Do we need comparative effectiveness research? Lots and lots of my intelligent colleagues think so. But as usual, I am more suspect.
That's because it will cost a bundle. $1.1 billion has been earmarked for this endeavor in the new Stimulus Bill.
And that's mere seed money.
Think about it: How many issues in medicine need "effectiveness" comparisons? Hundreds? Thousands? Tens of thousands? How much will each project cost? How many teams of "experts" will have to be assembled to tell us is enteric coated aspirin is as effective as plain aspirin for the treatment of arthritis? Oh sure, scoff at the notion, but with bureaucracies, there's virtually no limit to how detailed we can go with this.
And we might not even need it.
That's because comparative effectiveness research is being done, free of charge, right now, right on your computer, via the internet.
It's called t-r-a-n-s-p-a-r-e-n-c-y. Show us the technology, show us the price, show the the prospective, randomized trials, tell us what it'll cost, and let us decide. Plain and simple. Isn't that what where we're already going right now? Is there a better vetting body than the world? I mean, look at the drug costs now available on the internet. Look at the costs of procedures that hospitals are beginning to publish. More and more this will be the norm. Why? Because you and I are having to pay a larger and larger proportion of our health care bill right now.
We'll demand it.
Or are we to be fear-mongered that evil pharma and device companies will surely warp our tiny minds with their marketing schemes and exhorbitant prices so we have no choice but to accept comparative effectiveness reseearch as our ultimate fiscal and medical saviour?
One only has to recall the exposure of the marketing tactics by drug and device companies in the realm of direct-to-consumer advertising (never mind that Congress, and the FDA, remain beholden to the drug companies for funds never reads the public's tea leaves - (or the Stimulus Bills - d'oh!)). Or look to the remarkable migration of patients from pricey Vytorin to generic simvastatin after the negative results of the Enhance study failed to show an advantage with the combination medication. Was comparative effectiveness research responsible for these epiphanies?
Finally, there's some real-life research issues with comparative effectiveness research that are concerning. First: "effectiveness research" relies on the history of competing technologies. New technologies will almost always be at a disadvantage to older technologies because they do not have a history of experience with which to compare. If doctors require a learning curve in the application of any new medical advance, might there be a bias to pull new technologies before they're understood? Perhaps.
Secondly, the term "effectiveness" is bothersome because it implies there must be one correct answer. Take, for instance, a therapy that prolongs life "effectively" that is expensive (many of the new cancer drugs come to mind). If cost-effectiveness is the goal, then using none of the drug and letting the patient succumb to cancer might be the most "effective" use of the drug to save costs to our health care system. But if longevity is the primary effectiveness goal, then the best therapy might be incredibly costly in a younger patient. Which effectiveness goal will be chosen for each of the therapies tested? Cost or clinical outcome? If a "blended" goal is desired, who will decide how much of which goal will be ultimately chosen?
Finally, what about confounding factors? How can any of the millions of permutations of co-existing conditions be weighed in effectivness research? Take coronary stents, for instance. Whereas a drug-eluting stent might be the perfect choice in terms of limiting restenosis in a particular clinical situation, will comparative effectiveness research limit a cardiologist's ability to place a bare metal stent instead because he knows the patient will be undergoing hip replacement in four weeks? Can we really expect an algorithm mandated by researchers and bureaucrats to account for these situations? If so, how extensive will all the exclusion criteria become?
Suddenly to me, it seems the crystal clear goals of Comparative Effectiveness Research become very clouded.
Rather, I think this $1.1 billion earmark for comparative effectiveness research is really about stimulating research budgets for the "Chosen Fifteen" connected research politicos rather than helping doctors know how best to treat their patients. No one study or group of individuals can apply such studies to the individual patient - I don't care how much money we dump into their research. Clinical guidelines have been careful not to supercede clincal judgement and comparative effectiveness research shouldn't either. To do so invites liability claims and the potential for untoward health care delivery in the name of government mandates that might ultimately threaten the doctor-patient relationship.
Then what have we accomplished for our $1.1 billion dollars?