We need comparative effectiveness research, or, I agree with Paul Krugman for the first time ever

I usually disagree with pretty much everything that liberal rock star Paul Krugman writes from his pedestal at the New York Times.

However, when it comes to comparative effectiveness research, I’m with him 100 percent. Physicians need an authoritative source of unbiased data, untainted by the influence of drug companies and device manufacturers.

With treatments and medications announced daily, having an entity definitively compare these newer, and often more expensive, options with established treatment regimens will be particularly useful in everyday practice.

The only way to tackle such a huge project is with money, and indeed, the Obama administration recognizes this fact by including $1.1 billion in comparative effectiveness research in the economic stimulus package.

Clearly, the pharmaceutical and device industry would like both the public and physicians to continue to assume that “newer means better.” Not asking these questions allows them to continue promoting profit-making brand-name treatments.

Their motives in attempting to quash comparative effectiveness research could not be more obvious.

And for once, I concur with Mr. Krugman when he states, “This is truly vile.”

Duncan Cross, Robert Centor, and Bob Doherty offer their take on the issue.

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  • Dr. IKE

    I think it’s a fantastic idea, particularly if all treatment methods/procedures are included. Granted, in my corner of the healthcare world, “chiropractor” has many different meanings. In our group, we take a blended approach to care and recognize the benefits of collaboration are greatest for the patient, yet there’s always those that engage in more questionable practices and have local MDs looking at us distrustfully out of the corner of their eye.

    Maybe if there was some sort of way to distinguish the “type” of CAM practitioner…?

  • Jeff Segal

    There was a time when pharma embraced risk and were handsomely rewarded. The more recent paradigm has been: let’s release a me-too drug. We know the market is out there. We know the risk is low. And the benefits will flow.

    The biotech companies lived in an laternate universe. They were tetsing and releasing biological compounds such as TNF inhibitors. These were hardly me-too compounds. The companies are doing very well.

    Innovation will continue and those who embrace risk will benefit. Comparing effectiveness is a good idea, even for those who believe they will lose. Big pharma will need do little more than swallow up tiny biotech companies, and they can get back in the game. Or they can shuttle direct to consumer marketing funds back to R and D, just like the good ole days.

  • Anonymous

    IANAD, but I’m all for it! This needs to be done, but it needs to be done free from the monetary and other influences of pharma/device manufacturers, unlike TMAP. Nonsense like branded drug makers paying off generic manufacturers to delay market entry of generic drugs and branded drug makers raising prices exorbitantly to force doctors to write “son-of” prescriptions in hopes the patient will refuse the generic form of the original drug when it becomes available are just a couple of things I’d like to see stopped.(Can we get rid of DTC advertising, too, while we’re at it? I really hate those ads for web sites that purport to inform one about a condition, but are thinly-veiled drug ads.)

    Newer isn’t necessarily better – Vioxx, anyone? -except when it comes to lining manufacturers’ pockets and paying inflated executive salaries. Some patients may require alternate treatment if first-line, proven effective measures fail or don’t work well enough, but that is to be expected. YMMV.

  • Manalive

    I always was a little suspicious of big pharma; the problem now is that I no longer trust academia, either.
    The last few CME conferences that I have attended – at prestigious med schools – have been fraught with an overt anti-capitalism, anti-pharma bias.
    Academics can spin research studies any which-way; I wonder if they’ll say so if an expensive new medicine really works.

  • American Medical Association

    There’s no doubt that comparative effectiveness research (CER) is needed to help physicians gain knowledge about whether new treatments outperform existing treatments. The measures included in the economic stimulus bill are an important step toward getting that information into the hands of physicians. In fact, AMA President Nancy Nielsen, M.D. called on Congress to provide funding for CER in congressional testimony last September.

    As KevinMD implies, there has been much misinformation on what the bill would do on CER. What it will do is create a CER Advisory Council responsible for setting research priorities and avoiding duplication across various government agencies. It has no authority to restrict payments or make coverage decisions, or establish national practice guidelines and it does not grant Medicare officials new authority to impose a cost-effectiveness standard. I touch on this issue in a letter published today in the Wall Street Journal focused on the HIT provisions in the stimulus bill that points out that “medical treatment decisions remain in the hands of physicians.” More information is available in the AMA’s open letter to physicians on the AMA’s Web site at http://www.ama-assn.org/ama/no-index/news-events/rhetoric-reality-stimulus-package.shtml.

    J. James Rohack, M.D.
    President-elect, American Medical Association

  • Anonymous

    Kevin, We shouldn’t freely lend support until we extract further benefits. We physicians as the boots on the ground are crucial and for our support we should receive safeharbor if we follow comparative effectiveness guidelines. Otherwise we should be against it.

  • Manalive

    Wow. I occurs to me that I no longer trust big pharma, med school academia, the U.S. government, nor the A.M.A.

  • Alisha764

    This is vital and would create jobs, but it is disappointing that we have to spend 1.1B of taxpayer money to repeat trials just b/c some people are looking only at the profit & not the real results. Speaking of only looking at the profit, have you seen there is a new bill to stop allowing free access to clinical trials funded with government money(http://is.gd/jPvn). Basically make taxpayers pay for what they are already paying for (wow this sounds like a broken record with all the stimulus bills).
    Thank you for presenting another side to this story because when I first looked at it, I was just too disappointed in seeing money to reinvent something and could not see the need.
    TY~ Alisha
    Follow me on twitter: Alisha764

  • rohin

    I am curious how this will be done really. In applying literature to practice a lot of times, at least what we are told, is to go ahead and look at the patient demographics, what is the comparator, power, so on and so forth. I don’t understand how you can “recreate trials” that are landmark trials for instance. How do you “recreate ALLHAT or ACCORD etc.” Those trials took place over many years. And it makes sense that they are funded by the pharmaceutical companies because the FDA needs post marketing data and they cost a lot of money. Who else would fund these? Tax payer dollars to do trials all over the world? Also, it makes the use of pharmaceutical agents (like Lipitor) more definitive. For example, if a patient had a recent MI, it would seem to me that it would be more risk averse to use Lipitor 80 as opposed to Pravacol 80 or Crestor 40. Even though those agents may have similar lipid lowering, anti-inflammatory, and nitric oxide potentials, the evidence points to using Lipitor because the trials looked at that agent.

    Looking at these other comments, I do affirm though that comparative analysis are always beneficial and more beneficial when done prospectively. This would make more sense with disease states where it is hard to determine the efficacy of one agent to another. Furthermore, when there are no clear guidelines or guidelines with a lot of gray areas, for example, chemotherapy treatments.

    Also, a lot of times these trials look at certain strengths of drugs. It would be more prudent to do more analysis comparing drug strengths across classes. Similar to how statins have been compared. However, how do you go about designing a study looking at all the dosing levels of one agents, comparing it to its own class, and then looking at other classes? That would be a mess. And then going further to compare it to non-pharmacologic therapy.

    Underlying these comparative trial assumptions is that individual agents (classes of agents) are inappropriately lumped together as working the same way. A lot of times, agents within a class have different effects, mechanisms of action, and so on. Also, the pharmacodynamic and pharmacokinetic effects of the drugs are different. For example, look at citalopram and celexa. Classic ME-2 drug example. It can be argued that the drug companies should have just released Celexa because it knew ahead about it and so on.. but I am not arguing about the basis of their product arrival or marketing. Look simply at the PK/PD of the drug and its effects. Citalopram effective daily dose is 40 mg/day and inhibits 60 percent platelet serotonin receptors. However, escitalopram (celexa) is twice as potent. It has greater inhibitory effects. Does this mean it will be more clinically effective? I don’t know. But, when looking at the PK/PD of these ME-2 drugs, they aren’t necessarily the same. More so, the same class of medications are going to be different. And to create trials (double blind, placebo controlled, randomized, multicenter) and account for all the differences would be a nightmare.

    I am intrigued on how the government will design such a trial with so many confounders to look at. It makes sense, like I said before, if the government creates trials to address inadequacies in the literature. Otherwise, to recreate Landmark trials or long-term trials, it is wasting taxpayer dollars.

  • Michael Kirsch, M.D.

    While critics will attack comparative effectiveness, the concept behind it is unassailable.
    We are wasting billions of dollars on medical interventions that don’t work well. Comparative effectiveness is an opportunity to ultmately raise medical equality while reducing costs and inefficencies. If the critics have a better prescription to achieve this objective, then count me in.

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