Although few have resorted to the “R word” (rationing), Scott Gottlieb, M.D., a former FDA deputy commissioner, recently warned in the Wall Street Journal that the government’s interest in controlling healthcare costs might trump other considerations. The aim for this center, he wrote, “is to arm government actuaries with data that proponents hope will provide ‘scientific’ proof that expensive new drugs are no better than their older alternatives.” And that “as the government begins tying its own payment decisions to the results of its own studies, there’s a great temptation to selectively interpret data and arbitrarily release results,” he said.

 

Michael Mussallem, CEO of Irvine, California-based medical device maker Edwards LifeSciences, agrees. “If these kinds of studies can turn into opportunities to deny patients access to care, then we think that is a big negative. We believe that they should be used to help make clinical decisions, not payment decisions.” 

 

Mussallem also says that the medical device industry supports the concept of comparative effectiveness research but worries that the metrics will skew in favor of dramatic leaps, while their business model is based on the concept of incremental improvement. Device makers have similar concerns that the timeline necessary to prove the value of a new device may not match an arbitrary timeline imposed by comparative effectiveness researchers.

 

Randy Burkholder, associate vice president of the Pharmaceutical Research and Manufacturers of America (PhRMA), says that his organization favors government-supported comparative effectiveness research “when it is done right.” Pointing to examples of policies elsewhere in the world, he makes it clear that “done right” does not mean replacing physicians’ decision-making with the distant mandates of a centralized government body.

 

Nonetheless, the costs borne by citizens and third-party payers loom as an incentive for gaining a better idea of which treatments work better than others. The Organization for Economic Cooperation and Development reported that the United States spent $6,401 per capita on healthcare in 2005, the highest in the world and twice as much as many other developed countries. And yet, according to Census Bureau rankings, the U.S. has lower life expectancy than at least 22 other countries and higher infant mortality that at least 27 other countries. Evidently, some of those healthcare dollars are not being spent wisely. As United Health Care’s Reed Tuckson noted at a recent conference of biotech executives, “healthcare is the only industry in which innovation drives up the cost.” Describing his own industry’s role, he said, “There are extraordinary misuses of assets within the system. We have to play the role of policeman to root out the ‘garbagey stuff.’”

 

Gail Wilensky, a health economist who is a former head of the Health Care Financing Administration (now known as the Center for Medicare and Medicaid Services), and perhaps the center’s leading advocate, adds, “We simply cannot continue for the next 20 or 30 years to have an increase in spending on healthcare that’s 2 to 3 percent faster than the growth of the economy in real terms.”