Reductionist Science and the Evolution of Integrative Oncology

This post was written by Glenn Sabin

The placebo-controlled, double-blind, randomized controlled trial (RCT) is considered the most reliable scientific process to measure efficaciousness of drugs and medical interventions. The RCT measures one variable or intervention at a time against a control.

On February 25-27, 2009, the Institute of Medicine, with support from the Bravewell Collaborative, convened the Summit on Integrative Medicine and the Health of the Public in Washington, DC. The stated goal of the conference was to advance the science, understanding, and progress of integrative medicine—“healthcare that addresses together the mental, emotional, and physical aspects of the healing process”. IOM released its report on the summit last month. The following passage from the report speaks to reductionism science and its impact on the exploration of integrative interventions:

“Integrative health care is derived from lessons integrated across scientific disciplines, and it requires scientific processes that cross domains. The most important influences on health, for individuals and society, are not the factors at play within any single domain—genetics, behavior, social or economic circumstances, physical environment, health care—but the dynamics and synergies across domains. Research tends to examine these influences in isolation, which can distort interpretation of the results and hinder application of results. The most value will come from broader, systems-level approaches and redesign of research strategies and methodologies.”

The human mind and body, when confronted with malignancy, reacts with a complex set of physiological and psychological change that cannot be adequately addressed in isolation. As such, only whole person, multi-interventional synergistic approaches to scientific exploration will lead the way to 21st century personalized, integrative oncology care.

Millions of dollars have been expended on studies focusing on one variable against a control. Historically, this has been the only type of study design that has passed NIH’s research funding review boards. NCCAM and OCCAM have funded a number of single-modality studies over the years that follow these reductionistic standards of medical exploration. In fact, NIH has heretofore never funded research that explores more than one type of intervention at a time. There have been studies that have focused on multivitamins, vitamin E, calcium, acupuncture, exercise and many other single agents or interventions, but no complex, multiple modality trial designs have been funded or executed to date. Notably, Dr. Dean Ornish published positive outcomes on his seminal work in the areas of cardiac health and prostate cancer. There has been no significant research on truly comprehensive lifestyle interventions in malignancy since.

The time is now for the federal government, private entities, organizations and philanthropists to support and fund comprehensive, whole systems medical research.

There are creative ways to approach whole systems, integrative oncology study designs in such a way that they will pass government and private funding review boards as well as research ethics review committees, but it requires fresh, innovative thinking and very creative and committed research teams.

Random controlled trials are here to stay, and rightfully so, but a lot has changed since the Flexner Report. Personalized medicine is growing and evolving: over 30 billion dollars annually are being spent in the U.S. on complementary health services and products, and consumers are embracing integrative healthcare practitioners like never before. In addition to the RCT, we need a human clinical trial research model specifically designed for whole systems research.

The best of western, allopathic medicine, especially acute emergency care and diagnostics, is arguably the finest in the world. But it is clear that our so-called science-based processes and methodologies that result in FDA approved drugs do not always allow the most useful and important study designs in integrative medicine to be funded and executed.

There’s a certain mythology of science-based medicine that Deepak Chopra, Larry Dossey and Rustum Roy summed up best in a recent Huffington Post article. An addendum to that piece appears here.

Now is the time for the U.S. to institute a new research design paradigm that addresses the whole person, body and mind, with a synergistic, multi-interventional approach. We are on the cusp of true personalized, integrative healthcare/oncology, and we will get there a lot faster once whole system research is properly funded and executed.

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Jan 21, 2011 · Comment (4)

   

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2 comments · Add Yours

What is “whole system research” and how does it differ from a clinical trial? The link you provide is only a brief link describing that FON wants to do this type of research but not what it actually is.

The follow-thru links there lead to another section in which it is commented “As such, only whole person, multi-interventional synergistic approaches to scientific exploration will lead the way to 21st century personalized, integrative oncology care.” – without actually defining what “whole person, multi-interventional synergistic approaches” are. As best as I can glean, it seems to indicate using multiple dependent and independent variables at the same time and measuring outcomes, which include quality of life considerations. The page continues by saying:

“While randomized trials can be and are used for whole systems research, new approaches are needed to design, collect, and analyze data from such trials: multidisciplinary teams are employed, and models regard patient outcomes from several viewpoints, including an emphasis on patients’ quality of life.”

Since RCTs can be used (and are used) to study “whole systems” why are new approaches necessary, how do they differ, and what new would they bring to the scientific discourse? Looking further, it seems that the only difference elucidated is that “whole systems” approaches would be “addressing the body, mind, and soul.” Besides pre-supposing the existence of soul and a mind separate from the brain, how does the proffered approach intend to quantify and analyze such variables?

Besides introducing multiple variables so as to obfuscate the outcomes I am unable to see what the material difference would be between currently employed methods of “whole systems” research and analysis and what FON and you are advocating.

I would be quite grateful if you could clarify that for me, Mr. Sabin.

Thank you!

Reply

@Andrey Pavlov
My thought (only thought).

I agree with Glenn and Andrey (Yes both). The whole-person or whole-system approach is well described in Glenn post, mind-body medicine. Andrey is right in some sense, we (probably) do not need a new methodology than RTC, the design will be simply a RTC of “whole-person” approach vs “control”, the whole person is composed of a lot of things, like drugs, acupuncture, even prayer, all at once, without taking apart of them. Now you will have trouble in convincing the reductionist. The reductionist do not believe the whole, the natural question will be “ what part is the active component?” What do you want FDA to approve? The whole-person approach?

Personally, I do not think we need RCT to learn any now knowledge. RCT is for the mediocre medication only. If something works drastically, a single-arm study is sufficient. I believe we can formulate a highly effective therapeutic cocktail and test the whole cocktail in a simple single-arm trial. Cancer kill almost all stage 4 cancer patients, if something works, you will know it.

The hurdle will be how can you come to the super cocktail. Certainly you can not test all the possibilities in clinic. At our institution, we are using to so-called high-throughput screening to overcome this hurdle. We have some interesting findings(we can find ONE super cocktail from 1000 cocktails, this is a very good yield!). We are moving this forward with limited funding, but we truly believe this whole-person, whole-cell, whole-genome approach. I use a lot of “whole“s, part of the reasons is that we dot know(do not need to know) any cancer biology to get the cocktails, in another word, we do not know the parts—the genes, pathways, mutations. We only know the whole we started the experiments.

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