Tagged: Burzynski Clinic

December 20, 2015

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.

April 15, 2015

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.”

April 5, 2015

Burzynski Patient Amelia S.’s Story

[This is a repost of an earlier 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., Burzynski patient Sen. Ed G., and McKenzie L. 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.

Last week, we posted about the patient who had perhaps the most high profile campaign in the US in recent years. This one is perhaps the biggest in UK in recent years. The case of Amelia S. is a hard one to write about, because it tipped skeptics off to a pattern in the stories that patients at the clinic were telling, that their worsening symptoms were signs of improvement. As you will see, this is a story that Burzynski’s patients have been relating for decades. It’s a long post, but it’s important that you read to the bottom.

***

3-year old Amelia S. lived in Reading. In about September of 2011, Amelia started displaying neurological symptoms–wobbliness and a trembling left hand (often drawn into a fist). The family brought her in to the hospital after she started falling down. On Jan 30th, 2012, she was diagnosed with a brain tumor, and on the 1st of Feb it was determined to be a large tumor on the brainstem. Surgery revealed a grade 2 diffuse astrocytoma, which the family was given to understand meant that the core of the tumor was likely grade 3. Doctors were unable to remove much of the tumor, only the 4 biopsy samples.

Amelia’s medical team was honest. The benefit offered by radiation and chemotherapy, on average, could be measured in weeks. These are bad, bad tumors. The family brought Amelia home on the 20th of February, her mobility and speech impaired, opting to spare Amelia the unpleasantness of the chemotherapy and radiotherapy. When they saw Amelia improving (we’re not told what those improvements were–whether they were reduction in tumor size or reduced swelling as she recovered from surgery, for instance), however, family understandably felt obliged to look for other options.

They found Burzynski. Immediately, the enormous price tag of his antineoplaston treatments spurred the family on to raise funds. Amelia’s father began documenting their journey to Burzynski in a couple of places, at ameliasmiracle.com and on a Facebook page of the same name. As a whole, his story is the most moving and insightful account of parental heroism that I have read since I began this project, and I strongly recommend that you read it for yourself.

By the end of February 2012, the family had decided on Burzynski. We were introduced to Amelia on February 28th in a video posted by her father:

Attached to the video was a simple plea:

Our daughter, Amelia, was diagnosed at the beginning of February with a very rare type of inoperable brain tumour. She has only a few months to live. We have a ray of hope – treatment for her is available at the Burzynski clinic in Houston, Texas. This treatment in total will cost around £200,000. We need to raise this money to allow Amelia to have the chance to live a normal life.

From the beginning, the family sought media attention to raise money for the Burzynski Clinic, as we see in a Facebook post. the earliest example of Amelia’s story appearing in the press was in the local Wokingham Times on 8 March 2012. The public campaign was launched. And by 14 March, £45,000 had been raised by the community, enough to get Amelia in the door at the Clinic (recent accounts put that initial consult at $30,000). The Wokingham Times seems to have informally adopted the family and followed their progress closely for the rest of the year. These community fundraisers appear as human interest stories and reaffirm that people are basically kind and generous and trusting. In fact, my first exposure to Burzynski and realization that something was profoundly wrong came after I did a newspaper database search for all of the patients that I could find. Of those patients I could find an outcome for, every patient who appeared in the international press, usually begging for money, with a single exception was dead.

A week before Amelia hit the papers, on the 6th of March, Eric Merola, who made an uncritical hagiography to Burzynski unironically called, Burzynski: Cancer is a Serious Business, interviewed the family about their upcoming trip to Houston for his new movie, a sequel, which comes out soon. He planned to follow Amelia’s progress in the film. On the 17th, as they planned their trip to the US, the family put up a short video for Amelia’s donors:

So, she clearly she packed everyone’s hearts into her suitcase. Such a dear.

They left on the 23th of March for America, having raised a staggering £75,000 for Burzynski. In a Wokingham Times piece, her father stated some of the opposition that the family had met:

Mr Saunders added that he was amazed at the number of people who had suggested the American treatment would be fruitless.

He said: “I was warned about this before we decided to go with the Burzynski treatment – it is like there is a vendetta out against the man.

“It is so strange, and all I keep getting are contacts from patients who have been or are being cured by the treatment, or at the very least have had positive results.”

People for whom Burzynski’s treatments fail tend not get into contact with other patients. We are witnessing what is known as survivorship bias. You can talk to a dozen survivors and have a positive impression of a treatment but fail to take into account the 10,000 failures, which would put a treatment well below the efficacy of chance remission, misdiagnosis, and unrecognized responses to traditional therapies. This is why controlled trials are so important to determine efficacy, so we can sort out the background noise of chance from real effects. It is also an important reason that dependence on patient testimonials is a red flag for quackery.

Amelia has had a hole opened in her chest where a Hickman line has been inserted, where she will receive her ANP. These frequently have complications with infection and clogging.

By the 30th, Amelia has her backpack full of antineoplastons, as we see in a video. Her family will spend the customary 3 weeks or so in the US learning to administer the ANP themselves. They are infused at high doses almost continuously.

Amelia’s dad shares his first impression of the Clinic on the facebook page:

The clinic have been fantastic. I am still amazed that people give them such a bad press. They have literally bent over backwards to get this started for us. The receptionist Irena even has a photo of Amelia behind her desk, she is so lovely!

Well there is a reason, of course. It’s because they apparently tell patients that they can tell brain tumors are shrinking by looking at their urine:

Mr Saunders said: “Every day is a milestone and the clinic is being extremely thorough in its tests – Amelia has regular blood tests and these are all closely monitored to check for signs of all sorts of things.

“Interestingly, they can actually see the early signs of the tumour breaking down by how her body excretes it in her blood and urine. This might be the only time in my life I get excited by seeing this kind of information!

I’m not sure what this is supposed to mean, and before Amelia’s story I would not have even noticed this. I can see why a parent clinging to hope would sieze onto any augury of healing. Remember, this family has not had good news about Amelia since her diagnosis. Little steps, literally, mean the world to them. I contacted research oncologist David Gorski, who studies and treats breast cancer, about this claim, and he replied:

“Oncologists don’t monitor anything in the urine for tumor breakdown, at least not for that tumor. There is such a thing called tumor lysis syndrome, but that’s usually only seen in leukemias and lymphomas as a result of induction chemotherapy that kills a lot of cancer cells really fast, releasing potassium, and a number of other byproducts. However, as I said, you don’t generally see this in solid tumors (mainly because none of them respond nearly as dramatically to chemotherapy as hematological malignancies). It’s also a complication to be managed, because its most frequent result is renal failure. It’s possible that he’s referring to GFAP, which is a biomarker for glioma under study, but I don’t think it’s really been validated as a measurement of response to therapy.”

There are apparently no biomarkers for glioma that appear in urine. Amelia had chronically low potassium at this point in her treatment.

We don’t see a lot of what is going on at the clinic on facebook, where most of the story is told record, but we get a clue on Amelia’s other website:

10th April 2012

I realised I hadn’t updated the news section here for a few weeks, this is largely because we update our Facebook page daily and much of our time has been taken up going to and from the clinic. Every day has been a bit of a rollercoaster here. Amelia has been on antineoplaston treatment for a week and a half and at the end of last week we hit a bit of a wall with the treatment dosage. Amelia got pretty sick so we had to back down on the dose a little. Yesterday she started getting really bad headaches so we have now also put her on a low dose steroid as well. Other than this, she is doing well and responding well to treatment. We think there are some very slight improvements in her coordination of her left hand side. We are continuing the treatment, and the aim is now to increase the dosage more slowly to see how she responds. All in all we are doing well and looking forward to coming home soon!

So, she’s been up and down. The steroids are a recurring feature of treatment and can very quickly reduce inflammation in a way that leads to improvements of the type that the family is reporting. You see it a lot on this website. It’s hard not to think of John D., who experienced worsening symptoms while under treatment (and on steroids), which was met with joy on the part of the staff:

I want to mention that the IV nurse told mom today that 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. I know this nurse & she is very honest & helpful. She also runs the class they run every week for new patients.

On April 19th we hear that the family is preparing to return home, and on the Wokingham Times page where it is announced, we see that damned picture again, patients literally at death’s door, posing in front of the Burzynski Clinic. We get the update that they have arrived back in England on the 22nd. Amelia’s dad talks about the fundraising (truly amazing acts of generosity by the whole community) and how grateful he is for the immense support that the family has received. (Amelia gives her own thank you’s in an adorable little video a few days later.) He speculates on the road ahead:

I have come home from Houston with a strange kind of feeling. Perhaps a little apprehension, a bit of fear, a dose of happiness and a shot of hope. We still feel that every day is a roller coaster. We may be sitting on a ticking time bomb, and it may still be that any day we might lose Amelia. Every day truly is so precious, and it is a joy to watch her and her little sister back together again, albeit in a different way, a more careful one, where we have to watch them all the time.

The next day, it sounds like Amelia is having the unquenchable thirst that comes with ANP:

Amelia has been OK today, she was a bit sick earlier but we think this was because she drank too much too quickly – she was fine shortly afterwards. We’ve been getting used to life again at home and putting everything in place we need to.

And we hear that she is due for her first post-treatment MRI:

As far as the MRI goes, I just want to make a point that we aren’t expecting a lot to have happened with this next scan. As part of the medical trial we are required to get a scan done every 4 – 5 weeks – and these things take time to show any change. It is very likely the tumour may be the same or have grown slightly. This is fine and we expect this, and clearly if it has shrunk then great – but we aren’t expecting it to have done.

Tumors on which chemotherapy is working should probably not be growing at all. It’s the definition of “working.”

On the 25th:

Today has been a busy day. Unfortunately Amelia was pretty sick this morning – those of you who have been following our journey will know that we are trying to increase Amelia’s dose of drugs and it sometimes has side effects, this seeming to be the most common. She was fine afterwards and has been eating for the rest of the day.

We had an appointment at the hospital at lunchtime and ended up spending most of the afternoon there so we could get everything sorted. The doctors here are being very cooperative – but I must emphasise that they are recommending different treatment (chemo) and we have consistently turned this down. We have not found a single person with a DIPG tumour that has had any effect with chemo – so continue to find it strange that this is offered. Our plan is to continue the antineoplaston treatment for as long as required. We realise this is being frowned upon by the doctors here – but ultimately we are trying the only thing we found that had credible results.

Credible results would have been publication and replication of his trials. Burzynski can’t seem to complete his trials, much less publish them (which is odd given that he has the test agent already developed and the tumors he is working have outcomes comparatively rapidly). If trial completion were a batting average, he’d be at .015 and his trial publication average would be .000.

By May 4, Amelia is a celebrity. They have raised £160,000 (!) and she is meeting and hanging out with celebrities. And the paper has clearly been reading Amelia’s dad’s updates. Also, her dad’s website announces:

Well we have now been back from Houston for a few weeks – and Amelia has continued to slowly improve with both her walking and speech getting better. The Burzynski clinic were brilliant – we were made to feel so welcome and Amelia really made an impression on everybody there!

We had an MRI scan on Monday that revealed her tumour has stopped growing. Considering she has had no treatment other than the antineoplaston therapy from the Burzynski clinic, we are really pleased (and impressed) that the treatment seems to be working so quickly. We are now continuing the treatment and increasing her dose such that we try to get her to the ‘target’ dose for her weight.

This tumor “stopped growing” news is taken as validation that the treatment is working, so much so, that the Wokingham Times irresponsibly reports that result. According to her dad:

1. Amelia has been on treatment for less than 4 weeks.
2. She is not on full dose yet, and has some way to go to get there. This is a slow progress, perhaps taking another month or so to achieve this (or more).
3. She has a low grade tumour. Any response will be slow. In other kids where the treatment has worked it has taken many months to show response.
4. She is still on steroids.
5. Her previous scan showed a 13% growth in 7 weeks.

So, having now had several opinions of the scans, I can confirm that Amelia’s tumour has STOPPED GROWING. This is amazing news and we are over the moon that this is the case. For this tumour type, in this short time, with a tumour of the size of Amelia’s, this is an incredibly good result. This is an INCREDIBLY hard tumour to do anything with, one of the hardest to treat and normally very lethal. In most circumstances Amelia would no longer be here (in February there was no way we thought we’d get to May with her) so to have the thing stable is fantastic news.

A few important points. It’s a low grade (slow growing) tumor. This does not seem to have been a PET scan, which would give a sense how of active the tumor was–to see if it had in fact “stopped.” And initial responses to chemotherapy (and ANP is chemotherapy by every definition) correlate poorly to outcomes, which is, of course, the final goal that everyone involved is keenly interested in. Of course, the Clinic doesn’t convey that information:

I also had a good chat with our doctor in Houston earlier. Again all sounding very positive, and we have again increased Amelia’s dose tonight […] The clinic sound very positive that Amelia’s tumour stopped growing so quickly. Let’s just hope we have more positive news on the next scan in June.

On 12 May, we get an update about Amelia’s progress:

Amelia was on top form today, she was pretty tired after the wedding but perked up and during doses, when we unplugged her from her backpack, she was really bubbly. Later in the afternoon she was doing some proper walking – unassisted. I think we have now realised that a lot of the walking problem now is just her confidence. She was walking almost normally, and certainly the same or better than she was before her operation. Fantastic.

So, they are at point zero, which considering where they have been is wonderful from the family’s perspective, but it doesn’t tell us that the ANP is working of if she has just recovered from surgery to her brain stem and is now on steroids. And this may be important, as dad mentions on the 20th:

She really has improved. We’ve both noticed significant improvements in her speech, mainly in the quality of her pronunciations and also the speed and which she speaks. Slow speech is a classic symptom of her tumour location, so any improvement is a good sign here. This might be the steroids causing this improvement so we have to be careful, but we have a lot of fingers crossed we’ll be taking her off the steroids within the next few weeks if we can get her second bag to target dose. We’ll see.

On the 21st:

Amelia has been a bit groggy, fairly lethargic and pretty reluctant to do a lot. […] Because of the lethargy, the doctor in the US has recommended increasing her steroid dose very slightly. We’ll see if this improves things – if it does then this is a good sign. It does all tie in with us increasing her dose, which is now at maximum on her larger bag. No wonder.

Also on the 21rd, just over a year ago, the fundraiser reaches its goal of £200,000, and the tally continues to climb. In the intervening time, however, we hear that Amelia has had some complications with the Hickman line, which has been replaced because of a tear:

She is doing well otherwise, and we’ll be resuming her treatment tonight. She is now walking by herself, her coordination and balance have all improved and her speech is much better. It looks like the treatment is definitely helping her.

In early June, dad is rattled by the deaths of patients Billie B. and Supatra A., who had the same tumor as Amelia, and for a few days he rails against skeptics. Apparently some have been contacting him and criticizing him. This is wrong, in my opinion. Cancer patients have enough on their plate.

On the 21st, we hear that the tumor remains stable:

Firstly we are waiting on a further interpretation from Dr Burzynski, but as we suspected from our own view of the scans this morning, Amelia’s tumour remains stable. In other words, there is no change since the last scan.

The family accepts this as a sign that they have stayed the brain tumor:

We are 100% sure that without antineoplastons, Amelia would either be in a hospice by now or dead. She has a grade 2 tumour, on scans it appears as a grade 3, and it is very large and in a very dangerous part of the brain. Even a few mm of growth would cause a significant impact on her quality of life at this size. We are all walking on a knife edge. Dr Burzynski’s treatment is undoubtedly keeping her alive. I actually want to wave this in the face of all the skeptics we came across along our journey.

It’s worth noting that the tumor hasn’t shrunk. Small victories–including just not dying–are huge when your child has one of these tumors.

Amelia has her 4th birthday on the 22nd of June, and it is celebrated in the papers.

Again, we see that the steroid dose is being increased on June 25th to control the symptoms of the disease:

We have been advised by the clinic to increase her steroid intake back to how it was last week to see if we see an improvement in her. We will then try in a couple of weeks time to reduce it again but at a slower rate, reducing it by 0.25mg instead of 0.5mg per day. The steroid intake is a tricky issue as they are essential and help reduce the symptoms of this awful disease (headaches, tiredness), however long term steroid use is not good and cause side effects such as weight gain, muscle problems.

We still haven’t seen anything that looks like clear evidence of improvement past diagnosis; it sounds like the symptoms return when the steroids are tapered. She seems to be doing pretty well on this dose of steroids, going to school. (Her last day of nursery school is 11 July.)

On July 15th we hear:

Well – we have had a pretty good weekend. I had a truly amazing conversation last night. Purely by chance I’ve been contacted by the mother of another little girl, who is almost the same age as Amelia, who is receiving the same treatment (for longer), with the same tumour (DIPG) and her tumour just shrunk. By 36%. We are so, so pleased. There is so much hope in our hearts now.

I’ll just briefly mention how frustrated we still are to read so much crap on the internet about Dr Burzynski. I feel like we are ‘insiders’, in a way, and know how the whole thing works now. These doubters clearly don’t. The lady I spoke to last night was told her daughter would die. When she went to Burzynski, her doctor shut her off. Refused to speak. Thank God she chose to follow her heart, and not that doctors advice. She might just have saved her daughters life. There is no doubt this works, and we want it in every hospital in the world. We’ll keep spreading the word until it is.

This child, sadly, is now dead.

By August the tumor has not shrunk, but Amelia has been coping very well. A few weeks earlier she had a wonderful day at the zoo. She’s still a little wobbly on her feet and in the pictures her family put on the Facebook page, you can tell that her face is not symmetrical, but by God she’s enjoying her life, which is an immense thing in itself. On the 6th however, she gets pale and sick; when her blood work is done, they find that her potassium and magnesium are way down, though they stabilize her.

On August 8, we hear:

One of the many things I have said throughout this year is that I hope that maybe, one day, I can learn that another child has had success with this treatment because of the inspiration they gained from Amelia. I know of one little girl, Chey, who is waiting to go to the clinic right now. But due to some complications with the FDA and the clinic, there are some delays – but we are all hoping she will get there very soon. We felt so welcomed by the Burzynski clinic and everything we saw there made us puzzled why so many people don’t believe in it.

We just found out exactly what happened. According to an SEC filing:

In a letter dated June 25, 2012, the [Burzynski] informed the FDA of a serious adverse event which may have been related to the administration of Antineoplastons. On July 30, 2012, the FDA placed a partial clinical hold for enrollment of new pediatric patients under single patient protocols or in any of the active Phase II or Phase III studies under IND 43,742. The FDA imposed this partial clinical hold because, according to the FDA, insufficient information had been submitted by the Company to allow the FDA to determine whether the potential patient benefit justifies the potential risks of treatment use, and that the potential risks are not unreasonable in the context of the disease or condition to be treated.

According to the mother of patient Alynn H., her understanding was that a child had died (link is password protected). We have not heard anything else, only that the ANP trials, almost a year later, have not started up again and that the partial hold remains.

On August 13, Amelia’s dad posts a video about Amelia’s life since diagnosis. This write up an unusually long post for this blog, and I haven’t done justice to the support the family has received from their community or the sheer number of people who pitched in to help the family, and this video gives a sense of that:

On the fifteenth, we hear that the family is understandably anxious for the tumor to shrink:

Incidentally, we are well aware that a stable tumour is good. Mondays scan was one that we went into thinking ‘if it is stable then great’. I’ve had a few people come up to me and ask “is the tumour shrinking?”. Now I know people mean well – but it is a little like me walking up to somebody and saying “have you won the lottery yet?”. In other words, frustrating. I smile, say no, it will take time, and move the conversation on.

So far, the tumor’s behavior has been utterly unrelated to the dose of the antineoplaston chemotherapy. On Aug 25, we hear that Amelia is tired on treatment and that she has had a progression of symptoms:

We are still looking to increase her dose slightly as she has gained a little weight since Houston so she should be able to tolerate an increased dose (or at least we hope so). We will probably have to increase her steroids in line with this, but we have been considering this anyway as she seems to have become a lot more wobbly lately. We know from the MRI that the tumour hasn’t grown so an increase in her steroids should help this.

Now, I’m not sure how this was verified. The definition of a “stable” tumor can actually accommodate some growth, so, we can’t know exactly what is happening. And we hear from the family a few days later that they have come to a hard realization:

On the 27th, we hear:

Firstly, Amelia hasn’t quite been herself unfortunately. She has been very reluctant to walk, a lot more tired, slow and pretty lethargic. She was sick on Saturday night also. We are reasonably confident we have probably gone too far with the steroid reduction so we have actually increased these slightly again today. We decided we would rather have a happy and more alert Amelia than one who doesn’t want to do too much – so we made this decision today in coordination with the Burzynski clinic. We’ll see how she does. There is a small chance it is the tumour growing, but much more likely given the scans we have that this is due to swelling of the tumour caused by the treatment. Time will tell. […]

The symptoms we are seeing right now are a direct result of the tumour, hopefully due to it swelling, and the steroids will fix this. They are also what we would see if it has grown.

It really, really looks that her wellness is linked directly to how much steroid she is receiving. And here’s another example of something that is…desperately, desperately wrong at the Clinic. The patient is being told that the tumor is swelling because of the treatment. How is it that only at the Burzynski Clinic that getting worse is indistinguishable from getting better? Second point: this is a tumor on the brainstem. If a possible side effect were swelling of the thing pressing against the brainstem, you’d expect that to be on the informed consent form, right? The type of thing that would be among the “serious side effects,” right? It’s not, at least not in a version of the consent form used after Amelia had started ANP:

(Burzynski’s supporters who have been saying that the treatment has no long-term side effects would do well to look at that first paragraph. The paperwork that every patient signs says it can have exactly that.)

On September 5th, we see a candid moment on the facebook page. The parents are committed to seeing this therapy through, but the father has that lingering awareness that this nothing the tumor has not shrunk:

Whether we have returned to a feeling of optimism or not remains to be seen. I still feel uneasy about the fact that we are so far on without the tumour shrinking. It is frustrating, because we have worked SO hard with the treatment – our entire lives are ruled by it and it is almost a full time job sorting it all out – we just share it between us and make it happen. We just know to be patient, and we 100% know it can work.

At this time, Amelia was returning to school (she had already been going to nursery school on treatment). And the way it appeared in the press, and certainly how I and other skeptics read it, it was being promoted as, “See? This treatment is working enough to let this little girl go back,” a human interest story (The Mirror’s coverage was profoundly disgraceful–suggesting UK doctors “refused to treat” Amelia, whereas when you look above you see that in fact: “The doctors here are being very cooperative – but I must emphasise that they are recommending different treatment (chemo) and we have consistently turned this down”), and by god it was good to hear that Amelia was having a great time, but there’s a lot more going on than is contained in the articles. On the 5th we see how much support was needed to get Amelia in. This was not the return of a healed child that everyone took away from the coverage:

“There has been a LOT of organising around this, far more than getting a healthy child to school. We’ve arranged our nanny, we’ve had to work around the school timetable, we’ve had meetings with the school and the teachers and the hospital nurses and made everything happen. The school have been absolutely fantastic every step of the way – we literally cannot fault them.”

On the 8th, we see on the Facebook page:

“On Monday we have a physiotherapist coming to look at her to see if she can get her walking again. I tried a little walking with her today and she is really, really trying. You can see she struggles, like her brain doesn’t know how to do it but the conscious Amelia that we see and know does. It’s a bit like trying to write with the wrong hand – you know what to do but you can’t quite make your hand write as well as the other. She tries to walk, but can’t quite make it all fit.”

This is not a child improving.

September 10, on they were visited by Eric Merola for his utterly uncritical documentary about Burzynski. More on that in a moment.

On the morning of the 15th, Amelia woke up crying with a pain in her head. She went off treatment for a day or so and got better, not trembling, perhaps speaking a bit better. One wonders if she is not experiencing relief from the hypernatremia that can appear alongside such massive sodium doses and can have such side effects.

Amelia has a great couple of days in late September (and she really takes to her school!), and her dad talks about how the awful waiting game goes in between MRIs, which I have learned is how time is measured by cancer patients:

I’ve said this many times before, but the really frustrating thing for me is not having anything really tangible that tells you this is working, until we get the scan image in front of us. This means an 8 week wait between scans when you really have no idea what is going on, and if she gets worse like she did a few weeks back then I think you naturally assume the worst. Then she gets better, and you relax a little!

The October MRI shows no change. But later that month, the family is trying to come to grips with what life will mean in the likelihood that Amelia is not with them. It’s a beautiful post, and I hope you read it. It’s immensely sad and healthy and you can’t help but feel the full force of their grief and fear. This family is mentally preparing themselves for a horrible future, and this makes what happened next absolutely inexcusable by any measure.

By November 19th, Amelia’s right hand is immobilized, a clear progression, and the family gets the results of a recent scan:

What I don’t want to do is get ours, and everybody else’s hopes up about things. I could not bear thinking that this is working and then to be told it isn’t. (emphasis added)

What I will elude to is that the Burzynski clinic feel that there is a cyst forming inside Amelia’s tumour, very slowly. This does seem apparent on the scan images but we want to make sure this has grown over the longer timeframe. A cyst will form where there is cell breakdown, so clearly is a good thing from a ‘killing the tumour’ viewpoint, but possibly bad in that you then have fluid in a very difficult place to get to. We’ll address that little hurdle if we get to it being a problem in the first place.

This sounds exciting (it is), but we are really trying to be careful about getting too much so. Amelia has got worse, although she has had some improvement over the weeks before her MRI. This could be due to a number of factors and we know the tumour has not grown.

Another point with this is that the tumour isn’t shrinking, but if a cyst is forming then it might be some time before the tumour does shrink. We’ve always said that due to Amelia’s tumour being very slow growing, we have more time on our hands more than most kids who get this.

When this news was released on the family’s Facebook page, followed by rapturous confirmation the next day, it was brought to the attention of Orac at Respectful Insolence, who gave an honest medical opinion:

It pains me greatly to do this, because, no matter how I write this, it will be perceived as trying to take away the hope for Amelia’s survival that the Saunders family holds. Such is not my intent, by any stretch of the imagination. However, these “cysts” almost certainly represent areas of ischemia (low blood flow) leading to tissue death as the tumor outgrows its blood supply. This is a phenomenon commonly seen in advanced malignancy. I know this because tumor angiogenesis ia one of my areas of research interest. […]

Sadly, then, seeing “cysts” growing in Amelia’s tumor most likely says nothing one way or the other about whether or not it’s responding to Burzynski’s antineoplastons. That’s assuming that Burzynski’s interpretation of the scans is even correct, which I wouldn’t bet money on. Most likely, these “cysts” indicate that there is no therapeutic effect. I take no pleasure in saying this, but most likely this is true.

Amelia’s dad was understandably upset and actually responded to Orac on Nov 29th, but the day after Orac posted, the family updated their followers:

We know that some people doubt what we are doing. We understand that it is in human nature to question, and many people will not just take something on faith alone. But, ultimately, this is our choice. And that choice seems to be paying off.

Yesterday I sent a CD with the latest MRI scans on to our local oncologist and I’ll be waiting for their opinion. We’ll consider this, and then continue until the next scan and see if the cystic formation that we have been shown grows in some way. I don’t want anyone to think we just take things at face value and accept them – we consider what we see, what we are told, and get as many opinions as we can. We can see with our own eyes though that something has changed with the tumour and we hope this continues. Amelia’s tumour hasn’t enhanced or progressed, so we know it is unlikely to be anything other than cysts, but we will get that second opinion for sure.

Amelia had a magical week. She won a community award, the “Child of Courage” award, and was literally the star of a Nativity play with her friends. The reality of Amelia’s situation soon came upon the family, however. On 2 December:

The truth is, Amelia isn’t getting any better neurologically. We live with her every day and we see it. She is very slowly deteriorating and I think we would be putting our own heads in the sand if we didn’t accept this. On one hand we have the Burzynski clinic who believe the tumour is beginning to die. We are getting opinions here about this theory and we’ll very likely need another scan of a different type in early January to back this up. Everything is based on opinions – and nobody agrees, which makes it all very hard on us.

And the final assessment from the Great Ormond Street Hospital:

We had our meeting at Great Ormond Street yesterday and, sadly, they just don’t have anything for us. We kind of knew this before we went – but wondered if they might have a trial that we could take part in. Unfortunately they don’t.

They felt that Amelia is in the latter stages of the disease, and that what is called ‘progression’ has already started. This means her tumour is growing, the cancer is spreading and we don’t have a huge amount of time left. Again we had already guessed this was happening but it was good in a way to have another opinion of this.

Were it just a one-off bad interpretation of an MRI on the part of the Burzynski Clinic, we might have been able to write this off as a simple mistake. But it’s not. Not by a long shot.

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 up lying in state in his family’s front room for months.

Had Burzynski not used this line on the family who had given him by far the most publicity of any other in years, this recurring theme might have slipped by unnoticed. But it’s clear that this is not just a coincidence, it’s an M.O. predicated on false hope that strings parents and patients along. And it’s been going on for decades! And it leaves patients utterly crushed and confused. The few skeptics who have been working these stories in their spare time have found case after case of patients thinking that getting worse is getting better (a partial, growing list can be found in this post). Consider that the cases written up at this website represent 1/10th of the total cases we’ve been able to find and will be bringing to you, that we have only found a small fraction of cases, mostly from the most recent years, and that this guy has been operating for over 35 years! My god! Imagine what that means!

In light of this, when Eric Merola, in his new movie, says in a series of title cards:

Two months after this interview, Amelia’s tumor began to swell and fill with fluid.

There was confusion and disagreement among between their local radiologists and the radiologists in Houston, [sic] about why this was happening–

So her parents decided to discontinue antineoplaston therapy.

[Then he cuts to a picture of Amelia’s obituary and says,]

“Amelia passed away with her parents by her side on January 6, 2013.”

…it is fundamentally dishonest. There was no confusion. There was the right diagnosis and Burzynski’s diagnosis, a story that’s been spun for decades to desperate parents, and it’s a goddamned disgrace that Merola suggests that the parents’ evidence-based decision could have been related in any way to the outcome.

Instead of the usual plea for a donation to St. Jude Children’s Research Hospital, which researches children’s tumors and provides care for free, we’d like to ask you to make a donation to Naomi House, the children’s hospice center that cared for Amelia’s family in the last days and which seems to be the family’s preferred charity.

If you want to take action, protect the vulnerable, and put reliable information in front of patients who might be looking into this Clinic, the Skeptics for the Protection of Cancer Patients (facebook page here) have put up guidelines about how to boost good information into Burzynski’s search results.

March 12, 2015

Burzynski Patients, Legal Threats, and a False DMCA Takedown Notice

Over the last few days, I (Bob) have been contacted by a handful of parents whose stories are on The OTHER Burzynski Patient Group. I have received two legal threats. First was an email from a father who ended his angry email: “I suggest you take down the personal blog that I wrote about my son […].” (The story, by the way, was by any measure the most horrifying illustration of alternative medicine’s predatory nature I have ever encountered.) I replied that I do not take stories down. Ever. He repeated the threat:

I expect it taken down – PERIOD – or you’ll be hearing from MY lawyer …

You have absolutely NO right to republish my blog …

Just try me – you can look up my current company [website] to see that I’ve been building another successful business and I’ll gladly use ALL the resources I have to fight this unlawful use of my personal story.

You have NO idea who you’re messing with!!

The second threat came and went while I slept. On the morning of March 3rd I received an email from my host, WordPress, which read in part:

We have received a DMCA notice (https://www.eff.org/issues/bloggers/legal/liability/IP#dmca) for material published on your WordPress.com site.

Normally this would mean that we’d have to disable access to the material. However, because we believe that this instance falls under fair use protections, we will not be removing it at this time. (emphasis added)

Section 107 of US copyright law identifies various purposes for which the reproduction of a particular work may be considered fair, such as criticism, comment, news reporting, teaching, scholarship, and research. You can learn more about that here:

http://www.copyright.gov/title17

http://www.copyright.gov/fls/fl102.html

While we believe that your use of the material is protected (we have fought for our users in similar cases in the past –http://en.blog.wordpress.com/2013/11/21/striking-back-against-censorship/), please keep in mind that the complainant may choose to continue to pursue this matter, perhaps directly with you. If you would prefer, you are still able to delete the content from your site yourself.

The question of whether or not I will take down posts is a non-starter. I have tried very hard to balance patient privacy and responsibly publishing information that I believe is in the public interest while also citing my sources. That so few patients have contacted me over the course of the last few years (and despite the fact that TOBPG appeared in a feature-length Burzynski-themed infomercial by Eric Merola) suggests that I have largely succeeded.

The night before the DMCA notice arrived, the following comment appeared in the comments of the “About TOBPG” page:

I just want to thank you so much for this site. My best pal is two years into a most likely fatal cancer diagnosis. As the traditional treatments have failed to cure her, we are searching far and wide for the next possible step, and Burzynski’s name came up. Seeing the facts laid out on your site (and others) made it so easy to understand that this is nothing more than quackery. Thanks for helping us avoid what could have been a horrible misstep.

The site and all the stories stay.

I have retained counsel, Ken White of Brown White & Osborne LLC, who writes at @Popehat and who represents me pro bono on First Amendment and free speech issues.

February 14, 2015

Burzynski Patient Sen. Ed G.’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. This one is notable because not only was the patient a State Senator, but he also reported that a probable sign of getting worse was a sign of getting better. Oh, and he testified on Burzynski’s behalf in front of Congress.

In the last week of the 1996 Georgia state senate race, incumbent from Macon Ed G. tried to speak on the phone, but couldn’t. Also, printed letters looked scrambled. While he initially dismissed it as stress related to his campaign, a friend who was a physician sent him to the doctor the next day. An MRI on Nov. 14th revealed not the small stroke they expected, but a brain tumor lodged in the front of his brain.

The decisions that he made in the days following the diagnosis reflect his approach to his treatment:

I went to three of the best neurosurgeons in Atlanta and they seemed to contradict themselves in what the best options for treatment were for me. The last doctor was one of the best neurosurgeons at Emory University in Atlanta. This doctor suggested chemotherapy and radiation and said this might control the growth of the tumor for a while but eventually it would come back and be a lot worse and at that time we would have to see what options were available. Obviously this was not a very good option in my opinion. I decided against chemotherapy and radiation because of the toxic side affects and the increase chance of other cancers they themselves caused. A person that takes chemo and radiation is 25 times more likely to have another form of cancer than the average person.

I talked it over with my wife and we decided to look at an alternative type of treatment. I looked and studied the options for several weeks and decided that Dr. Burzynski had the cure for brain tumors.

This, of course, is the Nirvana fallacy. Chemotherapy and radiation, while not perfect and while they carry real consequences, might actually have been the best course of action. And you reject the best advice of the best neurosurgeons at your own peril.

In mid-December, he went to the Burzynski Clinic, and he reports:

three weeks later 50% of the tumor was gone. After five months the cancerous part of the tumor was completely gone. I have to remain on the IV part of the treatment until the end of this year and then will take the antineoplastons for several years by capsule.

Of course, he was sold on the treatment entirely at this point. Adding to his commitment was a $14,000 start-up fee and $5,000 for the first treatment, according to the Macon Telegraph, which broke the news of the state senator’s decision to undergo antineoplaston treatment on January 10th, 1997. This announcement seems not to have met any skepticism whatsoever, which is mildly surprising given that at the time Burzynski’s extensive legal troubles were at their height. The Senator’s state-run insurance was not going to cover the treatment, and so a number of public officials banded together to raise money for their unfortunate colleague’s doctor. Lt. Gov. Pierre Howard challenged people to raise funds for the treatment, and by the time the article ran, the church accepting the donations had received $35,000. The monthly treatment would cost an additional $9,000 a month, the church official interviewed reported: “He’s not sure how many months he’ll have to be in treatment. That will be decided as he goes along.”

The same representative reported that the Senator had had a brain scan the previous week:

“It showed that the tumor had not increased in size at all, so the treatment has stopped the growth,” Pardue said. “He said to us it was moderately growing.”

So (besides it growing and not growing at the same time), even if the tumor had stopped growing, it would not mean that the treatment was having any effect, because of a feature of solid tumors known as Gompertzian growth or “day 2 of your introductory oncology class.” We also hear that the Senator is flying out to Texas every month for treatment. This is interesting because at this time it seems that the Clinic is obeying the rules that federal prosecutors were trying to enforce. The Senator will participate in the upcoming 40-day legislative session but he will be carrying a “fanny pack” that has his infusion pump.

Four days later, the Telegraph reports that the 44-year old Senator has returned from his most recent trip to Texas, and that his sons help him prepare his bags of ANP. He reports:

“I can’t sleep at night sometimes because of the medicine. Sometimes I have to take naps.”

What this public official can’t say in polite company is that the quality of sleep of patients on antineoplaston is heavily degraded because the high sodium load means that the patient has an unquenchable thirst, and he is constantly at the toilet. At the same time, he reports:

“My condition is improving, and the cancer is reducing.”

As the Macon Telegraph reported the next day, the Senator thanked his colleagues in the Senate for their support. Due to their efforts, $45,000 had been raised for the expected $100,000 treatment, projected to last for a year. The paper reported that that he told his colleagues “that his tumor, located in the right front area of his brain has already been reduced by 30 percent. He said he will return to Texas on Feb. 20 for another treatment and is hoping that doctors will find his tumor gone.”

We get an update from the Macon Telegraph on the 12th of March about the Senator’s progress:

“Ninety-two percent of the worse part of the tumor is gone,” he said. “I think God is going to heal this thing in his timing. […] Burzynski is predicting that the ‘worst part of the tumor’ will be gone in a month, [the Senator] said. The treatment will run another eight months[.]

It’s a strange qualification. 92% of the worst part? How does that relate to tumor size? Nonetheless, the Senator is now fully behind Burzynski, as you might expect. The same day, the paper would report, he presented a bill to the Senate that would allow patients to take “experimental treatment” without facing legal repercussions, though the article mentions that doctors could already prescribe experimental treatments to patients. The Senator says it will protect doctors, but the Medical Association of Georgia opposes it:

“This is misguided public policy,” said David Cook, director of governmental relations for the Medical Association of Georgia. “In the bill, a doctor could tap dance around your bed and that could be the cure for cancer.”

At least the tap dancing doctor could be entertaining and someone would be getting some exercise. ANP doesn’t show even those benefits. The bill passed the Senate 74-2. It passed in the House 146-19, the Telegraph reported on the 26th of March. It was rushed through by the urgency of the Senator’s situation.

By June 26th, Burzynski has already exacted all of the money raised by the Senator, and another fundraiser is in the works, this time to raise $100,000. One of the guests at the fundraiser is future Georgia Gov. Sonny Perdue. Half way through the article, the Senator reports something horrible:

[The Senator] said the treatments have shrunk the tumor to the point that brain scans now pick up a ‘2-inch circle of fluid or something. It’s not an additional mass,’ he said. ‘It’s actually eaten through the brain.

And there it is. Another patient reporting that a cyst in a tumor is a sign of improvement, not a sign that the tumor has outgrown its blood supply and that the ANP has not arrested its growth one jot. Patients have repeated this horrible, unconscionable, misleading prognosis for what is ischemic necrosis 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).
Burzynski gave the same diagnosis 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.
Last night, I saw it again in the story of Christy M.
In the most grotesque horror show I have ever written about, Burzynski himself tells the family of Chase S. the same thing.

Why? I bet it has something to do with the 100,000 that the future governor is raising.

At this time, it seems that the Senator will be on treatment for up to two years, and that he has another 8 months at least hooked up to the IV pump. He here confirms that he is experiencing the most noticeable side effect of treatment: “The only thing that I have is a tremendous amount of fluid going going through my body. It just wears you out.”

The fundraiser nets only $25,000 for the Senator. “It just means we’ll have to have another one,” he says in the July 8th edition of the Telegraph. In November, the poor guy is asking for another $25,000. The paper reports that:

“[…] recent tests show his brain tumor is completely gone, but he must continue is treatment for several more months ‘just to make sure.’ He now needs $25,000 to pay for the intravenous and oral medications.”

This seems difficult to believe, especially given what’s coming.

In September, the Senator is one of the delegation who travel to Washington to appear before Congress on behalf of the man who is bleeding him, his family, his church, and his colleagues dry. In his testimony in front of the Government Oversight and Reform Committee, the Senator says:

After learning of alternative treatments and the problems they were having with the FDA, this past January during the Georgia General Assembly I introduced and was successful in getting passed an Access to Medical Treatment Act. The citizens of Georgia believe that patients ought to have the access to the treatment of their choice when their lives are threatened. Because I am a State Senator my name has been in many stories nationwide associated with Dr. Burzynski. This has led many potential patients to call and ask me about the treatment and for help getting into a protocol.

The most disheartening thing about the whole ordeal with the FDA is that while the FDA is allowing the antineoplastons to go through clinical trials to test their efficacy, they are making patients take treatments they do not want to take before they can become a part of a clinical trial. One reason we choose Dr. Burzynski is that his medicine is nontoxic. For the FDA to make a patient take radiation before they can become part of a clinical trial for antineoplastons is unreal.

The FDA will not allow patients that don’t fit the protocols to take the antineoplastons without a fight. One gentleman from Texas had high blood pressure and because the medicine is a sodium based medicine taking the normal dose the way the protocol requires would have caused him more problems. This gentleman needed a special treatment unique to him. It took six weeks of fighting with the FDA and getting his Congressman involved before he could take the treatment.

When the FDA was created it was with good intent. The citizens of this country needed help with determining whether drugs were safe or not. But if I allowed my two boys to grow up without supervision they would become something different than they are now. They would be arrogant, belligerent, undisciplined and uncaring much like the FDA has become. I believe it is time that Congress steps in and brings some discipline to this department and restore some integrity.

Of course, a protocol is called a protocol for a reason, so that you can get reliable data by comparing like cases. A patient who has high blood pressure (and presumably a brain tumor) should probably not be on one of the sodium bombs that Burzynski’s Clinic administers.

On 20 August of the following year, the Senator decides to not run for another term in office, as reported in the Atlanta Journal Constitution:

State Sen. Ed [G], Republican from Macon, has changed his mind about running for re-election. [Senator G] was diagnosed with a brain tumor two years ago, and has withdrawn from the race for health reasons.

[Senator G] had no opposition in last month’s primary. The state Republican Party’s executive committee has nominated Susan Cable, a Macon community activist and former Bibb County school board member, to run in his place for the 27th District seat. The Democratic nominee in the race is Floyd Buford, a Macon attorney.

[Senator G] said he plans to serve out the rest of his term. However, he said the rigors of campaigning, combined with the medication he’s taking will prevent him from seeking re-election. “I probably wouldn’t be able to do it — not as well as I should,” he told the Macon Telegraph.

Since his diagnosis, [Senator G] has been traveling to Texas for alternative therapy that he said has resulted in significant improvement in his condition.

Yet he’s too sick to continue. What happened to the “disappeared tumor”?

The Senator died on Nov 8, 1999 according to the AP, “of brain cancer.” He was 46-years old. If the Senator was in a clinical trial, it remains unpublished to this day.

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. Unlike Burzynski.

December 22, 2014

Burzynski Patient Douglas W.’s Story

Douglas W. was a Burzynski superstar. He was a helicopter crew chief in Vietnam and then became a corporate jet pilot. On June 26, 1994, according to a March 6, 1996 report in The Oregonian, Douglas received a bad diagnosis. He had a brain tumor, a glioblastoma. According to the report:

[Douglas’s] life gave way to surgery, 33 radiation treatments and four months of conventional chemotherapy. The worst still was to come.

In January 1995, [Douglas] and his wife, Lola, heard bad news from their oncologist: The tumor still was growing. The doctor told [Douglas] he had three or four months to live.

At this point, Douglas turned to the Burzynski Clinic and went on antineoplaston treatment. It was not cheap:

In the past year, his quest for life has taken him close to the center of a national medical controversy. He’s spent $75,000 traveling to Texas and paying for chemotherapy that his insurance wouldn’t cover.

Antineoplastons are the almost certainly ineffective chemotherapy that cancer quack Stanislaw Burzynski has kept “experimental” for 4 decades. Though the experiments have led to no reputable publications, he sure has managed to charge hundreds of patients top dollar for the drug derived initially from human urine and blood. Essentially, Burzynski posits that cancer is caused by a lack of “antineoplastons” in the blood, that cancer is basically an antineoplaston deficiency syndrome. No other physician on the planet recognizes this as a cause of cancer, and no competent physician says there is evidence of this alternative immune system that is supposed to take care of cancer.

Regardless, the reason why Douglas is a superstar is revealed in the next few paragraphs of the article:

Eleven months after he started a chemotherapy unapproved by the Food and Drug Administration, [Douglas] is in full remission. […]

Last week, [Douglas] testified before a congressional subcommittee investigating the Food and Drug Administration’s obligation to patients with life threatening illnesses. He appeared on “Nightline” with Ted Koppel in defense of Stanislaw R. Burzynski, a Texas doctor who has been giving unorthodox chemotherapy to cancer patients.

In fact, according to the transcript of the May 19, 1995 Nightline episode, Douglas was used as an example of “desperation”:

DAVE MARASH, ABC News: [voice-over] The first thing you feel in the waiting room of Dr. Stanislaw Burzynski’s Houston, Texas cancer clinic is the desperation.

DOUG [W.] My name is Doug [W.], and I’m from Estekay [sp?], Oregon, which is southeast of Portland, and I’ve got a- I don’t know what it is, but it’s a brain-

WIFE: It’s a glio- it’s a glioblastoma.

DOUG [W.] : -glioblastoma, stage IV.

Back to the Oregonian article, where we see some surprising endorsements:

[Douglas] is in the spotlight because his tumor, an aggressive, advanced stage of glioblastoma, no longer makes a blip on a brain scan. His remission amazed his doctors in Portland.

Dr. Gerald L. Warnock, a diagnostic radiologist with the East Portland Imaging Center, has evaluated four or five of [Douglas’s] brain scans in the past year. He said the most recent scan, in January, was totally clear of a tumor.

“I have never seen it happen before,” said Warnock, who has evaluated about 50 patients with brain tumors.

He said [Douglass’s] remission could be a delayed reaction to his conventional treatments, a miracle, or the result of antineoplaston, the drug administered by Burzynski.

Warnock said he is skeptical of unconventional treatments.

“One case doesn’t make a doctor a hero,” he said.

Still, Warnock is impressed with [Douglas’s] remission, because he’s seen his brain scans, both before and after antineoplaston.

“If I had a relative with that particular type of tumor, I think I would send him down there,” he said.

Dr. Bruce Dana, a medical oncologist who treated [Douglas] with FDA approved anticancer drugs, also is impressed with [Douglas’s] remission. He said he has never seen a glioblastoma disappear after earlier scans showed it growing.

By any measure, these doctors are being irresponsible. Going to the press with a data set of one person is irresponsible, especially when the stakes are so high, namely a treatment for an intractable tumor. This is not the last time we’ll hear from Dr. Warnock, however.

Of course, we have seen too much weirdness with Burzynski’s charts in the past (we’re thinking of the time that the FDA got two different sets of records, one from Burzynski’s IRB and a different one from the Clinic, about a child whose death sparked a federal investigation–whoops!) for us to accept the interpretations of anyone who has received records from the Clinic. This is a major reason that the definitive study of ANP can’t possibly come from Burzynski’s outfit. They have shown themselves endlessly incapable of maintaining charts and running clinical trials.

Douglas was out among the 75 patients protesting outside the courthouse as Burzynski faced federal charges in February 1996:

Doug [W], a patient of Burzynski’s, expressed hope that Lake will allow continued treatment. After being on the unorthodox treatments since last summer, [Douglas] said his brain cancer has disappeared.

“I had done everything my doctors in Portland told me to do and then after 33 treatments of chemotherapy and radiation, they told me to give up hope. They said I only had two to three months to live. But I wasn’t ready to give up hope. That’s why I came here.”

On the 29th of February, Douglas was in Washington, D.C. and had five minutes in front of a House committee as patients were paraded in front of congressmen and cameras to beg for their lives.

[…]

And here’s why Burzynski and his legal team use patients as human shields. Because patients channel their whole being, their entire hope into the campaign to keep their doctor, who they are allowed to believe is the only thing keeping them alive.

The next time Douglas appears in the media, it’s in the Peoria Journal Star on 5 July 1996, which opened:

Just months after Douglas [W.] went on national television and before Congress to praise an unproven drug for obliterating his brain tumor, he got a shock: The cancer was back.

[Douglas’s] trauma illustrates the contention swirling over “antineoplastons. ” Are they the wonder drugs that desperate patients insist? Or are patients the victims of a fraud charged in a federal indictment of the drugs’ creator, Dr. Stanislaw Burzynski? “There is a long history of promises of miraculous treatments, and they unfortunately generally don’t pan out,” said Dr. Richard Klausner, director of the National Cancer Institute.

[…]

[Douglas] even stands by Burzynski, abandoning antineoplastons only when his brain tumor tripled in size. “We believe that treatment did work with Doug for a year,” said his wife, Lola [W], of Estacada, Ore.

It is sad, but entirely to be expected, to see that Douglas supported Burzynski after a clear failure. They believe the treatment works, but from the outside it is impossible to distinguish between a tumor growing steadily but slowly for a year and a tumor growing like crazy only in the last weeks. This is why we need trials. This is why patient testimonials are veridically worthless.

And we’re not the only ones who question the value of Burzynski’s treatment. Dr. Warnock, the radiologist who said that it looked like he would consider sending a family member to the Clinic after he saw Douglas’s scans, has had a come-to-Jesus moment:

The biggest question is how patients fare over the long term.

Take [Douglas], whose brain scans showed in January that his tumor was gone. In April, it was back. Triple antineoplaston doses failed.

[Douglas’s] doctor cannot explain the initial disappearance. But the relapse and a second patient who had “a flagrant progression of the tumor in 60 days” make him “extremely skeptical,” said Dr. Gerald Warnock.

We suspect Warnock has learned to not speculate wildly in public and that’s why he doesn’t explain the initial disappearance. Doctors and other medical professionals who work with Burzynski’s patients have reported being stung when they see what giving him the benefit of the doubt leads to. Take Dr. Bennett, who treated a girl in New Hampshire earlier this year:

Bennett’s decision [to treat the girl] was based, in part, on a newspaper article that said Burzynski had agreed to donate the medicine required for [ML’s] treatment. But what Bennett didn’t know is that Burzynki planned to charge the family for the clinical costs associated with the therapy.

[ML’s grandfather] said the first month’s bill is expected to be $28,000. Every month after that is expected to cost $16,000. The treatment usually lasts eight to 12 months.

Bennett says a representative of the Burzynski Clinic called him on that date seeking payment for the first month of [ML’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.”

Elsewhere, Bennett said that the arrangement “meets all the criteria for a bait and switch operation.” And still elsewhere, he said:

“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.”

[…]

Bennett has become dismissive of Burzynski’s alleged treatment.

“His claims have no merit. He has never tested any of it realistically,” said Bennett.

And the IV-certified nurse who visited the Burzynski Clinic was apparently not impressed either:

Bennett noted as an example training for Ariel Dye, a registered nurse from Derry who oversaw the intravenous injections of [ML], which cost many thousands of dollars but provided nothing of value. Neither Bennett nor Dye were paid for their help.

“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.”

Nonetheless, in the same article, and despite the fact that ML reportedly had a bad reaction to the drugs, her grandfather still supports Burzynski:

But [ML’s grandfather] thinks Burzynski has shown at least anecdotally that his treatment has more promise than anything developed by mainstream medicine.

“If he had more funding, he could come up with answers, but nobody wants to do trials with him,” said [ML’s grandfather], who blames Burzynksi’s patent for the opposition. “Because one individual has controlling interest over this, they can’t make any money from this man.”

[ML’s grandfather] also thinks that if the FDA had allowed [her] to be treated at Burzynski’s clinic in Texas, rather than requiring it to be done in New Hampshire under the oversight of a local doctor, she might have done better.

“I don’t believe any of that nay-saying stuff. I’m not going into this blindly,” said [ML’s grandfather], talking about the months of reading and work and meetings he has held on the topic. If somebody else he knew was diagnosed with DIPG, he’d recommend going to Burzynski.

Even though knowledgeable professionals who have nothing to gain from seeing Burzynski shot down and who clearly want to help cancer patients in any way they can, once they have actually worked with Burzynski very commonly come out entirely disillusioned, the targets of Burzynski’s scheme, the fundraisers and family’s and patients, often cling harder to the Clinic, because the alternative is perhaps too horrible for the healthy mind to contemplate.

According to Douglas W.’s obituary in the Sept 8, 1996 Oregonian, Douglas died on the 6th of September, mere months after he appeared before Congress as an apparent cure to testify for Burzynski. He was 48.

For the stories of other patients who have testified for Burzynski but subsequently died, see the cases of Elke B. and Janet C.

December 20, 2014

Burzynski Patient Elke B.’s Story

As Stanislaw Burzynski heads to court again to answer charges made by a variety of patients to the Texas Medical Board, he is doubtlessly preparing by getting the testimony of current and former patients. In anticipation of this pony’s one trick, we are going to start 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.

Our first patient is an MD and stage-IV breast cancer patient who testified in court for Burzynski in 2012, named Elka B. She was receiving chemotherapy from Burzynski:

Elke’s obituary, which ran in early November of this year (and is lovely–you should certainly read it, as she was a staggeringly kind and generous person), encapsulates the desperation that Burzynski’s patients and their families feel:

By the time Elke’s cancer was discovered, it had spread throughout her body. Doctors gave her a 5 percent chance of living five years, [her husband] said. She lived for 12.

At one point, [her husband] took Elke to a clinic in Texas, where out-of-pocket costs ran in the tens of thousands. “I don’t care if I have to live in a barn with you,” he told her. “I just want you to live.”

We should note that we do not know how long Elke was at the Burzynski Clinic, only that she was under treatment not even two years ago.

Elke will not be testifying for Burzynski in the upcoming trial.

For more patients who have testified for Burzynski and who are now dead see: Douglas W’s story and Janet C’s story.

July 27, 2014

Burzynski Patient Andrew S.’s Story

*An appeal to help get Congress to take action follows this story*

When you read the Caring Bridge blog [the source of this story unless otherwise indicated] from the S. family at the beginning of their story, you may be confused. Andrew was diagnosed with a brain tumor only days after his mother was diagnosed with breast cancer, so the planning for Andrew’s initial round of radiation coincides with his mother’s biopsy. I just can’t imagine what the family has been through.

On the day before Halloween 2007, Andrew has a port implanted. He begins chemotherapy and radiation the next day. He does a week on chemotherapy, but is soon taken off. The same week, his mother has the mass removed from her breast. By the 11th, his mother is able to be with her son at the hospital. The poor kid gets salmonella while in the hospital and has complications from the antibiotic he is on. The family can’t catch a break.

On November 14th, we hear:

Finally, some of you are aware that we have found a clinical trial (in Houston, Texas) that may possibly help Andrew. I will post more information about the trial as soon has I have time.

And the next day:

Finally, there have been some questions about the treatment we are pursuing for Andrew in Houston. Rather than giving you my own interpretation of the information, I’m going to give you a web address so that you can have as much information as you would like to have. Please, go to [website redacted] to check out the Burzynski Clinic. Andrew will finish his radiation treatments here before going there. (His treatment here should be finished around December 14.) They have tentatively said they would like us to arrive on the 26th or 27th of December. We are working out the details.

Andrew will finish radiotherapy before going to Houston. He has a bit of crisis late November, which lands him in the pediatric ICU after his sodium dropped and he was having seizures.

The radiation may be having an effect by the end of the month:

Written Nov 29, 2007 12:32am

Andrew had an MRI done over the weekend. The report indicates “a large oval shaped mass which appears to originate from the right side of the pons.” (This is part of the brain stem.) The report also states, “…the mass does not appear larger and may actually be minimally smaller.” Dr. Saah said that the MRI itself shows that there is increased space between the mass and the back of the brain and that there is not as much swelling as there was when the first MRI was done on October 25th.

And the poor kid gets a damned kidney stone and UTI for Christmas. He still has salmonella.

Andrew is a clever, thoughtful kid. His parents take down all the weird little things that he says, and you should read them. There is a brilliant innocence in his use of language. My favorite example, I think, comes on December 7th:

Written Dec 7, 2007 8:51am

I’m having a PET Scan this morning, and Andrew has had lots of questions about it. A minute ago he told me, “I’ve had PET Scan.” I said, “You’ve had a CAT Scan.” He said, “Oh. (pause) Well, a cat is a pet, so I thought they were the same thing.”

Good news on the 15th. The cancer has responded to the radiation:

Written Dec 15, 2007 12:27am

Andrew’s CAT Scan report says “…the size of the mass is dramatically decreased.”Evidently this is somewhat unusual–even as a result of radiation. The nurse practitioner who works with oncology at the hospital has requested dimensions so that we have more of a specific understanding of what has happened.

Two days later, he’s back in the hospital passing kidney stones. Also:

They are checking on the possibility of scheduling an MRI (of the brain) for today–while we are still in the hospital. (It was originally scheduled for tomorrow night.) We need this MRI for the Burzynski Clinic.

His first appointment at the Burzynski Clinic is on the 27th at 9AM.

We met with Dr. Burzynski and one of the other doctors today at the clinic. Andrew will be having an MRI in the morning. There needs to be disease progression in order for him to begin treatment with the antineoplastons right away. (This is an F.D.A requirement; this medication is only available to those enrolled in a clinical trial.) If there is something–even something small–in the MRI that would indicate disease progression, Andrew will be able to begin the treatment. If not, he may become a patient of Dr. Burzynski’s in his private oncology practice; he will be treated with an oral medication–already F.D.A. approved–which is in the antineoplaston family. Being treated with this oral medication does not disqualify Andrew from being enrolled in the clinical trial in the future.

The financial side of this became more of a reality today as we paid–up front–for the consultation and began to look at the payment schedule for treatment with the antineoplastons or for treatment as a patient in Dr. Burzynski’s private practice. Andrew’s medical needs are fully covered in the state of Michigan, but only emergency care is covered out of state.

It is important to note at this point that the family believes that the treatment has had some success. This can not be backed up with meaningful clinical studies.

On the 30th, this update:

By the time we arrived back at the Burzynski Clinic, it was close to 4:00 pm. One of their doctors went over the films with us; he told us that there had been about a 10% decrease in the size of the mass since the last MRI only ten days earlier. The fourth ventricle of the brain–which had previously been pushed aside by the mass–now looks normal. Another doctor explained that because of this good news Andrew does not qualify for I.V. antineoplastons (one of the clinical trials) at this time. He will be seen in Dr. Burzynski’s private practice instead.

We met with one of the doctors who works in the private practice, to go over the specifics of Andrew’s situation. We will be continuing to taper the decadron (the steroid). Today we cut the dosage down to 3 mg (from 4 mg) in the morning and 2 mg at night. We also raised Andrew’s zyrtec dosage from 5 to 10 mg to see if that makes a difference with his chronic sinusitis. (This is something that shows up on the CAT Scans and MRIs.) We are discussing the possibility of switching him to Singulair because he also seems to benefit from the use of an albuterol inhaler at times. (Singulair would cover allergy AND asthma symptoms.) Andrew also takes Prevacid (15 mg twice a day)

The day after this consult, a Saturday morning, we get an example of the fine care that you receive at the Burzynski Clinic for top dollar:

We sat in the waiting room until we were the only ones left. I knew that the port needed to be checked, and I had heard that the workers try to be out of the clinic by 11:00 am on weekend mornings. I was becoming concerned about the time, so I said something to the nurse. We were taken to a room at 10:15 am to speak with the doctor on call. I quickly realized that they were not planning to touch the port; it was getting late, and if a problem was discovered it would take too much time to resolve. I had to insist that the port be checked because we needed to know if it was working. It still would not draw, and the area around the port seemed irritated. (Andrew had been complaining all morning.) The clinic staff member wondered if there was swelling and suggested that we go to the Emergency Room.

By the time he gets to the hospital, blood has soaked through the port’s dressing. He is ineligible for the “clinical trial” because he has just had radiation.

Written Dec 31, 2007 1:00am

Someone has asked how we are feeling about the way things are going here in Houston. Andrew is not on the I.V. antineoplastons because he does not qualify for the clinical trials yet; however he is taking an oral medication (sodium phenylbutyrate) in the antineoplaston family. Rather than waiting for disease progression, we are attempting to fight the glioma before it advances. The I.V. antineoplaston statistics are encouraging–about 30% of patients have a dramatic or partial response to the medication (the mass is completely or partially gone), about 30% of patients become stable (no change), and about 30% of patients experience disease progression. Since most of the Burzynski Clinic brain tumor patients are on the I.V. antineoplastons, there are no statistics for the oral medication. One of the doctors said he felt that being seen in the private practice was better for Andrew because the treatment will be based upon exactly what Andrew needs rather than on the strict rules of a clinical trial.

What is so aggravating about this is passage the way the information is presented to them. The stats that they receive is that 60% of patients are at least stable. Burzynski does not have the clinical trials to back up this assertion. A further complication is that “any response” and “complete response” are grouped together in the same group. Seems very disingenuous to me.

Andrew’s mother returns to Detroit to begin her own chemotherapy on the first. It’s amazing how rarely she mentions her own condition as she documents this story. Her priorities are clear.

After the mother left, the Clinic springs chemotherapy on the family:

While [the mother] was preparing to start her chemo, we were surprised to learn that Andrew’s doctors in Houston are recommending a chemotherapy (Temodar) for Andrew which would go along with the oral medication he has been taking. The doctors were wanting to start it today, but the [S family] want to discuss this option — and the possibility of doing it at home — with their oncologists here in Lansing.

He’s back in the hospital trying to pass one of his kidney stones (there are 3) but gets out around the 12th. We soon hear what Andrew is on:

Written Jan 15, 2008 1:41am

Andrew began treatment under the direction of the Burzynski Clinic again today. He will be on three different medications–PB (the oral medication in the antineoplaston family) to help bring into balance the relationship between the oncogenes (onco refers to cancer) and the tumor suppressor genes. (In those who have cancer, this relationship is not right.) The other two medications will target specific oncogenes found to be a problem in Andrew. The first medication will target VEG-F which relates to a tumor’s blood supply. The normal level for this is anywhere from the 40’s to the 90’s. Andrew’s is over 200. The second medication will target another oncogene which is at the very top end of normal in Andrew–right on the borderline between normal and abnormal. Since I don’t fully understand this particular oncogene yet, I can’t explain it!

On the 17th, a phone consult with the Clinic:

I listened by telephone to the meeting with Dr. Burzynski this afternoon. We are proceeding as planned–with the three medications; we are also lowering the decadron dosage. (We are supporting Andrew with two natural anti-inflammatories while we do this.) Dr. Burzynski indicated that it is unusual to see the results we have already seen from radiation alone, and that Andrew is doing extremely well. We have been told that dramatic response to treatment usually indicates a more aggressive tumor or cancer. He said that sometimes that is true, but not always.

Things proceed fairly uneventfully until we get the next update:

Written Jan 25, 2008 11:57pm

[…] We had a great appointment with Dr. Gera, Andrew’s oncologist, on Tuesday. She spent so much time with us that she got behind with other patients. We went to have some lunch to give her a chance to catch up; then we went back so she could examine Andrew and talk with us at length about the Burzynski Clinic recommendations. We were having some difficulty at that time getting a doctor from the Burzynski Clinic to contact Dr. Gera. Because of this, we are still sorting out their recommendations and discussing them–along with their reasoning. God has blessed us with a wonderful doctor who truly wants what is best for Andrew and for our family. We are so glad that we are home and that Andrew is under her care!

In mid-February, as the family seems to be off-treatment in anticipation of having the kidney stones treated, the family starts to discuss other, better courses of treatment than the Burzynski Clinic:

Written Feb 18, 2008 10:50pm For several weeks we have been communicating with Dr. Kathy Warren at the National Institutes of Health/National Cancer Institute regarding Andrew. She looked at Andrew’s MRI to confirm the diagnosis (diffuse intrinsic pontine glioma) this past week, and has been very helpful in discussing (by e-mail and by telephone) treatment options with us and with Andrew’s oncologist. We are extremely impressed–and grateful–with how accessible Dr. Warren has been. She is not–yet–Andrew’s doctor; however, she responds to our e-mails and phone calls almost immediately. She has not tried to talk us into the clinical trials she is overseeing, but has presented them to us as options and has been willing to discuss other options (the Burzynski Clinic recommendations) as well.

I am including part of a note I wrote to Dr. Warren earlier today because it accurately expresses our feelings about Andrew’s situation.

“…We understand the medical bottom line of Andrew’s diagnosis; however, we don’t want to live as if his life is over. He is full of energy, with relatively few physical problems–other than decadron side effects–right now. We know of kids who are doing okay with this diagnosis–2, 3, 4 and more years later. We can’t be assured that Andrew will be one of those kids, but neither can we be assured that he won’t.”

At some point, all mention of Burzynski simply….disappears. At some point I realized that I was simply following another patient’s progress through conventional, experimental treatments.

On March 2nd, we hear:

Andrew will be taking part in an Imaging Study under Dr. Warren’s direction. Dr. Warren’s research nurse is scheduling us to go to NIH some time in April. Dr. Warren has also encouraged us to take Andrew to see Dr. Stuart Goldman at Children’s Memorial Hospital in Chicago. We have already spoken to Dr. Goldman, and the plan right now is to wait to schedule an appointment at Children’s Memorial after we have the results of Andrew’s next MRI on March 10th.

So it seems that something has happened. A decision has been made. You would not know why they changed out of the Burzynski Clinic unless you go to the timeline in the family’s “my story” page:

February 2008

Andrew’s parents decide to stop the treatment recommended by Dr. Burzynski after conducting research and realizing that the children they could find who had been treated at the Burzynski Clinic for pontine glioma had not survived.

The family realized what skeptics know, that what happens in Houston does not save lives. Now, there is a note in March that the tumor had shrunk something like 65% from December. However, we can’t necessarily attribute that to Burzynski’s treatment, as Andrew was excluded from the clinical trial precisely because the results would have been muddied. Thankfully, the S. family had a longer time with Andrew after diagnosis than most families, 25 months, and it’s clear he brought much joy to his family.

UPDATE, July 2014

In private communication from Andrew’s family, we were informed:

“There were red flags for us all along the way, but pulling away from the Clinic was not easy. It’s a cult-like environment. You feel like you are walking away from the group who has the answers. You are going to become one of those people who don’t understand and who don’t believe…. It was traumatic. That is why we simply stopped mentioning it on the website. We officially ended our relationship with the Clinic mid to late February 2008. We just did not know how to explain what we had just experienced.”

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.

January 5, 2014

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.

December 17, 2013

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.