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Even in the heady economic boom of the late 1990’s, the financial concerns of health care delivery in America were severe. The United States was paying approximately twice per capita for healthcare as the nearest world competitor (Switzerland), yet ranked one of the highest in infant mortality and preventable death. The proportion of uninsured continued to rise (exceeding 15%) as did the health care costs as a proportion of GNP (also exceeding 15%). Even in those halcyon days of a balanced federal budget, Medicare was predicted to go broke sometime in the next generation. And those were “the best of times”! How are we to even approach the problems in a time of deepening depression, when increasing numbers of citizens will lose their access to health insurance as unemployment rises in an employer-sponsored model, and when the federal government is embracing trillion dollar-level debt??

There is no dearth of proposals available to address these issues—everything from a single-payer, government-sponsored national health service to a complex system of incentives and tax credits. What is lacking is a mandate. It seems as obvious as the virtues of mom and apple pie that every citizen is entitled to quality health care in the wealthiest nation on earth. What has always been much less clear is what constitutes quality care and how committed are we as a nation to paying for it. It is in this area of defining quality and ascribing value that research has emerged as a vital leader in the healthcare debate. Simply put, value=quality/cost. This formula implies two critical questions: What constitutes quality? And, how much are we willing to pay for it?

America’s commitment to a free enterprise system presents some unique opportunities and some serious shortcomings to answering these questions. To the extent healthcare is a business, it is able to attract large sums of capital, inspire remarkable ingenuity and innovation, and respond rapidly to evolving information. However, there is the inevitable double-edged sword—profitability rather than patient health becomes the driving force. It is only to the extent that these incentives are aligned that the system works. Let us take the simple example of a medication to treat patients who have suffered a heart attack. Let us say that this medication, if given to a group of patients who have suffered this life-threatening event, will, over time drop the late mortality over the ensuing two years from 8% to 4%. This is a huge victory. This represents a 50% drop in mortality, which, given the fact that one half million Americans die each year from coronary heart disease, the potential lives saved from this subgroup would be substantial. However, from another point of view, for every 100 patients given this drug only 4 benefited (4 died anyway, and the other 92 wouldn’t have died even if the drug didn’t exist). This means we must treat 25 people in order to save one life. Provided the drug had no side effects (doesn’t exist) and no cost (doesn’t exist), no thinking person would miss the opportunity to save that one life. However, all drugs have side effects and costs which must then be borne by 96% of those taking the drug while deriving no benefit. The healthcare system, however it is constituted, should it choose to administer the drug, must accept the fact that 96% of the expense is wasted (assuming there are no untoward side effects).

Wouldn’t it be “nice” to know how to determine who are the 4 individuals who will benefit from the drug, who are the 4 who will die anyway, and who are the 92 who will survive despite (rather than because of ) the treatment? Who is going to ask this question? The manufacturer of the drug has already invested in the range of $1,000,000 of research and development to get the drug to the point where it has actually received FDA approval. Can we even dream such a company would be so irresponsible to its shareholders as to invest further dollars into cutting its market share twenty-fold?! (from 100 down to 4) Suppose a competitive company was fast on the heels of this first company, and is now introducing an improved version of this drug, which needs to be taken only once a day instead of three times a day, or is chemically modified to avoid one or another complication. Do we summarily take drug A off the market when drug B arrives?

It is for issues like this that the government is launching a major investment into comparative effectiveness research. In order to proceed, an effort will be made to develop some sort of metrics for quality and outcome by which we can compare various available therapeutic approaches to determine which seems to be the best. As noble and important as such efforts may be, we need to understand what constitutes the “best”—is it the least expensive? Is it the most therapeutically effective? And what do we as a medical community or a healthcare system or a nation do with the information? That which may be most effective on balance for a population may, for a given individual patient, be totally ineffective or even dangerous. That which appears to be a wise communal decision of one product over another may stifle competition and the impetus for innovation, research and development.

Given that I was not blessed with clairvoyance, my recommendation at this time is that we approach these decisions with circumspection, with a clear definition of core values and priorities, and a sober assessment of the potential impact of our proposals.