The economic stimulus package that President Barack Obama just signed into law includes $1.1 billion for a Federal Coordinating Council for Comparative Effectiveness Research. Though it may be not be a popular point of view, let me say this is a bad idea. The fact is, this is a giant first step towards a U.S. version of the United Kingdom’s National Institute for Health and Clinical Excellence or NICE.

 

Whether or not you agree that such a notion is a bad idea, we should agree that it’s important enough to debate this on its merits – and not allow it to become law through legislative legerdemain by hiding it deep within the bowels of the stimulus package.

 

Senator Diane Feinstein, D-California, says that, “the purpose of the council is to coordinate comparative effectiveness research activities with the goal of reducing duplicative efforts and encouraging coordinated and complementary use of resources.” Senator Baucus, D-Montana, promises that, “Its charge should not go beyond that.”

 

Indeed, Senate Finance Committee documents detailing health provisions in the Senate's economic stimulus package say that the bill "specifically prohibits the government from making any coverage decisions based on this research, or even from issuing guidelines that would suggest how to interpret the research results."

But the original House language had no such limitations in mind. “By knowing what works best and presenting this information more broadly to patients and health care professionals, those items, procedures and interventions that are most effective to prevent, control and treat health conditions will be utilized, while those that are found to be less effective and in some cases, more expensive, will no longer be prescribed,” the House language said.

 

The problem is that comparative effectiveness, as it is currently designed, places into conflict the short-term budgeting dilemmas of government officials who are elected for relatively short periods of time with the ever-lengthening life spans of we the people.

 

Those in favor of comparative effectiveness favor large scale randomized trials to compare drugs. The problem is that randomized trials tend to ignore differences in clinical outcomes due to side effects or genetic variations. So whether you analyze them together or individually, researchers will most always find no difference in the effect of medicines, a result that is biased in favor of older, cheaper drugs. 

As currently organized, comparative effectiveness will be used to increase government control over the practice of medicine and introduce price controls. All rhetoric to the contrary, this is the first step towards allowing Uncle Sam to push a restrictive formulary on more and more Americans.

 

We need a new model. We need to develop proposals that modernize the information used in the evaluation of the value of treatments. Just as the key scientific insights guiding the U.S. Food and Drug Administration’s Critical Path program are genetic variations and biomedical informatics that predict and inform individual responses to treatment, we must establish a science-based process that incorporates the knowledge and tools of personalized medicine in reimbursement decisions: true evidence-based, patient-centric medicine.

 

For instance, the FDA, in cooperation with many interested parties, has developed a Critical Path opportunities list that provides 76 concrete examples of how new scientific discoveries in fields such as genomics and proteomics, imaging, and bioinformatics could be applied during medical product development to improve the accuracy of the tests used to predict the safety and efficacy of investigational medical products.

 

We need a Critical Path for comparative effectiveness to begin the process of developing a similar list of ways new discoveries and tools (such as electronic patient records) can be used to improve the predictive and prospective nature of comparative effectiveness.

 

It’s a complicated proposition, but such a goal is as simple as it is essential. Cost must never be allowed to trump care, and short-term savings must not be allowed to trump long-term outcomes. Just as we need new and better tools for drug development, so too do we need them for comparative effectiveness measurements.

 

A comparative effectiveness model for the 21st Century should reflect and measure individual response to treatment based on the combination of genetic, clinical, and demographic factors that indicate what keep people healthy, improve their health, and prevent disease. A rapidly aging society demands a new healthcare paradigm capable of providing for its needs in the 21st Century. Equality of care must be matched with quality of care. 

 

In an era of personalized medicine, one-size-fits-all treatments and reimbursement strategies are dangerously outdated. We are early in this debate, but at least we can all agree that this is not, and must not be exclusively, a debate about saving money. It must be about patient care. And it must be openly and robustly debated. 

 

When you use the same 20th century tools for clinical trial design – you get the same 20th century data.  It’s important to note that not one cent of the stimulus bill went towards the development of 21st century drug development and regulatory tools – precisely what the FDA’s Critical Path program is designed to address. 

Where you stand often depends on where you sit. If you’re a payer (either public or private), saving money can often mean denying expensive end-of-life care.  If you’re a patient, you might have another view.

If we want to provide excellent care and save money, there are two crucial public health issues that are being ignored by our elected representatives: compliance programs, and early diagnosis and prevention. No doubt members of Congress will say that such things will be addressed when we debate health care reform. But isn’t that what we’re doing now?