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But Where’s the Biology?

The views expressed are those of the author and do not necessarily reflect the views of ASPA as an organization.

By Burden Lundgren 
September 20, 2016

blThe best journal article I’ve ever read is “Revisiting Accepted Wisdom in the Management of Breast Cancer” in the September 1997 issue of Alternative Therapies. That is not just my opinion. I once shared the article with a National Institutes of Health (NIH) scientist and he thought it was the best he had ever read too. Many of my female students told me how meaningful it was to them and that they were keeping it “just in case.”

Written by an acupuncturist/surgeon team, the article’s turns what the public believes on its head. Most of us think the biology of a disease is determined first and then medical practitioners diagnose and treat according to the validated biological theory of the illness. But Beinfield and Beinfield, the authors of the article, state, “Standards of medical practice are established by well-intentioned authorities first and, ideally, validated by science later.” In other words, patients are the unwitting subjects of a giant science experiment.

To illustrate their thesis, the authors tell the story of the Halsted procedure. It has been the standard treatment for breast cancer from the 1880s until the late 20th century; nearly 100 years of mutilation to no good end. The procedure involves removal of the breast, the underlying chest muscles and all nearby lymph nodes.

The theory behind the surgery was that breast cancer is a disease that spreads by direct extension. It was a theory propagated by the well-known and powerful German scientist, Rudolph Virchow. Virchow was not a clinician and was not interested in the care of patients. Virchow’s theory was simply wrong. But with his name attached to a theory, whether right or wrong, brought almost instant acceptance.

However, as early as 1842, an experienced surgeon noted that if the lymph nodes were affected, radical surgery was not curative. And clearly if they are not affected, radical surgery is unnecessary. Why then, did the Halsted procedure become the standard of care?

It is hard to overestimate William Halsted’s reputation in his time. According to Beinfield and Beinfield, he, “Singularly hoisted surgeons to the pinnacle of the social caste of medicine.” Other surgeons did what he did just because he did it. Professional prestige drove the adoption of his procedure and the income it produced didn’t hurt.

Where else do we get our notions of the right treatments?  One way is through epidemiology, the study of patterns of disease in populations. Those last two words already make epidemiology problematic in terms of individual biology. People comprise populations, but a people within a population differ.

There are other issues. Epidemiology, once the province of clinicians, has morphed into a largely mathematical field divorced from medical practice. Epidemiologists themselves have been questioning the direction of their field for at least two decades. Much of the criticism has been leveled at reductionism, e.g., the simplistic quantification of risk or the idea that a risk factor leads to a certain outcome without taking other factors into account. Other factors have been visualized as a web of intersecting circumstances or as complex layers and hierarchies of circumstances. But there is no connection to how risk factors actually work in the body. And since the word “risk” signifies uncertainty, knowledge associated with it brings little comfort.

This is not to say that epidemiology is a useless discipline. Epidemiologists, after all, discovered the relationship between smoking and lung cancer well before solid biological evidence was available. And epidemiologists can certainly point to areas that biologists should investigate. But without understanding the biology of a disease, epidemiologic evidence alone is a slender thread upon which to hang medical practice.

Drug trials too drive the treatments we are given. If a drug “works” for 75 percent of the trial population, does that mean it will work for me? And whether it works or not, will it cause serious side effects? Lacking a full understanding of the biology involved, the only way to know is to try – another science experiment.

The randomized clinical trial (RCT) is thought to be the gold standard in health services research. But is it? Consider, for instance, the Women’s Health Initiative Study of hormone replacement therapy (HRT). This 15-year study, launched in 1991 with a study population of nearly 62,000 women, was supposed to settle once and for all whether HRT is indicated for postmenopausal women. A quarter century later the results are still being debated. The basic biology is not well-understood and even the philosophical question of whether menopause is in fact a pathological state which requires treatment is not settled. RCTs and other studies come and go, often leaving entirely contradictory findings in their wake – findings that have everything to do with statistics and nothing to do with biology.

Statistics are always interesting and often informative. But as long as the subjects of medical practice are people, biology is fundamental.

Author: Burden S Lundgren, MPH, Ph.D., RN practiced as a registered nurse specializing in acute and critical care. After leaving clinical practice, she worked as an analyst at the Centers for Medicare and Medicaid Services and later taught at Old Dominion University in Norfolk, Virginia. She has served as a consultant to a number of nonprofit groups. Presently, she divides her time between Virginia and Pennsylvania.
Email: [email protected]

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