R.I.P., McKenzie Lowe. Stanislaw Burzynski failed you.

R.I.P., McKenzie Lowe. Unfortunately, Stanislaw Burzynski was no more able to save you than anyone else, his claims of great success treating pediatric brain tumors notwithstanding:

HUDSON — Thirteen-year-old Hudson resident McKenzie Lowe died Friday evening after a 2-year-battle against an aggressive and inoperable brain stem tumor.

McKenzie died at 10:27 p.m. in her own bed at her home in Hudson.

McKenzie was diagnosed on Nov. 28, 2012 with Diffuse Intrinsic Pontine Glioma, or DIPG, a brain tumor located on the brain stem. Patients with DIPG typically survive for less than a year.

Months before her death, McKenzie underwent a controversial cancer treatment called antineoplaston therapy. She underwent chemotherapy and more than 40 kinds of radiation in 2013, but the treatments made her sick and tired. Her parents came across the therapy while looking for another alternative treatment.

Developed by Dr. Stanislaw Burzynski of Texas, the treatment was administered for 20 hours a day for six to eight weeks. McKenzie wore a backpack that would carry around the bag of liquid antineoplastons.

I can’t tell you how much this news saddens me, although it does not surprise me at all. Burzynski has yet to publish a truly completed clinical trial demonstrating the efficacy and safety of antineoplastons (although he has published partial clinical trials that were badly designed and badly reported). My heart truly goes out to the Lowes, although I fear that, if they know about me at all, they view me in the same way all too many of those who have fallen under Burzynski’s spell do: As someone actively trying to prevent them and parents like them from saving their children’s lives. In reality, what I and other skeptics are trying to do is to prevent children like McKenzie Lowe from suffering the risks of antineoplastons with no hope of benefit and families like the Lowes from paying boatloads of money for the privilege. We all have an idea of how desperate and sad families like the Lowes must be; it’s a horrible thing to face the loss of a child. What makes it worse is chasing after fantastical cures, like those claimed by Burzynski.

I’ve written about McKenzie Lowe on more than one occasion. As hard as it is to believe, the first time I wrote about her in detail was nearly a year ago, when she first came to my attention as the then-newest patient of Houston physician Stanislaw Burzynski. After a year of having fought her DIPG, her parents, unfortunately, were seduced by the siren sound of Burzynski’s antineoplastons, amino acid derivatives originally isolated from the blood and urine and then later chemically synthesized and manufactured by Burzynski.

At the time, Lowe was just the latest victim of a nearly four decades-old scam that began all way back in the late 1970s, where, after several years as a legitimate scientist at Baylor, Burzynski turned to the dark side and started administering his antineoplaston concoctions to actual patients. As I like to put it, Stanislaw Burzynski became Burzynski, the brave maverick doctor. So confident was he that his discovery was a breakthrough in the treatment of cancer that he struck out on his own to form his own clinic and, later, own manufacturing facility to make antineoplastons.

Since that time, Burzynski’s legend grew in the alternative cancer cure community, among whom over the years he managed to build a reputation for himself as the one man who could cure incurable brain tumors. It was a claim he could get away with in those heady early years in the late 1970s through the 1980s. After all, then all he had were testimonials, rather than clinical trials, and we all know how testimonials can deceive and how outlier patients who survive deadly tumors can have an outsized influence on the reputation of a cancer quack. Then, of course, these were pre-Internet days, where stories, anecdotes, and testimonials were swapped by word of mouth, pamphlets, and mimeographed newsletters. Once enough “buzz” developed, Burzynski made it to the big time, appearing on Sally Jessy Raphael’s daytime television show with four “miracle patients” claimed to have had incurable cancer and failed conventional therapies before finding Burzynski. In the show, they claimed to be cancer-free. Four years later, Inside Edition reported that two of the four patients had died and a third had suffered a recurrence, while the fourth had had a bladder cancer with a favorable prognosis. The widow of one of Raphael’s guests stated that her husband and five others from the same city had sought treatment with Burzynski and that all had died of their cancers.

In the 1990s, thanks to the rise of the precursor to the National Center for Complementary and Alternative Medicine (NCCAM), the federal government was actually taking interest in alternative cancer cures and tried to work with Burzynski. The results were a disaster, with constant conflict. Then, in 1995, Burzynski was charged with insurance fraud for charging insurance companies for his non-FDA-approved treatments. He got off, but it was worse than that. Not only did Burzynski get off, but, because a powerful Representative, Rep. Joe Barton (R-TX), was putting near constant pressure on the FDA for “persecuting” Burzynski, he was given a golden opportunity by the FDA to “legitimize” his quackery. Basically, the FDA caved and agreed to let Burzynski do clinical trials. Here’s what Burzynski’s lawyer, Richard Jaffe, later wrote about those clinical trials:

So we decided to hit the FDA with everything at the same time. All of his current patients would be covered in a single clinical trial which Burzynski called “CAN-1.” As far as clinical trials go, it was a joke. Clinical trials are supposed to be designed to test the safety or efficacy of a drug for a disease. It is almost always the case that clinical trials treat one disease.

The CAN-1 protocol had almost two hundred patients in it and there were at least a dozen different types of cancers being treated. And since all the patients were already on treatment, there could not be any possibility of meaningful data coming out of the so-called clinical trial. It was all an artifice, a vehicle we and the FDA created to legally give the patients Burzynski’s treatment. The FDA wanted all of Burzynski’s patients to be on an IND, so that’s what we did.

According to Jaffe, it was not because Burzynski was so interested in knowledge and finding out whether ANPs work. It was because he already believed they worked and wanted to keep treating patients without interference:

CAN-1 allowed Burzynski to treat all his existing patients. That solved the patients’ problems, but not the clinic’s. A cancer clinic cannot survive on existing patients. It needs a constant flow of new patients. So in addition to getting the CAN-1 trial approved, we had to make sure Burzynski could treat new patients. Mindful that he would likely only get one chance to get them approved, Burzynski personally put together seventy-two protocols to treat every type of cancer the clinic had treated and everything Burzynski wanted to treat in the future…Miracle of miracles, all of Burzynski’s patients were now on FDA-approved clinical trials, and he would be able to treat almost any patient he would want to treat!

This is how, 20 years after Burzynski had started treating cancer patients, the FDA “legitimized” him by giving him the chance to enroll nearly all his patients in clinical trials. Because they were all phase 1/2 clinical trials directed against deadly diseases, they didn’t necessarily have to be randomized placebo-controlled trials. So what Burzynski did was to completely abuse the clinical trial process, charging enormous sums of money to enroll desperate patients in his clinical trials. He also abused the process of issuing single patient INDs (colloquially known as “compassionate use exemptions”). More recently, Burzynski had come to my attention in a big way when one of his minions started issuing legal threats against online critics, after which I reviewed a propaganda movie made by a man named Eric Merola, a film that had served as an excellent advertising vehicle for the Burzynski Clinic.

Eleven months ago, when the Lowes were ensnared, no small part due to Merola’s propaganda “documentary,” Burzynski had just suffered the PR hit of a huge article in USA TODAY documenting how the death of a child as a complication of his antineoplaston therapy had resulted in an FDA site visit and investigation, as well as a partial clinical hold, first on all his pediatric clinical trials, then on all his adult clinical trials as well. In the meantime, all he had left was his “gene-targeted” cancer therapy, or, as I like to call it, gene-targeted cancer therapy for dummies based on ignorance, and that wasn’t going so well.

So Burzynski went back to doing what he does so well, what served him so well in the 1990s: Using desperate cancer patients, especially children, as shields and weapons against the FDA. McKenzie Lowe was the first of these after the revelations of the USA TODAY story that I noticed, but there were others, one of whom was even the wife of a rock star, Liza Cozad, the wife of the drummer in Sammy Hagar’s band.

Unfortunately, ultimately, much to the shock, horror, and amazement the FDA caved and lifted the partial clinical holds on Burzynski’s clinical trials earlier this year. I have no way of knowing whether the PR campaign using dying cancer patients worked—although it did net Senator Kelly Ayotte (R-NH) into writing a letter to the FDA requesting that its leadership let McKenzie Lowe receive antineoplastons—actually worked or whether the FDA was somehow convinced by Burzynski’s responses to its findings that he was going to clean up his act in spited of a long, long history on his part of telling the FDA what it wanted to hear and promising to be real, real good again and then going back to his old ways. Either way, it was a horrifically irresponsible decision, a complete abdication of the FDA’s duty to protect patients from ineffective and dangerous drugs.

If any other evidence of the FDA’s depraved and utter failure with respect to Burzynski were needed, what happened next seals it. The Lowes found a retired family practitioner named Dr. Terry Bennett who had had his own battles with the FDA to obtain a drug for himself and his cancer. Despite having originally promised to supply antineoplastons for free to any patients who were allowed access by the FDA under compassionate use protocols, Burzynski then proceeded immediately to be Burzynski and…well, let me just cite an article at the time quoting Dr. Bennett:

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

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

And health insurance won’t cover a dime of it.

The Lowe family has started a GoFundMe.org (GoFundMe.com/9a4geo) account, which raised over $5,800 as of June 17. And they set up an account with the Digital Federal Credit Union in Hudson that also has been taking donations.

Which led to Bennett’s lament:

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.”

Elsewhere, Bennett observed, “It meets all the criteria for a bait and switch operation.”

Bennett really shouldn’t be surprised. That’s what you sign on for when you deal with Burzynski. All it would have taken is a little due diligence and some Google searches on Burzynski to discover that this is how he operates. He’s long claimed that he provides antineoplastons for free and that his charges are “case management” fees and charges for the pump and supplies. Again, that’s how he’s operated for at least a decade. Moreover, it’s not as though Burzynski ever promised to provide free care. He just promised free antineoplastons, which is what he’s basically always done, while charging tens of thousands of dollars a month for other things. Unfortunately, Bennett ended up being a dupe, an unwitting accomplice to Burzynski’s operation. In the belief that he was helping them, he helped Burzynski extract large amounts of cash from them while helping to oversee pumping a bunch of useless chemicals into a dying child. Worse, I think he eventually realized it. I’m as angry about this as William London, but, sadly, I’m not surprised.

Recently, Burzynski has published a press release claiming that the FDA has given permission for the Burzynski Research Institute to conduct new clinical trial of antineoplastons against DIPG:

Burzynski Research Institute, Inc. (BRI) announced today that the U.S. Food and Drug Administration (FDA) has given the company permission to conduct an open-label study of Antineoplastons A10 and AS2-1 in patients > 3 months of age with a diffuse intrinsic brainstem glioma (DIPG). Study subjects will be placed in one of five treatment groups based on their age and whether or not they have received prior treatment for DIPG. The primary study endpoint is a decrease in the size of the tumor, either a partial response (≥ 50% decrease in the size of the tumor) or a complete response (disappearance of the tumor). The study is in its final organizational stage and will begin accruing patients as soon as this organizational stage is completed.

An open-label study? That basically means it’s completely unblinded. Blinding isn’t as important for studies like this looking at objective endpoints, but we all know that Burzynski is not known for being good at measuring tumor sizes on scans. For such studies, at the very least the radiologists interpreting the scans should be blinded to experimental group. More importantly, how big is this study? A study with five experimental groups is going to require a lot of patients in order to have the power to detect statistically significant results that aren’t so obvious that you don’t need statistics to see them. In any case, the study isn’t in ClinicalTrials.gov; so it clearly hasn’t even been submitted to the FDA, much less approved, yet. My guess? This is yet another mechanism by which Burzynski will suck unwitting patients and families in.

The Texas Medical Board has finally gotten off of its posterior again and is going after Burzynski, but the hearing isn’t expected until early next year. It’s become increasingly clear to me that the FDA is never going to stop Burzynski—ever—which is one reason why I have nothing but contempt for health freedom activists and “right to try” advocates who portray the FDA as a bunch of jackbooted thugs controlling everything. Such a view has nothing to do with reality, as the impotence of the FDA in the face of Stanislaw Burzynski demonstrates conclusively. That just leaves the Texas Medical Board.

I fear that patients with cancer are screwed, at least until Burzynski retires or dies. Weep for McKenzie Lowe. No child should suffer the fate she did, nor should any family have to endure the pain of watching a child die. But weep also for all the other children treated by Burzynski in all the years that our ineffective regulatory apparatus let him continue to practice. They deserve a share of the blame for having failed to stop Burzynski for 37 years.