"For every dollar Congress gives the National Institutes of Health to develop blockbuster treatments, it spends only one penny to ensure that Americans actually receive them," said Steven H. Woolf, M.D., professor and director of research in VCU's Department of Family Medicine and a member of the National Academy of Sciences' Institute of Medicine. "This reflects, in part, a misperception that the improved drugs, procedures and the like will improve health outcomes, and that does happen. But the health improvement would be far greater if we worried less about making incremental improvements on existing treatments and more on the system barriers that impede Americans from receiving those treatments correctly." The study was coauthored by Robert E. Johnson, Ph.D., an associate professor in VCU's Department of Biostatistics.
Woolf and Johnson, whose study appears in the Dec. 6 issue of the Annals of Family Medicine, said a mathematical construct proves the point. They used two case studies -- one involving statins and the other antiplatelet drugs -- to show that the billions of dollars spent on new generation drugs saved fewer lives and prevented fewer strokes than if the existing drugs had been taken by all patients who could benefit. They cited reports that Americans receive only half of recommended health care services and that disparities in care are worse for minorities and disenfranchised patients.
The study poses a contrast between efficacy, or how well a treatment works, and what they call the "fidelity of health care." Independent of the efficacy, fidelity is the extent to which the health care system provides patients the precise interventions they ne ed, delivered properly, precisely when they need them.
Woolf illustrated the concept with an example of a theoretical disease that claims 100,000 lives a year. If a drug is available that reduces the mortality rate from that disease by 20 percent, it has the potential to save 20,000 lives each year. But if only 60 percent of eligible patients receive the drug, only 12,000 deaths will be averted. Closing the gap in care -- making it available to 100 percent of eligible patients -- would save 8,000 additional lives. To save 8,000 additional lives by making a better drug and without closing the gap in care -- delivering the better drug to only 60 percent of eligible patients -- the drug's lowering of mortality would have to be increased from 20 percent to 33 percent. Woolf calls this the "break-even point" and notes that it is an unrealistic goal for many treatments. The study shows that the billions invested in statins and clot-busting drugs failed to reach the break-even point, thus saving fewer lives than if gaps in care had been rectified.
For example, getting aspirin to all eligible patients would have prevented more strokes than were prevented by developing more potent and more expensive antiplatelet drugs, Woolf said. In another example, Woolf and Johnson estimate that for every heart attack death prevented by the development of the new statin, Crestor, seven deaths would have been prevented by sticking with older, less potent statins but adopting simple reminder systems such as post-it notes on the front of charts that would alert clinicians when patients need cholesterol-lowering therapy.
"Society's huge investment in technological innovations that only modestly improve efficacy, by consuming resources needed for improved delivery of care, may cost more lives than it saves," they wrote. "The misalignment of priorities is driven partly by the commercial interests of industry and by the public's appetite for technological breakthrou ghs, but health outcomes ultimately suffer." The authors discuss the relevance of this concept at a time when the nation is struggling with the escalating costs of health care and unsatisfactory performance on quality.
"Health, economic and moral arguments make the case for spending less on technological advances and more on improving systems for delivering care," he said.