In May, Harvard Medical School Professor Dr. Jerry Avorn, critiqued the backlash regarding $1.1 billion in funding for comparative effectiveness research (CER) generated by its inclusion in the Stimulus Package. The funds, according to Avorn, threatened the livelihoods of both pharma and device makers. Why? Because current standards by the Food and Drug Administration require new drugs to prove efficacy relative to placebos rather than provide evidence of clinical benefit. In the case of device makers, Avorn notes that the standards are even lower whereby they must prove that “products are simply not…dangerous."  Yikes. 

The response to arguments like Avorn, often led by a conservative constituency fearful of government involvement in healthcare, is that comparative effectiveness research is simply a fancy way of saying, “rationing.” (Cue the Jaws music please…) Is that what it is, really?

Scott Gottlieb, former deputy FDA Commissioner, commented that CER would be “used to restrict coverage decisions, especially by Medicare.” Whoa…let’s jump back a bit there—CER is dictating Medicare coverage? First, it would be helpful to frame and implement this effectiveness research, right?

A definition will help here. According to the Dept. of Health and Human Services, the goal of CER is “to provide information that helps clinicians and patients choose which option best fits an individual patient's needs and preferences.” And most importantly, CER may inform physicians and patients as to “which interventions work best for specific types of patients (e.g. the elderly, racial and ethnic minorities).” For the layperson, this means that using patient data (de-identified), researchers can study what treatments work best given a patient’s characteristics and condition. This may translate into what drugs, devices, medical procedures, diagnostic tools, etc. are the best tools for a physician given a patient’s stage of illness. 

Congress allotted over a billion dollars in funding through ARRA for CER with a directive to form a Federal Coordinating Council for Comparative Effectiveness Research. In an HHS report to Congress and the President, the work of this Council is presented, outlining the CER strategic framework, goals, and plan to generate cooperation among the three funded agencies. The agencies are the National Institutes of Health ($400 million), HHS ($400 million), and the Agency for Health Care Research and Quality ($300 million)

The Council also reviewed the current status of CER. The concept is far from new and is being used already across many health care systems (see the VA, Geisinger Research, and is currently funded through AHRQ. Therefore, in order to expand the opportunities for CER that would benefit physicians and patients the most, according to the Council, the majority of funding should be directed to expanding and building data infrastructure. Or as the Council states more precisely, Data infrastructure could include linking current data sources to enable answering CER questions, development of distributed electronic data networks and patient registries, and partnerships with the private sector.”

This sounds familiar…oh yeah, electronic health records! Our friendly EHR offers CER a new future in data analysis. Oh the places we can go!

But wait, let us return to the poo-pooing of the CER opponents. How does one ease the fears of rationing? It seems illogical given the current health care cost conundrum. For example, the Wall Street Journal reported on findings from New England Journal of Medicine earlier in June that patients with diabetes do not have better outcomes when physicians use expensive stents rather than simply treating patients with inexpensive drugs. Do people want surgery? Isn’t that good information—a study based on over 2,000 patients? One would think so but the fears run deeper than that. There is no current legislative link between CER and health care coverage. And that is the ultimate fear—we get it. That being said, however, engaging more Americans in a conversation about what works and what does not may be the last stop before filing for national bankruptcy.