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Commentary
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!
==
"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
==
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 most 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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