Medical Device Daily Washington Editor
WASHINGTON — The push toward healthcare reform has gained fresh momentum with the passage of legislation in the House of Representatives, but there are a number of observers who are of the view that Congress's thinking fails to deal effectively with the structural defects in the various systems for delivery of care. Some of those doubters were present at yesterday's symposium on comparative effectiveness and healthcare reform, sponsored by InHealth (Washington).
Giving an overview of the session, Robert Rubin, MD, a professor of medicine at Georgetown University (Washington) reminded attendees that evidence-based medicine (EBM) is older than many might believe. Rubin noted that such an idea was posed at least as far back as 1992 in an article appearing in the New England Journal of Medicine.
Despite the promises that CE research would not be employed to allow the use of cost as a coverage determinant, "one of the risks is that policymakers would use the absence of evidence as a cost-containment tool," Rubin said, adding that an erosion of the physician-patient dialogue may ensue in such an environment.
In such a scenario, "cost control becomes a driving factor, and that leads to diminished access," Rubin said, adding that inappropriate evidence may come to the fore in making coverage decisions. Rubin argued that "careful and flexible implementation" is crucial for the deployment of EBM if the effort is to enhance, rather than damage, the delivery of care.
While some think EBM will save money, Rubin said "it may increase costs," given the possibility of under-use of therapeutics and diagnostics. Rubin said that an article in the New England Journal of Medicine in April 2004 by E.J. Topol made such a case for statin therapy. Topol's argument was that 36 million Americans should have been on cholesterol statins, but that only 11 million were at the time. Putting the balance of 25 million patients on a statin would have cost "basically about $900 a year" per patient, assuming a dose of 10 milligrams a day, which would have added almost $23 billion a year to healthcare spending. Rubin also noted that the described dosage level is widely seen as a sub-standard dose.
John Bridges, PhD, of the Johns Hopkins School of Public Health (Baltimore) asserted that comparative effectiveness "is just health technology assessment under a new name," and he made the case that three key issues must be addressed. They are the identification of the relevant therapies, the appropriate rubric of measurement, and the appropriate valuation of outcomes.
So far, Bridges said, "we've only focused on identification," so while technology assessment "could radically improve the quality of medicine," a potential problem looms in that while insurers might be willing to finance the conduct of such studies, "they focus on their problems," not those of patients.
As an example, Bridges said he was told by more than one party at Hopkins that "you can't get funded unless your research shows that you can save money." This approach creates a risk. "There's the potential that ... we're focused on the wrong outcomes," he said, which is wasteful "and can lead us down the wrong path."
It may come to pass that the view of comparative effectiveness will be that "we spend millions of dollars on the wrong questions and measuring the wrong outcomes," Bridges observed. If doctors and patients opt not to comply with the dictates of CE research, the cost problem grows because of the money invested to communicate and train doctors and patients so as to make them "compliant and obedient," he said.
CE research should "involve the patient and other stakeholders in the evaluation," Bridges said, even if patient-reported outcomes are "just one piece of the puzzle."
Bridges said his own research into anti-psychotic drugs, which was geared toward finding out what sort of outcomes patients are most interested in, suggests that patients "weren't too difficult to deal with" despite warnings to that effect. He said that the prevailing view is that such things as drooling are vital to sufferers of schizophrenia, but "that's not what people with schizophrenia think about." This group of patients wants clear thinking and fewer relapses, Bridges said, and "what we needed were clinical trials to maximize" the impact of a treatment on the things the patients saw as essential. "We spend years validating psychometric instruments and no time valuing" those instruments, he charged.
"The issue that I'm most concerned about," Bridges acknowledged, "is 'what is the deliberation process?'" FDA's overview of device approvals makes clear that "someone is still in the background making judgments" about what is a valid approach to treatment with little understanding of how such a treatment affects the patient, he asserted.
Bridges posed the hypothetical scenario in which a patient with Alzheimer's disease was presented with a choice of treatments whereby one of the treatments offered a greater degree of lucidity while simultaneously raises the risk of stroke. "FDA would never go for these kinds of risks," he said, noting that a survey indicated that many Alzheimer's patients would willingly make precisely that bargain.
"Despite all this money for CE research, the government is very reluctant to ask people what they want," Bridges stated, a fact which is "now hindering" such research.
Mark McCarty, 703-268-5690