• Typology of marginal medicine

    A June 2009 Health Affairs paper by Ari Hoffman and Steven Pearson includes this typology of marginal medicine:

    (1) Inadequate evidence of comparative net benefit for any indication; [] (2) use beyond boundaries of established net benefit. […] (3) higher cost when established benefit is comparable to other options; and (4) relatively high cost for incremental benefit compared to other options.

    They provide examples of each of the four types:

    1. Inadequate evidence of net benefit: Proton beam therapy.
    2. Use beyond boundaries of established net benefit: Off-label drug use, “Vagus nerve stimulation for depression (approved for seizures) and chelation therapy for autism (approved for heavy metal toxicity).”
    3. Higher cost with no increase in benefit: Brand drugs when generics exist, “One example has been demonstrated by a study using decision-analysis modeling to compare four different strategies for diagnosing deep vein thrombosis. The four strategies involve differing combinations of tests; all four strategies were found to be equally effective. But the results showed that the approach beginning with clinical evaluation and blood tests worked just as well as all of the options that started off immediately with some form of expensive high-tech imaging.”
    4. High cost, low incremental benefit: Chemotherapy for advanced cancer, expensive antifungal agents for onychomycosis (toenail fungus), “The drug clopidogrel (Plavix), for example, helps prevent myocardial infarction and stroke, which are clearly of great clinical significance to individual patients; however, compared to patients taking aspirin, only for approximately one in every 200 patients taking clopidogrel will a myocardial infarction or stroke be prevented; all other patients taking the drugwould not have had a stroke or infarction anyway.It has been estimated that giving all eligible patients clopidogrel instead of aspirinwould cost an extra $34 billion per year.”

    Related: Typology of health care technology.


    • Since you’re looking at older studies/proposals, Pearson and Bach’s proposal to set drug prices based on comparative effectiveness is also worth highlighting.

    • As it pertains to healthcare reform, I have serious concerns about whether or not any of the “market based” “consumer-cost sharing” plans being proposed (I use quotes in an intentional, pejorative manner) can really address any of these issues at all.

    • Unfortunately, the US health care system has fully embraced “marginal medicine” as the business model since it generates substantial revenues. The examples cited above are just the tip of the iceberg.
      I only listen to NPR radio but the hospitals have focused their advertising there on “robotic surgery” and the “proton beam” as well as other marginal treatments.

    • The matter of off-label drug use is more complicated and cuts both ways, one in which I am personally involved. 8 months ago I was diagnosed with wet macular degeneration. The vision in the affected eye is now better than it was 8 months ago. This has been due entirely to injections of Avastin into the affected eye.

      Now interocular injections of Avastin is strictly an off-lable use. And there are some issues: the drug must be repackaged into units suitable for interocular injection by a compounding pharmacy. And Genetech, who makes Avastin, also makes a drug (Lucentis) which is approved by the FDA for AMD. However, here are the facts of the case, as expounded by my retinal specialist (and verified by me as well as I can):

      1) Double blind studies have shown Avastin to be as effective as Lucentis.

      2) Avastin remains in the eye 6 weeks, while Lucentis has a 4 week life.

      3) Avastin costs about $40 per dose (the compounding fee adds $90 – $570 depending on whether or not one has insurance).

      4) Lucentis costs about $2150 a dose.

      5) Genetech reps get absolutely livid when doctors present these facts to their patients.

      Genetech’s position is that cost is not an issue, as most patients getting treated have both drugs covered by insurance.