As Stanislaw Burzynski stands in front of the Texas Medical Board to answer for yet another litany of abominations, patients are no doubt gathering to protest in front of the courthouse so they can beg for their lives. Many of his supporters in the past have been then-current patients who were convinced that Burzynski is their only chance at life. Burzynski’s patients often have dismal prognoses and their prospects do not improve when they buy into his medical adventurism. In anticipation of such patients being used as human shields yet again, we are focusing on stories of people who have testified on Burzynski’s behalf, begged for their lives in courts and in the public, but who of course died anyway. These patients, so far, include Burzynski patient Elke B., Burzynski patient Douglas W., Burzynski patient Janet C., and Burzynski patient Sen. Ed G. These patients may not be testifying in the upcoming trial, but their stories are perhaps the most important and are far more eloquent and revealing.
Today we start looking at the roster of the dead and dying known as the ANP Coalition. This is the collection of patients, mostly children, who came to Burzynski’s aid when his unproven “antineoplaston” chemotherapy was taken off the market following a juvenile patient’s death. The ANP Coalition did help get the trials reinstated, as best we can tell, however, out of the nine patients who have appeared in the Coalition’s pro-Burzynski campaigns, 6 have died. Not all of the patients received ANP, but all of the patients have been used. Only one, as far as we know, is on ANP at this time.
The first patient we will examine is McKenzie L. Hers was perhaps the most extensively covered story of all the ANP Coalition’s new patients. We have some 80 files on her story. It is horrible and long and frustrating, but it’s a story that must be told because it makes staggeringly clear the real harm that sloppy journalism can cause. Everyone here tried to do the right thing, but a selective blindness is pervasive and it has truly catastrophic results.
The first evidence that something is wrong appears on McKenzie’s grandfather’s Facebook page on 28 Nov 2012:
It turns out, as we hear almost two years later that McKenzie had been walking home from school with her grandfather and
“swayed in a crooked line down the sidewalk and her eyes seemed unfocused. When he asked her what was wrong she told him she was seeing double.”
The diagnosis is Diffuse Intrinsic Pontine Glioma, a tumor in the brain stem. Almost universally fatal. It catches the fifth-grader and her family mid-stride; McKenzie had just received a stellar report card and seems to be athletically inclined, swimming and riding horses. Within two weeks, she begins a long series of visits to the hospital for conventional treatment, radiation and chemotherapy, it seems.
Right out of the gate, the traditional therapy does what it is supposed to, beat back the cancer. It is unlikely to kill off it all, but is only a stop-gap measure. We hear on Jan. 7 that double vision and walking have been a problem, but the problems are lessening. On 20 February 2013, we hear that according to their first MRI after treatment, the tumor has shrunk by 50%.
By October, however, the tumor grows back.
Burzynski first appears on the family’s timelines in January 2013, when McKenzie’s grandfather posts an article about Burzynski, one riddled with inaccuracies and conspiracy theories (get a skeptic’s take on the same Burzynski decision here). In September of 2013, however, with the family running out of options, members of the Burzynski Patient Group begin appearing in the family’s Facebook timelines, especially an enthusiastic chemtrail, New World Order, and fluoride truther.
On 2 October 2013, McKenzie L.’s family goes to Houston looking for a miracle:
By the end of the month, there seems to be devotion to the Burzynski cause. At the time, Burzynski’s antineoplaston trials were suspended after the death of a child, Josiah C., whose story was told on the cover of USA Today in November 2013, just after McKenzie’s family seems to have committed to Burzynski’s cause. Neither the Clinic nor the FDA told Josiah’s family that the clinical trial that their son was on had been shut down following his death.
Five days after the expose of Burzynski appeared on the cover of USA Today, Michael Rosenfield of WBZ-TV files a report about a petition that McKenzie’s grandfather has started to lobby the FDA for a compassionate exemption for her to receive Burzynski’s drug. At the time, the compassionate exemption seemed to be the only way that Burzynski could get patients on the drug. All of the trials were closed. The list of Burzynski’s horrific violations seemed too unthinkably long to permit him to continue. Burzynski’s response to the charges was clearly inadequate for the FDA. This is the first point where the media failed to serve the public interest. An 8-month investigation raising profound doubts about whether the “doctor in Texas,” as Rosenfield refers to him, and his “controversial drug,” as Rosenfield refers to it, was completely ignored. Indeed, the absence is conspicuous given the horror with which the article was received. We believe that Rosenfield had a journalistic obligation to report that the FDA had observed that:
- Burzynski (as investigator, the subject of the inspection) “failed to comply with protocol requirements related to the primary outcome, therapeutic response […] for 67% of study subjects reviewed during the inspection.” This means that several patients who were reported as “complete responses” did not meet the criteria defined in the investigational plan, as were patients who were reported as having a “partial response” and “stable disease.” This means that his outcomes figures for these studies are inaccurate.
- Additionally, some patients admitted failed to meet the inclusion criteria for the study.
- Even though patients needed to have a physician back home to monitor their progress prior to enrolling in a trial, the FDA found a patient who began receiving treatment before a doctor had been found.
- Patients who had Grade 3 or 4 toxic effects were supposed to be removed from treatment. One patient had 3 Grade 3 events followed by 3 Grade 4 events. Another patient had 7 disqualifying toxic events before he was removed from the study.
- Burzynski did not report all adverse events as required by his study protocols. One patient had 12 events of hypernatremia (high sodium), none of which was reported. There are several similar patients.
- The FDA told Burzynski: “You failed to protect the rights, safety, and welfare of subjects under your care. Forty-eight (48) subjects experienced 102 investigational overdoses between January 1, 2005 and February 22, 2013, according to the [trial number redacted] List of Hospitalizations/SAE (serious adverse events) [redacted]/ Overdose [redacted]/Catheter Infection report. Overdose incidents have been reported to you [….] There is no documentation to show that you have implemented corrective actions during this time period to ensure the safety and welfare of subjects.” [emphasis added] It seems that these overdoses are related to the protocol, which requires family members to administer the drugs via programmable pump on their own. Further, patient records show that there were many more overdoses that were not included in the Hospitalization/SAE/Overdose list.
- “Your […] tumor measurements initially recorded on worksheets at baseline and on-study treatment […] studies for all study subjects were destroyed and are not available for FDA inspectional review.” This is one of the most damning statements, as without any…not a single baseline measurement…there is no way to determine any actual effect of the antineoplaston treatment. This means that Burzynski’s studies–which by last account cost $30,000 to begin and $7000 a month to maintain–are unpublishable.
- Some adverse events were not reported to the Burzynski Clinic IRB for years. (One patient had an adverse event in 1998 and the oversight board did not hear about it until 2005.)
- The FDA observed that the informed consent document did not include a statement of extra costs that might be incurred. Specifically, some informed consent documents were signed days to weeks before billing agreements, and in a couple of cases no consent form could be found.
This document was available online for anyone access to Google to see. Nonetheless, this is the doctor to whom Rosenfield unquestioningly commended young McKenzie’s eager and vulnerable family. The audience of this report was not informed about the true magnitude and nature of the controversy before the station linked to the petition, which was certainly relevant and available. Michael Rosenfield must share some of the blame for what comes.
Three days later, WMUR files a similar report about the petition. McKenzie’s grandfather, again, appears in the report. The interview with McKenzie’s grandmother is heartbreaking, but reporter Jean Macken does not put their grief and fear in context. And they link to the petition, which has already received at least 9,000 signatures following Rosenfield’s report. Jean Macken must share some of the blame for what comes. Incredibly, WMUR had already reported about a fundraiser for the antineoplaston treatment that DIPG patient Justin B. received. Sadly, Justin died.
The next day, the New Hampshire Union Leader publishes an article called, “Hope for McKenzie; A girl vs. bureaucracy.” It is wretched. For instance:
The FDA exists to improve the health of Americans. It screens and tests drugs so that unsafe ones do not reach the market. But what about people who are terminally ill? If someone is facing imminent death, who cares about possible negative side effects of an experimental drug? The FDA does.
Doctors do. For instance, a patient who is facing immanent death may forego palliative care. They risk having their remaining limited time and their savings squandered by a quack. They may get killed quicker. Their quality of life may decline. The cost of trying to deal with the side effects may escalate. They may become ineligible for trials that might actually have a chance of helping them.
Terminally ill children and adults can get unapproved drugs through a policy called “compassionate use.” But even that takes time. Patients have to apply, and the FDA has to approve the use. It is time that some patients do not have.
In emergency cases, the FDA can get approval for compassionate use or “expanded access” overnight.
McKenzie [L.] is fighting for her life. No one knows how much time she has left. We pray that it is longer than the time the FDA will take to respond to her parents’ request. If you would like to help, you can sign the online petition asking that McKenzie be allowed to take the one drug doctors say could save her life.
This last line is deceptive, making it sound like more than a tiny number of uninformed or self-interested physicians would say that ANP would be the one and only drug that could save her. In fact, as we will see, the family has a hard time even finding a physician who would be willing to administer the drugs. This is factually misleading, emotionally manipulative, and irresponsible in the extreme. The New Hampshire Union Leader’s editors must share some of the blame for what comes.
The same day, 25 Nov 2013, the Nashua Telegraph reports on the family’s attempt to get signatures for the petition and to raise money. This is in the news section, not the opinion section, and the reporter, Dean Shalhoup, does not recommend that readers support the initiative. He just reports. Nonetheless, there are some disturbing lapses in judgment that warranted a little research that was either not done or not included.
[The family was] so intrigued by Burzynski’s apparent success in raising from near zero to around 27 percent the cure rate of patients diagnosed, as was McKenzie, with an inoperable pediatric brainstem tumor that they traveled to Houston about two months ago to meet him. “The man has a success rate with this drug,” [McKenzie’s grandfather] said. “I have been in touch with (cancer) survivors who used this drug.”
Of course, Liz Szabo, by this point, had already made it abundantly clear why one should doubt the value of Burzynski’s testimonials:
Yet independent oncologists say that appearances can be deceiving, and that patients shouldn’t be too quick to credit Burzynski. Experts say there are several reasons to be skeptical of Burzynski’s claims.
• Burzynski often relies on anecdotes, which don’t tell the full story. […]
• Burzynski’s therapies are unproven. […]
• Burzynski’s patients may have been misdiagnosed. […]
• Burzynski’s patients may have been cured by previous therapy.
Also, I should mention that sometimes weird things happen. Flukes and fortune can also, rarely, lead to remissions. Next, the “apparent success” cited was easily shown by a little research to be “illusory success.” For instance, Szabo had just reported that the FDA had found that Burzynski had been:
Inflating success rates in 67% of cases, by inaccurately reporting how tumors responded to treatment.
This fact was available and relevant to Shalhoup’s story. Secondly, Burzynski had not–and has never to date–published a reputable study stemming from the 60+ clinical trials he’d opened in the 1990s. This fact checking didn’t need investigative reporting; Szabo, her colleagues, and her editors had done that. All it needed was a Google search. While this is somewhat better than other reporting on McKenzie’s case, Dean Shaloup must share some responsibility for what comes. He allowed desperate people to parrot poppycock.
The next day, on 26 Nov 2013, New Hampshire Senator Kelly Ayotte issued a press release titled:
“Ayotte Urges FDA to Consider Compassionate Use Request for 12-Year Old New Hampshire Girl Fighting Brain Cancer”
The entirely Burzynski has routinely benefited from patients who believe that he is their only hope. They go to public officials and beg for their lives, which is a bargain that politicians are not in a position to make. They beg in and outside of courts, in statehouses, and in the halls of Congress for the perversity of paying to be in a clinical trial. I don’t doubt that Sen. Ayotte wanted to do the best thing for her constituent. We ALL wanted McKenzie to live a long life. And once Sen. Ayotte had thrown in with Burzynski’s patient, well, someone in her position is in the awkward position of not being able to retract that support gracefully. I had hoped that what happened to McKenzie would lead to the Senator sponsoring radically increased funding for rare childhood brain tumor research in McKenzie’s memory. Research into these tumors is underfunded and patients deserve more options than quackery. There should never be a patient who has to say that “no other treatment options are available,” to quote Ayotte’s press release.
Of course, Shalhoup had to follow up on the story after Ayotte’s office got involved, but when he did, he included a link and instructions on how to find the change.org petition. This is not to his credit. By the 27th, the petition had received 40,000 signatures, no doubt largely from the people who had been misinformed by these reporters. Quackery thrives when reporters opt to do almost entirely uncritical human interest stories. April Guilmet reported in the Union Leader Correspondent that:
Ayotte noted, however, that there have been documented cases of patients reacting positively for the treatment, while the [L] family noted that some patients in past studies have even had their tumors shrink over time.
Burzynski “documented” cures are just as “documented” as UFO abductions and sightings of Bigfoot. This is why scientists–and the regulatory process–requires a higher standard than mere anecdote for miracle cancer claims. Woe to everyone if every nostrum-pushing quack is allowed to circumvent the regulatory process.
On January 13, Shalhoup, from the Telegraph, reports on how the community has committed to help McKenzie, as is to be expected. Strangers can be endlessly kind, but they need to be informed. They need better information than:
“The FDA recently banned the drug, prompted in large part by Burzynski’s 1995 indictment on multiple charges stemming from allegations he violated the federal Food, Drug and Cosmetic Act.”
No. He beat those charges. The FDA didn’t revisit that case. The immediate cause of the suspension appears to be Josiah C’s death and the subsequent investigation. Again, it was in the USA Today piece. While Shalhoup does give a strong half a sentence to vague, uninterviewed detractors of Burzynski, there is nothing like balance in the article, as, again, the link to the petition and info on how to donate is included.
On 28 January Carol Robidoux at the Nashua Patch published an entirely credulous snippet called, “Saving McKenzie [L]: How You Can Help.”
This article ended:
McKenzie’s grandfather […] said the FDA has proof the controversial treatment, available through a clinic in Texas, has a 33 percent cure rate, versus that of conventional cancer treatment, which has a 0 percent cure rate for the kind of cancer McKenzie is up against.
Watch the YouTube video, uploaded here, in which McKenzie and her grandfather tell their story. Then, go to change.org and sign the petition.
Then, pass it on.
Links were included throughout the original. Skeptics did contact Robidoux to try to put what was happening in context. In reply to one skeptic’s email expressing concern, she wrote:
They are going into this with open eyes.Just as people every day fly to foreign countries for treatments or surgeries that aren’t approved or legal in the U.S., this family has the right to pursue whatever treatment they would like, based on what they’ve tried and what their options are, what’s available, and what offers some shred of hope in a hopeless situation. If it is snake oil, if Burzynski is a fake, there are certainly enough local authorities and national news outlets delving into Burzynski’s claims to bear that out. I see Texas authorities have been investigating him since the 1980s. That’s a long time.If the family does nothing, McKenzie will die. What they’ve tried already, within the realm of approved treatment – also very toxic to the human body – has not netted any positive results.People make bad investments every day – in stocks, in get rich quick schemes, in religious organizations that promise healing, in New Age crystals and other remedies. Maybe Burzynski realizes he’s capitalizing on the desperation of people who truly have no other options. Maybe he believes something about his treatment has merit for some percentage of patients. I’m not a medical reporter, or even an investigative reporter, by my own or anyone’s standards.
Her standards clearly mean nothing. She’s in fact wrong about this, as conventional treatment unquestionably had abated some of her symptoms and initially shrunk the tumor as hoped. Orac called out her credulousness on the 30th, and she showed up in the comments:
As the other “credulous” reporter referenced here, I just want to reinforce that the story I wrote was one of several written about a family taking desperate measures to save a child with cancer who had run out of “conventional” treatment options. They were well aware of the quackery charges against Dr. Burzynski, yet were willing to take a calculated risk. It is not my duty as a journalist to tell them they are making a mistake – although I did discuss with the grandfather what I had learned about Burzynski in researching it on background for the story. He knew it all, and had visited the clinic himself. For the poster of this blog to persist in calling me a “credulous” reporter in the context of this blog reinforces to me that he is unable to comprehend that sometimes the elements of a story are not what the story is actually about. I cannot and will not investigate Dr. Burzynski – it was out of my realm of expertise and resources, and has already been done by other investigative health and regional reporters; I will report why a New Hampshire family is feeling so desperate that they are willing to petition the FDA for an unproven and controversial treatment. There was nothing about what I wrote that added credulity to Dr. Burzynski or his method.
The question left unanswered is how a decision can both be calculated and desperate? Robidoux’s staggering lack of self-insight to not realize that a call to “pass it on” might suggest to readers that there was something worth fighting for in Burzynski suggests she is in the wrong business.
On the 30th, we hear from April Guilmet that the family has received the support of Senator Jean Shaheen too. We hear how things were going in mid-December:
In a letter sent to Commissioner Hamburg Jan. 17, both Ayotte and Shaheen urged the FDA to communicate directly with the [L.] family.
In early December, the [L.] family was told that McKenzie would be permitted to start ANP therapy in Texas, provided the family could find a physician willing to monitor her progress locally, [a] family friend […] said.
Burzynski even offered to provide the therapy to McKenzie at no cost, according to her family. [emphasis added]
But just over a week later, further complaints against Burzynski were revealed and the FDA told the family they could no longer issue a compassion exemption.
“It’s come down to this,” said [McKenzie’s grandfather] via his cell phone as he drove on the interstate Tuesday morning. “So now I’m headed out to bang on a couple doors.They may want me to go away but I’m not backing down.”
[McKenzie’s grandfather] said he recently learned that the FDA has made more than 50 claims against Burzynski and at least one of his patients died while being treated.
And despite this, the commitment has been made. The grandfather is crashing through warning barriers that were meant to protect McKenzie and other patients
On the same day, the Skeptics for the Protection of Cancer Patients reached out to the reporter to let her know about our strong reservations about the treatment. We offered documents to substantiate our concerns and gave her contact information of patients who claimed to have been maltreated. She immediately replied that she would like permission to use portions of our letter because:
I think its important to share all sides of this story and there are so, so many.
We consented and appeared in the follow up article a few days later:
Of the Burzynski therapy, the American Cancer Society said last week: “Relying on this type of treatment alone avoiding or delaying conventional medical care for cancer may have serious health consequences.’’
Science blogger Robert Blaskiewicz of the Skeptics for the Protection of Cancer Patients group, said he’s been researching Burzynski for the past two years and is genuinely concerned for [McKenzie’s] well-being, should she ultimately be able to obtain ANP treatment.
“I’m all for patient choice,” Blaskiewicz said. “But I’m also for informed consent. Is [McKenzie’s family] aware of the stories, of the 20-year pattern of patients believing that unambiguous signs of progression are signs of success?”
Dr. David Gorski, an oncologist and the administrator of the sciencebasedmedicine.org website, has likewise devoted much of site to speaking out against Burzynski as well as the anti-vaccine movement and various forms of alternative medicine.
Contacted this week, Gorski said he believed previous trials of ANP “were designed to let Burzynski treat patients, not find answers.”
Gorski is right. We know almost nothing more about antineoplastons than we did when the trials were opened. We have detailed the unambiguous signs of progression (especially ischemic necrosis, or tumors breaking up in the middle because they have outgrown their blood supply) on this site. All we want is a reputable paper to fact-check us, because if we’re right, this is a potential medical ethics scandal that involves 8 times as many patients as the Tuskegee Experiment:
- We first noticed this pattern in the story of Amelia S.
- The family of Haley S heard this (also, see the clinic’s heartless reaction to a stroke that the child had).
- The Clinic gave the same prognosis to Justin B’s family in 2006.
- We see a similar cyst in Leslie S.’s story (2006), and it nabbed Burzynski an extra $7,500 before she died.
- We see it AGAIN–as far back as 1994!–in Cody G.’s story.
- We saw it again in the case of Samantha T.
- We saw it again in the story of Christy M.
- A similar story came from Georgia State Senator Ed G.’s story.
- In the most grotesque horror show we have ever written about, Burzynski himself tells the family of Chase S. the same thing. Poor Chase ended lying in state in his family’s front room for months.
Also in the article, we also hear about McKenzie’s grandfather’s trip to Washington, D.C.:
[He] met individually with some legislators or their staffs last week, including U.S. Sens. Kelly Ayotte, R-N.H., and Jeanne Shaheen, D-N.H., as well as Elizabeth Warren, D-Mass., Ted Cruz, R-Texas, Rand Paul, R-Ky., Ed Markey, D-Mass., Dianne Feinstein, D-Calif., and Tom Harkin, D-Iowa.
He also attended a meeting with seven FDA officials, though FDA Commissioner Margaret Hamburg was traveling and wasn’t present at the meeting.
“Basically, we told (the FDA) that it would be nice if we could get everyone sitting down at one table with them — doctors, patients and legislators,” [the grandfather said] said. “Because there hasn’t been enough communication here.”
When skeptics said that we had concerns, we were not making things up. We had warned and warned and warned everyone about what was going to happen to McKenzie if the family charged ahead and circumvented patient protections. We were concerned that if the doors were opened for one patient, then the FDA would have no justification for denying the treatment to other desperate people.
This is why we were devastated to hear on March 23rd in USA Today:
The FDA acknowledged Friday that it has agreed to allow [7 Burzynski patients] to use the experimental drug, but only if they can find a qualified, independent physician to administer the drug. Beyond infusing the drug and overseeing their care, the doctor would have to formally apply for expanded access to an “investigational new drug,” as well as get approval from an institutional review board, an independent panel that reviews safety and ethical issues involved in clinical trials.
The FDA grants an average of more than 1,000 requests a year for expanded access.
Burzynski will supply antineoplastons for free, says his attorney, Richard Jaffe. [emphasis added]
The next step is finding a doctor to administer the drug, as pointed out in the Billerica Minuteman on March 27th in an article called: “Help McKenzie [L.] Get Needed Treatments.” Again, links are included to the various petitions and projects that can really only help Burzynski and nobody else. The family is still having a hard time finding someone to sign up to work with Burzynski, as we hear in the Nashua Telegraph on 29 March:
That second hurdle, to date a seemingly insurmountable obstacle, is finding a doctor who would agree to administer the drug, called antineoplastons, or ANP, [McKenzie’s grandfather] said. “They said she can use it if we can find a qualified doctor,” he said. “But who knows what ‘qualified’ means? An oncologist? Do they want a research doctor?”
Essentially, the answer to the last question is yes. Which means, [he said] said, even if there’s a doctor out there who would take McKenzie’s case, he or she would likely have to spend lots of money and jump through a lot of hoops to become qualified.
“We can’t even find a doctor to go that far,” [he] said.
This is another red flag; when qualified researchers are unwilling to sign the papers, you have a problem.
Following a visit to Dana Farber in mid-April, according to a public Facebook page set up of McKenzie, the docs say that she “looked really good.” We don’t hear about progress getting a doctor to sign up with Burzynski until May:
This doctor is Terry Bennett, who explained his participation in the June 15 Telegraph:
The latest move came several weeks ago in the person of a Rochester physician who battled the U.S. Food and Drug Administration to get access to a similarly expensive drug that he felt confident would stem the cancer that was ravaging his body and buy him some time.
Dr. Terry Bennett said his experience prompted him to come forward when he learned the young Hudson girl and her family were beseeching the FDA to grant a compassionate exception that would allow McKenzie access to ANP treatments. […]
Bennett said it didn’t take long after he met McKenzie to agree to be her “backup” doctor in New Hampshire, as he calls his role.
“I thought, if there’s any way they can make this happen, I’m all for it,” he said.
“We have a (sick) little girl here. I will supervise what goes on here the best I can.”
Though you might think, based on the things said above (in bold), and in keeping with common research practice, that the Burzynski Clinic was going to foot the bill. Nope. The family is being charged the customary $15,000 a month in ancillary charges.
Even though the clinic is providing the medication free of charge it is still going to cost approx. $15,000.00 per month for medical supplies, consultations, & administrative fees that insurance will not cover.
While we expected Burzynski to charge out the nose for this treatment, some people thought it was going to be free including the doctor and the nurse who volunteered their services on that basis. On the same day that McKenzie’s Facebook group announced that she was starting on the ANP…
….and article by Dylan Morrill appeared at Fosters.com, which revealed in part:
Nearly two months later, Bennett and his employees spent more-than 100 hours filling out the FDA application to become the sponsoring doctor and perform the therapy using Burzynksi’s medicines.
Dye was then contacted through “a friend of a friend of a friend,” and decided to offer her nursing services for free to McKenzie. She took two trips down to Burzynski’s Houston clinic to learn about the therapy.
Both Dye and Bennett are not charging for their services, and they thought that Burzynski would also be working pro bono. In December, 2013, Burzynski wrote a letter to U.S. Sen. Kelly Ayotte’s legislative assistant Dan Auger explaining that he would provide antineoplaston therapy for free if the FDA granted the exemption.
The letter read: “This is to confirm S.R. Burzynski, manufacturer of Antineoplaston A10 and As2-1 infusions is willing to provide these agents for free and for compassionate means.”
Bennett said he was told in May during a phone conversation with Burzynski that the medicine was being donated. It was after that conversation that Bennett decided to sponsor McKenzie.
[McKenzie’s] family also believed that McKenzie’s medicine was being provided for free. But […] McKenzie’s mother, said she received an itemized bill from Burzynski showed up in her mail a few weeks ago.
The family was told that the first month will cost $28,000 and every month after that will cost $16,000.
The family received an itemized bill from Burzynski? I think the FDA would be interested in seeing it. I smell a refund!
“It meets all the criteria for a bait and switch operation,” said Bennett. [emphasis added]
The next day, Bennett appeared in another article, which reported:
Bennett said he will not withdraw his sponsorship of McKenzie, despite the cost of treatment. But he’s extremely upset over what he calls a very disturbing phone call that he received on May 28.
Bennett says a representative of the Burzynski Clinic called him on that date seeking payment for the first month of McKenzie’s therapy. Prior to that, Bennett, who is donating his services, thought Burzynski was doing the same.
Instead, said Bennett, “I’m supposed to be the bag man for all of this. They want me to collect the $30 grand for the family and send it to Burzynski.” [emphasis added]
He later said:
On the other, there’s the opinion of Dr. Terry Bennett of Rochester, who agreed to be the overseeing local physician for the treatment of Burzynski.
“This is a classic bait-and-switch operation,” Bennett said of Burzynski in a recent phone interview. “He suckered me and this family into buying into a very expensive treatment plan.”
That second article, by the way, is titled, “Dr. Feels Misled in Cancer Treatment Costs.” It sort of reminds me of the headline. “Amelia S.’s Family ‘Misled By Clinic’” It reminds me of the gouging of Denise D., who was treated so badly by the clinic. It reminds me of Supatra A’s family, who had budgeted but still found themselves in debt to the clinic. It reminds me of poor Kathy B. who said that she:
made this video [of a patient visit with Greg Burzynski] in anticipation that I would be receiving the antineoplastons. Apparently after spending over 30,000 here I found out that the Antineoplastons are only reserved for brain cancer patients who have already undergone chemo radiation. FDA put this restriction on the Burzynski Clinic, so any other cancer patients are BASICALLY ONLY GETTING THE TRADITIOINAL ALLOPATHIC TREATMENTS OF SYNTHETIC ANTINEOPLASON PILLS THAT DID NOTHING FOR ME.
All of these patients are dead. This is what we are dealing with here. This is why reporters need to do a better job of checking the public record before they endorse a shameless quack.
Registered Nurse Ariel Dye also volunteered her services to help McKenzie. She was the one who, instead of the patient, went down to Houston to learn how to use the ANP pumps and administer the drugs. I suspect that patients being trained to administer the drugs themselves may have contributed to the huge number of overdoses observed by the FDA and that this was a fix to the protocol the FDA demanded that Burzynski never got around to doing. He only had 15 years, after all. In November, we hear about Nurse Dye’s experience at the Clinic. She is scathing:
“I went out there and watched the nurse teach a layperson how to work off a central line. It was nothing,” said Dye, who is an IV-certified RN. “It was crazy to me that they charged this.”
“I got little to no instruction saying (things like) if there are major reactions, this is what you’re going to do in this case, in that case,” she said. “They made it seem like it was this big training program they put me through, but they lied and were looking to make money.”
Dr. Bennett came around fully by this point:
“His claims have no merit. He has never tested any of it realistically,” said Bennett.
On day 2 of the treatment, McKenzie feels pretty good, her grandfather reports. But not long thereafter, a few weeks after the start of ANP treatment, we learn that McKenzie is suffering from side effects of ANP:
On July 27th, we see that the disease is progressing unabated, which is what you would expect if she were put on snake-oil, and what we have seen so many times:
At about this time, Burzynski was whacked with a 200-page list of charges against him by the Texas Medical Board. This development was announced at The Amazing Meeting, the premier conference on science in the public interest:
In response to this action by the TMB, Fosters.com printed an article “Do Not Take Her Hope Away,” which was entirely irresponsible. For instance, they mentioned Dr. Bennett but not his opinion of the clinic. They did not mention that the tumor had continued to grow, as was to be expected. In fact, by July 31st, we hear how ineffective antineoplastons had been:
In late September, April Guilmet tells us what has happened:
The ANP treatments cost the family about $15,000 per month.“She had crippling headaches and her blood counts got very low,” [McKenzie’s grandfather] said. “At full dosage, her body just couldn’t handle it.”
[McKenzie] went off ANP in mid-August, he said. Since then, her family has been researching other treatment options. She is currently on a regimen of gene-targeted drugs prescribed by doctors at Dana Farber. The family departed for University of Chicago on Sunday, where they will meet with another team of physicians.
The tragedy of fringe medicine is that her tumor might well have been treated by something with a chance of working instead of antineoplaston. To all the reporters who wondered, “What’s the harm in in treating someone with a terminal illness with….whatever they want?” I refer them to the energy, money, and precious time squandered on this course of treatment.
By September 28th, the family is in Chicago pursuing experimental treatment, and Burzynski is, blessedly, out of the picture.
They are cutting into the brain stem which is usually a surgical no-go zone (and is why so many of Burzynski patients haven’t had biopsies to confirm radiological diagnoses).
McKenzie died at home on 23 Oct 2014. A radiant light went with her, and hundreds of people McKenzie had touched saw her off.
To think that all of these powerful people were following McKenzie’s story and for want of critical commentary of the treatment in the media, McKenzie suffered for it.
I think Telegraph reporter David Brooks offered a fair summary of McKenzie’s ordeal in his write up after the funeral, “Alternative Methods are Not Safe Bets,” and he concluded:
It’s hard for an outsider not to feel sympathy for a desperate family struggling to save a loved one.
But we should give more weight to a medical establishment that has doubled the human lifespan, that has created a huge, complicated system of peer review, double-blind tests, treatment protocols which is far from perfect but has done more for your health and mine than has a millennium of hopes and dreams.
Brooks apparently interviewed some of McKenzie’s family in the aftermath:
The treatment over the summer accomplished nothing except making McKenzie sicker for a while, and cost McKenzie’s family and supporters many thousands of dollars, even though it was stopped quickly because of side effects, said McKenzie’s grandfather […] .
But [McKenzie’s grandfather] who says the total cost was “less than $25,000,” thinks the effort was worthwhile and might have succeeded if so many obstacles hadn’t been placed in its path […].
Most frightening is the lesson that the grandfather has apparently taken away from this. According to Brooks:
If somebody else he knew was diagnosed with DIPG, he’d recommend going to Burzynski.
The lack of regret is eerily similar to sentiments of the families of Burzynski patients going back decades. For example, in 1982, The Windsor Star reported that a family member still believed in the treatment “with all my heart” but her sister-in-law Deanne had arrived too late for the six weeks of antineoplaston treatment to be effective.
I hope that when the Texas Medical Board drags Burzynski to stand before a judge in Austin on June 15 the press remembers that treating this issue as a human interest story, such as we have seen in the case of McKenzie L., perpetuates misery and magnifies suffering.
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:
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.