Wednesday, April 22, 2009

Not Passing the Sniff Test: ACC, PIPC, and CE Research

In my previous post,, I provided a link to a Bloomberg News article on foes of comparative effectiveness research, which had been called to my attention by Marilyn Mann. Marilyn has also very kindly called my attention to two subsequent posts by Dr. Jack Lewin, CEO of the American College of Cardiology:

Dr. Lewin's points appear to be very moderate and reasonable on the surface:
  • The Bloomberg article mentions the ACC and its involvement with an organization called Partnership for Improving Patient Care, hinting that PIPC is nothing but a Pharma front and that by joining PIPC, ACC is promoting the industry's cause with regard to comparative effectiveness (CE) research
  • Dr. Lewin thinks it wrong to suggest that just because the drug industry is part of anything, that automatically makes it bad
  • ACC agrees with the drug industry on the need for CE research--it is good
  • ACC disagrees with the drug industry on the need to take costs into account in relation to CE research, and holds that cost effectiveness is indeed a central duty of organized medicine
  • Nevertheless, within PIPC, groups that have slightly different stands on these details can all promote better patient care
  • ACC is firmly behind CE research and also is behind cost-effectiveness research, but believes that the two should be separate but parallel efforts

So if all this is reasonable and moderate, why do I think that something here does not pass the sniff test? Several reasons.

One reason is past history. Over the years, ACC has been one of the major medical organizations whose published practice guidelines have tended to be viewed by my evidence-based-medicine friends as among the lowest on the based-on-evidence scale--and just by coincidence, ACC has been happy to pocket major cash from the drug industry. So if the ACC has suddenly turned into a drug industry skeptic, that's a fairly recent development. Also don't forget that when critics of American medicine show you good-quality evidence that roughly one-third of tratments administered to U.S. patients are medically unnecessary, and somebody asks you for some examples, cardiology procedures always show up near the top of the list. So putting the ACC in charge of cost-effectiveness research is sort of like the old adage about the fox and the henhouse.

A more pertinent reason is: just what is being claimed in the guilt-by-association game? It is not simply that if Pharma joins a club, that club must be bad, even if its other members are all good. It is rather that over the years, Pharma has proven to be amazingly adept at joining a club, and then turning that club toward its own interests and advantage, regardless of who else the members are. When you have the deep pockets that Pharma has it is relatively easy to hijack other people's organizations and bend them to your will. (Assuming that PIPC really is somebody else's organization and not Pharma's own creation, which is certainly possible and indeed likely; I personally have not done the research. Pharma has created many organizations, as I explain in HOOKED in my chapter about "astroturf", that are deliberately made to look as independent from Pharma as possible.)

The final and perhaps most serious reason is to be found in this statement from Dr. Lewin: "Cost effectiveness has to be a critical issue for the nation, but it should be a parallel process, as PIPC members believe. " The claim appears to be: Both ACC and PhRMA can be members of PIPC because they believe that CE research is very important, and also that CE research should be kept separate from cost-effectiveness reserch. ACC differs from PhRMA's position in claiming that cost-effectiveness research is very important too, but only so long as it is parallel to, not combined with, CE research.

I cannot claim to be a research methodologist but I think I know something about what counts as a good cost-effectiveness study. (We know what bad ones look like--the major drug firms sponsor a ton of them. They all seem to come out showing that even though their drug costs 10 times as much as the rival treatment, once you make a set of highly questionable assumptions, the drug still turns out to be cost-effective.) A good cost-effectiveness study addresses both whether a treatment is better or worse than some rival treatment, when cost is not an issue; and then adds cost estimates to see whether the treatment is still a good deal when costs are taken into account. A good study is very explicit in making its assumptions about costs as well as any other variables. A good cost-effectiveness study also addresses the range of values over which its conclusions hold--so for instance, if the cost of the drug were reduced by 50%, would a non-cost-effective drug then become cost-effective, or not?

Suppose that some scientists did a high-quality cost effectiveness study and the results showed that while drug A was somewhat better than drug B, drug A also cost a good deal more than drug B. And suppose that insurance companies then used that study to say that they would not cover drug A but would only pay for drug B. Further suppose that patient advocates disagreed with the insurers, and claimed that the advantages of A over B were so substantial that it was worth the extra cost, and it was a violation of patients' rights to be denied access to A. My point is simply that if the study was a good study, there would be no hidden data. The data needed to carry out this debate would all be included and fully transparent within the research study itself. You'd have no need for a "separate but parallel" CE study; the CE study was built into the cost-effectiveness study and is there for all to see.

So if that's what a good cost-effectiveness study is like, what do you mean when you say that this is all very well, but it should be kept separate from "real" CE research? You could mean two things in my view. One is that you are in favor of good cost-effectiveness studies but not lousy ones. That'as very nice if ACC feels that way, but in that case, why is it jumping into bed with the organization that funds more lousy ones per square inch than anyone else alive?

The second thing you could mean to say is that really, truly, you are against CE research if it makes any mention at all of costs, or in short, limits your chance to make a buck. But you know you'd look unscientific or socially irresponsible if you said so out loud, so you need a cover--and your cover is this nonsense about "separate but parallel." Sort of like how Jim Crow schools were supposed to be separate but equal, maybe. The "separate but parallel" formula, in short, allows you to oppose CE research while all the time claiming that you do not really oppose CE research.

That's why Dr. Lewin's smooth talk does not pass the sniff test, in my humble opinion.

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