An idea has taken hold in the minds of legislators, academics and many private citizens that medicine suffers from a paucity of “quality” and that this deficit underlies the often quoted statistic that the United States spends more on healthcare than any industrialized country, but by many metrics, suffers worse health than those spending far less. Few practicing doctors would disagree with the notion that medicine is rapidly changing. Although the exact nature, extent and timing of that change are topics for more thoughtful consideration elsewhere, that such change is at our doorstep is a largely unassailable contention. At the highly granular level of quality improvement, data is both the driver, and the mechanism for this coming change. Data will, it is argued, show us our strengths, expose our weaknesses and force us all to adjust accordingly.

To this end, ‘Quality Improvement’, and its attendant dependence upon data has become almost synonymous with a panacea for our current medical system. As a consequence of our renewed faith in the idea of data, we are taking what had largely been an internal process (performed by physicians and hospitals) and turned it into an external one, where third-party agencies, often with little or no involvement in patient care, have a substantial voice in care.

For all this talk and effort, data in healthcare are relatively new. In 1986, the Heath Care Financing Administration publicly released hospital mortality rates, the first such comparative data available to patients. Today, data on both physicians and institutions are increasingly available through Pay for Reporting, P4P, and public “report cards,” in addition to online patient-driven rankings. Actual practice is increasingly compared with established metrics or standards. Remuneration will be linked with these comparative data, thus quantifying value. The purpose of this column is not to agree, disagree nor argue merits (if any) to the above vision. Rather, I intend something entirely different: to ask the radically important, but largely ignored question of whether this coming change so dependent upon data will succeed? That is, assuming a world of abundant and credible and transparent data, would a data-rich snapshot of medical practice carry the needed force to affect change? Would the data matter? Would data serve as the engine of change? Would those data be transformative? As is almost always the case, history is rich with examples that may help us to better answer this question.

Vaccination against smallpox was not generally accepted until the early 19th century yet, on at least three occasions prior to 1801, it had been shown that variolation (the practice of inoculating uninfected persons with effluent from open sores on persons infected with smallpox) against smallpox was protective. The variolation debates of the mid and late 18th century were based on religious doctrines that the practice was “endeavoring to baffle Divine judgment.” Even as late as 1885, Catholics in Montreal refused vaccination on religious grounds, believing smallpox to be the result of Sin. The first major attempt at “change” using a very modern idea of “data” occurred in 1721 when a major epidemic of smallpox struck Boston. Cotton Mather (1663-1728), a Boston Minister and influential early “doctor” in the English Colonies, was an advocate of variolation. So in 1721, when smallpox again struck Boston, Mather arranged to successfully inoculate the his own children as well as those of a prominent town person. The result was that variolation was shown to be overwhelmingly effective at preventing death from smallpox, and in 1723 the Royal Society of London, the source of the original narratives on variolation, requested that Mather publish an account of his activities. Why then did variolation not become generally accepted until nearly 80 years later?

The variolation experiments of 1721 demonstrate clearly the importance of the social environment for scientific advancement. Even though variolation, based upon reasonable evidence, was proposed in the early 18th century, the social environment was such that the general population reacted not with approbation and acceptance, but with vitriol and violence. In 1721, intervening in smallpox epidemics was viewed as heretical. Many of the townspeople expressed sentiments that the practice of variolation was “heathen” and “un-Christian.” Ironically, Mather noted in his diary that, “the town [at] this time is strangely possessed by the devil”, and a bomb was tossed through Mather’s window appended with the note “COTTON MATHER You Dog, Dam you; I’l [sic] inoculate you with this, with a Pox to you!” The rejection of variolation by some of the Boston colonists can be understood not by examining the merits or weaknesses of the experimental evidence, but instead with the difficulty that persons had in simply accepting the actual idea itself. Beecher and Altschule’s statements from their well known History of Harvard Medical School that “Mather’s data should have cleared the air” and that they could not “get at the reasons for this remarkable behavior [by the townspeople]” demonstrates a failure to appreciate the underlying issue that, as Thomas Kuhn best stated, “the issue of paradigm choice can never be unequivocally settled by logic and experiment alone.”

Variolation, despite evidence of its’ effectiveness, was not uniformly adopted in New England until after 1790, and much of this eventual adoption owed more to the collective horrendous experiences of the colonies with smallpox during the Revolution, than with a sudden late 18th century re-evaluation of previously accumulated evidence about the practice. The effectiveness of variolation and then vaccination became accepted and broadly embraced in due course, but only when a slate of social conditions which were not present in the Boston of 1721 had come to be. Thus, toward the end of the 18th-century, when Boston was again hit with a smallpox epidemic, because of the striking maturation of the culture there, the social and political response was astonishingly different from that to the outbreak of 1721. Late 18th-century Boston presented an environment where genuine medical advancement and its acceptance were now possible. In 1798, a Boston physician, Dr. Benjamin Waterhouse (1754-1846), was the first to perform vaccination and experimenting first upon his children and then on selected members of the general populace, became convinced of the efficacy of the vaccine and sought to disseminate it widely. The publication of his experiments was directly responsible for the spread of the practice of “vaccination” to Philadelphia, New York, and subsequently to the rest of the United States. Waterhouse personally vaccinated President Thomas Jefferson. Like Mather in 1723 Waterhouse produced evidence of vaccination’s efficacy, but it was the acceptance of the general populace and the governing leaders of Boston that were a major factor in Waterhouse’s success compared to Mather’s failure 80 years prior.

The importance of a cultural readiness for new ideas shows itself often in medicine. Again in Boston in 1843, Dr. Oliver W. Holmes (father of the Supreme Court justice) published on “Puerperal Fever,” stating that puerperal or “childbed” fever was “due to a contagion conveyed by the hands of physicians from one patient to another.” The ready publication and acceptance of this concept in Boston contrasted against very different cultural conditions in Austria. There, the acceptance of the same concept proffered by Ignaz Philipp Semmelweis a contemporary of Dr. Holmes, was not to be had. Semmelweis’s contemporaries argued that physicians were gentlemen and consequently it was simply not possible that their unwashed hands could be the source of sickness. The result in Austria? Dr. Semmelweis died in 1865, alone in an insane asylum, having been rejected by his peers and colleagues. The best evidence, however, that Boston was far advanced relative to other major centers in the culture necessary for medical advancement is evident in the rapid and enthusiastic acceptance by Bostonians of the use of ether to induce anaesthesia, a term coined by Holmes, in the first months after October 1846. This was not the case in any other major medical center in America or Europe.

The uniqueness of the variolation, hand washing and Ether events rests therefore not with the fact that it they were conceived or occurred in Boston. Rather, it rests on the fact that the demonstrations occurred in a place where afterwards they would be understood and accepted. It is this framework of acceptance that ultimately explains why in one time and place an idea is proffered and no matter what its soundness, will eventually lie in the dustbin of history while that same idea, proffered under a different slate of social conditions, confers immortality and fame to those speaking. What lessons are there for us in 2009 as we begin to talk about the transformative power of data? Of the many, I think that one stands head and shoulders above the rest.

Simply put, data, no matter how much, how prevalent or how compelling have never abrogated or attenuated the flow of life that is human behavior. We will do well to educate others as to this fact as they seek to ride this deluge of data into a new era of healthcare reform.