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Selling an alternative medicine cancer cure testimonial as an “N-of-1” trial: Integrative medicine’s new propaganda technique? [Respectful Insolence]

Thursday, January 5, 2017 7:25
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If there’s one thing that proponents of “integrative medicine” (or, as it’s been called in the past, “complementary and alternative medicine,” or CAM) take great pains to emphasize whenever defending their integration of prescientific and pseudoscientific medicine into medicine, it’s that they do not recommend using “alternative medicine” instead of real medicine but in addition to real medicine. Indeed, even the “gods” of integrative medicine, such as Barrie Cassileth at Memorial Sloan-Kettering Cancer Center, not only emphasizes that but actually takes umbrage when it is suggested that integrative medicine ever suggests that alternative medicine should be used instead of science- and evidence-based medicine. She’s even written articles attacking cancer quackery, seemingly oblivious to the fact that many of modalities that fall under the rubric of integrative medicine are based on the same mystical or pseudoscientific ideas that the quackery she decries is.

Certainly, that’s what I thought about Glenn Sabin. You might remember Glenn Sabin because he’s been featured right here on this very blog a few times over the last several years. For instance, his admission that integration medicine is a “brand, not a specialty,” served as the basis for my discussion of the evolution of integrative medicine as a concept. More recently, he declared that CAM is dead and that “evidence-based, personalized integrative medicine continues its ascent,” and still more recently he wrote an ebook listing what he considered to be the 125 milestones in the development of integrative medicine. Through it all, if there’s one unerring talking point that proponents of integrative medicine never abandon, it’s that message that the woo is supposed to complement real medicine, to be “integrated with real medicine” and not to be used in place of it. Sabin promoted this message himself. Worse, he has co-opted “N-of-1” trials to promote his message, using them not as an experimental method whose usefulness is not yet sure but rather as a slogan for integrating quackery with medicine.

I was actually surprised—but perhaps shouldn’t have been—when I discovered that Sabin has what is in essence his very own alternative cancer cure testimonial. I really don’t know how it could be that I didn’t know this before. To be honest, I’m a little embarrassed that I didn’t know, but now I do, thanks to his new e-book alluded to in his book about the milestones of integrative medicine. That ebook is entitled N-of-1: One man’s Harvard-documented remission of incurable cancer using only natural methods. I recognized immediately that this is not a book about an “N-of-1” clinical trial (an interesting topic for another day), but rather a book describing an alternative medicine cancer cure testimonial co-opting a hot new area of clinical trial research.

Given the number of such stories that I”ve deconstructed in the past, I couldn’t let this one pass without examining it more closely, particularly given that it features quotes by Lee M. Nadler, MD, on how he has “witnessed an extraordinary patient who achieved a clinical response through non-conventional treatment approaches” and by David Rosenthal, MD on how Sabin “understands the importance of the mind and body in reducing stress and improving overall clinical outcomes in cancer. We are pleased to be able to work with him.” Both, of course, are Harvard faculty. I even took advantage of the ability to download an excerpt from the book. Because it required me to provide an e-mail address, I used a throwaway.

Here’s the blurb on his website:

In 1991, Glenn Sabin was a 28-year-old newlywed diagnosed with chronic lymphocytic leukemia (CLL)–a disease doctors called “uniformly fatal.” Treatments could buy him some time and eventually ease his discomfort, but there was no conventional cure. Glenn’s prognosis was clear: he was going to die.

Although Glenn and his wife, Linda, continued to consult with doctors, cancer specialists and top oncologists, Glenn made a monumental decision: he would become his own health advocate. While he continued to “watch and wait,” Glenn would figure out how to stay alive.

No one could predict when a large-scale clinical trial would discover a cure for CLL, so Glenn began his own, medically monitored and carefully researched lifestyle changes. He would conduct his own, single patient clinical trial.

He would become an “n of 1.”

Today, Glenn is not only alive, but a 2012 biopsy at Harvard confirmed that his bone marrow contains no leukemic cells. His case is now part of the medical literature.

I was glad to see that this case was part of the medical literature in the form of this case report now, because it gave me a far better account than I usually get upon which to base my discussion. So I headed straight to the source to check out this case report and was actually a bit surprised to notice that one of the authors is someone I knew, albeit not well. I also noticed that the authors included Jeffery White, Director, Office of Cancer Complementary and Alternative Medicine, National Cancer Institute. (That’s OCCAM, an office that has a budget approximately as large as that of the NCCIH.) The first author is someone named Dawn Lemanne, who is affiliated with Oregon Integrative Oncology. Let’s just say that this is not a particularly evidence-based practice.

So what does Sabin claim? Basically, he claims that his “natural therapies” resulted in his remission from CLL, not once, but twice. In 1991, Sabin was diagnosed with CLL and underwent a splenectomy because they lymphocytes had infiltrated his spleen. It was noted that, after his splenectomy, from 1992 to 2003, From 1992 to 2003 Sabin remained asymptomatic, but serial bone marrow biopsies revealed increasing lymphocytic infiltration. During this period, the peripheral white blood cell count fluctuated between 5.3 and 14.8 g/dL. Also, in 1993, Sabin did this:

Meanwhile, in 1993, at age 30, the patient began a self-directed health regimen. This included a near-vegetarian diet with occasional seafood, filtered water, over-the-counter nutritional supplements, and exercise (mainly resistance training with some aerobic activity consisting of power walking). He avoided processed foods and obtained organic or unsprayed produce whenever possible.

So, while Sabin was undergoing this self-directed health regimen, his numbers were getting worse. This is not particularly good evidence supporting the efficacy of diet and exercise for curing CLL. In fact, in 2003, Sabin developed fever, malaise, night sweats, and fatigue. Basically, he developed a relapse of his CLL and treatment with steroids, rituximab, and cytotoxic drugs was recommended. He declined, and amended his supplement regimen to include conjugated linoleic acid, whey protein with lactoferrin, and the botanical extract artemisinin. This is how the testimonial goes after that:

Despite feeling poor, he walked and swam daily. By October 2003, a few months after the episode began, the hemoglobin had risen to a normal value of 13.4 g/dL. The constitutional symptoms abated, and the patient made a complete clinical recovery.

In May 2006, when the patient was 42, a bone marrow examination showed lymphocytic replacement of 30%. This was decreased compared to the 2003 examination during the hemolytic anemia episode when lymphoid aggregates had replaced 90% to 100% of the marrow.

So, over three years, he got better, but not completely better. Three years later, in 2009:

In December 2009, the white blood cell count rose to 17,500/µL, with a lymphocytosis of 63%. Hemoglobin was 13.6 g/dL, and platelets measured 293,000/µL. The patient, now age 46 and asymptomatic, consulted author KB.

Based on early-phase clinical trials showing the efficacy of epigallocatechin-3 gallate in chronic lymphocytic leukemia, author KB prescribed a supplement formula containing reishi mushroom (Ganoderma lucidum), chaga mushroom (Inonotus obliquus), and green tea (Camellia sinensis) [2]. This formulation was chosen because the green tea fraction provided approximately 1200 mg daily of epigallocatechin-3-gallate.

In addition to this directed anticancer treatment, the patient’s constitutional resistance to cancer progression was assessed via detailed testing of inflammation and glucose metabolism. High-normal fibrinogen levels and modest elevations in D-dimer and C-reactive protein were interpreted as signifying hypercoagulability and mild generalized inflammation. Although levels of insulin, blood glucose, and fructosamine were normal, C-peptide was above ideal at 5.3 ng/mL, suggestive of aberrant glucose metabolism. In addition, 25-hydroxy vitamin D was 46.7 ng/mL, slightly below the optimum range of 50 to 70 ng/mL.

To address these issues, the patient was placed on high-dose fish oil containing eicosapentaenoic acid (10.8 g) and docosahexaenoic acid (2.4 g daily), curcumin (4 g daily), vitamin D3, Scutellaria baicalensis, and probiotics. Calcium and magnesium were added to address a reported decrease in lumbar vertebral bone density.

Despite this approach, by October 2010, the white blood cell count had reached 47,800/µL, with lymphocytes at 81.6%. At this time, author BRK detected an immunoglobulin variable region heavy chain (IgVH) mutation in the peripheral blood by PCR.

So basically what is clear is that the woo wasn’t working. Sabin was slowly getting worse. At least, his laboratory values were slowly deteriorating. His CLL was still active. Then this happened:

In December 2010, author KB increased the dose of epigallocatechin-3-gallate to 4 g daily, basing the dose on that used in a clinical trial at Mayo Clinic [2].

In February 2011, two months after the patient began the higher dose of epigallocatechin-3-gallate, the white blood cell count peaked at 50,600/µL, with 84% lymphocytes. Fibrinogen, D-dimer, C-reactive protein, and C-peptide levels had dropped to low-optimal ranges. The vitamin D level had reached a supranormal level of 110 ng/dL, and the dose of supplemental vitamin D was decreased.

In March 2011, the white blood cell count had dropped, measuring 30,600/µL. By August 2011, the white blood cell count was 6800/µL, with a lymphocyte fraction of 49%.

In January 2012, when the patient was 48, a marrow examination at the Dana-Farber Cancer Institute demonstrated slightly elevated cellularity at 60%. However, lymphocytes represented only 5% to 10% of the cellularity. Flow cytometry of the aspirate also showed no evidence of a lymphoproliferative disorder. These findings were interpreted as being inconsistent with a lymphoproliferative disorder.

In September 2014, when the patient was 51, the marrow was hypercellular at 80%. However, lymphocytes again comprised only 5% to 10% of the cellular component. Of particular note, these lymphocytes were specifically tested and found to be predominantly CD3 positive T cells, whereas B cells would have been consistent with chronic lymphocytic leukemia. For a second time, flow cytometry of the aspirate showed no molecular evidence of a lymphoproliferative disorder. IgVH mutation was no longer detected on PCR. The entire study was interpreted as being without evidence of a lymphoproliferative disorder.

So let’s get this straight. The patient’s white blood cell count kept increasing after Dr. Block increased the dose of epigallocatechin-3-gallate. It kept increasing for two full months and peaked at a pretty impressively high level. Then it decreased some and took a total of eight months after the dose change to decrease to a level within normal parameters. A year later, he appeared to be in remission, but even more than three years later, although there didn’t seem to be molecular evidence of a lymphoproliferative disorder, Sabin’s lab results can’t be said to be exactly normal. Yes, in 2015, three years after his last flare-up followed by a seeming remission, Sabin is doing well. I hope he contineus to do well.

Unfortunately, this testimonial is thin gruel to attribute Sabin’s good fortune to any sort of “natural” regimen that he undertook. After all, the first time around in 1992, he did a radical lifestyle alteration, but it clearly didn’t impact the course of his disease over more than a decade. Similarly, his later experiences don’t demonstrate that epigallocatechin-3-gallate or any of the other woo that Sabin undertook is the cause of his remission, no matter how much Sabin and the authors of the article describing his case report want to make it so. Correlation does not equal causation. It can indicate causation, but quite frequently it does not. Basically, this whole case report is singularly unconvincing.

Why?

I learned right away why I should be skeptical of this testimonial right from the very beginning of the case report:

Clinical remission of chronic lymphocytic leukemia without conventional therapy is a rare event, estimated to occur at the rate of 1% per year among cases of CLL [1]. Moreover, most such remissions are incomplete; a recent review of 21 such cases found persistent monoclonal B lymphocytosis in 67%, with only 33% regressing to a molecularly normal phenotype

So right away, we know that approximately 1% of patients per year with CLL will undergo spontaneous remission and that around 33% of those patients will completely regress to the point where molecular techniques can’t find any cancer cells. We also know that one publication has listed 21 such cases, of which seven were complete molecular remission. In other words, if these figures are accurate a grand total of around 0.3% of patients with CLL per year will undergo a complete molecular remission. that’s 3 out of 1,000. Admittedly, that’s a low number, but I wouldn’t call it so low as to be so out of the ordinary that most likely explanation for why Sabin has done well over the last quarter century must be the woo that he indulged in. A more likely explanation is that he was one of the 3 in a thousand (or one in a thousand or even lower if you think his chances of a spontaneous remission were lower because his young age and splenic involvement with CLL, which usually portends a more dire prognosis. None of this is to say that the epigallocatechin-3-gallate couldn’t have had an effect. Clearly, it might have, What I am saying is that Sabin is far too confident that his use of alternative medicine and integrative therapies were the cause of the remission of his cancer, particularly given that, according to the case report, Sabin remained asymptomatic throughout his entire course over 25 years, with the exception of the times he had his two relapses.

So one has to ask oneself when confronting a testimonial like this: What is more likely, that Sabin cured himself with lifestyle and by increasing the dose of one supplement or that he was lucky, one of the handful of patients who were fortunate enough to have a complete remission with no molecular signs of the tumor? While it is possible that Sabin’s interventions might have impacted his cancer in a positive manner, this testimonial isn’t particularly strong evidence of that. The timing isn’t as compelling as it’s sold, which is this way in the introduction to Sabin’s book:

When I was diagnosed with chronic lymphocytic leukemia in 1991, most doctors
would have said that modern medicine had no cure.

Most doctors believed then, that finding effective cancer treatments required huge sums of money to be spent on randomized controlled trials, in which expensive pharmaceuticals, many with harsh side effects are tested on numerous human subjects over many years. Such undertakings require the concerted efforts of exquisitely trained, well-funded, and very persistent scientists.

Most doctors believed then that nothing I could do for myself would help me survive leukemia. Although diet, supplements, and exercise—the pursuit of good health—might make my body stronger, my lifestyle choices would have no effect on the leukemia, and would therefore be a waste of time and money.

In 1991, most doctors would have said that there was no way I could successfully treat my own cancer, at home.

It is now 2016, and I am alive. And although I am well, very well indeed, many physicians still say that a patient cannot successfully treat cancer at home. However, perhaps it can be done. Perhaps I have done it. I don’t know. This book is my story, and it is above all the story of an experiment. As an experimenter I have catalogued my failures as well as my successes, in hopes that interested readers might find some instruction in both.

I note that I can’t evaluate Sabin’s cataloguing of his successes and failures for the simple reason that the book excerpt he sent me was only the first few chapters that described his initial diagnosis. It’s compelling reading, the story of a young man recently married who was diagnosed with a chronic disease excepted to be lethal, but it doesn’t really provide any details. I also note this case report of a spontaneous remission of CLL, in which there was no apparent triggering event and the authors noted that “even after the complete spontaneous clinical and laboratory regression of the disease, there were still occult CLL cells in the remaining microenvironmental niches of the bone marrow that could be detected by molecular techniques.” Again, I hope Sabin continues to do well. I really do. However, there’s a good chance he still has leukemic cells lurking at a level that is currently undetectable.

I discussed Sabin’s case for a simple reason. Sabin is one of the leading lay popularizers of “integrative medicine.” He is in big time with many of the leading integrative medicine physicians, as evidenced by the blurbs they provided for his book and the quotes of praise by them on Sabin’s website by luminaries such as Drs. Jun Mao, Debu Tripathy, Mark Hyman, David Rosenthal, Lorenzo Cohen, Moshe Frenkel (who’s affiliated with M.D. Anderson and into homeopathy and co-authored a study testing homeopathic remedies on breast cancer cells), and others. Yet, clearly he believes that alternative medicine probably cured him of a fatal disease and has published a book documenting that process based on his “N-of-1” self-trial. In reality, his “N-of-1” is not a clinical trial, Sabin’s use of the term notwithstanding. There was no predetermined protocol, and his story shows none of the hallmarks of a real N-of-1 trial. Basically, Sabin’s story is nothing more than, at best, a case report, but, as told on his website, an alternative cancer cure testimonial masquerading as an “N-of-1” trial.

In this, he is little different from Suzanne Somers, Chris Wark, a Stanislaw Burzynski patient, or any number of believers in medical pseudoscience who use their testimonial of survival as evidence that quackery works. Sure, Sabin is less quacky than Somers or Wark, and—who knows?—maybe green tea extract has effects against CLL, but, whatever denials he might make otherwise, his book is selling the message that you don’t necessarily need conventional medicine to treat cancer, that you can treat your cancer on your own with “natural” methods. That’s a message that’s bound to lead to preventable deaths. It’s also counter to the number one talking point of integrative medicine in general and integrative oncology in particular: That alternative medicine should be used with medicine and not as an alternative to medicine. It’s a premise that is belied by the embrace of naturopathy by integrative medicine, given how naturopaths frequently substitute quackery for real medicine.

Finally, you can see the way “integrative oncology” is going by this description of Sabin’s co-author, Dawn Lemanne, MD, MPH:

Dr. Dawn Lemanne is a practicing oncologist and integrative medicine authority. One of a small but growing number of oncologists integrating conventional and complementary therapies to treat cancer, Dr. Lemanne approaches each patient as an n of 1. Her practice draws patients from around the globe.

Dr. Lemanne is a proponent of rigorous single-subject research design development and is active in the quantified self movement. The first medical oncologist to serve on the faculty of New York’s Memorial Sloan Kettering Cancer Center’s integrative medicine service, she currently teaches physicians in the University of Arizona’s flagship integrative medicine fellowship. She is the author of peer-reviewed scientific articles, textbook chapters, and works for the popular press. Dr. Lemanne speaks by invitation domestically and internationally.

After earning the MD degree at the University of California, San Francisco, Dr. Lemanne trained in medical oncology at Stanford University and in integrative medicine at the University of Arizona. She also holds advanced degrees from UC Berkeley and Johns Hopkins University.

Rigorous? I’d hardly call the case report on Glenn Sabin that I just examined rigorous.

Clearly, since most integrative medicine modalities fail in rigorous randomized clinical trials, this is the way the specialty is going, both because “N-of-1” trials can be sold as evidence that the woo being integrated into medicine works without the need for all those pesky expensive rigorous randomized trials and because N-of-1 trials cater to the very core beliefs of CAM and integrative medicine. After all, integrative medicine is based, above all on catering to “special snowflakes.” Its proponents claim to treat each patient as an “individual” and to treat the “whole” person, and N-of-1 trials make it all about the individual patient and move medicine away from rigorous science and back towards pre-clinical trial medicine, in which anecdotes and case reports ruled. It’s all of a piece with how integrative medicine “turns back the clock” on medicine. Yes, there is a role for “N-of-1” trials in conventional science-based medicine, but it’s still controversial how useful and rigorous they can be, when and under what circumstances they should be used, and how they should be designed. Unfortunately, Glenn Sabin is showing integrative medicine the way to put the cart before the horse and make “N-of-1” the slogan for integrative medicine.



Source: http://scienceblogs.com/insolence/2017/01/05/selling-an-alternative-medicine-cancer-cure-testimonial-as-an-n-of-1-trial-integrative-medicines-new-propaganda-technique/

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