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Commentary
Also see When Laypersons give Medical Advice
I often found Robert Miller (RM) interesting and likeable, but I think there are many subtle and sometimes overt reasons for concern regarding his message and delivery system ... and many reasons patient groups should be wary of endorsing his "strategies for long term survival." ... this very phrase I find misleading, because it presumes he knows that his strategies can influence survival. He doesn't.
On a list I moderate a women reported that she declined treatment of localized stage I fNHL, and is taking curcumin. Did she decline because of a belief in curcumin and other RM strategies? Stage I, fNHL is potentially curable, as you know, about 50% of the time.
Another reason for discomfort with RM is his relationship with Grouppe Kurosawa (a group led by a convicted felon), a layperson who promotes among other bogus "natural" practices, high dose glutamine as treatment for aggressive lymphomas.
Add to this, RM's past tendency to dissuade patients from following doctors advice on CVP, based on a personal lay theory. There are many accounts of people reduced to tears, believing that because they had CVP that they won't respond to CHOP in future, which is not true.
While RM's "natural" strategies are not likely to be harmful in themselves, the concern is that his message can leads to a strong belief, and to delays or avoidance of proven treatment in susceptible people - who understandably fear standard treatments. The evidence supporting faith in his strategies does not exist, but the tone, and the take-home-message is consistently this: There is ample reason for faith in my "winning strategies" and "success." Beware the skeptics!
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"No one.with nothing to offer but negative or pedantic thoughts.
has the right to stifle or ridicule someone else's hope.initiatives, or
success."
"It is totally unacceptable for clinicians to brush this off as something
that "just happens" or that it's just another case of "wax and wane" ~ RM
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RM is a very good writer. His message can be convincing even to a smart audience. I think he can have a harmful influence on how people evaluate other evidence - not just what he presents. He provides the customary disclaimers, but many times we see people he has influenced expressing strong beliefs, citing RMs survival. The disclaimers may often be considered as given with a wink and a nod, a gesture to appease the authorities. Consistently we see the language within the body of his statements communicate strong belief, as shown.
Because the natural history of indolent lymphomas is variable, it cannot be known if RM, and others, would have done as well or better with a different script. This is the reason controlled studies are done. Because it's the only way to determine causality - if an action leads to a result. It's well accepted that observation can't be relied upon. The HRT study is a clear example. Without it, women would still be taking hormones and significantly increasing their risk to heart disease and cancer based on the misleading *observations* of medical doctors, and the expectations generated by untested theories.
Pseudoscience:
Specifically, RM cites petri dish experiments as scientific evidence, but does not provide any data on bioavailability, unless forced to by our critiques. .... nor does he describe how malignant cells are significantly changed when removed from the body. ...
When it's brought up that only 3% of turmeric is curcumin, his strategy changed to using curcumin supplements instead. When bioavailability issues are illuminated by an expert in the field, he advances Kurosawa's theory/adjustment that the curcumin needs to be mixed with fats. .... In other words, the script changes as needed to address new questions, but never are his premises "his strategies" ever questioned.
Regarding mixing herbs with fats, RM leaves out the initial step in digestion when citing the "evidence" in his most recent newsletter:
"After ingestion and mastication, the food particles move from the mouth into the pharynx, then into the esophagus. This movement is deglutition, or swallowing. Mixing movements occur in the stomach as a result of smooth muscle contraction. These repetitive contractions usually occur in small segments of the digestive tract and mix the food particles with enzymes and other fluids. The movements that propel the food particles through the digestive tract are called peristalsis. ... Absorption: The *simple molecules that result* from chemical digestion pass through cell membranes of the lining in the small intestine into the blood or lymph capillaries.
This process is called absorption:
http://training.seer.cancer.gov/module_anatomy/unit10_1_dige_functions.html
Whatever your interpretation of "simple molecules that result", I think it's clear that the bottom line is the need to test the levels of the compound achieved in the blood. Mixing curcumin with fat does not mean it gets bound to the fat, or remains bound, when it reaches the intestines.
It does not seem a difficult task to test for blood levels of a compound. And because the agent is a food, there's no safety concerns in doing such an experiment.
Once the bioavailability question is resolved I could admit that it's reasonable to say that taking curcumin is *plausible* and worth trying - given it's safety. We are not there yet. Having both Petri dish activity and bioavailability accounted for would not, however, translate into a conclusion that curcumin provides clinical benefit. The cells removed from the body and put in a test tube dramatically changed - like fish removed from the ocean and put in soda water.
[As an aside, perhaps one day curcumin will be tested as an infusion. I can't say. But I have not seen this possibility raised by RM. Is it because this does not fit with what RM did to extend his survival: his strategies for survival?]
It's worth noting that a PCR test is not considered a biomarker for testing the efficacy of a compound, as stated by RM. It does not inform about the affect of the agent on cancer cells in lymph nodes or bone marrow, where tumor cells cause problems and are more resistant to treatment than in peripheral blood.
Has anyone asked RM how it is that curcumin influenced his survival if he took it incorrectly, as turmeric without fats, for 15 years? Isn't this a valid question?
RM presents the virtues of "natural," as superior to synthetic. But aren't drug compounds many times made of the same basic elements or building blocks, whether produced by organisms, or otherwise? Does it really matter if a gene recipe produces a compound, or if it's assembled or tweaked by other means?
In the past RM has made statements that foster mistrust in medical doctors, and investigational therapies. As I recall, he has described what might be called a doctrine of greed, leaving out how profit incentives are an essential driver of innovation, and that there are checks and controls on industry bias, including peer review, scientific method, and independent FDA review. Without patent law and the promise of exclusivity, new drugs would never reach the market, because the endeavor is high risk and very costly (about 1 billion per drug on last estimate). Doesn't this perspective deserve public scrutiny?
Another myth promoted by RM is that the "industry" is not interested in natural compounds because profits cannot be made from them. See for details: A Natural Evolution: Advances and Trends in Natural Products Research http://www.nci.nih.gov/newscenter/benchmarks-vol4-issue4/page1 which informs on this topic, and gives a very different story, with examples.
When a weakness of a particular RM strategy is raised, he will sometimes argue it's the *combination* of "natural" approaches that makes it a "winning strategy." But this argument is built on multiple suppositions, instead of one. I think it weakens, instead of strengthens the theory, .... not unlike the results you would get if you fielded a baseball team of individual players, each with no credentials -- whose basic skills have not been determined or tested in the minor league, or in any real engagement.
RM has also endorsed the use of low dose Naltrexone. I recall that Bihari, the doc who presumably makes a good living consulting on it and prescribing it, telling patients that it works on virtually all patients with lymphoma ... When this claim did not match up with experience, Bihari, predictably, changed the recommended dose. The "evidence" Behari used was the same as RM's, as was the moving strategy: The script adjusted to deflect questions; the evidence being the testimonials of people with indolent lymphomas. See also Low Dose Naltrexone?
Notably, the natural history of indolent lymphoma is quite variable. For example, as many as 20% to 30% of patients will experience regressions at some time in the clinical course of their disease." 1 The range of survival for indolent lymphomas is also quite wide. You can live 3, 4, 10, 20, 30 years, or more.
Consider that when a practitioner prescribes an alternative protocol for 100 patients with indolent lymphoma, as many as 30 are likely to experience improvements, because of the natural history of the disease as described above.. This "effect," - which has a good probability of being unrelated to the practice - will often result in strong belief and promotions, as in: "How can you argue with success?"
Alternative practitioners must love indolent lymphomas. It's estimated from clinical records that ~70% of people with indolent lymphomas have a truly indolent course, and that 30% will regress spontaneously. The jargon for the underlying variability of a disease is heterogeneity. See http://content.nejm.org/cgi/content/full/351/21/2159
Clearly, RMs adjusts his strategies in response to criticisms that anjou and I have raised; most recently, on the need for caution with vitamin D, and the bioavailability of curcumin. Also, his past inappropriate medical recommendation for grade III fNHL, and his past advice to use Celebrex off label.
The delivery of the message.
Why do some believers in RM's strategies recruit people from lists to purchase subscriptions to his newsletter and access to his private website? Is RM afraid of the peer review that takes place in open forums? Is he concerned that the discussion and questions will negatively impact on recruitment, and therefore on his income? Perhaps this is happening without prompting from RM? I can't say, but the question hangs there.
I think we should be uncomfortable with this business model. That is, lay persons dispensing medical advice and experimental natural approaches for a fee. The Kurosawa's, the Ralph Moss's, the RMs. What is the standard for licensing this type of medical service?
I think offering unproven theories should be limited to discussions in open forums, and not paid for. And that reasons to avoid promoting of same should be explained.
It's worth noting that any practicing physician is bound by a code of ethics not to practice outside the realm of their expertise and training. It would be unethical for a PI to advise on oncology, for example.
As on-line patient navigators we have limited capacities to help others. We know nothing from direct experience. We are not doctors, or scientists, and have no direct contact with patients. We learn what we read, and share it. We are prone to error. We remind about the limitations of the information we provide and of our interpretations; we remind of the need to check the sources and pay attention to the different levels of evidence, etc. We are at our best when we are cautious; when we suggest questions to ask of experts.
The tone of RM's message seems contrary to these values. He actively promotes in advance of testing a hypothesis. It's a message with a clear agenda, that argues, ironically, to be cautious of the "skeptics." The potential motives include profit and having influence on others. That it gives hope and a feeling of control is not adequate to offset the potential harm. He could, instead, propose his ideas as something worth testing and fully disclose the limitations of the evidence that exists so far. He could take a more neutral, a more scientific, position. In addition to the risks of unfounded belief described above, strong belief tend to limit what one looks at and considers. Do followers of RM consider and review clinical trials?
I agree that there's nothing wrong with having strong opinions and ideas about natural strategies; or wrong with trying unproven natural products if they are safe ... Unless these ideas are promoted as worthy of faith - as "winning strategies."
The bigger problem for me is how RM delivers his message to cultivated groups, who are recruited to a restricted website and newsletter. Here, the conversation and questions that are vital to informed consent, probably do not take place very often, or at a high level. Not because the subscribers are not intelligent -- they are often very intelligent -- but as subscribers to this group they have a shared belief, and may not yet have the background or inclination to ask informed questions.
I'll end this too-long-a-critique by saying I have often enjoyed the conversations with RM on the lists, and I think it gave people observing an opportunity to see both sides and make their own decisions on interesting topics. So I'm not about censoring his, or anyone's views. That said, I believe that when a medical idea is promoted as a fact, we need to look hard at the information and try to judge it objectively. It's important to hear, but also *question* ideas and theories. Some people interpret this as censorship. I don't think asking questions can be called that fairly.
~ Karl Schwartz
President, Patients Against Lymphoma
References and Resources:
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Curcumin - part I: scienceblogs.com
Why Petri dish [in vitro] studies don't always translate into benefit for patients
"To understand the translation of cell culture studies to the whole person, we must first consider all of the systems operating in the human body that are not present when human cells are grown in plastic Petri dishes. .... drug absorption, distribution, metabolism, and excretion"
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Curcumin - part II: - scienceblogs.com
It is rare for a herbal or dietary supplement company to conduct, much less publish, the results of the bioavailability of their products. For dietary supplements, these studies are not required by the US Food and Drug Administration or by any federal regulatory authority in the world. By "bioavailability," we mean a study as to what fraction of a given oral dose actually makes it into the bloodstream. While measuring bioavailability, scientists also conduct more sophisticated calculations to determine the peak blood concentrations, when they occur, and how quickly the body clears the substance.
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Prediction of Survival in Follicular Lymphoma Based on Molecular Features of
Tumor-Infiltrating Immune Cells
Sandeep S. Dave, M.D., George Wright, Ph.D., Bruce Tan, M.D., Andreas Rosenwald, M.D., Randy D. Gascoyne, M.D., Wing C. Chan, M.D., Richard I. Fisher, M.D., Rita M. Braziel, M.D., Lisa M. Rimsza, M.D., Thomas M. Grogan, M.D., Thomas P. Miller, M.D., Michael LeBlanc, Ph.D., Timothy C. Greiner, M.D., Dennis D. Weisenburger, M.D., James C. Lynch, Ph.D., Julie Vose, M.D., James O. Armitage, M.D., Erlend B. Smeland, M.D., Ph.D., Stein Kvaloy, M.D., Ph.D., Harald Holte, M.D., Ph.D., Jan Delabie, M.D., Ph.D., Joseph M. Connors, M.D., Peter M. Lansdorp, M.D., Ph.D., Qin Ouyang, Ph.D., T. Andrew Lister, M.D., Andrew J. Davies, M.D., Andrew J. Norton, M.D., H. Konrad Muller-Hermelink, M.D., German Ott, M.D., Elias Campo, M.D., Emilio Montserrat, M.D., Wyndham H. Wilson, M.D., Ph.D., Elaine S. Jaffe, M.D., Richard Simon, Ph.D., Liming Yang, Ph.D., John Powell, M.S., Hong Zhao, M.S., Neta Goldschmidt, M.D., Michael Chiorazzi, B.A., and Louis M. Staudt, M.D., Ph.D.
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