When Mainstream Cancer Care Runs Out of Options — The SCIENTIFIC Alternative to Alternative Medicine

I. MAINSTREAM MEDICINE AND ALTERNATIVE MEDICINE ARE NOT JOINTLY EXHAUSTIVE

The term ‘Alternative Medicine’ exists because of a dualistic worldview: One the one hand, there is the accepted “mainstream” standard of care which has a scientific basis, and on the other hand, everything outside of mainstream medicine is considered Alternative Medicine and by implication (and here is the error of thought), non-scientific. But these two are not jointly exhaustive as the logician would say: the two options that they cover together are not the only options — the world is not binary. The problem is that mainstream medicine itself is not exhaustive in embracing all scientific views. It is agnostic of any scientific rationale outside of itself because it has equated ‘scientific’ with ‘supported by evidence’: Mainstream medicine it is now essentially identical with “evidenced-based medicine” — a movement in clinical medicine that started in the late 1980s and puts emphasis on treatment for which there is “evidence” of efficacy. The term ‘evidence’ refers to the empirical demonstration of efficacy (and of safety) of a given new treatment, obtained in a clinical study that compares patients who are treated vs. not-treated with said treatment. Clinical trials (which must meet some design criteria) is the gold-standard to establish a standard of care.

II. THE EPISTEMOLOGICAL BACKGROUND

Current medicine is a prisoner of evidence-based medicine (EBM), which has become a major rate-limiting factor that slows down innovation because evidence of efficacy is tedious to obtain, requiring large and lengthy clinical studies, and in addition, safety must be demonstrated. The fact is that there is no way around obtaining empirical evidence through rigorous clinical trials (which essentially means: randomized, blinded, controlled studies in sufficiently large cohorts). For all its virtues, clinical studies are also riddled with obvious and less obvious technical issues — this is not the subject here. But there is a more subtle, profound concern: In a culture in which empirical evidence from clinical trials is everything, few appreciate that in the grander scheme, empirical proof is not the only pillar of a scientific knowledge. Moreover, limiting medical research to gathering evidence from trials stifles creative use of the human mind — the driving force of innovation.

The Two Pillars of Scientific Knowledge: Empiricism and Rationalism. In medicine the emphasis on empiricism and the distrust of rationalism, which due to the complexity of the living organism has not led us very far (unlike in physics and chemistry), have resulted in “evidence-based-medicine”, s essentially the sole source of “medical facts”. Rationalism (“thinking”) is sidelined.
If flying to the moon were an empirical science like clinical medicine…. (Illustration by S.H.)

III. THE PERCEIVED PROBLEM OF MECHANISTIC REASONING AND THE OVERREACH OF EMPIRICISM

The current problem with such rationalism and the associated mechanistic reasoning in medicine is that the living organism is so complex that logical deduction based on a mechanistic rationale and elementary principles, even with supporting experimental evidence, cannot be trusted, and thus, cannot be applied to a given, real clinical scenario. Few generally valid fundamental principles exist in the biomedical sciences. There are too many unaccounted for, often individual-specific details left out of the equations, making the latter unreliable. (I will write on Personalized Medicine and “N-of-1 trials” another time).

Most new anticancer drugs do on average not extend life of cancer patients by more than 6 month compared to existing therapy. From: Fojo et al., JAMA Otolaryngol Head Neck Surg 140: p. 1225–1236 (2014)

IV. A NEW UNCHARTED LAND OF THE SCIENTIFIC SOUND AND SAFE THAT IS NOT MAINSTREAM

Times are changing. The intellectual climate that has nurtured the culture of hyper-empiricism is evolving. In the past decades our knowledge of the function of the human body, from molecules to cells to organs, has drastically increased. The amount of factual knowledge deposited in medical knowledge sources, from PubMed to gene ontology and pathway databases to disease compendia has exploited. Moreover, our understanding of the theoretical principles of how the human body works has revived interest in logical reasoning and mechanistic rationales. The pendulum in the oscillating historical confrontation between empiricism and rationalism shows signs of swinging back towards the latter. One sign for this development are the physical science inspired research funding programs for cancer research established by the NCI and NSF (although execution still lacks, see here).

NSSS: The no-man’s land of Not-approved but Scientifically Sound and Safe treatments (green area) is an uncharted territory in the epistemological landscape, outside of mainstream medicine, yet scientific and thus, not “Alternative medicine”. What if there exists indeed a domain of treatment options that are (i) scientifically sound, holding promise of efficacy based on careful reasoning that uses all known biological mechanisms, and (ii) have not yet proven effective but (iii) appear safe based on all our experience and knowledge? Shouldn’t terminal cancer patients have access to an NSSS treatment option?

V. A NEW ERA OF SCIENTIFIC UNDERSTANDING STRENGTHENS THE USEFULNESS OF LOGICAL REASONING IN MEDICINE

When a late-stage cancer patient proposes an Alternative Medicine treatment that is deemed safe, doctors often empathetically refrain from objecting, independent of any assessment of efficacy. If the alternative therapy, such as high doses of vitamins or an exotic dietary supplement is known to be safe and does not interfere with standard care, then, so goes the thinking, in the worst case “it won’t help but won’t hurt” and in the best case “it might help”. But now the unprecedented scientific knowledge base of molecular and physiological pathways together with new theoretical tools to study tumor behavior dynamics affords the new capacity to support or reject, at a new level of scientific rigor, treatment strategies proposed by both traditional Alternative Medicine (“this dietary compound may stimulate your immune system”) as well as Precision Oncology (“this gene is mutated in your cancer, so let us target its product”) BEFORE empirical evidence of efficacy is obtained. So far such proposals have been based on plausible, albeit superficial, hand-waving type of rationales. But the new epistemological territory of NSSS also could lead to the identification of specific molecular and cellular “lever points” for specific instances of tumors, based on the tumor and the patient’s molecular profile.

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Sui Huang

Sui Huang

Institute for Systems Biology