Deconstructing another Stanislaw Burzynski cancer “success story”

A key pillar of the Stanislaw Burzynski antineoplaston marketing machine, a component of the marketing strategy without which his clinic would not be able to attract nearly as many desperate cancer patients to Houston for either his antineoplaston therapy (now under a temporary shutdown by the FDA that, if science were to reign, will become permanent) or his “personalized gene-targeted cancer therapy,” which Burzynski represents as a discovery of his that large NCI-designated comprehensive cancer centers like M.D. Anderson or Memorial Sloan-Kettering are only now starting to copy, is the collection of patient testimonials that are used to sell Burzynski as able to cure cancers that no one else can cure. Of course, as someone relatively knowledgeable about the state of personalized cancer therapy, I can’t help but wonder why the Burzynski machine never mentions Moffit Cancer Center, which has a very active genomics program and personalized cancer therapy initiative itself, or Mt. Sinai or Cornell, both of which are engaged in a genomics “arms race.” Maybe he isn’t as knowledgeable about personalized cancer therapy and targeted therapies as he claims. (Oh, wait. He isn’t!) In any case, lacking any compelling clinical trial data (or at least, never having published a completed phase 2 clinical trial), despite having registered over 60 such trials, all Burzynski has is patient testimonials, what his propagandist Eric Merola likes to tout as patient success stories, patients like Hannah Bradley, Laura Hymas, Mary Jo Siegel, and Tori Moreno, all of whom featured prominently in one of Merola’s movies promoting Burzynski. The problem is, although these cases seem compelling on the surface, when you look at them in more detail inevitably they turn out not to be very good evidence that Burzynski’s antineoplastons or “personalized gene-targeted cancer therapy” can result in better outcomes than the existing standard of care.

So it was that when I wrote about Fabio Lanzoni teaming up with Eric Merola to promote Stanislaw Burzynski, multiple people asked me about a new patient, one who appeared for the first time in a Burzynski advertisement—excuse me, Q&A by Eric Merola. This is a patient who of late has been very active on Twitter both attacking Burzynski critics and singing the praises of Stanislaw Burzynski, all the while touting how Burzynski cured her stage IV triple negative breast cancer. She has also recently become one of the main users of the @BurzynskiSaves Twitter account, which formerly was run by someone whom many Burzynski critics suspected to be an employee of the Burzynski Clinic but was recently apparently handed off to a cadre of Burzynski patients, as revealed in Merola’s last video. Clearly, she is a new recruit to the patients whose testimonials Burzynski and Merola use to promote the Burzynski Clinic. Her story, that Burzynski saved her from stage IV triple negative breast cancer, seems very compelling at first glance. But is it?

It is with a bit of trepidation that I tackle this case, because, no matter how careful, respectful, and nuanced I am, I can reasonably expect that I will be accused of “attacking” this patient. It is even possible that someone will call my university again to complain about me. Of course, I’m doing nothing of the sort and have no doubt that this patient genuinely believes that Burzynski saved her. My analysis of her anecdote, however, leads me to believe that she is probably not correct in attributing her survival to Burzynski. I also know that to a patient who is not an expert in cancer, a story like hers can seem all the world as though Burzynski really did save her and realize that I’m not going to change this patient’s mind, no matter what I say. I do, however, want to critically examine her story, as told on various pro-Burzynski websites, because her story is being touted by Burzynski and Merola as yet another “success story” that proves that Burzynski can cure cancers that others can’t.

The patient, Sheila Herron, touts her experience as a nurse for over 30 years and is a passionate defender of Burzynski, so much so that she sometimes gets a bit—shall we say?—carried away, invoking stormtrooper analogies and calling Burzynski critics “fascists,” then trying to make nice with them not long after. She was diagnosed with triple negative breast cancer three years ago, and that happens to be my area of specialty. Triple negative breast cancer is an aggressive subtype of breast cancer that lacks hormone receptors or the HER2 receptor. Stage for stage, it tends to have a worse prognosis, with a higher recurrence rate and lower survival rate. Worse, contrary to hormone receptor positive breast cancer, which can be treated with Tamoxifen or aromatase inhibitors (drugs that block the action of estrogen) or HER2-positive tumors, which can be treated like Herceptin, triple negative breast cancer has no molecular targets for therapy that have been identified and validated yet. As a result cytotoxic chemotherapy is the only systemic treatment. It turns out that triple negative breast cancer is often very sensitive to chemotherapy—more so than estrogen receptor-positive cancers, by and large; the problem is that it rapidly develops resistance.

So what’s Ms. Herron’s story? The official version is recounted at—where else?—the Burzynski Patient Group’s website. There’s also a version of her story on Cancer Compass, which touts itself as a website that advocates the use of alternative cancer therapies. (No kidding.) On the Burzynski Patient Group website, the story is told thusly:

In Nov. 2009 I developed pneumonia and had a chest x-ray which showed a mass on the left upper lobe of my lung. This proved to be cancer. The PET scan leading up to the lung surgery, showed masses in my breasts. I had a left upper lobectomy in Nov. 2009, and bilateral mastectomies with reconstruction in Feb. 2010. I chose to take the holistic route, as I have seen the ravages that traditional chemotherapy inflict on the human body in the patients I have cared for. I will attach the link to the “Cancer Note” I wrote on Facebook which describes the steps I took to build up my immune system. (Let me know if the link doesn’t work, and I will cut and paste it to you. A few weeks ago I had a local recurrence of my breast cancer and had surgery to remove it. This led me to call the Burzynski Clinic

It’s not entirely clear from the account above (at least not to me) whether Ms. Herron had an early stage lung cancer successfully treated surgically and then was soon after diagnosed with breast cancer (in other words, had two independent primary tumors, each successfully treated with surgery) or whether her lung cancer was actually a metastasis from her breast cancer that was resected, followed by her diagnosis with breast cancer and successful surgical treatment (i.e., stage 4 disease). Her Cancer Compass account doesn’t help in this regard, as it concentrates only on her treatment with Burzynski (and, as we will see, a whole lot of other woo), and her initial treatment was before she found her way to the Burzynski Clinic, although she does say she has “thanked my cancers (lung and breast) for all they have taught me, and have told them they can leave now,” which sounds as though she had a lung cancer and a breast cancer. A little deeper digging was required.

It turns out that there is more information on this part of Ms. Herron’s treatment odyssey on Facebook, contemporaneously dated April 2010. In a comment, she writes:

My cancers were discovered in Nov. 2009.

By MIRACULOUS good luck I got the flu (probably H1N1). I got pneumonia, went to urgent care and they did a chest x-ray, which showed a mass on my left upper lobe. I had a CT the next day, a thoracic surgeon consult 3 days after that, then a CT guided biopsy, a PET scan and a pulmonary function study done in the 3 days after that, and the next week had a mediastinoscopy/bronchoscopy and video assisted left upper lobectomy (12 days after the first x-ray- an example of the allegedly “terrible” healthcare system we have. In Canada I might just now be seeing the thoracic surgeon or having the PET scan. I am SOOOOO grateful to live here!!!). The PET scan I had (where they inject radioactive sugar and do a CT looking for metastastis) showed no lung metastasis, but a weird area on my left breast. After I recovered from the lung surgery, I had a mammogram, and an ultrasound guided biopsy (it turned out to be another, seperate cancer from the lung). I then had an MRI and underwent bilateral mastectomies with reconstruction in Feb…

My final reconstruction surgery will be May 4th- the new and improved me, breast cancer free.

What a miracle that flu was!!!!! I would have been walking around oblivious to both cancers if I hadn’t needed that initial chest x-ray for the flu. My breast cancer turned out to be in both breasts as well. Amazing!! It never showed up on mammograms, (35% of breast tumors don’t- surprise to me!)

I am taking the naturopathic route vs/ chemo/radiation and am doing great. There is SOOOOOO much we can do to help our incredible immune systems heal our bodies and/ OR (preferably) STAY healthy!! I was certainly not paying attention, or taking care of my body before this happened.

I AM now.

In a comment made on the Burzynski Scam blog, Herron writes (you’ll need to scroll down a bit):

I was diagnosed with Adenocarcinoma of the left upper lobe of my lung in Nov. 2009, and had a lobectomy. The pre-op PET scan found my breast cancer, which turned out to be Stage III triple negative invasive ductal carcinoma. I went the naturopathic route vs/ chemo and radiation, because as an RN for 34 years, I have seen the ravages the traditional route can cause.

This clarifies things. Up to this point, these accounts are most consistent with two separate primaries, one an adenocarcinoma of the lung, which was resected thoracoscopically, and a second cancer in the left breast, arising from the breast. Consequently, up until this point, what we most likely have is a woman who was unfortunate enough to have two different cancers in two different organs, but fortunate enough that both of them were sufficiently early stage that they could be successfully resected surgically. Like so many testimonials I’ve discussed before, she refused chemotherapy and radiation in favor of lots and lots of woo, including naturopathy, massive changes in diet, green tea, juicing, Resveratol, reiki, “detox,” and acupuncture. (And that’s not all.) As is so frequently the case, by refusing adjuvant chemotherapy and radiation, which are the “icing on the cake” for surgery in breast cancer that decrease the chance of recurrence, she decreased her chance of survival. I did a bit of prognosticating using Adjuvant! Online, which allows me to estimate 10 year survival rates for cancers with various characteristics. If Ms. Herron had a stage III cancer, that means it was either rather large (greater than 5 cm), had a lot of positive lymph nodes, or both. According to Adjuvant! Online estimation, a patient with a stage III triple negative cancer treated with surgery alone has, depending on the specific features of the tumor, between a 24% and 57% chance of being alive in 10 years. (I ran the estimate using the worse features I could think of consistent with a stage III triple negative cancer, ran it again with the most favorable features I could think of, using an estimate of Ms. Herron’s age to be around 58 based on her time in nursing.) Sure, those odds aren’t fantastic, and I doubt she’s at the 57% end of the scale, but even though Ms. Herron’s odds were most likely less than 50-50 without adjuvant chemotherapy, they weren’t so horrible that it would be considered highly unusual or rare for her to have survived.

So why did she go to the Burzynski Clinic? She tells the tale in multiple places. First, here’s a continuation of the account on the Burzynski Scam blog:

I developed a small localized recurrence in Aug. 2011. After surgery, I went to the Burzynski Clinic in Sept. 2011. They ordered a PET scan which discovered my T-2 spinal metastasis. I started on his treatment and was followed up by an oncologist near me who works with Dr, Burzynski for my monthly labs and an injection. Twelve weeks, almost to the day of starting his treatment, my cancer was gone, as verified by my follow up PET scan Dec. 22, 2011. The radiologist had the before and after films up and showed me that it was all gone and that “there is no active cancer anywhere”. This treatment had no side effects, I did not lose my hair, and my monthly labs remained normal. How many other cancer treatments out there can say this? NONE!!!

And on the Burzynski Patient Group website:

I was encouraged to stay a few more days. A whirlwind of actions occurred the next 2 1/2 days. I had thorough blood and urine work-ups, as well as an echo-cardiogram and a PET scan, which was miraculous, for the PET scan showed a metastasis to T-2 on my spine. I was started on his medication on the first day and then low dose chemo for my metastasis and an injectable to keep my bone strong and prevent further metastasis. It is a miracle!! I would not have known about this situation until it had spread further, or until, possibly, my spine had a pathological fracture, which, that high up, could have caused quadriplegic, so I can, and I DO, say that Dr. B and his team have already saved my life by finding this tumor and getting me on their gene targeted regimen to remove it.

So about a year and a half after Ms. Herron’s radical surgery rendered her disease-free, she developed a local recurrence. This is unfortunate. We also don’t know for sure whether she underwent radiation therapy, although the story sounds very much as though she did not. Radiation therapy is indicated after surgery for a stage III breast cancer, because that can greatly decrease the risk of a local recurrence, even after a mastectomy. In any case, this recurrence must have been small, localized, and amenable to resection with a wide margin. In this, Ms. Herron was again fortunate, because all too frequently chest wall recurrences like hers presage metastatic disease, and all too often they tend to be too extensive to be amenable to a simple surgical excision.

But, wait, you say. Wasn’t the spine lesion on PET metastatic disease? The answer to that question is: Maybe. We don’t know. Why do I say that? The reason is simple. As far as I can tell, there was never a tissue diagnosis to prove that that T2 lesion was in fact metastatic disease to the spine. Most oncologists will not treat a breast cancer patient for metastatic disease without first doing everything within reason to obtain a biopsy and thus proof that the lesion is a metastasis. Just as important, tissue allows the oncologist to look at markers; sometimes estrogen receptor-positive tumors turn negative as they metastasize or sometimes the HER2 status changes. Such information is very useful for planning therapy, rather than just basing additional therapy on the original surgical specimen. I’ve looked around, and nowhere have I been able to find an account of Ms. Herron’s treatment in which Burzynski got a biopsy of the spinal lesion before initiating treatment. PET scans can be misleading; they can have a not insignificant false positive rate. Actually, in fact, depending upon the clinical situation, they can have a high false positive rate. There are lesions on PET that can mimic metastasis. For instance, fibrous dysplasia of the bone can mimic skeletal metastases, as can osteonecrosis, inflammatory lesions, and others. Quite frequently, these lesions disappear when a patient is rescanned a few months later.

True, there are exceptions to the “tissue rule,” such as if it’s unsafe to biopsy due to location or patient comorbid conditions or if the lesion is so characteristic on an MRI or CT of the involved vertebrae that there is no doubt. (One notes that no mention of imaging of the spine is made other than the PET scan.) Even accepting those exceptions, a tissue diagnosis would still be essential, especially in this case, before starting treatment of bone metastases. Remember, this is a patient who apparently had two different cancers diagnosed three and a half years ago. Although less likely than breast, the spine metastasis, if it was real, could have been lung cancer. However, despite every indication for obtaining a tissue diagnosis, as far as I can tell Burzynski apparently never got a biopsy of the lesion detected on PET scan before beginning treatment in order to confirm metastatic disease and identify tissue type. In retrospect, given the clinical behavior of this “metastasis,” most likely what happened is that Burzynski treated a false positive PET lesion, and it did what nearly all false positive PET lesions do: It disappeared within a few months.

Alternatively, it is possible that this lesion was a metastasis and that the chemotherapy that Burzynski administered shrank the tumor to microscopic disease, but, most likely, did not eliminate it entirely. Personally, I’d prefer the first possibility over the second. No, the reason is not because it would mean that Burzynski’s “personalized gene-targeted cancer therapy” doesn’t work, but because the first possibility would imply a good chance of long term survival for Ms. Herron. The second possibility would be much less favorable for her; it would mean that, sooner or later, her cancer will likely recur. I do not want that to be the case. Regardless of my wishes and whatever the case really is, without a report of a tissue diagnosis, it’s impossible to distinguish between the two possibilities. The point, of course, is that Ms. Herron’s case, like virtually every other Burzynski patient case I’ve analyzed, is not convincing evidence for an antitumor effect due to Burzynski’s treatment, although it is also possible that her story could mean an antitumor effect due to Burzynski’s “everything but the kitchen sink” approach to combining chemotherapy and targeted therapies. As is always the case whenever Burzynski mixes and matches chemotherapy and targeted therapies, he might have gotten lucky, and Ms. Herron’s tumor was responsive to the cocktail. Without a lot more information, we just can’t tell which possibility is most likely. We can tell, however, that it’s unlikely that Burzynski is the cause of Ms. Herron’s good fortune.

Finally, Ms. Herron is not undergoing antineoplaston therapy, but rather Burzynski’s “gene-targeted therapy.” This led me to wonder: On what basis is he “targeting” his therapy? As I’ve recounted before, Burzynski usually sends off blood and tissue samples to Caris for testing. The Caris Target Now™ test, which since my discussion of Burzynski’s “personalized therapy” appears to have been renamed Caris Molecular Intelligence and is now available at more levels of service (although its reports look much the same to me), is nothing unique to the Burzynski Clinic. Anyone who is willing to pay for it can have it, and the report will be the same. Given that Burzynski appears not to have gotten tissue before treating Ms. Herron, what did he send to Caris for testing? Maybe he sent blocks from her original tumor. Who knows? In any event, there is as yet no convincing evidence that the Caris tests (or any of the other competing tests) result in better outcomes.

I’d like to conclude by saying that I wish Ms. Herron well. Really, I do, despite her intemperate behavior on Twitter. That’s actually why I hope that Burzynski really did treat a false positive PET lesion, because that explanation for her good fortune would be most consistent with its continuing indefinitely, in contrast to an actual treatment effect, which would imply eventual relapse. When it comes to Burzynski, on the other hand, I’m not nearly so benevolent. In my ever-Insolent opinion, he and his propagandist Eric Merola are cynically using patients like Ms. Herron as human shields to deflect criticism. I can put up with a lot from cancer patients, even Burzynski cancer patients, and never respond in kind. Burzynski’s activities I cannot countenance.