Unleavened Thoughts About the Healthcare Regime

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  • 04/02/2010

I don't want to think in terms of repeal. Rather, I would prefer to use a medical or scientific analogy in describing how to respond to the effects of the legislation.The bill itself is a virus and we the people are the host if you will. Or consider it an experiment with every American forced into participation. Either way, we will be subject to new "solutions" that will have unknown consequences and side effects.  As with any social experiment or massive program of social engineering, we will experience the end product in ways much different than promised.  (If anyone has used on-line dating services, you know what I am talking about.) 

Strategically, demanding outright repeal or defunding of health care reform sounds great to a small group. To build support for fundamental changes in what is now law will require exactly what the supporters of the current bill engaged in, nothing less and probably more:

1.    Consistent and persistent evaluation of the performance of health care delivery systems. These standards should be easily grasped by most people and communicated easliy in visual form too.   Are doctors leaving the system? Are people paying more or less for insurance? Are people any healthier?  

2.    Warning signs. The other side is hell bent on using health care reform to reduce our long term debt. Debt will rise because of spending unrelated to health care reform.To turn health care reform and by extension, every doctor and hospital, into any agent of deficit reduction first and foremost is a rationale for rationing care. And it is an immoral one at that. 

3.    An increasing reliance on the use of comparative effectiveness research to shape policy and health care coverage decisions. Increasiningly, to justify the need to avoid financial Armageddon,  policymakers will rely upon CER to help make hard choices to slow health care spending in order to avoid “financial catastrophe.” If that sounds a lot like the narrative of the climate change crowd who used self-serving and secretive studies to support policies that also would lead to a decline in economic growth in order to save the planet, you are right. The “science” of CER demonstrating that a half to a third of health care spending is wasteful  has much in common with the that of the hockey stick project about the atmosphere evaporating. It is not empirical or biological, it is speculative and has never been evaluated for it’s real impact on public health or human well-being. Should we take prescriptions that are not tested or are not based on an accurate representation of human or biological mechanisms? Yet CER is precisely that and it may be used to determine what preventive services are covered and what new benefits will qualify for reimbursement.  It is possible to opt out of government run care because of conscientious objection to CER? I hope so..

4.    Impact on innovation. Largely unnoticed, drug companies are filling up pipelines with new products.More and more of them are based on  novel targets and rely on biomarkers linked to specific pathways and small populations. The number of molecular diagnostics to help predict,  diagnose and monitor the progression of diseases or response to medicines are growing as is the business capacity to provide doctors and hospitals the ability to use this information. The progress will be incremental but it will come. The question is will future policies add to the cost and pace of progress or not?  CER is only one such challenge.  And alone it’s proponents will be left looking foolish and backwards. However changes to the FDA regulatory process can easily increase the time and cost of bringing new products to market and reduce the effective patent life of niche medicines.  Demands to have a new center for drug safety review all NDAs before they go to market and for CER studies as a condition for approval would impose huge costs on innovation and the pubic health.   Similarly, CER requirements can add more delay and uncertainty to the R&D process.    

These are substantive concerns about the new health care bill that can be  addressed through the writing of regulation and new legislation.  We intend to track these issues as we have in the past.   I don’t care if someone wants to call this approach repeal or reform or a do-over.  I would like to think of restoring and improving the health of the system and all Americans.

CMPI

Center for Medicine in the Public Interest is a nonprofit, non-partisan organization promoting innovative solutions that advance medical progress, reduce health disparities, extend life and make health care more affordable, preventive and patient-centered. CMPI also provides the public, policymakers and the media a reliable source of independent scientific analysis on issues ranging from personalized medicine, food and drug safety, health care reform and comparative effectiveness.

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