Watch Out When These Foxes Guard the CER Henhouse

I've been getting e-mailings recently about a conference to be held in Washington, on July 22, called "Delivering on Patient-Centered CER" (Comparative Effectiveness Research). This is sponsored by the group, Partnership to Improve Patient Care (www.ImprovePatientCare.org). No less a light than Sen. Max Baucus will be a keynote speaker.

This conference will bear close watching for reasons that I have previously posted about (http://brodyhooked.blogspot.com/2009/05/stealth-campaign-to-shanghai-ce.html). PIPC is funded in part with Pharma money and in part by medical specialty societies such as the American College of Cardiology, whose motto is, "Do all the CER you want so long as you don't take away any procedures that bring profits into the coffers of cardiologists." (The ACC's CEO is also one of the featured speakers at this conference.) Their clear agenda is to steer CER away from any research that would actually be used to save money in patient care, and hence cut into corporate or specialist profits. By pushing the language on CER that was in the Senate version of the health reform bill (instead of the House language which was more friendly to real cost containment and kept industry out of the CER picture) , Sen Baucus did a signal service to this "partnership," and will no doubt be appropriately thanked at the conference.

With these kinds of foxes watching over them, I am sure that the CER hens will sleep more comfortably at night.

Comparative Effectiveness Research: Reform's New Hot Potato?

Trudy Lieberman of the Columbia Journalism Review has been doing an excellent job critiquing the media's coverage of the health reform debate, but as best as I can tell, she slipped up a little in her assessment of the role of the AMA:

http://www.cjr.org/campaign_desk/who_will_be_at_the_table_8.php?page=all

Overall she noted the pattern, that the AMA seems to be in bed with Big Pharma and the Republicans in opposing key aspects of the Democratic health reform proposals. The AMA indeed seems less interested in defending either health or medicine, and rather more committed to extolling the presumed virtues of the "free market." However, if you read the detailed AMA statement (to which she provides convenient links in her article) in response to the Senate Finance Committee, you'd see that in one key area, the AMA parts company with the drug lobby. Even the right-leaning ideologues who make up the leadership ranks of the AMA could not stomach the industry's position opposing comparative effectiveness (CE) research. Being, in the final analysis, physicians, they could not oppose a system that would perform scientific studies and inform them of what works and what doesn't.

Meanwhile, the Kaiser Daily Health Policy Report tells us today that the Republicans are pushing back harder against the Democratic bills, and that a ban on CE research is a key feature of the response bill that they are now offering:

http://www.kaiserhealthnews.org/Daily-Reports/2009/June/16/Comparative-Effectiveness.aspx

This suggests both that the pharmaceutical industry has basically bought off the GOP lock, stock, and barrel and harnessed the elephant to its opposition of CE. The fearmongers are now working overtime to convince us that CE is a sneaky way for the government to take over medical care and "come between you and your doctor." It seems quite intriguing that CE research has zoomed to the top of the charts, right alongside a public insurance option, as the hot potato of partisan bickering over health reform--another sign of how successful Big Pharma's lobbying machine is in imposing the industry's preferred agenda on the entire political process.

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

In my previous post, http://brodyhooked.blogspot.com/2009/04/why-is-industry-so-scared-of-finding.html, 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:

http://lewinreport.acc.org/post/Clinical-and-Cost-Effectiveness-The-Bloomberg-Boo-Boo.aspx
http://lewinreport.acc.org/post/Committed-to-Comparative-Effectiveness.aspx

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.

Why Is Industry So Scared of Finding Out What Really Works?

In a previous post: http://brodyhooked.blogspot.com/2008/08/massachusetts-gift-law-industry-took.html, I suggested that the way to find out what the drug industry really is thinking is to find out what they are fighting the hardest to avoid. (At that point, it was about how the Massachusetts state house was overrun with Pharma lobbyists when it considered a bill to require open reporting of and strict limits on payments to physicians.) This would sound terminally paranoid were it not for the fact that the drug industry is so slippery--they have become so used to never saying what they really mean, that you have to search for all sorts of indirect clues as to what might be on their minds.

So my esteemed colleague Marilyn Mann is surely onto something by passing along this news report: http://www.bloomberg.com/apps/news?pid=email_en&sid=aHjr0BP1zvgo, which basically shows how several big companies are hurriedly adding more lobbyists to fight against the Obama administration's plans to include comparative effectiveness research of pharamceuticals as a part of the economic stimulus package. We might ask: Just what is it about comparative effectiveness research that so frightens Pharma?

Some previous opinion pieces and news reports have distinguished between comparative ("head to head") trials which simply try to establish the superiority of one treatment over another, as opposed to those that explicitly take cost into account. Then the industry opposition is focused on the latter. From that example, it would seem that the industry is deathly afraid that we might figure out that some very slight improvements in outcomes are being purchased only at huge increases in cost. They'd much rather, for example, that we know that a new chemotherapy drug prolongs the life of the average cancer patient by 2 months; but not that it costs $150,000 to get that extra 2 months of life.

Now the argument against comparative effectiveness research (with or without costs explicitly taken into account) is based on one possible use of the resulting data, which we have to admit might actually occur. The sequence would go as follows:

• Comparative effectiveness research is carried out on drugs A vs. B.
• The research shows that drugs A and B are roughly equivalent in outcome, but B costs less.
• If you look very carefully at the research findings, you'll see that the average outcomes obscure a good deal of individual variability. A sizeable minority of patients actually do better on drug A.
• However, the payer for care (the government in the most-feared scenario; private insurers in today's scenario) seizes upon the uncritical reading of the data from the trial, and issues guielines that demand that physicians use drug B and that essentially eliminate any payments for drug A.
• Bottom line--a significant number of patients are denied the drug that would most help them, just so the skinflint insurers can save a few bucks.

As I say, this could happen, and occasionally has. But we need to notice that there are a number of intervening steps between the actual conduct of the comparative effectiveness trial, and the result that we find so upsetting. If the drug industry was focusing its lobbying efforts on those intervening steps, we could have more sympathy for them. But it's noteworthy to me that they are aiming all their big guns at the very first step in the process--long before anyone has drawn inappropriate or simplistic conclusions or constructed straitjacket clinical guidelines.

Against the drug company orchestration of outrage are the moderate voices of good sense. Physicians today are starved for good data on what treatments work better than others--since more than 80 percent of trials of drugs are industry sponsored, and industry overwhelmingly chooses to compare drugs to placebo and not to already effective treatment. Everyone (except maybe the pharmaceutial industry) agrees that we can only have a sustainable health system in the future if we can rein in costs. If we want docs to help us to save money, it makes a heckuva lot more sense to ask them to save us money by doing less of what doesn't work, instead of trying to deny them the data about what works better or worse.

Against these voices of reason, drug companies are reduced to doing much what the AMA had to do in the 1960s when it tried to fight the Kefauver-Harris amendments that gave the FDA the responsibility to test the effectiveness and not just the safety of new drugs. The AMA was forced in that instance to act like scientific Neanderthals. They had to claim, for all intents and purposes, that the average physician in the boondocks was just as capable of deciding what drugs are effective as the scientist conducting a multicenter clinical trial. They had to claim that anecdotal evidence was just as good as any randomized controlled study. Similarly, today the drug industry has to stress how different everyone is from everyone else, so that the average results of comparative effectiveness trials are sure to be misleading. This of course, taken to its logical conclusion, undermines any reliance on evidence-based medicine.

I conclude from this sorry spectacle that the drug industry--which shouts so loudly that when it markets its drugs to physicians, it's really engaged in "education"--is in fact deathly afraid that we will someday find out how effective its expensive new drugs really are. That bodes very poorly for what we haven't yet found out amidst the marketing smoke screen that the industry has managed to proliferate around its products.