The history of the Federal Food and Drug Administration is a fascinating story that balances the federal government’s actions in support of keeping the citizenry safe from snake oil salesman selling poison and the food and drug supply “pure” against the capitalist that drives innovation in the area of health care improvement. The story of the FDA is one that will never be over but unless someone actually understands what has happened in the past and WHY certain official positions have been imposed, the beneficial nuances can be completely lost in the jargon.
For example, the FDA was charged with assuring that a manufacturer wishing to market a health, food, or cosmetic product in this country was SAFE. Later, impositions regarding proving the “efficacy” of the product, in line with the manufacturer’s claims, were added. This became of particular interest as health care financial risk was born by third parties, including the Government under Medicare and Medicaid payments.
Now, CER (Comparative Effectiveness Research”) has taken the FDA’s scope of authority yet farther as the research manufacturers must assume before and after a product is launched involves establishing more than just, “Can I prove that this product is more effective than a placebo?” Defined in various ways, CER is described by the IOM as “the generation and synthesis of evidence that compares the benefits and harms of alternative methods to prevent, diagnose, treat, and monitor a clinical condition or improve the delivery of care. The purpose of the research is to help consumers, clinicians, purchasers, and policy makers to make informed decisions that will improve health care at both the individual and population levels.”
The American Recovery and Reinvestment Act of 2009 (ARRA) and the ACA reignited the federal government’s interest in CER.
There is a cost (which is not surprisingly added to the cost of the product) to prove safety and a cost to prove efficacy. When you go to prove comparative efficacy, you are risking that you will lose. It’s tantamount to betting your bank account at the craps table in Las Vegas because you cannot really be sure which way it will turn out.
In fact, this CER craps table, has become part of the requirement under new federal requirements but sometimes the forest is lost for the trees. For example, the Forbes article linked below cites TWO studies on diabetes drugs that concentrated on Safety (being no worse than placebo) but said nothing about effectiveness. At what cost? The author concludes, “Rather than mandating narrow studies of cardiovascular studies, we should be encouraging studies that let us know which regimen is best for which patients, based on what they actually do for patients.”
He does not recommend ignoring safety, he’s just looking for an equally important conclusion. I am sure there are also CER studies underway to answer his question.
The other perspective on this is from the Heritage article linked below, referencing that this concept in the UK resulted in a system whereby CER was used to reject certain treatments for mostly budgetary reasons.
“CER use in the U.K. has been a far cry from what is implied by the rhetoric used to promote PCORI. Rather than focusing on the individual needs of patients, the United Kingdom’s National Health Service (NHS) uses comparative and cost-effectiveness information to limit options as a budgetary tool.
The NHS offers health coverage to all British citizens and determines which treatments will be covered and paid for, and under which circumstances. Decisions are based on “recommendations” by the National Institute for Health and Clinical Excellence (NICE), who’s stated purpose is to create clinical guidelines and standardize care using cost-effectiveness information, but the NHS is required to adhere to all of the recommendations made by NICE.
If a treatment is not covered, patients are able to go outside the NHS and receive it privately without regulatory or statutory obstacles—if they are able to afford this. (Because of Medicare’s restrictions on private contracting, American seniors would not have this same option.)”
http://www.heritage.org/research/reports/2012/04/comparative-effectiveness-research-under-obamacare-a-slippery-slope-to-health-care-rationing
http://www.heritage.org/research/reports/2012/04/comparative-effectiveness-research-under-obamacare-a-slippery-slope-to-health-care-rationing
Thus, the benefits of CER (which may derive clarity for the practitioner to apply to individual patients) must be weighed against the need to treat each patient as an INDIVIDUAL whose needs, wants, and situations may require the flexibility which a system conformed to the latest CER may not allow.
Terri is a Senior Partner at Valiant Health, LLC, and founder of Cambria Health Advisory Professionals. The thoughts put forth on these postings are not necessarily reflective of the views of her employers, clients nor other Valiant Health colleagues. Terri has had a varied career in health related settings including: 9 years in a clinical hospital pharmacy setting, 3 years as a pharmaceutical sales rep serving government, wholesaler, managed markets and traditional physician sales, 3 years working for the executive team of an integrated health system working with physician practices, 4 years as the director of pharmacy for a large BCBS plan, 12 years of experience as founder and primary servant of a health technology company which was sold to IMS Health in late 2007. She has both a BS and a PharmD in Pharmacy and an MBA. 
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