Tuesday, May 12, 2009

Clinical Guidelines and Technology Assessment

“Clinical Guidelines and Technology Assessment”? Well, there’s a yawner!

Maybe you'll be one of the few who won’t say “I think I’ll skip this one”, but if you are not, I’d have to be empathic. I’m thinking about the time I picked up a “Technology Assessment” document (I think it was on the use of lithotripsy for ureteral stones) issued by the Agency for Health Care Policy and Research (AHCPR), now known as the Agency for Health Research and Quality (AHRQ). It was a long time ago because, as noted by Barry Meier in the Business section of the New York Times (May 7, 2009), in his article reporting on efforts to re-institute Federal guidelines for procedures and technology through ARHQ, it has been 15 years since they have been issued.[1]

Meier's piece begins by focusing on the last time that ARHQ (then AHCPR) did publish such guidelines in the 1990s, they ran into big trouble. Specifically, the guideline that did not recommend spinal fusion for acute back pain generated attacks by spine surgeons and device manufacturers that were far more than verbal:
One medical device maker, Medtronic, sued unsuccessfully to block its release. Republican lawmakers tried to kill the agency that issued the report. It survived, but its funding was drastically cut and it decided to stop issuing guidelines.”

So what’s the problem? Well, the evidence showed that these fusions did not, on the whole, work. The evidence was there to support the AHCPR guidelines; indeed, for the federal agency, that was the whole goal, to review the evidence; they had no “skin” in the outcome. But for spine surgeons and device manufacturers, such a recommendation would lead to loss of money. Unable to respond on the evidence, they tried strong-arm bully-boy tactics. Which largely worked. AHCPR, then AHRQ, has issued no guidelines since. Until this year, with the Obama administration appropriating $1.1 billion for technology assessments and prepare guidelines (only $400 million going to ARHQ, the only agency that has a history of doing and funding such work; the rest is inexplicably going to NIH and others), there haven’t been any such guidelines issued for 15 years. How does this help the American people?

Not at all. Guidelines based upon evidence that help physicians choose between alternative therapies for different conditions would only be beneficial to our health: “Supporters include many medical researchers, consumer groups unions, and insurers [and, indeed, physicians]. They say such studies are essential to curbing the widespread use of ineffective treatments and to helping control health care costs, which totaled $2.2 trillion in 2007, or 16% of the nation’s gross domestic product.”

It would seem to be difficult to argue for using “ineffective treatments”, but that would only be if you were not the one to profit from it: “…potential opponents, which include medical products companies, some doctors and their political allies, warn that the comparative effectiveness movement could lead to inadequate treatment for some patients and even the rationing of health care.” Wait a minute. How does knowing that some treatments are more effective than others, or that some treatments are virtually ineffective, lead to inadequate treatment? Are we sure that they are not talking about inadequate profit? And what about rationing? What do we have now? Those who are well-insured get everything, whether it works or not, whether it has the potential to do harm or not, while those who are not insured get nothing, even when we know it would work. How is this better?

These opponents argue that such guidelines would decrease “personalized medicine”. “Personalized medicine” sounds good until you look into it, when you might well ask “but on the basis of what evidence are you personalizing my treatment?” Unfortunately, often it is at best doctor preference and at worst driven by opportunity to make money. This issue is addressed by three “Perspectives” in the May 7, 2009 isssue of the New England Journal of Medicine. Garber and Tunis point out that “personalization” requires the evidence; for example, that bypass surgery has lower mortality for coronary disease in people over 65, while angioplasty is better for those 55 or less. They note that the greatest “personalization”, understanding your genetic makeup, requires studies to look at how much a particular gene affects a person’s likelihood of getting a disease or responding to treatment; that is, how well such testing strategies work.[2] Naik and Petersen discusses the purposes of comparative-effectiveness research, and examine the three levels needed to decide if it will work in actual people[3]. Avorn directly takes on the opponents of such research, including demagogues such as Rush Limbaugh.[4]

The leader in this effort is a new industry lobbying group, the “Partnership to Improve Patient Care” (don’t you love these names, picked to entirely obfuscate what they are really about? It does sound a lot better than “the Partnership to Maintain our Profits”, a name that would fit it, and indeed virtually all of these lobbying groups). Its spokesman is former California congressman Tony Coelho, a former Democratic whip. He is “former” because he resigned in the wake of a junk-bond investment scandal. So it is certainly not surprising to see him fronting for such a group; he is well-paid, we can be sure. One of the bugbears raised by these opponents is the British government’s National Institute for Clinical Effectiveness (NICE). (Now isn’t that a nice name?) NICE evaluates the clinical effectiveness of various interventions and also associates them with a price tag – how much will it cost to treat enough people that one person will have an improvement of a certain amount of quality life (usually measured in quality-adjusted life years, or QALYs). This concept takes into account the number of people that would need to be treated for a beneficial effect to be seen, the percentage of people who will see a benefit, and the degree of that benefit. By looking at the cost to do this intervention in enough people to result in an increase from the therapy of 1 QALY, different treatments can be compared to each other. Thus we can see the relative benefit, and cost-benefit, for different treatments for the same disease, as well as assess where there is more “bang for a buck” in funding treatments for different diseases.

In Britain, the governmental NHS has used recommendations from NICE to deny coverage for treatments that exceed a certain cost-per-QALY, and has predictably come under some criticism for this. But the criticism generally, and rightfully, is related to the question of what the appropriate cost is. It is clear that $5000 (or pounds) per QALY is well worth it; it is also clear that $500,000 is extremely high, probably too high. In the US, there is no plan for AHRQ to even assess cost as part of its guidelines, not to mention use that as basis for reimbursement.

But it is probably true that Medicare, as well as private insurers, are unlikely to pay for procedures which, on the basis of the evidence, are assessed to be ineffective or significantly less effective than alternatives (indeed, many insurance companies have long had preferred drug lists, with 3-tiered co-pays, preferring generic, lower cost drugs). This would be, on the whole, a good thing, for cost control and for quality of patient care. But it would be bad for the profits of companies that make products not judged to be effective and the physicians and surgeons who currently make money from using them, just as with the spinal fusion issue in the 90s. And they have power, and clout, and lobbyists like Tony Coelho.

Ironically, research in basic science laboratories, the kind that is most of what is done with the $30 billion NIH spends, tends to be uncontroversial. By its nature, it is unlikely that any particular study of this kind will ever have an impact on the health of people, and if it does, the likelihood is that it will be decades before that is seen. So it rarely hits any individuals or companies in the pocketbook (we ALL pay for it in tax dollars). In contrast, the paltry (even with the increase to $1.1 billion) funding for ARHQ generates a lot of opposition because it actually assess existing approaches to treatment and makes recommendations as to which are most likely to benefit people.

Duh. Don’t we want that? Avorn notes that “Fortunately, Congress did not let warnings of a dystopian scientific police state undercut the nation’s need to learn what works best in medicine.” But he warns that while comparative-effectiveness research “…dodged a barrage of well-coordinated bullets this time, the debate is bound to continue.” I agree; the battle may be won, but the war is not over. Given the well-funded opposition, it will be critical for the American people to let them – physicians, industry, lobbyists, and their lawmakers -- know that we want our government to support research that may actually benefit us.

[1] Meier B, “New effort reopens medical minefield”, New York Times, May 7, 2009, pB1
[2] Garber AM, SR Tunis, “Does comparative-effectiveness research threaten personalized medicine?”, NEJM May 7 09;360(19):1925-7.
[3] Naik AD, LA Petersen, “The neglected purpose of comparative-effectiveness research”, NEJM May 7 09;360(19):1929-31.
[4] Avorn J, “Debate about funding comparative effectiveness research”, NEJM May 7 09;360(19):1927-9.

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