game on…

Posted on Sunday 26 October 2014

One way to be boring is to become too detailed on a topic, and I’m there right now. The topic is obviously the European Medicines Agency Data Transparency policy released in early October. I did a timeline [European Medicines Agency: a timeline…], but it keeps on going and growing. Here are a couple of pieces that need to be added:

In the wake of the release of the final EMA policy, it’s becoming clear that there were significant private communications between PHARMA and the EMA – only some of which have come to light.
  • European Medicines Agency: a disappointment…
  • Ben Goldacre: Pharma industry has destroyed its own reputation
  • Undermining the European Medicines Agency’s transparency policy
  • Documents released by the European Ombudsman

  •   There was a widespread outcry about the decision to move the EMA from the Health and Consumer directorate. The EFPIA denied lobbying for the change. And Jean-Claude Juncker scrapped the move, saying "Responsibility for medicines and pharmaceutical products will stay with the Directorate-General for Health because I agree with you that medicines are not goods like any other"
  • a change of heart!…
  • Pharma industry denies it lobbied for medicines to move to DG Enterprise
  • Juncked: Plan to move EMA from DG Health to DG Enterprise is abandoned
  • Juncker u-turn puts pharma in health Commissioner’s portfolio
  • Instead of bludgeoning you with these fragments, I put the timeline on a separate page that you can call up or ignore. I happen to think in "timelines." It’s how I remember patients’ narratives [or for that matter, almost everything else]. So no more fragments. I’ll just put a link to the page when it changes and leave it up to you [TIMELINE].

    Another way I think is in pictures, and it’s obvious from my graphics that this process has felt like a game of chess to me. My point in this post is that as monotonous as it may seem, I don’t think the game is yet over. That TIMELINE shows moves and counter-moves, small victories and concessions, gambits and sacrifices, advantages gained only to be out-maneuvered. And the moves still keep on coming. When I first did the timeline [European Medicines Agency: a timeline…], I wrote it like it was over [European Medicines Agency: a disappointment…]. But I was just plain wrong about that. It feels still very much like game on.

    One of my favorite books [that I didn’t quite understand] was Gödel, Escher, Bach: An Eternal Golden Braid, a 1979 book by Douglas Hofstadter. One of the central themes of the book was things that are self-referential and recursive – where the same principle is repeated at multiple levels. This is one of those things. The content of the controversy is Data Transparency – insisting that reports on clinical trials are accompanied by access to the raw data rather than having it cloistered behind industry’s claim that they own the data. But if you think about it, this fight over the EMA’s policy is different from past versions, because it’s playing out in real-time, on a closely watched public stage, and it’s playing out Transparently. The fight over the Transparency of Clinical Trial data is being fought with the proxy being the Transparency of the EMA’s process in setting their policy about Data Transparency.

    When the Cochrane group went after the hidden Tamiflu data, they did it by going public, joined by the BMJ, later AllTrials, and many others. It went to UK Parliametary Committees, and Parliament itself. When AbbVie and InterMune sued the EMA, one could read of little else. David Healy put up a petition and the blogs whirred. When the EMA quietly released a draft of a policy that was much more restrictive than previously promised, many fronts immediately turned it into a noisy cause célèbre. The EMA backed down somewhat, eliminating the periscope screen-only clause and some of the restrictive application process. Moving the EMA from health to business was announced with no fanfare, but the BMJ, editor Godlee, and supportive MPs were on top of that change like hyenas on fresh kill. President Junckers came around. Now, it’s becoming clear that PHARMA likely had secret meetings or input with the EMA along the way, and the noise is escalating. I anticipate we’ll be hearing about those communications real soon.

    Ben Goldacre’s line was famously, "Sunlight is the best disinfectant" [something of value…]. That’s true of the way to clear up this terrible mess of ghostwritten, jury-rigged, journal articles and the associated Conflict of Interest problems. But whining about that wasn’t getting us anywhere. Moving it up a level and applying it to the EMA process of setting their Data Transparency policy is not only an equally valid application of the principle, it’s moving things along in the right direction. PHARMA has gotten away with living in the shadows for far too long, and is having a hard time playing in the light of day. And it’s the principle of the "Sunshine Act" as well – flushing the KOLs out into the public eye. I guess there’s something powerful about the simple adage, "We’re only as sick as our secrets."
      Joseph Arpaia
      October 26, 2014 | 3:28 PM

      Not on topic but an interesting article I thought might be a seed for a blog post. Its on the use of brief rating scales leading to over treatment with antidepressants.

      Potential Antidepressant Overtreatment Associated With Office Use of Brief Depression Symptom Measures
      Anthony Jerant, MD, Richard L. Kravitz, MD, MSPH, Erik Fernandez y Garcia, MD, MPH, Mitchell D. Feldman, MD, MPhil, Camille Cipri, BS, Denyse Nishio, MD, Anca Knoepfler, MD, M. Kaleo Wooddell, MD, Victor Baquero, MD, Peter Franks, MD
      J Am Board Fam Med. 2014;27(5):611-620

      October 26, 2014 | 7:37 PM

      PHQ-9s are the sixth vital sign. Of course they result in too many antidepressant prescriptions.

      In reading the paper that authors seem to know what the results of their subjects with PHQ-9 scores of 6-10 will be. Giving someone a diagnosis of depression based solely on this rating scale is absurd and more has to be done than that. and yet this appears to be the basis of collaborative care arrangements. The overprescribing problem needs more study than to just say that it exists.

      James O'Brien, M.D.
      October 26, 2014 | 9:23 PM

      Subjective fifth and sixth vital signs are the road to hell paved with questionable intentions.

      October 27, 2014 | 5:44 AM

      From the Patient Health Questionnaire-9 study: Kroenke K, Spitzer RL. The PHQ-9: a new depression diagnostic and severity measure. Psychiatr Ann 2002;32:509–21 comes this disclosure re the lead author: “Dr. Kroenke’s research is supported by Pfizer Inc. and Eli Lilly. He is also a member of Eli Lilly’s advisory board.” Enough said. Herding patients to the pharmacy.

      James O'Brien, M.D.
      October 27, 2014 | 12:10 PM

      The problem with PHQ-9 isn’t sponsorship (you can’t complain about nondisclosure and then complain when they disclose), the problem is that its so damn brain dead and antiintellectual that no thinking person should take it seriously.

      We need to start passing out tomatoes during Powerpoint presentations. Agreeableness is highly overrated in the Five Factor Personality model. Agreeableness is the source of a lot of junk science. It’s about time some of these academics and journal editors start calling some fouls instead of logrolling each other.

      Steve Lucas
      October 27, 2014 | 5:19 PM

      Pharma’s only function is to sell. A few deaths will be spun into the need for greater medication and deaths linked to the product, as long as they are few in number, represent the cost of doing business.

      My wife will go to her OB/BYN next week and the major problem will be with the nurse who will state that with insurance she needs to be medicated and have 90 office visits with a GP. Her doctor and NP have no problems with her current schedule since they cannot find any medical problems.

      As I have been corrected many times on this blog medicine now treats symptoms. I have also highlighted my issues with clergy and for the last several weeks have been treated to a minister relating how he now has ADHD, OCD, is dyslectic, reflects a paranoid personality in his interactions, and has been treated multiple times for depression.

      The question becomes is he self diagnosing or is he playing a GP’s good intent to cover his failures in his chosen profession. I find the long list of personality issues incompatible with a person holding a PhD and has done other graduate work while employed.

      Pharma has created an almost mass hysteria where everyone can be “better” if medicated and every doctor can be “successful” by medicating everyone on their panel.

      This is now a shadow cast on society and getting the sunshine needed for change will be difficult.

      Steve Lucas

      October 27, 2014 | 7:26 PM

      Yes, Steve. Though I do have PTSD, what they call ADHD (results of a head injury) and MS, I think I have few problems, and am actively resisting all efforts to be psychiatrized and medicalized. I canceled my last MRI, because there isn’t anything that can be gleaned from it— I have MS and likely always will. Unless I suspect a brain tumor, the imaging is a waste of my time.

      Also, the best thing I’ve done for my health is weaning off a plethora of prescriptions— both psyche meds and drugs prescribed for the symptoms of MS that cause more problems than they solved. And this is with the V.A., which, I suppose, uses the same guidelines that HMOs do.

      On the bright side, I can do myself a lot of good by not taking statins and other drugs that don’t pan out in the calculations of risks vs. benefits.

      I do have an appointment with a psyche nurse, and will ask her to prescribe me some benzos in case I become hypervigilant. The anniversary of my trauma is coming up, and I think a short-term prescription for tranquilizers will do, if I need them.

      Nothing too much.

      October 28, 2014 | 11:25 AM

      Wiley, your situation is a perfect example of my telling people that drugs aren’t an issue of being pro vs. con but an issue of fully weighing the risks vs. benefits and being able to make a fully informed choice as you have obviously done.

      October 28, 2014 | 6:52 PM

      Yeah, AA, drugs can be useful, and I think the field of psychiatry should do long-term studies on the drugs they’re using now, to learn how to use them better. Simply lowering the doses of some drugs and not assuming that they need to be taken for life, might open doors to better thinking, more responsiveness on the part of mental health professionals, and better results for patients.

      Today I was prescribed valium, and my prescribing nurse explained in detail why that was her choice— I really like her. I’ll take one to see how it affects me, then— knowing what to expect— will take them as prescribed should I become hyper-vigilant. It’s a very painful state that I see no reason to suffer in full. In fact, I might be able to process what’s going on with me (if I suffer from symptoms of PTSD) enough to make some progress with it. Would rather not suffer it, at all; but we play the hands we’re dealt.

      James O'Brien, M.D.
      October 29, 2014 | 12:07 AM

      Just curious, have you ever tried Prazosin?

    Sorry, the comment form is closed at this time.