“Newspeak,” as you Orwellian cognoscenti know, is the official language of Oceania – the land ruled by Big Brother. Newspeak was designed “not to extend but to diminish the range of thought” (author’s original italics). Its goal was to “make all other modes of thought impossible.”
Further, per Mr. Orwell, “A Newspeak word was simply a staccato sound expressing one clearly understood concept.”
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”).
All of which brings us from the nightmare fantasy of 1984 Newspeak to the healthcare debate of 2011, the concept of comparative effectiveness research, and a new term we must all become familiar with -- “Cost-think” (which defines everything that reduces short-term costs as a benefit to the patient).
The Recovery Act of 2010 (aka – “the stimulus package”) gave the Agency for Healthcare Research and Quality (AHRQ) $1.1 billion to conduct (according to the HHS press release) “comparative effectiveness research” into various “healthcare interventions.”
Except that’s not what Congress funded. Per the Recovery Act, that $1.1 billion was earmarked for clinical comparative effectiveness not comparative effectiveness research. And this is not splitting hairs. Enter cost-think.
Those in favor of comparative effectiveness research favor large scale trials to "compare" drugs and other healthcare “technologies, striving to show which medicines are most effective for any given disease state. Is there a “more effective” statin? A “more effective” treatment for depression?
But how do you compare two molecules (or three or more) that have different mechanisms of action for patients that respond differently to different medicine based on their personal genetic make-up?
Comparative effectiveness relies heavily on findings from randomized clinical trials. While these trials are essential to demonstrating the safety and efficacy of new medical products, the results are based on large population averages that rarely, if ever, will tell us which treatments are “best” for any given patient.
Two such studies, the Clinical Antipsychotic Trials in Intervention Effectiveness (CATIE), study and the Antihypertensive and Lipid-Lowering Treatment to Prevent Heart Attack Trial (ALLHAT) study, were two such “practice-based” clinical trials, sponsored in part by the National Institutes of Health, to determine whether older (cheaper) medicines were as effective in achieving certain clinical outcomes as newer (more expensive) ones.
The findings of both CATIE and ALLHAT were highly controversial, but one thing is not: even well-funded comparative effectiveness trials are swiftly superseded by trial designs based on better mechanistic understanding of disease pathways and pharmacogenomics. And, since most comparative effectiveness studies are underpowered, they don’t capture the genetic variations that explain differences in response to medicines by different patients. Comparative effectiveness in its current form leads to a “one-size-fits-all” approach to healthcare, which means that it doesn’t fit anyone all that well.
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. The very definition of personalized medicine.
All this to say that the differences between comparative and clinical effectiveness studies are profound and that by changing the actual legislative verbiage, the legislative intent is likewise altered.
As Mr. Orwell wrote, no word in the Newspeak vocabulary was “ideologically neutral” and a great many were “euphemisms.” Welcome to cost-think, where anything that has to do with healthcare reform cannot be spoken about in terms of cost but must be entirely based on the philosophy of reducing short term costs.
And nowhere is cost-speak more crucial than when it comes to publicly bankrolled dissemination of the findings of tax-payer-bank funded and AHRQ-fielded comparative effectiveness research.
The first question to ask is whether or not these studies will be peer-reviewed before they are allowed to be released? (CATIE and ALLHAT were not.) Another query is to whom will the studies be communicated – and how? Will physicians be “academically detailed?” And if so, will they be required to be detailed? Will physicians be given incentives to spend time with AHRQ’s comparative effectiveness angels (i.e., CME credits) and punished if they do not (via Medicare and Medicaid restrictions)? And how will Uncle Sam decide which doctors are to be visited? Will “high prescribers” of on-patent medicines be on a priority list, identified by mechanisms being developed to enforce multiple state physician “sunshine” laws?
Congressional oversight must be required for the $42.3 million that AHRQ has already awarded for public and physician outreach.
And relative to academic detailing (aka, “counter-detailing”), what safe guards are in place to certify that physicians are being presented 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.
Asked another way – how can an “academic detailing” program funded by our nation’s largest payer (Uncle Sam) be considered neutral? Just like detailing programs run by pharmaceutical companies, there is an inherent “interest.” And that’s okay – as long as that “interest” is transparent. Who will be the arbiters of transparency?
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 DDMAC send a letter? Whom does the Department of Justice investigate? Who pays the fine?
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. As Orwell commented, Newspeak was constructed as to “give exact and often very subtle expression to every meaning that a Party member could properly wish to express, while excluding all other meanings and also the possibility or arriving at them by indirect methods.”
As currently organized, comparative effectiveness research will be used to increase government control over the practice of medicine and is a slippery slope towards the introduction of price controls.
Government sponsored comparative effectiveness research is the first step towards allowing Uncle Sam to push a restrictive formulary on more and more Americans – with step one in the process being unfettered (and unregulated) communications efforts. 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 healthcare rationing.
As Rudyard Kipling said to London's Royal College of Surgeons in 1923, "Words are, of course, the most powerful drug used by mankind ... They enter into and colour the minutest cells of the brain."
We allow them to be usurped and corrupted at our own peril.
