Friday, June 19, 2009

Roy Poses on EBM and CER

Roy Poses M.D. is one of the bloggers over at Health Care Renewal. He's no stranger to EBM and the related issues of helping physicians keep up with the onslaught of scientific information and helping them put best evidence into clinical practice. I have participated with him in several Medscape Roundtable Discussions. Although we sometimes disagree on areas of public policy in medicine, particularly the role of industry, I respect his views.

Recently he has written one of several posts on comparative effectiveness research (CER). Like many opinion writers on this subject he conflates CER (which is nothing more than head to head clinical trials, which we've been doing for decades) with an agenda for more government control of research and health care. That conveniently enables him and other writers to accuse skeptics of this advancing agenda of being opposed to CER, a fallacy which I exposed here. Any defense of CER, as Dr. Poses purports to be making, presupposes that somewhere there's opposition. But, as I said in that post, there is no serious opposition to the pure notion of CER.

The first example he cites is a piece by Robert Goldberg from almost 2 years ago, originally published in the Washington Times. There Goldberg ranted against the government agenda to control costs and limit health care choices and criticized the ALLHAT study. As Poses points out the article was distorted and a little over the top, but while Goldberg spoke derisively about the “comparative effectiveness crowd” and the “evidence based crowd” nowhere in the article did he say we shouldn't apply the best evidence to individual patient circumstances, and nowhere in the article did he call for a moratorium on head-to-head clinical trials conducted in real world situations. (I have criticized the EBM crowd myself although I love the pure notion of EBM). I don't know what Goldberg really feels about the pure notions of EBM and CER. He didn't say in the article.

The next example is this op-ed in the New York Times in which Peter Pitts wrote:

...the provision would allocate $300 million to create a Center for Comparative Effectiveness that would test whether newer, more expensive drugs work better than their older and cheaper counterparts. Medicare would use the center’s findings to help decide which drugs to cover. If the center found that a newer, pricier pill was no more effective than the older, cheaper version, Medicare would probably refuse to pay for it.

This sounds reasonable. But it will most likely result in Medicare covering fewer breakthrough medicines, which would, in turn, force doctors to prescribe only the drugs that Medicare will pay for — not the ones that are best for the patient.

Again, Pitts is against government control of the research and the likely agenda to surrounding it, not the research itself. In the same way Dr. Poses has been critical of some research agendas. He once wrote:

Vested interests may also try to manipulate the design, implementation, and analysis of research studies to increase the likelihood that results will be favorable to them. Some possible manipulation tactics were noted by Smith and Brophy. Such manipulation has been made easier by the surprising willingness of US medical schools and academic medical centers to let commercial sponsors, rather than their own faculty "investigators," control clinical research studies.

Like Pitts, Dr. Poses is not arguing against any particular type of research, but he is concerned, like Pitts, about who pays for it and who controls it.

Dr. Poses points out one of the shortcomings of EBM in seeking to apply the best available evidence: the best available evidence varies in quality from one clinical problem to another. For some conditions we have very good evidence, but for others it is lacking or of poor quality. We all agree on the need more and better evidence. No one is arguing for a moratorium on head-to-head clinical trials or any other type of research.

But later in his post, purportedly in support of his “defense” of CER, he quotes a New York Times piece by Tyler Cowan which deals with health care spending but is not about CER at all. Here's some of what Cowan says:

Drawing upon the ideas of the Harvard economist David Cutler, the Obama administration talks of empowering an independent board of experts to judge the comparative effectiveness of health care expenditures; the goal is to limit or withdraw Medicare support for ineffective ones. This idea is long overdue, and the critics who contend that it amounts to “rationing” or “the government telling you which medical treatments you can have” are missing the point.

Incidentally, note that Cowan doesn't dispute the idea of government wanting to ration and tell us what treatments we can have, he just thinks it's beside the point. But Cowan isn't calling for more research. He's talking about a government panel to judge the findings of existing research evidence. Because he blames the problem on doctors' financial incentives he wants to take an essential step of EBM, critical appraisal, away from the treating doctors and put it in the hands of a government panel! That's what the naysayers are riled about. Will that help the cause of EBM? Is it what Dr. Poses really wants? (Take a look at the abysmal failure of what the government panels have handed us so far).

Cowan goes on to make this interesting observation:

Of course, we have not made such Medicare spending cuts yet, and there are few signs that we will. A Kaiser Family Foundation poll found that 67 percent of Americans believe that they do not receive enough treatment and that only 16 percent believe that they have received unnecessary care.

That's uncannily close to what the best research on the appropriateness of health care utilization shows (!):

We also classified indicators according to the problem with quality that was deemed most likely to occur, and we found greater problems with underuse (46.3 percent of participants did not receive recommended care [95 percent confidence interval, 45.8 to 46.8]) than with overuse (11.3 percent of participants received care that was not recommended and was potentially harmful [95 percent confidence interval, 10.2 to 12.4]).

Put another way, if doctors were 100% adherent to evidence based practice expenditures would more likely rise than fall. Government policy makers are smart, and surely they know this, but they don't want the rest of us to know. So much for transparency. The government is extremely conflicted in their research agenda, every bit as much as the private interests. They want to convince us that cheaper is better. Given the research that shows otherwise it will take some creative design and interpretation to support their agenda.

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