Tagged: Dr. Burzynski

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:

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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:

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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:

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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…

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….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:

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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:

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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:

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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.

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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 Patient Andrew S.’s Story

*An appeal to help get Congress to take action follows this story*
When you read the Caring Bridge blog [the source of this story unless otherwise indicated] from the S. family at the beginning of their story, you may be confused. Andrew was diagnosed with a brain tumor only days after his mother was diagnosed with breast cancer, so the planning for Andrew’s initial round of radiation coincides with his mother’s biopsy. I just can’t imagine what the family has been through.
On the day before Halloween 2007, Andrew has a port implanted. He begins chemotherapy and radiation the next day. He does a week on chemotherapy, but is soon taken off. The same week, his mother has the mass removed from her breast. By the 11th, his mother is able to be with her son at the hospital. The poor kid gets salmonella while in the hospital and has complications from the antibiotic he is on. The family can’t catch a break.
On November 14th, we hear:
Finally, some of you are aware that we have found a clinical trial (in Houston, Texas) that may possibly help Andrew. I will post more information about the trial as soon has I have time.
And the next day:
Finally, there have been some questions about the treatment we are pursuing for Andrew in Houston. Rather than giving you my own interpretation of the information, I’m going to give you a web address so that you can have as much information as you would like to have. Please, go to [website redacted] to check out the Burzynski Clinic. Andrew will finish his radiation treatments here before going there. (His treatment here should be finished around December 14.) They have tentatively said they would like us to arrive on the 26th or 27th of December. We are working out the details.
Andrew will finish radiotherapy before going to Houston. He has a bit of crisis late November, which lands him in the pediatric ICU after his sodium dropped and he was having seizures.
The radiation may be having an effect by the end of the month:
Written Nov 29, 2007 12:32am 
Andrew had an MRI done over the weekend. The report indicates “a large oval shaped mass which appears to originate from the right side of the pons.” (This is part of the brain stem.) The report also states, “…the mass does not appear larger and may actually be minimally smaller.” Dr. Saah said that the MRI itself shows that there is increased space between the mass and the back of the brain and that there is not as much swelling as there was when the first MRI was done on October 25th.
And the poor kid gets a damned kidney stone and UTI for Christmas. He still has salmonella.
Andrew is a clever, thoughtful kid. His parents take down all the weird little things that he says, and you should read them. There is a brilliant innocence in his use of language. My favorite example, I think, comes on December 7th:
Written Dec 7, 2007 8:51am
I’m having a PET Scan this morning, and Andrew has had lots of questions about it. A minute ago he told me, “I’ve had PET Scan.” I said, “You’ve had a CAT Scan.” He said, “Oh. (pause) Well, a cat is a pet, so I thought they were the same thing.”
Good news on the 15th. The cancer has responded to the radiation:
Written Dec 15, 2007 12:27am
Andrew’s CAT Scan report says “…the size of the mass is dramatically decreased.”Evidently this is somewhat unusual–even as a result of radiation. The nurse practitioner who works with oncology at the hospital has requested dimensions so that we have more of a specific understanding of what has happened.
Two days later, he’s back in the hospital passing kidney stones. Also:
They are checking on the possibility of scheduling an MRI (of the brain) for today–while we are still in the hospital. (It was originally scheduled for tomorrow night.) We need this MRI for the Burzynski Clinic.
His first appointment at the Burzynski Clinic is on the 27th at 9AM.
We met with Dr. Burzynski and one of the other doctors today at the clinic. Andrew will be having an MRI in the morning. There needs to be disease progression in order for him to begin treatment with the antineoplastons right away. (This is an F.D.A requirement; this medication is only available to those enrolled in a clinical trial.) If there is something–even something small–in the MRI that would indicate disease progression, Andrew will be able to begin the treatment. If not, he may become a patient of Dr. Burzynski’s in his private oncology practice; he will be treated with an oral medication–already F.D.A. approved–which is in the antineoplaston family. Being treated with this oral medication does not disqualify Andrew from being enrolled in the clinical trial in the future. 
The financial side of this became more of a reality today as we paid–up front–for the consultation and began to look at the payment schedule for treatment with the antineoplastons or for treatment as a patient in Dr. Burzynski’s private practice. Andrew’s medical needs are fully covered in the state of Michigan, but only emergency care is covered out of state. 
It is important to note at this point that the family believes that the treatment has had some success. This can not be backed up with meaningful clinical studies.
On the 30th, this update:
By the time we arrived back at the Burzynski Clinic, it was close to 4:00 pm. One of their doctors went over the films with us; he told us that there had been about a 10% decrease in the size of the mass since the last MRI only ten days earlier. The fourth ventricle of the brain–which had previously been pushed aside by the mass–now looks normal. Another doctor explained that because of this good news Andrew does not qualify for I.V. antineoplastons (one of the clinical trials) at this time. He will be seen in Dr. Burzynski’s private practice instead. 
We met with one of the doctors who works in the private practice, to go over the specifics of Andrew’s situation. We will be continuing to taper the decadron (the steroid). Today we cut the dosage down to 3 mg (from 4 mg) in the morning and 2 mg at night. We also raised Andrew’s zyrtec dosage from 5 to 10 mg to see if that makes a difference with his chronic sinusitis. (This is something that shows up on the CAT Scans and MRIs.) We are discussing the possibility of switching him to Singulair because he also seems to benefit from the use of an albuterol inhaler at times. (Singulair would cover allergy AND asthma symptoms.) Andrew also takes Prevacid (15 mg twice a day)
The day after this consult, a Saturday morning, we get an example of the fine care that you receive at the Burzynski Clinic for top dollar:
We sat in the waiting room until we were the only ones left. I knew that the port needed to be checked, and I had heard that the workers try to be out of the clinic by 11:00 am on weekend mornings. I was becoming concerned about the time, so I said something to the nurse. We were taken to a room at 10:15 am to speak with the doctor on call. I quickly realized that they were not planning to touch the port; it was getting late, and if a problem was discovered it would take too much time to resolve. I had to insist that the port be checked because we needed to know if it was working. It still would not draw, and the area around the port seemed irritated. (Andrew had been complaining all morning.) The clinic staff member wondered if there was swelling and suggested that we go to the Emergency Room.
By the time he gets to the hospital, blood has soaked through the port’s dressing. He is ineligible for the “clinical trial” because he has just had radiation.
Written Dec 31, 2007 1:00am
Someone has asked how we are feeling about the way things are going here in Houston. Andrew is not on the I.V. antineoplastons because he does not qualify for the clinical trials yet; however he is taking an oral medication (sodium phenylbutyrate) in the antineoplaston family. Rather than waiting for disease progression, we are attempting to fight the glioma before it advances. The I.V. antineoplaston statistics are encouraging–about 30% of patients have a dramatic or partial response to the medication (the mass is completely or partially gone), about 30% of patients become stable (no change), and about 30% of patients experience disease progression. Since most of the Burzynski Clinic brain tumor patients are on the I.V. antineoplastons, there are no statistics for the oral medication. One of the doctors said he felt that being seen in the private practice was better for Andrew because the treatment will be based upon exactly what Andrew needs rather than on the strict rules of a clinical trial.
What is so aggravating about this is passage the way the information is presented to them. The stats that they receive is that 60% of patients are at least stable. Burzynski does not have the clinical trials to back up this assertion. A further complication is that “any response” and “complete response” are grouped together in the same group. Seems very disingenuous to me.
Andrew’s mother returns to Detroit to begin her own chemotherapy on the first. It’s amazing how rarely she mentions her own condition as she documents this story. Her priorities are clear.
After the mother left, the Clinic springs chemotherapy on the family:
While [the mother] was preparing to start her chemo, we were surprised to learn that Andrew’s doctors in Houston are recommending a chemotherapy (Temodar) for Andrew which would go along with the oral medication he has been taking. The doctors were wanting to start it today, but the [S family] want to discuss this option — and the possibility of doing it at home — with their oncologists here in Lansing.
He’s back in the hospital trying to pass one of his kidney stones (there are 3) but gets out around the 12th. We soon hear what Andrew is on:
Written Jan 15, 2008 1:41am
Andrew began treatment under the direction of the Burzynski Clinic again today. He will be on three different medications–PB (the oral medication in the antineoplaston family) to help bring into balance the relationship between the oncogenes (onco refers to cancer) and the tumor suppressor genes. (In those who have cancer, this relationship is not right.) The other two medications will target specific oncogenes found to be a problem in Andrew. The first medication will target VEG-F which relates to a tumor’s blood supply. The normal level for this is anywhere from the 40’s to the 90’s. Andrew’s is over 200. The second medication will target another oncogene which is at the very top end of normal in Andrew–right on the borderline between normal and abnormal. Since I don’t fully understand this particular oncogene yet, I can’t explain it! 
On the 17th, a phone consult with the Clinic:
I listened by telephone to the meeting with Dr. Burzynski this afternoon. We are proceeding as planned–with the three medications; we are also lowering the decadron dosage. (We are supporting Andrew with two natural anti-inflammatories while we do this.) Dr. Burzynski indicated that it is unusual to see the results we have already seen from radiation alone, and that Andrew is doing extremely well. We have been told that dramatic response to treatment usually indicates a more aggressive tumor or cancer. He said that sometimes that is true, but not always. 
Things proceed fairly uneventfully until we get the next update:
Written Jan 25, 2008 11:57pm
[…] We had a great appointment with Dr. Gera, Andrew’s oncologist, on Tuesday. She spent so much time with us that she got behind with other patients. We went to have some lunch to give her a chance to catch up; then we went back so she could examine Andrew and talk with us at length about the Burzynski Clinic recommendations. We were having some difficulty at that time getting a doctor from the Burzynski Clinic to contact Dr. Gera. Because of this, we are still sorting out their recommendations and discussing them–along with their reasoning. God has blessed us with a wonderful doctor who truly wants what is best for Andrew and for our family. We are so glad that we are home and that Andrew is under her care!
In mid-February, as the family seems to be off-treatment in anticipation of having the kidney stones treated, the family starts to discuss other, better courses of treatment than the Burzynski Clinic:
Written Feb 18, 2008 10:50pm For several weeks we have been communicating with Dr. Kathy Warren at the National Institutes of Health/National Cancer Institute regarding Andrew. She looked at Andrew’s MRI to confirm the diagnosis (diffuse intrinsic pontine glioma) this past week, and has been very helpful in discussing (by e-mail and by telephone) treatment options with us and with Andrew’s oncologist. We are extremely impressed–and grateful–with how accessible Dr. Warren has been. She is not–yet–Andrew’s doctor; however, she responds to our e-mails and phone calls almost immediately. She has not tried to talk us into the clinical trials she is overseeing, but has presented them to us as options and has been willing to discuss other options (the Burzynski Clinic recommendations) as well. 
I am including part of a note I wrote to Dr. Warren earlier today because it accurately expresses our feelings about Andrew’s situation.
“…We understand the medical bottom line of Andrew’s diagnosis; however, we don’t want to live as if his life is over. He is full of energy, with relatively few physical problems–other than decadron side effects–right now. We know of kids who are doing okay with this diagnosis–2, 3, 4 and more years later. We can’t be assured that Andrew will be one of those kids, but neither can we be assured that he won’t.”
At some point, all mention of Burzynski simply….disappears. At some point I realized that I was simply following another patient’s progress through conventional, experimental treatments.
On March 2nd, we hear:
Andrew will be taking part in an Imaging Study under Dr. Warren’s direction. Dr. Warren’s research nurse is scheduling us to go to NIH some time in April. Dr. Warren has also encouraged us to take Andrew to see Dr. Stuart Goldman at Children’s Memorial Hospital in Chicago. We have already spoken to Dr. Goldman, and the plan right now is to wait to schedule an appointment at Children’s Memorial after we have the results of Andrew’s next MRI on March 10th.
So it seems that something has happened. A decision has been made. You would not know why they changed out of the Burzynski Clinic unless you go to the timeline in the family’s “my story” page:
February 2008
Andrew’s parents decide to stop the treatment recommended by Dr. Burzynski after conducting research and realizing that the children they could find who had been treated at the Burzynski Clinic for pontine glioma had not survived.
The family realized what skeptics know, that what happens in Houston does not save lives. Now, there is a note in March that the tumor had shrunk something like 65% from December. However, we can’t necessarily attribute that to Burzynski’s treatment, as Andrew was excluded from the clinical trial precisely because the results would have been muddied. Thankfully, the S. family had a longer time with Andrew after diagnosis than most families, 25 months, and it’s clear he brought much joy to his family.
UPDATE, July 2014
In private communication from Andrew’s family, we were informed:
“There were red flags for us all along the way, but pulling away from the Clinic was not easy. It’s a cult-like environment. You feel like you are walking away from the group who has the answers. You are going to become one of those people who don’t understand and who don’t believe…. It was traumatic. That is why we simply stopped mentioning it on the website. We officially ended our relationship with the Clinic mid to late February 2008. We just did not know how to explain what we had just experienced.”  
Usually, this is where we would put an appeal to donate to St. Jude’s. You may still do that, if you like, but we are now actively campaigning for an investigation into how the FDA decided to allow Burzynski not only to continue his ridiculous trials, but to actually get a phase III trial after a decade of abominable site visits. Go to thehoustoncancerquack.com and you will find the resources you need to put primary documents–the FDA inspection notes–into the hands of your representatives so they can conduct an investigation. All appeals to understand this made to the FDA have failed, so now we need to press the issue onto the committees that oversee the FDA. Please help us uncover what went wrong so we can fix it and so this never happens again.