progressing. One of the most scary things that we have found here is a pattern of descriptions of tumors breaking up on the inside and patients rejoicing, when the fact of the matter is that it is far more likely to be a sign of a tumor outgrowing its blood supply. And we’ve seen this for decades:
- We first noticed this pattern in the story of Amelia S.
- The family of Haley S heard this (also, see the clinic’s heartless reaction to a stroke that the child had).
- The Clinic gave the same prognosis to Justin B’s family in 2006.
- We see a similar cyst in Leslie S.’s story (2006), and it nabbed Burzynski an extra $7,500 before she died.
- We see it AGAIN–as far back as 1994!–in Cody G.’s story.
- We saw it again in the case of Samantha T.
- We saw it again in the story of Christy M.
- A similar story came from Georgia State Senator Ed G.’s story.
- In the most grotesque horror show we’ve ever written about, Burzynski himself tells the family of Chase S. the same thing. Poor Chase ended lying in state in his family’s front room for months.
On February 2, the family celebrated the life of Baby Briannah, as she was known to the community that rallied around her. Her mother bravely posted an image from her daughter’s services on her website. This makes all the more galling the following post on the website:
Usually, this is where we would put an appeal to donate to St. Jude’s. You may still do that, 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 at the FDA so we can fix it and so this never happens again.
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
MIDDLETOWNThe 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 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.”
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.
- 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.
- 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.
- 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.
“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.”
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.
[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.
On November 1, 1990, Ryan displayed complete remission.
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.
Burzynski Patient Adam M.’s Story
[Update: Adam M. died on Sunday, 7 July 2013.]
This is an especially sad story. His wife tells the story about the first days, waiting outside while Adam was in the operating room. The surgery was successful and the doctor suggested it was “possibly a mid-grade [glioma].” In three days, Adam had sprung back:
That’s when we started researching like crazy. Regardless of what the result was, we were going to go alternative. Adam definitely did not want chemo or radiation, and the more research we did, the more comfortable we felt with that decision.
If the tumor recurred, Adam’s prognosis was probably very bad. They made (generally healthy) lifestyle changes and stopped using cell phones, hoping to ward off a return of the cancer. They also got in contact with the Burzynski Clinic, who are completely incapable of making any promises. Apparently, by the end of January, they were planning to go to Houston.
Their first consultation with the Burzynski Clinic was on the 6th of February of 2012. The parents were not available and missed 2 of their children’s birthdays during that trip. They rented a Chevy HHR, left the kids with the grandparents, who were in from the UK, and drove down to the clinic. And then they were hit with the bad news, and an interesting look at what goes on inside the Burzynski Clinic (emphasis added):
Dr. Szymkowski met with us to discuss Adam’s medical history and confirm the details of his brain cancer. She also briefed us on the two possible approaches that Dr. Burzynski would take in Adam’s case. The first case scenario is his patented antineoplaston therapy. To qualify for that therapy, you have to apply to the FDA for special permission, and show that the cancer is “persistent” after using traditional therapy. Well, we assumed that this approach would not be appropriate, simply because the tumor has been removed and hasn’t had time to become what could be considered “persistent”. We then got to meet the man himself! The meeting lasted less than 10 minutes. He briefly explained that he would most likely be using a “gene targeted” approach to treat Adam’s cancer. […] One of the medications is sodium phenylbutyrate, which is one of Dr. Burzynkski’s signature medications. We were definitely excited about that one, because obviously we can only get that here. After being shuffled around a bit more, we were then sent to the financial coordinator. She showed us the fee chart that we had already received in our information packet. So, no surprises there. But… then she starts lis[t]ing the medications that Dr. Burzynski has prescribed for Adam, which are not included in the treatment costs. Sprycel… $8,314.80. Votrient… $3,098.40. (emphasis added)
The family found that the cost would be in the area of $25,000 a month. And it’s simply not true that the only place to get sodium phenylbutyrate is the Burzynski Clinic. It’s an orphaned drug usually used to treat urea cycle disorders. Just about the only place on earth where they’ll prescribe it for cancer is the Burzynski Clinic.
Clearly these patients were being told that Burzynski would be treating these patients. Legally, this is very interesting since the entire premise of the TMB withdrawing their complaint against Burzynski in October 2012 was that Burzynski was not directing treatment.
Bunk. And this is going on even as his lawyers are arguing in court that he is not responsible for the “decisions” that his doctors make. The family then became aware of the serious side effects of these chemo cocktails that Burzynski was proposing, contrary to the hippy-dippy natural side-effectless hype that his supporters parrot:
At home we started talking. I did some online research into the drugs, and really didn’t like what I was reading. Side effects like “severe or like-threatening liver damage”, and “may cause you to develop a hole in the wall of your stomach or intestine”. My favorite one was, “may cause abnormal passage in the body”. Abnormal passage? So, not only would we have to spend $25,000 a month for the drugs, but Adam might develop a whole host of other problems as a result.
The family had initially decided against any chemo treatment, but (surprise, surprise) when they announce this to the Clinic, the doctors tell them that they have found lesions on the MRI, which makes Adam a potential candidate for one of the 60 ANP trials that never seem to get finished or result in any meaningful publications.
The family is about to back away from the therapy and, and only after that threat to Burzynski’s bottom line does the Clinic bother to inform them that there are more lesions in Adam’s brain:
Dr. Sano was very nice, and said she would certainly respect our wishes. However, since they found lesions in Adam’s brain this morning, it looks like the cancer may have returned and therefore the drugs would really be necessary. I nearly dropped the phone. Lesions? Already??!! It just wasn’t possible. The doctor explained that due to the change in circumstance, she would need to meet with Dr. Burzynski and discuss what he wants to do next, and she asked us to go to the waiting room where she could talk to us face-to-face.
Boy, Texas Medical Board, it sure looks like he is directly managing patient care, doesn’t it? And that doctors working under him defer to his judgment instinctively, doesn’t it? I wonder whose signature is on those records? That would be very interesting to know.
And we were totally honest with [Dr. Sano]. We can’t afford the meds. We just can’t do it. She told us that it was now possible that Dr. Burzynski might want to put Adam in the clinical trial. Now he had a “persistant” tumor, and there was something measurable. If he was given permission by the FDA to receive the antineoplaston treatment, now there was material they could measure and watch it shrink. This is essential to be considered for the trial. […] (emphasis added)
Later that evening, they receive a phone call:
Dr. Burzynski is putting Adam forward for the trial. He is going to receive the antineoplaston therapy. The therapy we have read about from the beginning. The real reason we came here. She doesn’t know anything about the financials, which we’ll have to work out with the counselor tomorrow.
So, the Burzynski Clinic is doing a wallet biopsy, the only procedure that they are any good at. The M. family went ahead with ANP. They are desperately looking for supernatural signs that what they are doing is right, and they find them everywhere.
On the 15th of February, they received news that the FDA would abet another patient’s entry into a trial:
Adam’s approved!!!!! Tomorrow morning Adam has an appointment at a Houston clinic to have his catheter fitted, then Friday he gets hooked up to the antineoplastons. […] Also, we’ve been told that Adam’s sodium intake has to be meticulously watched, and his fluid intake and excretion carefully monitored. I’ve been told, “If you can’t wake him up in the morning, get him straight to the hospital.” Fluid can accumulate in the body or brain and cause complications. (emphasis added)
As always, even the ANP can have dramatic and potentially lethal side effects, no matter what you hear.
Healer in your Heart: Researching the treatment
And, WOW, when you look at the status of all those lesions that Burzynski’s group “found” on the MRI, it looks like their status/existence was not completely certain:
We also had an appointment with the radiologist which was a bit depressing as well. We were misinformed before. The current tumor was NOT there immediately post-surgery. The post-surgery MRI shows a clear cavity. But, 6 weeks later there was definitely a “suspicious” enhancement within the cavity. It’s no bigger than a pea, but it’s probably a recurring tumor. There’s a small chance it might be nothing, only time will tell. I don’t know why, but that news really got me down. (emphasis added)
Are you paying attention, Texas Medical Board? That needs to be clarified.
On Feb 25, the doctors at the Clinic show that they are having a hard time distinguishing between someone retaining water and being dehydrated:
Although Adam had drank 11 liters (yes that’s right) of water, he had excreted 12 liters. His weight had dropped by 2 pounds, so Dr. Barbara explained that he is probably dehydrated. She recommended that we only increase the dosage by 20ml on Saturday just to be on the safe side, but to keep an eye on his fluid intake and weight. So, Adam has been drinking and eating like a champ and polished off a massive dinner last night. He drank even MORE water this morning to make sure his weight was back up. He still came up a bit short on his fluid totals (intake was 12 liters, but output was 13 liters), but weighed in at a much healthier 155lbs. this morning. But, the substitute doctor wasn’t happy. She thinks that Adam is retaining water. What?? He excreted more than he took in. He can’t possibly be retaining water. What the heck is he retaining? His weight gain can be easily explained by the mountain of penne bolognaise I forced him to eat last night. But, she refused. No increase in dosage.
So who’s really in charge of the patients at the Burzynski Clinic?
The other good news is that Adam is at his target dose. Dr. Burzynski himself has been reviewing Adam’s case, and for mixed gliomas the dosage can be lowered and still be effective. Adam is NOT on any steriods and has not suffered any fatigue at all. This is nothing short of miraculous. Many patients have ended up in wheelchairs because of the debilitating fatigue. And everyone has to take Decadron to keep cranial pressure down. Adam hasn’t needed any. Everyone is really pleased with how well Adam is doing so far. And Dr. Burzynski has a prediction… he believes that Adam’s tumor will be gone within 2 months, and after 8 more months of maintainance treatment, it should never recur. I LOVE that prediction. (emphasis added)
Since I started exploring extraordinary claims, I have noticed that people are willing to pay almost anything for 1) hope and 2) flattery.
In March, after Adam and Vanessa have returned home, they received the results of their first MRI after treatment began:
We just received a call from Dr. Barbara. The radiologist still has to do a few more measurements, so he cannot say for sure if the tumor has shrunk. However, there is considerably “less enhancement” in the tumor. This means that there is less activity, and the tumor is showing up less dense on the MRI than before. That explains why it is so difficult to see in the image. All good news!!! Dr. Barbara said, “Geeve Aatum beeg hug frum mee and goa celebrate!”
I’m no doctor, but it just doesn’t sound like the tumor is shrinking. And this seems to be confirmed in the May 12th update, when it is revealed that the tumor has grown 20% in the last 8 weeks. (The progress of the disease, as is often the case w/ Burzynski, seems independent of the ANP dosage.):
The MRI showed that the tumor that had shrunk by 40% 8 weeks ago, has now increased in size by 20%. There is also another lesion that has remained unchanged. […] The tumor seems to be affected by the treatment, but apparently this dosage level just isn’t going to cut it. So, Dr. Barbara has decided to increase Adam up to the maximum dosage. To put it bluntly, this sucks. It sucks on so many levels.
Soon he is up to drinking 12 liters of water a day! By the end of May, the family’s finances have gotten so bad that Amanda starts talking about it on the website.
On June 11th, we get a report that looks like someone at the Burzynski Clinic nearly gets Adam killed (they never find out who it was…apparently they don’t put things like “calls to patients” in patient files at the Clinic or something) when they call saying that his blood work is bad, setting off a chain of events that leads to him nearly slipping into a coma.
On the 22nd of June, the MRI shows that Adam’s tumor is “stable,” which is a “success” at Burzynski’s Clinic, but it is a loose interpretation of “success” that no other researchers find acceptable. According to a site review of Burzynski’s clinic: “Moving from protocols to results, I am surprised by Dr. Burzynski’s statement that stable disease is a positive outcome. That runs contrary to established criteria for trial design. In the context of phase II trials, which are short-term studies, stable disease is not reported as a positive outcome.”
By August it seems that the tumor is growing again, and we get the sad news in one of the most raw moments I’ve seen since I’ve started this project:
It’s 5:00 in the morning, and I just can’t sleep. Adam and I have been talking, holding hands in the dark. The bedroom is actually dark for the first time in 6 months. And completely silent. The whooshing of the pump is gone, as is the pump’s bright display that used to cast a glow around the whole room. It’s over. We received a call yesterday that shocked both of us to the core. Adam’s lesions have grown since the last MRI 8 weeks ago, and there is now a third lesion. The treatment didn’t work. It’s worked for so many others. It is the one treatment that gave us any hope of Adam seeing the boys grow up. He probably won’t ever get to meet his grandchildren. He probably won’t see his boys get married or finish school. He may not ever get to hear Finlay say “Daddy”.
What is all the more galling, that after failing to help Adam in any meaningful way, the Clinic suggested that he come back and start a NEW course of treatment:
We don’t know what we are supposed to do next. We have discussed a few options, but they all look so awfully wrong. The Burzynski clinic is encouraging us to come back to Houston so he can start gene-targeted therapy. It just feels wrong. First of all, we need to come up with $30,000 to start the other treatment, not to mention all the expenses of going down there. It makes both of us nauseous just thinking of going back to that place and starting over. The monthly cost of the treatment is over $20,000. And it has a much lower rate of success than the antineoplastons.
They eventually moved on to another therapy. He died in July 2013.
For reliable information about clinical trials, visit to clinicaltrials.gov. Please contribute to St. Jude’s Children’s Hospital, which cares for sick children even if they can’t pay.
Burzynski Patient Leo D.’s Story
*An appeal to encourage Congress to investigate this follows Leo’s story*
On Father’s Day 2006, 3-year old Leo D. was wobbly on his feet, and his doctor had his family take him to the emergency room. He was diagnosed with a tumor on his brainstem, which, after surgery, was determined to be a diffuse intrinsic pontine glioma. It’s a horrible diagnosis to receive, and Leo was not expected to live a year. His family kept a comprehensive blog about their experiences.
Initially, the family had three options. Radiation and chemo, just chemotherapy (Thalomide and Carboplatin), or palliative care. He started on steroids immediately.
The first thing that the family does is to go to New York to see some Thai monks, Sifu Keith and Sifu Kevin. They prescribe a weird diet (“For breakfast, Leo was supposed to have Cocoa Puffs with soy milk and pickles, but the diner recommended to us didn’t have these on the menu, so chocolate chip pancakes had to do.”) and ask an evil spirit to leave:
“Afterwards, we were told more of the mystery. In a previous life, Leo was a bystander to lynching of slaves and that one of those slaves wasn’t forgiving him for not helping. The Thai exorcism would be very complicated and we were told that Sifu Keith, who had been doing all the treatments, would have to call his Master in Thailand over night to get help. We were to come back at 8am Sunday to their house again, but that Leo would be fine and live a long life..and have 2 sonds of his own. That statement gave us so much hope that we were willing to believe and do just about anything.
“The family is told the next day:
“…the slave that Leo watched lynched forgave Leo overnight, with some convincing from the Master in Thailand by phone. Marina needed to have more (male) children; we were given a macrobiotic-style diet to follow, but pork was ok; what colors to wear and have at home; good luck charms and trinkets; etc. We don’t know, but one thing was for sure: Leo was walking much better, talking better, stopped drooling, and generally seemed happier, especially given the circumstances. We caught an earlier flight home, which got us back on-time because of delays, filled with hope.”
It sounds like the steroids are doing their job.
Leo started radiation on June 29, the same day they first hear of Burzynski, and he soon started chemotherapy, which made him sluggish and unresponsive, clearly scaring the hell out of the parents. The family is talking to members of the Burzynski Patient Group. According to the family:
“…got a call from Dr. Barbara Szymkowski, who was very nice and described the process. She told me that because Leo had had radiation already, there was a chance he’d have to wait before joining their trial, but she’d check with Dr. Burzynski, himself. She called back later and said an exemption would be requested from the FDA because of Leo’s condition and age. We should hear back by Thursday evening. Having seen the side-effects of chemo, read about the long-term effects of radiation, and remembering the horrific odds we were given, we have decided not to follow Dr. Goldman’s trial. We know we’re taking a huge chance, but the basic statistics/evidence we read on Dr. Burzynski’s web site offered much, much better odds. If that doesn’t work, we can always try one of these horrendous radiation/chemo studies — unfortunately they’ll probably be there for quite a while. Needless to say, the radiation oncologist, et al were very unhappy about our decision. We’re praying for antineoplastons to work. […] The only issue seems to be money. It may cost upwards of $400,000 for a multi-year treatment (in addition to monthly MRIs, weekly blood draws, etc.). Needless to say, we’ll find the money one way or another, since insurance probably won’t cover the cost.”
This is infuriating. Burzynski does not have the studies to back up any claim of efficacy. This is perhaps why he was slapped with a warning letter from the FDA in November of 2012 for marketing his chemotherapy (ANP is chemotherapy) and now no mention of antineoplastons appears on his website. By the fifth, the family has taken Leo off of all treatment except the steroids.
Leo goes into the hospital with an infection. And we see this update:
On the other hand, yesterday (Thursday) I got a call from Dr. Szymkowski asking us to come to Houston for an evaluation (no FDA approval yet). We had an appointment on Monday and she suggested we plan on staying for the 3 weeks. So Houston is out for now because their protocol says no infections.
What about the tumor? No radiation and no chemo, what do we do?
It turns out that the physicians were not just unhappy the family’s decision to suspend conventional treatments, but they formalized their objections with a letter, which was received by the family when Leo was in the hospital:
Dr. Szymkowski says that even if he were undergoing radiation and chemo, they would have stopped that even, so this doesn’t seem like just a little cold. But Dr. Chang doesn’t want to hear about any of this and honestly believes that traditional treatment is all that Leo needs. Marina spoke to him a few days ago and, in summary, he said that even if we wanted to come back to him, he would not treat/radiate Leo. Today he stopped by the hospital and handed Marina a typed letter on Lutheran General letterhead to that effect.
If we are reading this letter correctly and it is representative of what happened, this letter exposes Dr. Chang to potential charges of patient abandonment. David Gorski, an oncologist, surgeon, and researcher, notes that there are specific requirements to fulfill and procedures that need to be followed when “firing” a patient. Firing a pediatric patient is even more fraught with moral and legal obligations and obstacles. Regardless of the ethical implications of transferring a patient into the care of Burzynski, legal obligations need to be met and continuity of care needs to be assured. Dr. Chang is probably lucky that the family did not contact the Illinois state licensing board, as there seem to be no laws allowing the immediate severing the patient-doctor relationship, as is promised in the letter.
This is in every way a bad situation, and I suspect that it is is up to regulators and legislators to make sure that parents can’t get into these fixes.
On July 11, Leo is sputtering and having a very hard time being understood. The family are waiting to go to Houston. Meanwhile, they get another update from the hospital, and the doctors are are still opposed to the family’s decision. They even drop the word “neglect” in there, which is strong stuff, but indicates the seriousness of the situation.
On Monday morning, July 17, 2006, the family is at the Burzynski Clinic.
After countless forms, we were taken to a large conference room and met with Dr. Szymkowski. She explained various aspects of treatment, including an overview of the regimen: 22 hours of infusions per day (4 hours per cycle) via a 2-channel pump. Leo will be getting 2 antineoplastons: AS10 and AS2-1. We aren’t quite sure of the difference yet, although she did explain, and will post here when we “get it.” She said she couldn’t quote an exact prognosis and that Dr. Burzynski, himself, would talk to us shortly. The few things I do remember her quoting were general side-effects and their statistics. Dangerously high sodium levels were present in about 5% of the patients. Dangerously low potassium levels were less frequent. White blood cell counts dropping were even lower than the potassium levels, so we’re talking 1-2% or something like that. The other side effects were the similar to everything: nausea, vomiting, etc. The good thing is that all these seem to be manageable.
Sounds like they don’t understand the treatment. Informed consent is important.
This next paragraph is interesting, but I’d really get a 3rd opinion:
She also told us that Saturday’s MRI did not provide the good news we originally thought. Although the overall size of the tumor has not increased, there was more “enhancement” than before. […] Continuing, she said FDA approval was no longer required because of the disease progression, more “good” news. Internal Review Board approval was still needed, though, and is expected by close of business tomorrow. The most important question was whether there was an issue of “if.” She said there were no “ifs.” Treatment would begin; it was now just the matter of Wednesday morning or Wednesday afternoon.
Now I settle in for rage.
Then we met the man himself: Dr. Burzynski. He looked exactly like the photos we’d seen and said something to the effect of our coming here was for “hope,” which is something the oncologists, radiation oncologists, neurosurgeons, and other medical staff at home and other places can’t provide. He exuded confidence, but not arrogance. He gave us a glossy brochure of a couple of recent studies that showed statistics about antineoplaston treatment in children under 4 with intrinsic brain stem tumors that were presented at a neuro-oncological conference:
- Complete response (no disease): 30%
- Stable disease: 40%
- Progressive disease: 30%
Those numbers are incredible: instead of about 2-5% chance of Leo surviving, their statistics show something like 70% survival! We understand that there are no guarantees, but we’ll take odds like this anytime over the traditional ones!!!
Who wouldn’t? I am so angry that Burzynski is giving people quotes from a study presented at a conference. Jesus, it’s like as far from peer review as possible. And the father is right, they are grasping at a shadow of hope. Again, this family has heard nothing but bad news since the diagnosis. This is a miraculous claim they are hearing. They are vulnerable. They do not have a clear understanding of the likely outcome of the treatment. They are walking into a lion’s den, and it frustrates me to hell that I can’t help them. Here’s another red flag:
Antineoplastons are gene-based therapy, meaning their belief is that there are certain malfunctioning genes that make people susceptible to cancers. Unfortunately there is no genetic test at this point to validate that, but someone’s working on it.
Leo started ANP on the 19th:
After the usual nurses’ visit, we spoke at length with Dr. Weaver and asked dozens of questions…until we noticed he was getting antsy and trying to stand-up. But we kept on and got all of our questions answered. Good thing they’re all pretty patient over there. Of course Leo was approved by the Internal Review Board for treatment under protocol BT-11: PHASE II STUDY OF ANTINEOPLASTON A10 AND AS2-1 IN PATIENTS WITH BRAIN STEM GLIOMA.
The next weeks are apparently typical, learning to work the pump, draw blood, etc, for when they return to Chicago and have to fend for themselves.
By the 26th Leo is experiencing the effects of being on ANP, the tiredness that comes from getting up constantly to pee and drink water. This is universal, as best I can tell, and after months of this, yes, you can detect a palpable decline in the quality of life based on the treatment alone. By July 30th, this 3-year old is drinking 3 qts. of water a day.
It’s clear that they are raising money as a “treatment fund” is mentioned. While they are there, kids from Oregon and Italy come to the clinic. The same diagnosis as Leo. As the family prepares to leave Houston, they apparently run up against the ol’ court order that says Burzynski can’t ship ANP across state lines…and then somehow that barrier disappears and gets a tracking number…:
The shipping person tried to tell Granpa how things worked around there — that he wouldn’t ship the first batch (i.e. we had to take it with us). That was his first and last mistake, since the Doctor’s orders were clear, meaning the supplies would be shipped to us, without questions. I guess the person in shipping was at least bright enough to quickly understand with whom he was dealing and shut-up. I’ll have Granpa get the tracking number from him tomorrow. 🙂 We left the building about an hour after this process started, with Leo absolutely ravenous. This is the one day we didn’t bring food with us, of course…
That the Clinic seems to be shipping this drug is evident from the next post, on the 4th of August:
Granpa got the tracking number from the shipping department, which sent the supplies and antineoplastons home yesterday.
There was a quick detour to the ER when Leo is screaming in pain at the Clinic after his pump kicks in. The nurse’s reply?
Nurse Louise said she was too busy to help at that moment and that we would have to wait for some time for her to have a good look, but she didn’t know how long — maybe 15 minutes, maybe 3 hours. So we left knowing either Leo would be ok or in an emergency room.
They go to the hotel, and again, when the pump kicks in, Leo is in pain. They go to the ER. It turns out the needle was no longer in the vein, but pumping ANP directly into his chest.
Their last day at the Clinic is Aug 8.
On the 11th, back home, the father reports that another patient, Justin B., who I have already written about, has had great news about the ANP working. Justin has since died. The other patient, Gus L., I can find no continuing record of. The family ups his steroid because Leo is having more headaches and his arm is not working so well.
On Aug 19, Dr. Dr. Szymkowski from the Clinic calls. They are upping the steroids again. (Leo is still not walking.) She delivers this message:
First, if the symptoms get better, that may be a sign that there’s just increased intracranial pressure from all the antineoplaston fluid that’s being pumped into Leo, which causes more swelling. The antineoplastons seem to cross the blood-brain barrier and at the current doses he’s getting 1,260mL of A10 and 90mL of AS2-1, for a daily total of 1,350mL. Obviously not all of this gets into his brain, but probably enough to cause some swelling. Second, if the decadron doesn’t seem to help too much with the symptoms, that means “something” is happening with the tumor…
For the first time, I heard the following in relation to Leo. She said the tumor may be breaking down. Unfortunately in the same sentence she said that it may also have increased its own evil activity. The evil portion seems unlikely because these symptoms occurred virtually overnight and even this aggressive tumor doesn’t grow that fast. Logically (but no one said these damned tumors are logical) that gives us hope for the best-case scenario: the antineoplastons are working.
It’s depressing because, in hindsight, we know what’s happening. And then that same damned story again:
Leo’s symptoms aren’t getting any better. In fact, maybe they’re again a bit worse, like the drooling that’s slightly started and the coughing while drinking. I honestly believe that it’s because something good is happening with the tumor. We were told several times that things may get worse before they get better because the tumor first breaks-up. That causes more swelling. Then the cancerous cells die and get cleaned-up by the body, which of course reduces swelling.
Or it’s growing and you are getting bad advice. I have seen this again and again and again. Burzynski’s staff have been feeding people this line for decades: getting worse is getting better. See the cases of Evan W, Justin B, Georgia M, Cody G, Leslie S, Domenica P., Chase S, and Andrea W. Think of Amelia S. Again, I think of the nurse told John D.:
“[…] she’s been there for 10 years & has seen this before & many times, the more severe symptoms that are seen as a result of the therapy is really a good sign that it’s working better.”
As the symptoms are getting worse, the Clinic has the first post-Houston scan done early, on Aug 29th. That same day, Leo’s dad mentions Chase S, whose case is the worst, absolutely the worst case I could imagine. It’s what opened my eyes to how bad alternative medicine can be.
On the 30th, they hear that the tumor has decreased 6%:
IMPRESSION: There appears to be slight decrease in size of the pontine glioma compared to 07/15/06 with slightly less compression of the fourth ventricle and minimally decreased size measurements. There is a slightly different contrast enhancement pattern of the tumor compared to prior exam of uncertain significance.
I know that all they heard was “decreasing.” It’s really not significant, especially when you have some chemo, some radiation and a bump in the steroid dosage. Leo develops a bad case of thrush, a fungal infection in his mouth (due to the depressed immune response caused by the steroids?). And the poor child seems to not be getting any better:
When I got home, Leo wanted me to hold him, which I did. He’s been pretty “floppy” for a little while, like a newborn whose head and entire body need to be supported all the time.
The poor kid’s been through so much that even faint, fleeting exertion on his part is seen as progress. Scared parents pay so much attention to every little thing. OnSeptember 9, the father mentions:
In our own analysis of Leo’s physical condition, it seems to us that decadron has caused Leo’s state, possibly more than the tumor:
1. He started to dislike walking after we started him on decadron after the initial diagnosis in mid June. The radiation people lowered the dose from 10mg to 8mg within a week, but since it had been such a short period of time, there was nothing to gain in either direction.In Houston his dose was immediately increased back to 10mg and he stopped walking and talking normally, but he was still able to move around and stand.2. Once we got home, because of headaches, his dose was again increased by 2mg, to 12mg daily. After this, he basically stopped moving, making “normal” sounds, and sometimes has trouble holding-up his head, etc.3. Naturally all the other side-effects, like the weight gain/water retention/sleeping trouble/etc., got worse as well.
Leo’s back in the hospital on Sept 12th having an infected port removed and replaced. On the 23rd his thrush comes back hard, making drinking nearly impossible and ANP has to stop. On the 28th, the first results of another MRI:
By the time we got home, Dr. Kroin faxed me the preliminary results, read by a different doctor than the first MRI. These were more confusing than usual and partly said good stuff and partly not so good stuff, so on average there’s no change. I spoke to Dr. Barbara of course, who said not to rely on these kinds of things especially when read by a different doctor. She said they all see and measure things differently, which was obvious. Consistency is key. Dr. Khan at the Burzynski Clinic would be working on measuring and analyzing the MRI and we’d get a final, signed copy sometime Friday afternoon. He’s the radiologist that’s read all of Leo’s MRIs down there, along with Dr. Dolgopolov. So the wait continues…
On the 30th, the family is considering a feeding tube, since Leo isn’t eating (thrush).On October 2, Leo has a feeding tube and we hear that he has been off ANP for about 3 weeks. Leo is still in the hospital on October 8th. The dad’s frustration is all that is left in his posts. Leo’s digestive tract is not working like it should and he seems to have an unidentified bleed somewhere, which lands him in the PICU, and we hear that his responsiveness is really way, way down:
Obviously this is extremely disturbing to everyone following Leo, and of course us. The other bit of bad news, his mental state, hasn’t really improved. His eyes react to light and he generally reacts to pain. I’m sure he can hear us because his eyes sometimes open wide.
A staff meeting at the hospital is called on Oct 11th to consult about the case:
The 12pm meeting among the doctors happened at 2pm. Unfortunately the specialists that needed to be there weren’t. Drs. Kroin and Battle, a palliative care nurse, a care coordinator, and Clint from Clinical Ethics were present. We weren’t sure exactly why Clint was there, but he left after 10 minutes anyway because he had to be somewhere else. In a nutshell, we realized that Leo really needs an oncologist to follow him. I told the doctors that we don’t need an oncologist’s treatment (i.e. chemo and radiation) or his personal opinions. But we do need his experience and knowledge, especially to anticipate problems and take measure to avoid them. We will be more than happy to discuss Leo’s tumor treatment, but as long as that discussion centers on the facts of antineoplastons. Dr. Battle said she’d try to get someone for us as soon as possible and we believe she’ll come through. She and Dr. Kroin have been there all along, continue to do so, and we can’t thank them enough for at least trying to help and watch Leo.
On the 12th, Leo’s out of intensive care. As they start feeding him again, he apparently in intense pain. On the 17th, he’s home. It looks like they are planning to start ANP again on the 21st. On the 23rd, Leo died.
It’s hard to see how the ANP had any effect on the progression of this disease. I’m just broken over this. I am so, so sad for Leo’s family and hope that they have found something like peace.
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. Find out about real clinical trials by visiting clinicaltrials.gov.
Burzynski Patient Andrea W.’s Story
*An appeal to encourage Congress to investigate this follows Andrea’s story*
In June 1997, 26-year old Andrea W. was diagnosed with a glioblastoma, a brain tumor, and this one was growing fast. Andrea was a nurse in Jordanville, NY, and after surgery, she was offered chemotherapy and radiotherapy. In August, she was in Houston with her family at the Burzynski Clinic. The clinic, according to the family, told them that Andrea had a 30% chance of recovery. Now, imagine that you have been told that the best chemotherapy and radiotherapy could offer you would be a few months, but you had a 1/3 chance of a life if you went with Burzynski. Well, hands down, this is what gets people into the clinic. Whether or not those claims can ever stand up to scrutiny, we won’t know because Burzynski apparently won’t publish.
The family put $16,000 up to start treatment at the Burzynski Clinic.
According to a 2000 article in US News and World Report (the source of much of this story):
Over the following six weeks, [Andrea’s mother] says, her daughter suffered side effects ranging from disorientation and high fevers to constant thirst. She and her husband […] repeatedly complained to clinic personnel. Each time, she says, “the nurses were jubilant. They said this [side effect] was a sign the tumor was breaking up.”
Burzynski’s staff have been feeding people this line for decades: getting worse is getting better. See the cases of Evan W, Justin B, Georgia M, Cody G, Leslie S, Domenica P., and Chase S. Think of Amelia S. Again, I think of the nurse told John D.:
“[…] she’s been there for 10 years & has seen this before & many times, the more severe symptoms that are seen as a result of the therapy is really a good sign that it’s working better.”
How is this allowed to continue, and for how much longer? The mere existence of this misery factory baffles.
On September 22nd, the family received results of a scan that showed that the tumor had DOUBLED in size, the Clinic said that Andrea had to come back down to Houston or she would be dropped from the clinical trial. On the 28th, instead of going into hospice and receiving palliative care, Andrea went to Houston with her best friend Mary. What we hear next is stunning:
After they arrived, according to [Andrea’s friends and family], another doctor at the Burzynski clinic told the two women the tumor was dissolving. That doctor called Andrea’s parents on September 29, telling them the tumor was shrinking and their daughter would be back to work. “I can’t tell you how happy we were,” says [Andrea’s] mother. She and [her husband] ran up their credit cards to come up with the $7,000 for the next month’s treatment.
This is extremely important. The family had just sunk a lot of money into the treatment, having been told that Andrea was improving:
On October 1 [Andrea’s] brain swelled massively, just as her flight home was beginning its descent. Henry Friedman, a neuro-oncologist at Duke University, and Victor Levin, a brain-tumor specialist at MD Anderson Cancer Center in Houston, and Boehm, her neurosurgeon, say she should never have traveled any distance from a hospital emergency room. Counters Burzynski: “It’s not up to us; that’s up to the local physician.” Boehm says the Burzynski clinic never called to ask him whether Andrea was fit to fly.
The patient history in Burzynski’s report to the FDA states that [Andrea] did not die under his care. She is listed as having withdrawn from treatment September 30, two days before she died. But according to the [W]s and [Andrea’s friend], a nurse, Andrea was still receiving antineoplastons just before she boarded the plane. “If she withdrew, why was she carrying a suitcase full of the medicine?” [her father] asks. Burzynski says he listed [Andrea] as having withdrawn on September 30 because that was the last day she was treated.
This is some dark, dark stuff here. As far as I can tell, it is cold, merciless exploitation of the desperate. Having read so many dozens of patient stories, I am of the opinion that not a word that comes out of that place is to be believed, not a prognosis, not an interpretation of a scan. Not a patient record. My heart goes out to Andrea’s family.
According to the Globe and Mail (9 March 2000), Andrea’s parents were still paying off the debt that they had run up for Burzynski two and a half years later.
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. Find out about real clinical trials by visiting clinicaltrials.gov.
The OTHER Burzynski Patient Group 
