at least it’s movement…

Posted on Friday 4 October 2013

I live in a fairly isolated place: eight miles to town for groceries and gas; twenty-five miles  to a movie theater; sixty plus miles to Atlanta for the amenities and services of modern civilization. I say that cable television and fast internet enhance my wilderness experience, and it’s not a joke. I get calls about matters medical often and answer what I can. Yesterday, a friend had just gotten out of the hospital with a cardiac rhythm disturbance, and had a lot of worries, so I went down to see him. I was surprised at my retention. I did the pertinent exam, took a history, and I felt comfortable answering his questions. His medications were newer versions of drugs I knew well. His main problem was fear, and the treatment yesterday was explaining and reassuring him about what he was afraid of. I left Internal Medicine almost 40 years ago and have spent my time far from a stethoscope, EKG, and such things – but it was all there in my head, at least for the problem at hand.

On the way home, I was thinking about C.M.E. It means Continuing Medical Education, and it’s a requirement for medical licensure. I don’t need any C.M.E. for atrial fibrillation, cardioversion, or congestive heart failure. Those things are like arithmetic, built-ins – just newer versions of old drugs. C.M.E. is occasionally review, but usually it’s about new stuff. The specifics of C.M.E. are something doctors choose – filling in the gaps. While it’s basically a good idea, in psychiatry it became a major conduit for pharmaceutical promotion because people often choose their C.M.E. hours by going to courses about new stuff, particularly in therapeutics – and the last thirty years in psychopharmacology has really only been about newer versions of old drugs [newer more expensive versions of old drugs].

There’s a news report related to all of this in the current PsychiatricNews. It’s about a journal article I’ve already commented on [see a “top-down” problem…]:
PsychiatricNews
by Aaron Levin
September 19, 2013
The journal article and news report are about the work of a person who is one of the real good guys – Adriane Fugh-Berman, M.D., at the Georgetown University Medical Center. She’s the brains behind the web-site PharmedOut:
PharmedOut is a Georgetown University Medical Center project that advances evidence-based prescribing and educates healthcare professionals about pharmaceutical marketing practices. PharmedOut promotes evidence-based medicine by providing slideshows, videos, other resources, and links to pharma-free CME courses. Learn more about us.
Part of their work has been to point out the corruption of C.M.E. and to provide alternatives for free C.M.E. that are not Pharma contaminated. In the article behind all of this [Physicians Under the Influence: Social Psychology and Industry Marketing Strategiesfree download], the authors hypothesize that if physicians are aware of the ways they’re being gamed by the drug companies, they’ll be much less vulnerable to Pharma influence. That just has to be correct.

When I wrote about this article, I said it sounded like it would really help in physical medicine, but I didn’t think it was big enough for the problems in psychiatry. But I’m putting that aside for the moment [maybe the next post]. I want to stick to the visit to my friend yesterday and one of those newer drugs he was on. When you have atrial fibrillation, a chaotic heart rhythm, you’re vulnerable to forming clots that can cause stroke – even if they convert your heart to a normal rhythm – because the atrial fib can and does frequently make a comeback. So anticoagulants [blood thinners] are a mainstream preventative part of treatment. Without them, the risk of stroke is very real, not just statistical. That was true back when I had brown hair and it said Internal Medicine on my door. Until recently, anticoagulation meant Coumadin [Warfarin], a Vitamin K antagonist that requires monitoring with blood tests, or sometimes Heparin, that requires frequent injections.

But my friend was on Rivaroxaban AKA Xarelto®, discovered and manufactured by Bayer and marketed by Janssen. It has been around for a few years. It’s essentially an oral anticoagulant that doesn’t have to be monitored – the best of both worlds. Having seen a jillion people on Coumadin in the past and adjusting doses endlessly, it’s not better medicine, but it’s a breakthrough in convenience. As for comparisons, all roads lead to this article:
by Patel MR, Mahaffey KW, Garg J, Pan G, Singer DE, Hacke W, Breithardt G, Halperin JL, Hankey GJ, Piccini JP, Becker RC, Nessel CC, Paolini JF, Berkowitz SD, Fox KA, Califf RM; and ROCKET AF Investigators.
New England Journal of Medicine. 2011 365[10]:883-891.

BACKGROUND: The use of warfarin reduces the rate of ischemic stroke in patients with atrial fibrillation but requires frequent monitoring and dose adjustment. Rivaroxaban, an oral factor Xa inhibitor, may provide more consistent and predictable anticoagulation than warfarin.
METHODS: In a double-blind trial, we randomly assigned 14,264 patients with nonvalvular atrial fibrillation who were at increased risk for stroke to receive either rivaroxaban [at a daily dose of 20 mg] or dose-adjusted warfarin. The per-protocol, as-treated primary analysis was designed to determine whether rivaroxaban was noninferior to warfarin for the primary end point of stroke or systemic embolism.
RESULTS: In the primary analysis, the primary end point occurred in 188 patients in the rivaroxaban group [1.7% per year] and in 241 in the warfarin group [2.2% per year] [hazard ratio in the rivaroxaban group, 0.79; 95% confidence interval [CI], 0.66 to 0.96; P<0.001 for noninferiority]. In the intention-to-treat analysis, the primary end point occurred in 269 patients in the rivaroxaban group [2.1% per year] and in 306 patients in the warfarin group [2.4% per year] [hazard ratio, 0.88; 95% CI, 0.74 to 1.03; P<0.001 for noninferiority; P=0.12 for superiority]. Major and nonmajor clinically relevant bleeding occurred in 1475 patients in the rivaroxaban group [14.9% per year] and in 1449 in the warfarin group [14.5% per year] [hazard ratio, 1.03; 95% CI, 0.96 to 1.11; P=0.44], with significant reductions in intracranial hemorrhage [0.5% vs. 0.7%, P=0.02] and fatal bleeding [0.2% vs. 0.5%, P=0.003] in the rivaroxaban group.
CONCLUSIONS: In patients with atrial fibrillation, rivaroxaban was noninferior to warfarin for the prevention of stroke or systemic embolism. There was no significant between-group difference in the risk of major bleeding, although intracranial and fatal bleeding occurred less frequently in the rivaroxaban group. [Funded by Johnson & Johnson and Bayer; ROCKET AF ClinicalTrials.gov number, NCT00403767.].
Yes, it’s an industry-funded study that actually looks well executed. If you went to a C.M.E. course, I can’t imagine not hearing that the way to go with anticoagulant therapy for atrial fibrillation is now Xarelto® from the most industry neutral presenter imaginable. Maybe there’s something behind the report, but I didn’t see it. So everything is fine until you go to the Drug Store. Coumadin? around 15¢ a daily dose. Xarelto®? between $9 & $10 a daily dose. If it’s pre-certified and approved by your "plan" and you and your doctor make enough phone calls, it goes down to between $1 & $2 daily. The point being, the atrial fibrillation set is an elderly, fixed income, unemployed group.

This isn’t my usual fare, risk::benefit::convenience::cost ratios. It’s too many numbers for the likes of this old man, and it’s hardly medical. But even a solid medical recommendation is fraught with conflict and confusion – and the bureaucracy around delivering health care just keeps expanding, stacking structure upon structure to pit cost containment and profit maneuvers against each other with almost every patient interaction.

I started with "I get calls about matters medical often and answer what I can." What I didn’t say was that the majority of those calls have to do with negotiating the hurdles and impossible binds in the many systems involved in the simplest of matters medical. I see the term Affordable Health Care as a dream. But I support the Act only because in its not working, it may expose why it’s not possible in America and may lead to something that does work after a decade or so of tooth gnashing and blood letting. At least it’s movement…
  1.  
    October 7, 2013 | 12:00 PM
     

    I’m on Xarelto for atrial fibrillation. There’s no question in my mind that it’s been marketed for maximum profit. It’s advertised on television! It’s manufactured in a fussy little triangle shape to communicate it’s a luxury “designer” drug.

    One can only imagine how many people might take it for palpitations sloppily diagnosed as atrial fibrillation by GPs.

    However, warfarin makes eating fresh vegetables a challenge. This is more than a small inconvenience.

    I’ve also looked at the studies, and Xarelto does seem sound for an anticoagulant. The details of the research are widely debated among cardiologists, who are much, much more diligent in understanding research for heart problems than doctors in general are in understanding the literature behind psychiatric drug prescription.

    Cardiology has those measurable outcomes that psychiatry lacks. However, they will throw out antidepressant prescriptions — many of them have also been bamboozled by pharma when it comes to the unmeasurable.

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