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:

2012-11-26

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 chemtrailNew World Order, and fluoride truther.

On 2 October 2013, McKenzie L.’s family goes to Houston looking for a miracle:

Untitled

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:

  1. 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.
  2. Additionally, some patients admitted failed to meet the inclusion criteria for the study.
  3. 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.
  4. 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.
  5. 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.
  6. 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.
  7. “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.
  8. 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.)
  9. 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:

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:

Clipboard01

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…

Clipboard01

 

….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:

Clipboard01

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:

Clipboard01

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:

Untitled

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.

Clipboard01

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.

Screen Shot 2014-10-29 at 1.13.25 AM

To think that all of these powerful people were following McKenzie’s story and for want of critical commentary of the treatment in the media, McKenzie suffered for it.

I think Telegraph reporter David Brooks offered a fair summary of McKenzie’s ordeal in his write up after the funeral, “Alternative Methods are Not Safe Bets,” and he concluded:

It’s hard for an outsider not to feel sympathy for a desperate family struggling to save a loved one.

But we should give more weight to a medical establishment that has doubled the human lifespan, that has created a huge, complicated system of peer review, double-blind tests, treatment protocols which is far from perfect but has done more for your health and mine than has a millennium of hopes and dreams.

Brooks apparently interviewed some of McKenzie’s family in the aftermath:

The treatment over the summer accomplished nothing except making McKenzie sicker for a while, and cost McKenzie’s family and supporters many thousands of dollars, even though it was stopped quickly because of side effects, said McKenzie’s grandfather […] .

But [McKenzie’s grandfather] who says the total cost was “less than $25,000,” thinks the effort was worthwhile and might have succeeded if so many obstacles hadn’t been placed in its path […].

Most frightening is the lesson that the grandfather has apparently taken away from this. According to Brooks:

If somebody else he knew was diagnosed with DIPG, he’d recommend going to Burzynski.

The lack of regret is eerily similar to sentiments of the families of Burzynski patients going back decades. For example, in 1982, The Windsor Star reported that a family member still believed in the treatment “with all my heart” but her sister-in-law Deanne had arrived too late for the six weeks of antineoplaston treatment to be effective.

I hope that when the Texas Medical Board drags Burzynski to stand before a judge in Austin on June 15 the press remembers that treating this issue as a human interest story, such as we have seen in the case of McKenzie L., perpetuates misery and magnifies suffering.

Burzynski 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.

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.

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.

Burzynski Patient Derek T.’s Story

Derek T. first appeared in the press in June 1993. At the time, he was suffering from a brain tumor and the community was rallying around him (and 2 other kids with cancer) to raise money for the Children’s Wish Foundation. Derek was 6 years old and had been taken to Sea World by the charity. According to his mother, who appeared in the Hamilton Spectator:

Derek’s mother […] was also overwhelmed.

“I just can’t believe how much the community is pulling for us,” she said. “People really didn’t know what to do, so they did this. It has helped the family and I think the trip to Sea World helped Derek’s health.”

Derek’s journey was chronicled by the Hamilton Spectator, so we have a pretty good record of his progress. At the time of the fundraiser for the Children’s Wish Foundation, according to an article that appeared in April of 1994, his tumor was shrinking thanks to radiation treatment. He went back to school in September but, then we hear in the issue from April 18:

But, around Christmas, his flu-­like symptoms turned out to be the tumor growing again and pressing on his brain.

‘It happened very fast,’ said his aunt.

Before long, he was confined to a wheelchair. As the condition overtook him, Derek could only shake his head and move his hands to communicate.

That’s when the [family] re-­mortgaged their home and decided to ignore the advice of caregivers at McMaster University Medical Centre.

They were on their way to Houston, to the Burzynski Clinic, where they have used an unproven experimental chemotherapy for nearly 40 years under the guise of clinical with no good evidence for efficacy. The Spectator is way out of its league and has basically no idea what the treatment entails as we see in April:

In Houston, he hopes to receive a new treatment involving injections of plasma­like antineoplaston cells through the chest catheter.

No, not even close. If only the Spectator had reviewed the 1982 report by Canadian physicians Blackstein and Bergsagel commissioned by the Ministry of Health in Ontario, which had some damning revelations:

We were left with the impression that either [Dr. Burzynski] knows very little about cancer and the response of different tumors to radiation and hormonal measures, or else he thinks that we are very stupid, and he has tried to hoodwink us. As we look back over the cases were were shown, we are left with the impression that the only patients who are still alive either had slowly growing tumors, or had received effective treatment before being referred to Houston.

The 1982 Canadian report concluded:

After reviewing 20 case reports, selected by Dr. Burzynski as his best examples of clear cut responses to Antineoplastons we were unable to identify a single case in which therapeutic benefit could be attributed to Antineoplaston.

And even more from the 1982 Canadian report:

We believe that it is unethical to administer unproven agents such as Antineoplastons to patients without satisfying the requirements of the FDA and an ethics committee, that the minimum standards for human experimentation are being met. We also believe that it is immoral to charge patients for this unproven, experimental treatment.

So, in April 1994, the family, facing the progressing disease ends up in Houston. Instantly, unnecessary life-threatening complications arise just trying to get Derek on treatment:

His parents […] and his five-­year­ old sister […] flew to Texas last Thursday, when Derek was admitted to hospital for insertion of a catheter in his chest through which the new drug will be pumped. ‘They had trouble inserting the catheter because they couldn’t find a vein, then when they got him stabilized … his heart went wild and started beating 200 times a minute,’ said his aunt […] in a telephone interview yesterday. ‘He has a very low blood count and when your blood count is down you don’t heal properly,’ she added. ‘We’ve been told the next 24 hours are going to be critical.’ The child has already received one blood transfusion and may need another, she said

The doctors objected to antineoplastons for a reason. At the same time, the family is feeling the pinch:

Money, she added, is becoming a major worry for the family. ‘This hospital stay isn’t something we’d planned on,’ she said. ‘OHIP doesn’t cover any of this because it’s an experimental treatment and you pay for your Kleenex and bedpans and everything.’

This is the case at Burzynski’s clinic, though it would probably not be elsewhere. Usually, patients receive medical care in exchange for being on a clinical trials, because the developers intend to make their money when the drug goes to market. R&D is an investment in real drug trials. At the Burzynski Clinic, patients pay dearly to receive experimental treatment.

When Derek was let out of the hospital, he moved into a motel, where they hoped treatment would begin:

‘They figured on Wednesday Derek was stable enough that they could start the treatments, so what’s going to happen is that they’ll set up all the medical equipment they need in the motel so they can do the treatments there rather than having to get Derek to the clinic every day,’ said [Derek’s aunt]. ‘I think someone will be coming over every day to spend a couple of hours to get this treatment into him. ‘We’re told they may be able to come home in two to three weeks, but it could be four to six weeks before they start to see any effect from the treatments,’ she added.

The kid’s too sick to go to the Clinic.

Two days later, we hear:

They have been told the treatments could last six months, or continue indefinitely at a cost of between $3,000 and $10,000 a month. Yesterday, Derek’s aunt […] said: ‘Yesterday was a good day for him, his spirits are up and he seems to be gaining strength. ‘What they’re going to do is continue the treatments for 10 to 14 days and then see about letting him come home. His parents seem to feel better now that the treatments have started. They seem to be a little more up now.’

All the while the community is rallying around Derek to raise money for Burzynski. A few days later, Derek’s uncle returns home and talks to the press:

‘I think our little guy’s getting better,’ [Derek’s uncle] said yesterday afternoon. ‘They’re saying that if he makes it through the next month his chances will improve fantastically.’ ‘I think the next two weeks are going to tell it all,’ he added.

The child is in a pretty horrible state, almost locked in, it seems:

‘Now he’s a lot more alert and staying awake a lot longer,’ he said. ‘They’ve worked out a little sign language to communicate with Derek ­­he looks up for yes and closes his eyes for no.

And in this interview we get a sense of the power of testimonials, which are nearly worthless as evidence of a treatment’s efficacy:

In the weeks before Derek’s parents […] decided to make one last attempt to save their son’s life, they contacted several former and current patients of the clinic to ease their natural suspicion. ‘We had a lot of suspicion before we went down,’ the uncle said. ‘We were asking ourselves should we go or should we just stay here and let Derek die in peace.’ That’s when they started talking to former patients, gathering uniform reports of miracle cures.

‘I sat there on the phone in tears talking to these people and then told John and Brenda they had to make a try,’ he said. ‘Everyone we talked to had a different story, but it was all one miracle after another.’

And that’s the hook. These patients stories are deceptive, and it’s not because the patients are lying (though they are almost certainly wrong in every case). USA Today reporter Liz Szabo documented some of the problems and practices at the Burzynski Clinic that explain the apparent “miracles” without crediting Burzynski.

On May 6, we hear that money has been pouring in for Burzynski on the back of this kid’s suffering. The uncle seems to be hearing that things are going well:

According to Derek’s uncle […], the child is improving every day. ‘He’s starting to move his arms and say things like ‘Mom’ and ‘No.” ‘They’re quite enthusiastic at the clinic about the progress he’s making. ‘Everything sounds really good so far.’

That may sound like a gain, but it also sounds… really, really slight. Almost imperceptible, and you know that the family is scanning and interpreting every grunt and motion as a reflection of what is going on with the tumor. Except the next week, on the 14th, we hear:

The Winona boy, 6, who is undergoing an experimental treatment for the brain ­stem cancer that threatens his life, was taken to hospital earlier this week for treatment of fatigue and because he wasn’t eating. Derek’s uncle […] said the hospital treatment was needed because the megadoses of the serum he’s receiving frequently left him too tired to eat properly. After two days, however, he was returned to the motel room where he’s staying with his parents. ‘He had a bit of a turn for the worse, but now he’s doing fine again.’

So, by the family’s account, this was a life-threatening side effect of the treatment.

But the fundraising for Burzynski has gone well. By May 25th, some $40,000 in donations have arrived for the treatment. The family is still in Houston. I wonder if he is too sick to move:

In a telephone interview yesterday, Derek’s mother said the child remains weak from the constant flow of drugs he is receiving, but she is learning to take great pleasure in small victories.

“I got really excited yesterday because I heard him laugh a little while he was watching cartoons,” she said. “That was the first time I’d heard him laugh in two months.”

When Derek was discharged from a Hamilton hospital two months ago, his parents were told there was little hope he would survive. That’s when they decided to make a last­-ditch stand against the disease.

“When he got out of the hospital in Hamilton, they said his time was limited, but now we’ve celebrated another birthday and that’s got to say something,” [his mom] said. “If you saw him in the hospital when he could barely move his arms, you’d know just how far he’s come.”

Honestly, I’d be interested in seeing what type of anti-inflammatory steroid dose the kid is on. As reported by USA Today, according to an FDA warning letter from April of 2013:

In a written response to FDA inspections sent to the agency in April, Burzynski had argued that patients with brain tumors often need anti-inflammatory drugs, called corticosteroids, to restore normal levels in the body. The FDA did not accept this explanation, however, noting that Burzynski had patients on steroid doses that were five to 64 times higher than the levels that doctors would expect patients to need. [emphasis added]

This does throw into question, as the FDA noted, the reliability of Burzynski’s results. And in reality, things are not going well, as we hear on the 28th of May:

A thousand miles from home, in a tiny motel room on the outskirts of Houston, Tex., [Derek’s parents] pray for a miracle.

On the bed in front of them lies their seven-year-old son Derek, his mouth hanging open, his pale body limp. A tumor the size of a golf ball is pressing on the stem of his brain, paralyzing most of his body and causing pain no child should suffer.

[…]

The youngster can’t move his limbs, he can’t talk, and it’s a struggle to even open his eyes. But he is alive.

[…]

“As a parent, you can’t just sit there and watch your son die,” [Derek’s mom] says. “You do everything in your power to save his life. You try anything and see anyone who might be able to help because that’s all you can do. You are so desperate.”

Yes. And that’s why the FDA and the TMB need to step up and stop playing ball with predatory alt med peddlers. In the same article, we see the family is having doubts:

At the moment, the [family is] not convinced Dr. Burzynski is Derek’s miracle maker.

[…]

It’s costing the [family] as much as $1,000 a day for doctors’ visits, equipment, emergency trips to the hospital, and to keep up the steady flow of Dr. Burzynski’s concoction for their son.

[…]

“Sometimes I wonder if maybe we should just hop on a plane and go home,” [Derek’s father] says. “But then the next day we’ll see an improvement and think, this is his only chance.”

And at this point, improvement is indistinguishable from just not getting worse. In some ways, this case is reminiscent of the course of Chase S.’s story. Chase was essentially lying in state for months in his parents’ living room, while the family insisted that he was improving.

The family has been in Houston much longer than the usual 3 weeks, and they are thinking about trying to get Derek home in early June, as we hear on the 4th:

While there’s no evidence yet to show the treatment is working with Derek, [his dad] said they are eager to come home. “We’ve been here quite a while now and we are comfortable administering the medication so we could do all that at home,” he said in an interview yesterday.

There were plans to do an MRI scan on Derek to determine if the brain tumor is shrinking but he’s been too weak the last 10 days to undergo the procedure.

He’s been battling fluid in the lungs and cold­-like symptoms; yesterday was his first day back on solid foods in a week.

The father says that Derek is better than when he came down, but how can that be? They plan to return to Canada with a 2-month supply of antineoplastons.

Once the family returns, the paper seems to give us a more frank assessment of Derek’s lack of progress:

“His eyes are much more alert and although he can’t talk, he’s able to communicate with us,” [Derek’s mom] said.

They don’t know for sure if the experimental treatment he received at the clinic ­­- called antineoplastons ­­- has shrunk the boy’s tumor; he has been too weak to undergo the scan that would determine its size.

But they believe the medication has at least stopped the tumor’s growth, based more on what they saw at the clinic than improvements in his physical condition.

“We really truly believe in that clinic,” Derek’s mother said. “We saw so many miracles down there, people coming in real bad shape and walking out of there. We are believers.”

She said seeing those people get better helped keep the two of them going during times when Derek was not doing so well.

“It made us strong and gave us hope,” she said.

“We have no regrets about going down. We’re glad we went and we hope everything works out,” [Derek’s dad] added.

If there is one regret, it’s that they didn’t discover the clinic earlier, when the tumor was smaller, [Derek’s mom] said.

The statement that they “saw so many miracles down there” is curious. It’s too bad they weren’t more explicit about the nature of those “miracles.” They even turn blame back on themselves for why they aren’t seeing improvement, that they did not get their sooner. It probably would have made no difference to anyone but Burzynski’s accounting staff if they had.

Another thing, there’s no evidence that Derek has received palliative care, which is surely indicated. And on June 21st the Spectator headline says it all:

“All we can do is hope, pray,’ says mom: No sign experimental drug is working for Derek”

On September 15th, Derek died. During the intervening time since the last update in the paper, Derek had been in the hospital a lot:

[His mom] explained Derek has been in and out of hospitals in Grimsby and Hamilton for the last five weeks suffering a variety of ailments that included a bleeding ulcer, pneumonia and urinary infections.

And in the end, the family rationalizes why the treatment did not help, as we see in the paper:

Derek’s father […] said they’d been told their son would need to get the anti­neoplaston treatment, delivered through a catheter inserted in his chest, for a solid six weeks in order to show any benefit.

Because of his recurring health problems, however, the longest stretch they managed was five weeks. “We got the treatment into him, but it was never as much as he needed,” [Derek’s dad] said.

This is the first time that we have heard this “six solid weeks” nonsense. As we know from any number of patient reports, nurses have claimed that it begins working immediately. It’s hard to say why in this case the family would be told this (if that is in fact accurate that they were), but it does give the Clinic an easy out when the boy arrived too sick to even make it to treatment.

Burzynski Patient Rebecca L.’s Story

In January of 2000, according to the New Hampshire Union Leader (24 Apr 2000), 9-year old Rebecca L. became unsteady (she was not skiing well during a family trip, and couldn’t get off the bunny slopes) and she started vomiting.

The Boston Sunday Globe (14 May 2000) tells the story:

For the next few days, Rebecca didn’t feel like going to school. Then, when she did go, her parents received a phone call they will never forget. “Her teacher, who know the signs of brain tumors because she lost both her parents to brain tumors, called us,” [Rebecca’s dad] said. “She was crying when she called us. She said, ‘You’ve got to get her checked out today.'”

When they got to the doctor, according to the Union Leader:

The next day, the doctor told them: “We’re going to be looking for a brain tumor.” The [Ls] were stunned.

Becky was taken directly to the Elliot Hospital and following a CAT scan was transferred to Dartmouth by ambulance, where she underwent an MRI. [Rebecca’s dad] said doctors initially thought she was suffering from a benign tumor on the brain stem and scheduled surgery.

It was not benign. It was a malignant glioblastoma multiforme, and without treatment, Rebecca might have 2 months. She underwent 6 weeks of radiation. And that was about all that could be done. After hearing of two of the patients in area who claimed success on Burzynski’s treatment, they determined to go see him:

The family’s insurance policy with Anthem Blue Cross won’t cover the Burzynski treatment because it’s part of a Food and Drug Administration trial. Their old insurance policy with Tufts would have covered it, [Rebecca’s dad] said.

But he said Blue Cross did more than just refuse to pay for the Texas clinic treatment. “They cut us off from all the support,” he said, and won’t pay for MRIs, blood work or anything else.

While the costly Burzynski treatment offers only a 44 percent chance of success, “I have to try it. If you give up hope, you have nothing,” said [Rebecca’s dad].

The drugs that were supposed to be in trials were Burzynski’s patent medicine, antineoplastons. There is no compelling evidence that the substances originally derived from blood and urine have an effect on cancers. The Boston Globe (14 May 2000) also reported on this:

“The treatment in Boston offers no cure, but down there [in Texas] 44 percent of his patients have a response,” [Rebecca’s dad] said. “It affects their tumor in some way. And, half of that 44 percent are in remission. That’s not bad, going from zero percent chance of living here to 20% down there. When you are talking about your child, I would do it for a 1 percent chance.”

The 20 percent cure rate the father believes is absolute, unmitigated, unsubstantiated bunk. There has never been a trial that established efficacy; there have been zero convincing publications. That number is apparently conjured from the ether. It’s even sadder to realize that when the FDA went in and examined his trial results, they found the recorded outcome did not match the actual response 66% of the time, and apparently it was always inflated. Rebecca’s dad unwittingly lays out exactly why Burzynski has been so successful attracting desperate parents into his office. He oozes hope to the hopeless. How anyone could give that number to this family when they are the most vulnerable is unfathomably cruel.

The cost was sufficient that Rebecca’s father, like those of so many other desperate dying children, went to the media to raise money.  Both the Globe and Union Leader ran the address of the fund that had been established for Burzynski. The Globe quoted Rebecca’s father:

“There are a lot of expenses and I don’t know how we’re going to do this, but we love our daughter and we’re going to do it.”

And they did it. They raised over $100,000 for Burzynski. The stunning generosity of communities is Burzynski’s cash cow, and he milks it over and over. In March of 2001, the Union Leader filled in some of the gaps about the fundraising:

Their insurer would pay none of the bills, so the family let Becky’s plight be known. Fundraisers included a Christian music concert at Veterans Park, a golf tournament at Tory Pines and a NASCAR fundraiser at the Pinardville Athletic Club.

A phenomenal effort. We don’t get a play-by-play about what happened with Rebecca’s treatment. We get a summary from her father:

For a while they worked, said her father […]. “The money, if people donated, it was so worth it. We had a whole year with her. Every day was treasured,” he said […]. She took a turn for the worse in November, and doctors said nothing else was possible.

Yet another family reporting that the treatment was working before it wasn’t. There are endless cases of this on the website. We don’t see what “working” means here. Not growing? Shrinking? Unknown.

It’s difficult to explain why the father credits the treatment with the year, as it is exactly what the doctors at Dana-Farber said the radiation might give her before the family even went to Burzynski, as reported in the Globe on May 14, 2000:

Clipboard01

Sadly, the intervening year can’t reasonably be credited to Burzynski, no matter what the family believes, though it is wonderful that they did have a year together before the end.

On February 22, 2001, teenaged singer Aaron Carter performed in the area, and a local radio station managed to get tickets and a back stage pass for Rebecca. The encounter was described the next day in the Union Leader:

Before the show, he met with 10-­year ­old Becky [L], a wheelchair-bound Manchester girl with inoperable brain cancer. Her meeting with him was quiet ­­ she was really too shocked to speak.

“I like your nails,” he said to her. She grinned . She’d had them done for the show.

Then he wrote “Becky” on his palm and said, “I might even mention your name on stage.”

And when it was time for the thin, towheaded superstar to go, he told her, “You better enjoy the show.”

“I will,” she said back. He “adiosed” and ran toward his backstage area.

Becky’s mother […] said her daughter acted like any other teenage girl this morning.

“She couldn’t wait to start getting ready,” she said. “She knows every word on his CD these days.”

The following Tuesday night, her breathing became erratic.

The nurse gave her sedatives, then pain relievers. Before Becky closed her eyes, she and her father exchanged their last words.

“I asked her if she was still in pain. She shook her head she was,” he said.

[He] stayed up until 5 a.m., and went to bed after the hospice nurse said it could last for days. His wife […] checked on Becky at 6 a.m.

She died before 7.

Rebecca L. died at home on Feb 28, 2001.

Burzynski Patient Janet C.’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.

Janet C. was diagnosed with neuroblastoma at age five. According to her father, who testified for Burzynski in front of Congress in 1998, two years after her diagnosis:

Over a period of 17 months beginning on February 28, 1996 she has suffered through 10 months of very aggressive chemotherapy, 6 days of ablation chemotherapy, 3 days of total body radiation therapy. Twice each day. And then a very gruesome bone marrow transplant resulting in the doctors telling us on February 17 and 18, 1997 that our daughter had only hours to live […].

She was discharged, in remission only to incur 3 life threatening secondary infections. She has been in relatively good health since August 1997. That may sound like good news, but this disease has 93% rate of recurrence which results in death. Most medical journals do not give survival rates after 2 years. They know what happens.

At this point, we need to understand that Janet has been put in remission by grueling yet effective conventional chemotherapy. She had been given more time, but that is, understandably, not enough for a parent who will see anything but a child living a full life to be a failure. It is at this point, when she is remission, that the family starts looking at Burzynski’s treatment. At this point, in order to receive antineoplastons, Burzynski’s unproven treatment, originally isolated from human urine and blood, Janet will need to be on a clinical trial.

It sounds like Janet’s dad had an awful time getting a timely response or even acknowledgement from the FDA that his daughter’s case was being considered for a clinical trial. This is not to the agency’s credit and is a part of the Congressional record. Once everything is filed, of course, as is usually the case, the reply was back very quickly, according to Janet’s father:

The protocol package was sent to the FDA via fax. It was returned to the Doctor’s office, disapproved in less than five hours. The Doctor’s office called and said the FDA had disapproved the protocol and would not allow the Doctor to treat Janet prophylactically. I was shocked by this response from the FDA.

The important thing here is that Janet’s dad wanted to treat the disease prophylactically. This poses some methodological problems for a clinical trial. Let’s say that Janet doesn’t progress. Does that mean that the antineoplaston worked? Or does it mean that she was one of the 7% who happened to not relapse? Well, you can’t in principle know. But the situation here is even less secure, and it’s understandable to see why the FDA would slap the proposal to pump ANP into Janet down so quickly. It’s not even meant to be used as a prophylactic treatment, but only for present disease. This radical departure from normal protocol more than justifies rejection of this particular proposal (not that Burzynski has ever been particularly scrupulous about adhering to protocols):

The father despaired:

The morning after I called Mr. Zimmerman at this home I received a call from Mr. David Banks, also from the FDA. I cried and begged both of these men to at least give my daughter a fighting chance at life. My pleas fell on deaf ears. Mr. Banks sent me a write-up apparently from the Journal of the American Medical Association by a Dr. Green. It was dated 1992 I recall. It was a smear of the treatment I was seeking and the Doctor who invented it.

I called Mr. Banks back He told me to cal a Dr. Blaney at the Texas Children’s Cancer Center. I was referred to a Dr. Stacey Berg. WE discussed janet’s cancer. Dr. Berg stated that a patient in remission was not eligible to participate in the clinical trial for obvious reasons — nothing to measure.

And there you have it. An eminently reasonable explanation. Further, they explained what one of the most important medical journals had to say about Burzynski. Though to the desperate, that gets waved away as a “smear.” The father goes on to say that this Dr. Berg said that Janet had nothing to lose by going on the ANP. If true, it’s a bad thing to say to a patient’s father. What happens if Janet is in the 7% who do not relapse and she has a toxic event like Josia C’s? Prophylactic treatment might possibly kill her for nothing (presumably safe and effective doses for prophylactic treatment hadn’t been figured out anyway). Or what if she is in the 7% and has one of the numerous toxic events the FDA observed to have been ignored or unreported in Burzynski’s studies in 2013? Quality of life or life itself could easily be lost. With no reason to expect that antineoplaston would have any prophylactic effect, why submit a child (a protected class of patient) to unknown dangers?

Not only did the family appear before the House committee to testify for Burzynski, but the father went on TV with John Stossel to make his case to the public.

STOSSEL: Consider Janet [C]. While she looks healthy, Janet has a form of cancer that’s likely to kill her before she becomes an adult. Her parents want to take her to this Texas clinic, run by Dr Stanislaw Burzynski. He has a treatment that might help her. It’s now being studied by the Food and Drug Administration. But only the FDA gets to decide who can be treated, and the agency turned Janet down. They say it’s not safe if people pursue medical treatments the government hasn’t sanctioned. […]

LYLE [C]: My daughter has a terrible disease called neuroblastoma cancer. I know what the survival rates are, which is essentially zero, and I’m trying to do something that may save my daughter’s life. We have absolutely nothing to lose and everything to gain.

We know, of course, that these last statements are not, strictly speaking, true. Further, there is no mention of the fact that the father wanted to give the drugs in a way that they are not being studied to be given or any sense of real risks that actually exist, which a desperate father would be willing to overlook. By April 15th, 1999, when the interview with Janet’s dad aired, we know that the FDA had caved to the pressure of the Congress. Again. Janet got the antineoplastons.

According to the page that used to be up at the Burzynski Patient Group, but has disgracefully been removed:

Janet is now 8 years old, and she continues to be in remission. After only 6 months of antineoplaston therapy, it is still not certain if she has beaten the odds against cancer. It is known, however, that she and her family have won the fight to decide for themselves how they can best save their child’s life.

[Lyle C.] says, “This was and still is the greatest struggle of our lives. I spent 42 years of my life defending this country, 26 years as a soldier and 16 years as a civilian employee. I find it ironic that I served the same government that attempted to deny my daughter a treatment that may very well save her life.”

It apparently did not save her life. Janet died on October 21, 2001 at age 11.

For other patients who testified for Burzynski over his lamentably long career, see the cases of Elke B. and Douglas W.

Burzynski Patient Douglas 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 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.

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.

testimony-1-censored

[…]

testimony-2-censored

[…]

testimony-3-censored

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.

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:

ElkeB

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.

Burzynski Patient Sophie M.’s Story

Sophie M. was 5-years old. Her parents took her to the doctor when her eye started blinking uncontrollably. Then she became unsteady and harder to understand. On August 23, following an MRI, the doctors at the Children’s Hospital of Orange County told her family that she had an inoperable brain stem tumor and said that she had months to live. (Sophie’s story was captured in the Orange County Register on 21 September 2000.)

Almost immediately, [the M. family] and members of the community began racing against time to raise money for a costly experimental treatment.

Before the [M family] left for Houston, where Dr. Stanislaw Burzynski administers the almost $15,000­ per ­month gene therapy he says has saved hundreds of lives, 28 aunts and uncles gathered at the home of [Sophie’s father’s] brother­-in-­law to brainstorm fundraisers.

This was not Sophie’s large family’s first encounter with Burzynski. As reported in the 21 September 2000 Orange County Register:

“[Sophie’s father] says he is angry that insurance won’t pay for what he regards as his daughter’s last, best hope. After all, cousin Roman [M.] of Garden Grove, who first told [Sophie’s dad] about Burzynski, said the treatment reduced his 2-year-old daughter’s brain tumor by 85 percent.”

The daughter, Tori M., frequently asserts that she was cured of a brain stem glioma as an infant. Her family is among the most vocal of Burzynski’s supporters, however, there is reason to doubt her family’s conclusions.

If Burzynski says he has saved hundreds of lives, they do not appear on the Burzynski Patient Group, which has fewer patients on it than this website and has had 33 more years to gather names. His therapy is as much gene therapy as is drinking an Orange Whip.

As is so often the case, the entire family mobilized to pay the Burzynski bill, and this apparently large family had wide and deep connections in the community, as the list of contributors who immediately jumped on board to raise money for Burzynski’s worthless treatment illustrates: the family’s parish, the Chamber of Commerce, the local Family Support Center, and so on. The director of the FSC hit the nail on the head when she discussed what was going on:

Center Director Ann Nguyen said she understood the difficult choice the family faced when they decided to pursue an expensive, unproven treatment they could not yet afford. “It’s hard to be in the center of this and say what is right and what is wrong,” she said.

Agreed. One of the tragedies of the whole sordid career of Stanislaw Burzynski is that in times of desperation, it becomes more difficult to discern what is the appropriate course of action. However, with time and distance, as is clearly evidenced on this site in spades, patterns emerge that call for harsh judgement on the whole Burzynski enterprise.

By the time the story hits the local paper, the family is already in Houston for the 3-week training course that all ANP patients undergo:

Still, the family faces an enormous financial hurdle. For this first round of treatment, they owe Burzynski $12,000.

It is, of course, not covered by insurance. Nonetheless, the coverage in the local paper yielded a flood of money from the community, as reported a week later:

The parents of Sophie [M.] say response has been overwhelming to a Register story last week on their attempt to pay for an experimental treatment for their daughter’s brain­stem tumor. Checks totaling $15,000 have been sent from all parts of Orange County.

Quack cancer cures don’t just victimize families, but entire communities. They also keep patients out of legitimate clinical trials, unnecessarily and unthinkably delaying the development of effective treatments.

In November there is more fundraising by the Chamber of Commerce. On March 1 we get an update in the Orange Country Register. The same author reports on a day at a local elementary school where they children are planting a tree for Sophie.

On Saturday students, teachers, parents, city officials and family members gathered to plant a star pine tree in honor of Sophie [M], a Stanton 5-­year ­old currently undergoing experimental treatment for an inoperable brain tumor.

Though she has already outlived physicians’ expectations, Sophie is still very sick, and wasn’t able to watch as the tall tree with fluffy needles was lowered into the ground by four volunteers from Shade Tree Plantings, an Irvine­ based foundation that plants trees for charity.

[…]

Students at Carver said they learned about Sophie in their classes, and knew the significance of Saturday’s planting.

“We’re doing this so the family has money,” said fourth grader Shyla [W], gesturing toward the bake sale she was helping run.

The statement that Sophie has “outlived physicians’ expectations” is inaccurate and gives Burzynski’s treatment more credit than it deserves. In the first article, the reporter said that:

At best, she had 10 months to live.

Two weeks later, when Sophie’s death is announced and the enduring impact of Sophie’s struggle was documented, we are told:

Before she passed away Wednesday after a seven-month battle with an inoperable brain tumor, she united the city of Stanton by spurring an outpouring of support and hope. (emphasis added)

Sadly, this type of upbeat inflation of cancer patients’ prognosis and progress is typical in the media. And it’s hard to announce or even accept that someone is dying. See the spectacularly inaccurate case of Amelia S., for instance, where what appeared in the press and what was actually happening differed greatly.

Poor Sophie M. passed away on 14 March 2001, well within the time of her initial prognosis.

As of this writing, Burzynski and a number of his staff members are up in front of the Texas Medical Board on a fairly impressive array of charges. Let’s hope that the TMB can end this ongoing, endless abomination.

Burzynski Patient James W.’s Story

Dec. 18 2003, was 5-year old James W. of Lake Arrowhead, CA’s third day of headaches and vomiting. His story was captured by the Mountain News & Crestline Courier-News. His parents took James to the doctor, but he sent them to the hospital for a CAT scan. By the end of the month, he would have two surgeries for a Grade 2 astrocytoma. It’s a bad diagnosis.

James underwent normal therapy, chemo and surgery, for this tumor. By September 2004, the family had run out of options. They decided to head to Stanislaw Burzynski’s clinic in Houston. Their decisions and treatment were recorded in great detail in an online journal. On Sept 27, James’s mom writes:

okay, big news: we are leaving for houston, texas early tomorrow morning. we will be going to the Burzynski Treatment Center for cancer. he’s controversial, not all in the medical community like him, but we’ve heard very good reports from patients.

This is not entirely accurate. I have yet to encounter a physician who would knowingly send a patient to that clinic. It is telling that Burzynski’s patients are mentioned here, as they have often been the principle recruiters for Burzynski. They fanatically support him. This is to be feared.

James and his family flies down to Texas on seats that were purchased by a friend. On the 28th, they are there. A family member updates the blog:

[James’s mom] just called to say that they went into the clinic to drop off James’s medical records.
She described the scene like this:

“As you walk into a large reception area you see several secretaries at a desk. Above them is a large crucifix, and behind that is a large picture of (Dr.Burzynski)the doctor who founded the clinic with the Pope!”

There is also a picture in the reception area of the Pope at his recent visit to Lourdes. You may remember that the Pope was given James’s name to pray for at Lourdes.

As you know, [James’s parents] are devout Catholics. This “Catholic connection” uplifted her spirit.

Burzynski’s connection to the Pope is tenuous at best, but he milks it for all it’s worth. Earlier this year, when John Paul was beatified, Burzynski ended up on local news talking about, well, himself:

Puke

The piece, which seems to have been written by someone completely credulous (I would not be the least bit surprised if it was fed to the station by Burzynski’s own people), suggests that maybe, just maybe, he went to treat the Pope. This is, of course, a load of horse feathers. A photo proves nothing. Heck, my mom has a picture with John Paul II. She also cured him of imaginary cancer.

On Sept 29, we hear:

Today [Jim’s parents] met with two doctors from the Burzynski Treatment Center in Huston, TX.

After a full explanation of the treatment and a complete physical of James, they have decided to go ahead with it. No miracle cure is promised, and as she posted before, this is non-standard treatment. [James’s Dad] is looking into their Blue Cross Insurance to see if any part of this treatment is covered.

James will be treated with antineoplastons, a treatment only available at the Burzynski Treatment Center.

The routine is similar to chemo, James is infused and then progress is measured with scans.

[James’s family] plans to be in Huston for three weeks.

Of course it won’t be covered. It almost never is.

We see that the family is doing what so many other patients do, learning to administer the treatments themselves when they return to California:

James has a portable pump and [his mom] is being trained to administer all medications. Specifically flushing the porta-cath and handling IV equipment. She has emergency contact numbers and is becoming even more knowledgeable about medical treatment.

After three weeks she will be fully trained to take care of all medical needs. She takes James to the clinic every day and tests are done to monitor his condition.

On the 4th, more detail is given:

James feels really good. This is NOT chemotherapy. He is NOT in the hospital. We take him to the Burzynski Research Institute each day. We are there for about 3-4 hours getting trained on how to give James his treatments. He started this treatment on Thurs, Sept 30. A pump is constantly hooked up to his porta-cath and he receives the treatments every 4 hours. Each treatment lasts about a half hour. The treatment he gets is called antineoplastons. Really there are 2 different meds involved- one is to stop the part of the tumor that makes it grow, and the other is to kill the tumor. The side effects of these meds are minimal (especially compared to chemo!!). It creates an electrolyte imbalance, in that the sodium goes up and the potassium goes down. So, we have to have him on a very low sodium diet, and a high potassium diet (James is loving bananas!!) Also, to keep his sodium in check he has to drink ALOT of water. (I don’t have to mention that Burzynski’s patients have to pee ALOT!) Yesterday we got him to drink over 2 liters, and it made his sodium level go down today- so it worked like we wanted! If his sodium is even 1 point higher than 147 (the top end of “normal”), the FDA says that the patient cannot receive the treatment until it comes down. We REALLY don’t want him to have to miss treatments, so are on “sodium alert.”

To be clear, antineoplastons are chemotherapy by any measure. The list of side effects is gargantuan:

consent1consent2consent3

Hypernatremia, elevated sodium, is the most frequently reported side effect on this website, I think. And the prodigious amount of fluid that patients end up drinking because of the insatiable thirst decreases their quality of life. They are up running to the bathroom constantly and sleep deprived. Sometimes the sodium levels can get out of control. For instance, take the case of Luna P., who was rushed to the hospital with a sodium level of 178. This is how her doctor reacted to that news:

A9kdZhJCAAA3PJO

Make no mistake. Antineoplastons are dangerous on a good day. Further, leaving the patients to fend for themselves may have contributed to the over 100 overdoses that the FDA reported had taken place (only in the files they happened to review, mind you) with no evidence that any corrective action was taken on the part of Burzynski. These lapses are not in dispute. Josia C. died with a sodium level that is basically unseen outside of Burzynski’s trials. Nobody told Josia’s parents that, though.

On Oct 7, we hear that James is having very bad headaches, for which he is giving decadron, a steroid, to reduce swelling:

These doses are given i.v. by [James’s mom]. Part of the training that she is getting at the clinic includes giving this “emergency dose” when/if James gets headaches, so we are assuming that this is just part of what happens under this treatment. Who knows, maybe the pain is from tumor breakdown??!! The doc did say that if they continue, they could decide to send him to the hospital, which has special rooms set up just for Burzynski’s patients.

[His mom] will talk with the doctor tomorrow about the headaches. For tonight, the doctor said to hold the antineoplastons until tomorrow when they can look into the headaches.

What’s disturbing here is the suggestion that the pain is from “tumor breakdown.” This is a trope that is as loud as any in the stories of Burzynski patients and, by god, someone ought to investigate it.  Here’s how it is put the next day, right before James’s pulse drops and he goes to Texas Children’s:

We figure that with everything that is going on, especially the headaches, something is going on in his head. Who knows, it could be tumor breakdown, which is accompanied by swelling, which causes headaches, which requires steroids to reduce swelling- so much for my extensive medical training!

This is something that many patients have reported. Take Rory Z’s parents, who reported:

I am now an old pro at giving the Decadron…it’s amazing how things can change in 24 hours. I gave Rory his dose this evening…he started to eat dinner and w/in about 30 minutes he threw up again. Darn. Perhaps we have to wait longer until he eats? I talked to [Nurse] Marlene tonight before the Group Meeting…and she said vomiting isn’t that uncommon at first…they may increase the Decadron tomorrow. She explained that as the Antineoplastons turn off the cancer cells..they die…and the white blood cells rush to the area to clear out the dead cells. This causes swelling…which can cause the vomiting  She said, unpleasant as it can be..it’s actually a good thing.

Or you could look at Levi G’s story, another child with a brain tumor, whose parents reported:

The next day we talked to the doctors at the clinic in Houston and found some answers. According to them the tumor was breaking down. When it breaks down it causes swelling which causes pressure. We had to up the decadron (steroids) a little to keep the swelling down so that he could tolerate a higher dose of the treatment. They told us before this that he would get worse before he got better. But at this rate I wonder if he’ll ever get to the “better” part.

And this “getting worse is getting better” narrative is EVERYWHERE in the Burzynski patient stories. It’s a nightmare that we have found it as often as we have.

As James’s grandparent is writing this post, we hear:

[James’s Mom] just called me to say that the nurse said to call 911 and have them take him to Texas Children’s Hospital because he still has the headaches, his pulse is pretty low (about 60, it is usually 90-100) and he’s pretty sleepy (eventhough it is nighttime). Mare said that it may be a blockage of the shunt, thereby creating head pressure. We have seen in the past that when he gets head pressure, his pulse goes down, he gets sleepy and he has headaches. Anyway, I’m sure they do a c.t. scan.

The next day we hear how the visit to the ER went:

They went to the hospital, got a c.t. scan (which showed no enlargement of the ventricles, i.e. the shunts are working fine), got a dose of mannatol (which is supposed to reduce swelling- mare said she didn’t think it did much), and got an increased dose of decadron (steroid). The decadron seemed to help, in fact Mare said that now he is sitting up, drawing pictures, writing his name, talking, and drinking. Mare was in contact with Burzynski’s doctors the whole time, and she told the Texas Children’s Hospital doctors the whole story. They said, “wow, you guys have been through a lot.”

That’s not all that Texas Children’s Hospital doctors have to say about Burzynski’s patients. According to Jeanine Graf, director of the pediatric intensive care unit at Texas Children’s said, “I’ve never seen one survive long-term.” According to an interview with Dr, Graf that appeared last year in USA Today:

After caring for some of the Burzynski patients, Graf said she wouldn’t recommend his clinic to anyone. Although Burzynski’s patients can’t always be cured, she says, they do have choices.

“The most valuable commodity that a person with a terminal illness has is time,” Graf says. “You want to make sure that when you’re investing time in any therapy, that you are going to get a return on your very valuable last investment.”

Even Burzynski’s supporters, like Luna P’s mother, reported that Texas Children’s Hospital staff were always “cleaning up Burzynski’s messes.” As reported to the BBC investigative show, Panorama (reviewed by Orac at Respectful Insolence):

Luna was brought to the Texas Children’s Hospital during her time in Houston, and the staff there recognized right away that she was a Burzynski patient because they had seen so many similar patients suffering the same complications before. It was also clear how much contempt the staff there had for the Burzynski Clinic. If there’s one thing Panorama did right in this report, it’s showing how seeing so many already dying children show up in our ICU because of hypernatremia due to antineoplaston therapy will do that. Perhaps the most devastating part of this segment was seeing Dr. Graf stating, point blank, that she’s never seen a Burzynski patient survive. [emphasis added]

The next day, James is admitted formally into the ICU at Children’s, according to his mom:

James was admitted and is in ICU. The doc from Burzunski’s clinic said we are at a very critical stage. the tumor has swelled up and is bleeding. he had an mri yesterday which showed that it doesn’t seem to be bleeding anymore than it was the night before with the cat scan. we are very touch and go right now. every hour is critical. james may pull through this if his body can stop the bleeding itself, or he may not. he is on the highest dose of decadron that adults get. he does not have any more headaches except occasionally and they go away. we now understand how necrosis can cause problems just like the tumor.

I wonder about the necrosis statement. In fact on the 15th, James’s mom describes this whole episode leading to James’s admission into the hospital as an “intratumoral bleed.” His mom reports that the doctor (whose affiliation is not mentioned, so we don’t know if it is one of Burzynski’s people or someone from TCH) said:

the doc said that the bleed could have possibly helped if it was destroyed then part of the tumor could be dying since it no longer has that blood supply. i’m hoping the low grade fever is a sign of white blood cells cleaning up dead tumor

So a bleed inside the tumor with possible necrosis. We have seen innumerable patients who talk about necrosis in the center of tumors as if they were a positive development instead of the more likely scenario, that the tumor has outgrown its blood supply.

On the 15th, James is still touch and go, it seems. His breathing is labored (possibly because of the steroids) and he seems to not be able to get much rest because if it. On the 22nd, James’s grandpa writes that the boy is too sick to travel home from Houston, as was planned. And on the 23rd:

James was admitted earlier today to a nearby hospital and later transferred to Texas Children’s Hospital. His symptoms are headache, vomiting, non-responsiveness, and incoherence. He had at least one seizure.

[James’s mom] called and said that the doctors do not think his present condition is related to the tumor but rather to a low sodium level. They are adjusting his medication to try to keep his sodium level where it should be. You may recall that the medicine from the clinic causes highsodium levels cured only with large intakes of water.

Over the next two days doctors bring James’s sodium up in the ICU.

On Oct 31, after a clot in the chest port and low white cell count, the family returns to California. On Nov 3, however, it’s off to the hospital in an ambulance again, as James’s sodium is off and he’s having symptoms similar to the ones in Houston. The staff at the hospital, Loma Linda, is very accommodating and takes over the administration of the antineoplastons. They are hoping this move will “minimize trips to the hospital.” Further they put in a g-tube:

that will allow fluids directly into his GI tract will be done. It may be tomorrow. That’s what all the testing was about. If they can successfully do this, it will allow large amounts of fluids directly into his digestive system to counter high sodium levels, a side effect of the antineoplastons (from Huston clinic).

As his grandfather puts it on the 8th:

The medicine he takes to defeat the tumor (6 doses a day) contains 12 GRAMS of sodium as well as other chemicals. The only cure for high sodium is ingesting extremely large quantities of water. It is difficult to get a six year old to force himself to drink so much water.

The costs are mounting and the family opens a fund for James on the 17th. On the 19th they are at home again, and we quote James’s mom at some length:

we are trying to get settled in, setting up all our pumps and equipment. the home health nurse who came to help last night said that we are basically running an ICU unit. she said it’s the same level of care and responsibility and we believe it! we practically have a whole pharmacy on our dining room table.

last night was ok until 2 am when james’ steroids kicked in and he stayed up until morning asking for food. so,

we opened up the kitchen and got to work!

so much has happened since texas, i’ll never have time to tell it all. on the outside, james seems worse than before. all the hard work he did over the past year, re-learning to walk and use his right arm, disappeared overnight when he had the intratumoral bleed. he is now weaker than ever on the right side. his left side is also weak simply from being in a hospital bed so much. his left eye is also weak, but seems to be getting stronger. however, we’ve noticed subtle improvements in his personality, interest in the outside world, and vocabulary. these improvements come and go. with this kind of treatment, you have to “get worse” before you get better.

It’s hard to write this and not seem like you are attacking the family, but it is crucial to illustrate how someone can rationalize staying on a treatment that is not working. First, you see basically contradictory assertions: James’s condition is deteriorating and he is getting better, but even those less objective improvements are flickering. The merciless trap that so many patients of the Burzynski Clinic fall into is summarized in the last line: You have to get worse before you get better.

James is getting worse. He does not get better.

His sodium is up again on the 20th and he’s off treatment. Then he crashes hard after going for a walk with his family. His heart rate is down. They think this might be because his sodium is too low and so they feed him. After getting 2 feet of snow on the morning of Nov 22nd, the fire department comes to the house twice to collect James’s daily blood sample and then to take him to the hospital when his platelets are at 36,000, what the family calls “a major medical emergency” (usually they would transfuse a patient at 70,000). He is at risk of bleeding out. At this time James’s father reveals how much this decline is costing in an appeal for help, as the insurance company (of course) is not going to pay for Burzynski’s treatment:

Now, I am humbly asking for donations to help us pay for this treatment. Each month, it costs $7,600 for James to be in the clinical study at the Burzynski Clinic. If the cancer is responding to the medication, James could be on the treatment for up to a year and a half- or even longer! We pray that this will be the case (of course, we continue to pray for the instant, miraculous healing of James as well!). We will find out if the tumor is responding by the MRI’s that he will get every 2 months. So, this is very costly, and we need to once again ask all of you, our wonderful support network, to help us.

The family moves in to Ronald McDonald House facilities because:

the docs at loma linda really want us to stay nearby. we agree.

By this point, James has already had about a dozen transfusions. On the 28th his sodium tanks. His father writes:

Loma Linda Hospital has been EXTREMELY cooperative in letting us do these trial meds with their help. It is cool because I can see that they are really interested and they want to know all the details of James’ history and of what this treatment is all about. Hopefully in the future, many more kids will be able to benefit from the medication from the Burzynski Clinic.

We have not seen James benefit from them. He has been living in a hospital a huge percentage of the time since he went to Houston. And the family asks for money again the next day. They are able to bring him to Ronald McDonald House with them. He seems to not be producing platelets, white cells or red cells.

On the 9th of December, the long awaited MRI takes place, though the fluid on James’s lungs makes them decide to not sedate him for the 2.5 hour procedure, and he gets through like a champ. Says his mom:

the doc from burzynski’s clinic said that we are going to hold off on the antineoplastons for a “few days” to see if his blood counts start to go back up. it’s not supposed to suppress bone marrow, but with james nothing ever seems to happen the way it’s “supposed to.”

tomorrow he will go back over to the hospital for 2 transfusions: packed red cells and platelets.

we are glad this day is over, i was worried about him being sedated with that cough. i’m trying not to obsess about the scan, but it’s very difficult.

On the tenth, no word on the scan:

we still don’t know too much about the scan results…the main problem is that they wanted to compare it to the one we had during the tumor bleed in texas, but nobody could find that scan!

Hm. A CD of the scan has been sent to Houston. In the meantime, they are trying to determine if James has pneumonia. The steroids he’s been on have suppressed his immune system and he might not be showing the typical symptoms, like fever.

Finally on the 14th, the results from Loma Linda:

“Except for a .5 cm (1/4 inch)growth into the hypothalamus, the tumor has not changed since the Texas/bleed MRI. The bleed is smaller and there is less edema(swelling.)” !!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!

This is what Dr. Fae relayed to me over the phone today. We are very happy because from August 9th to Sept 21st, while on chemo, it grew over 100%.Basically, it seems as though the antineoplastons have put the brakes on this tumor even though we were never at our maximum dose and we had many interruptions in treatment.

we have not heard from Bursynki’s docs yet. as soon as we do, we will let y’all know!

This means it’s growing. A tumor growing explosively like it was before they went to Houston levels off as a matter of course. The size of the tumors follows something called a Gompertzian growth curve, which looks something like this curve (for another cancer):

cancer_clip_image002_0000 So, it’s probably a bad idea to lean too hard on a second data point and conclude that the tumor’s progression has been altered by the antineoplaston treatment. And let’s say that the tumor has actually stopped progressing–how do we know that it is the ANP that is doing it, not any of the dozens and dozens of other treatments and procedures that James is undergoing? No, at best one must conclude it is too early to say.

On the 18th, the 1-year anniversary of James’s first symptoms:

Although the doctors at Loma Linda said that the last mri showed no change except for the quarter inch growth toward the hypothalimus, the doctors in Houston say that there has been “about a 15% increase in enhancement.” (enhancement means blood flow and activity) They said what this means is that the lower grade aspects of the tumor are being stopped, while the higher grade aspects seem to be “enhancing.” […]

Anyway, we are deciding to not dwell on the “enhancement” issue. All we can do is to continue to take care of him on a hourly basis (minute by minute really). Worry really doesn’t help. So much is involved in taking care of him that there really isn’t time to go down that road, although we find ourselves in very distinct moods, depending on how he’s doing. We get all excited when he is just able to open both eyes (which he practiced today, but was very difficult).

This does not seem to be a boy getting better.

On the 21st, the mom notices that James hadn’t had a sneeze or yawning reflex for a while (those reflexes originate in the brain stem), and how he has them. Granting that this is true (and not, say, confirmation bias), James is able to squeeze his dad’s hand on command and they even took him home for a bit. He feels good on this day, and the way she describes it is telling:

i even checked the pump that infuses the medicine into him, because i started thinking it wasn’t working right…he was feeling so good.

Antineoplastons can degrade the quality of life for the terminally ill.

He is still receiving infusions, and his sodium is too high for them to keep infusing him. On the 26th, after James was unable to stay awake for opening Christmas presents. We now see that his steroid doses have been enormous:

[The doctor in California, James’s mother] and I agree that this is most likely due to the weaning process with the steroids. We had gotten down to 2mg, 1mg, 1mg over 24 hours. Back a month or so, he was on 8mg, 8mg, 8mg, 8mg over 24 hours, so he was getting 32mg/day!! (an extremely large dose even for a huge adult!!) Anyway, we all decided to get him back up to 2,2,2 and see what happens.

On the 29th, James is still lethargic and he has had a poor appetite, and they think that the tumor is bleeding again. He is getting 4 liters of water a day through his tube. This may be leading to low sodium the next day, when they take him back to the hospital, where they find:

he was still very lethargic, could hardly hold his head up, and his right pupil was fixed and dilated, not responding at all to the flashlight.

The pump, it turns out, was broken, not pumping the high sodium ANP into James, and while he was still getting what are typically dangerous doses of water. The Burzynski Clinic sends a new pump. On the 30th, mom’s description suggests James is very poorly:

after this morning of eating popcorn and perking up a bit, he went to sleep and has been asleep, or just laying there with his eyes closed. he is not talking or even answering our questions. i know he hears and understands us because he will squeeze my hand when i tell him too, but he just won’t talk or open his eyes…although sometimes i catch him with one eye open a tiny slit but then he closes it when i see him. the nurse from houston said he may be sleepy for a couple of days because of the pump malfunction, etc.

On New Year’s Eve, the only update is:

james has a very large bleed happening now. doctors are very concerned. urgent prayer and fasting needed

The next day he manages some extremity-wiggling on command and swallow a few bites of food. The doctors are trying to “dry James out,” as his parents put it, and his heart rate picks up, but he’s not usually there.

Sadly, the poor kid seems to be really slipping away (some of the reactions seem like he’s in a vegetative state). To get a sense of where he is, on the 6th we receive a report:

Today, Mare and I got some good (and much needed) encouragement! We sat James up like we did the yesterday and the day before with the physical therapist. James was able to hold his head up for about 35 seconds several times! While he was doing this, his right eye was slightly open and he seemed much more alert than he has in the previous 5 days. Of course, we made a huge deal and told him how proud we are of him that he is working so hard. Also, at one point, I asked him to hit a ball that Mare held in front of him. He didn’t do it, so I did it hand over hand with him. Then I asked him is he could hit the ball, and he actually shook his head “no.” That was very encouraging because he really responded to me, which he hasn’t done much lately.

That seems an ambiguous response at best. On the 7th, acidosis is setting in, a condition that can be fatal very rapidly, but it reverses and he levels out. On the thirteenth, the father reports that James says, “What?!” in response to a question. The staff is manually moving food out of his stomach using a syringe in the g-tube.

On the 25th, James is still “asleep.” It’s clearly not sleep at this point. By the 31st, the doctors say that James has pneumonia. On February 3, James’s dad reports:

James’ breathing is extremely labored. He is now on a special type of mask that has a very large amount of humidified oxygen going. He is breathing through his mouth, his nose is inflamed, clogged (with blood), congested. We have been cleaning it out with saline and some non-invasive suction. Still he is breathing through his mouth and having a very difficult time.

They have been staying at a Ronald McDonald House by the hospital since November, and on the 4th, the manager tells them that they need to move out by the 11th. On Feb 9, however, someone at his bedside reports that James is acidotic, his breathing is failing. He dies an hour and a half later. He was 6 years old. Burzynski’s treatment seems to have done nothing but make the boy miserable while he was conscious.

It’s a disheartening story. We have a thousand names, a thousand stories. We are working on them, one by one.*