The differences between comparative and clinical effectiveness

by Peter J. Pitts

“Newspeak,” the language of Big Brother, was designed “not to extend but to diminish the range of thought.”

Some well-known examples of Newspeak are Bellyfeel (a blind, enthusiastic acceptance of an idea), Duckspeak (meaning literally to quack like a duck or to speak without thinking), Crimethink (the Newspeak word for thought crime) and Goodthink (or “political orthodoxy”).

Which brings us from the nightmare fantasy of “1984″ to the health care debate of 2011 and a new term — “Cost-think,” which defines everything that reduces short-term costs as a benefit to the patient.

The Recovery Act of 2010 gave the Agency for Healthcare Research and Quality $1.1 billion to conduct, according to the Health and Human Services Department news release, “comparative effectiveness research” into various “healthcare interventions.”

Except that’s not what Congress funded. Per the act, that $1.1 billion was earmarked for clinical comparative effectiveness, not comparative effectiveness research. And this is not splitting hairs. Enter cost-think.

Comparative effectiveness advocates favor large-scale trials that “compare” drugs and other health care “technologies,” striving to show which medicines are most effective for any given disease state. Comparative effectiveness means cost effectiveness.

Clinical effectiveness, on the other hand, measures outcomes on an individual patient level. Clinical effectiveness studies help us to understand how to design treatments based on patient variation rather than cost. This approach represents the very definition of personalized medicine.

The differences between comparative and clinical effectiveness are profound. By changing the legislative verbiage, the legislative intent is likewise altered.

Welcome to cost-think, where anything that has to do with health care reform must be entirely based on the philosophy of reducing short-term costs.

And nowhere is cost-think more crucial than when it comes to so-called “academic detailing” of publicly bankrolled comparative effectiveness research.

The first question to ask is, will these studies be peer-reviewed before release? And to whom will the studies be communicated — and how? Will physicians be required to be detailed?

Will physicians be given incentives (i.e., continuing medical education credits) to spend time with AHRQ’s comparative effectiveness angels and punished (via Medicare and Medicaid restrictions) if they do not? How will Uncle Sam decide which doctors are to be visited? Will “high prescribers” of on-patent medicines be on a priority list?

Congressional oversight must be required for the $42.3 million that AHRQ has already awarded for public and physician outreach.

What kind of safeguards are in place to certify that information that is unbiased? Previous government detailing efforts have often focused on demonstrating their own value by highlighting the cost effectiveness of initiatives through savings generated from the increased utilization of generics and other low-cost therapies. Who will be the arbiters of transparency?

Left unsaid, but clearly implicit, is that academic detailing is required to offset the devilish doings of industry. That’s why the more common appellation is counterdetailing.

Who will decide what these detailers can say or not say? Will these government “reps” have to play by the same rules as their pharmaceutical counterparts? And, importantly, what is the oversight mechanism? If academic detailers stray into off-label conversations, to whom does Food and Drug Administration send a letter? Who does the Department of Justice investigate?

Most importantly, who will determine the difference between “communicating” these findings and “promoting” them? Alas, such finesse is unlikely under a regime of cost-think.

Government-sponsored comparative effectiveness research is the first step toward allowing Uncle Sam to push a restrictive formulary on more and more Americans. Unless we are aware and vigilant, such cost-think may very well lead to a single-payer system referred to in cost-think as “universal coverage” — but in reality will be nothing short of health care rationing.

Peter J. Pitts is co-founder and president of the Center for Medicine in the Public Interest and a former FDA Associate Commissioner. He blogs at Drugwonks.

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  • Thomas Reid MD PhD FACP

    Rationing and formulary restrictions have already begun. The future is bleak with “bundling” and ACOs.

  • doc99

    Anyone know when CMS is going to share with us peons, the regulations covering ACO’s?

  • http://drpullen.com medical blog

    I like the “counter-detailing” moniker better. I do hope the same rules apply re off-label use. Many of the cost savings we employ are by using meds off label to replace FDA approved new branded drugs. Should these be “detailed” without FDA approval? Probably not.

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