spin is for politicians…

Posted on Wednesday 28 October 2015

On has to be awed by blogger Neuroskeptic whose scope far exceeds the rest of us combined. Here, he clears up the dilemma I obsessed about recently. When the results of the RAISE study were published a few days ago, the extensive press coverage proclaimed that the NAVIGATE [NAV] patients received a much lower dose of antipsychotics than those with treatment as usual [TAU], yet the paper itself said nothing about the drug doses. That’s a hot issue at the moment. Traditional psychiatric teaching has been that maintenance medication [and plenty of it] was an important ongoing part of treatment to prevent psychotic relapses, whereas an initiative from Mad in America, the British Psychological Society, the studies of Wunderink and Harrow, etc. suggest that maintenance medication interferes with long term functional recovery. And the ideological and guild-driven overlay on this point hangs heavily over any and all opinions on this matter. So the difference between the media hype and the actual papers caught the eye of many [including yours truly – see raising a dilemma…]. Says Neuroskeptic on this point:
Neuroskeptic: Discover Magazine
By Neuroskeptic
October 27, 2015

According to the New York Times [NYT] a week ago, a major new study found that lower doses of antipsychotics are better for the treatment of schizophrenia:
    The findings, from by far the most rigorous trial to date conducted in the United States, concluded that schizophrenia patients who received smaller doses of antipsychotic medication and a bigger emphasis on one-on-one talk therapy and family support made greater strides in recovery over the first two years of treatment than patients who got the usual drug-focused care.
The paper, by John M. Kane and colleagues and published in the American Journal of Psychiatry [AJP], is called Comprehensive Versus Usual Community Care for First-Episode Psychosis and it presents the results of the NIMH “RAISE” study. Three days ago the NYT accordingly issued a correction:
    An article on Tuesday about a study of the treatment of first-episode schizophrenia referred incorrectly to the conclusions of the study. Though it studied a program intended to reduce medication dosages, the researchers do not yet know for sure if dosages were lowered or by how much. Therefore, the study did not conclude “that schizophrenia patients who received smaller doses of antipsychotic medication and a bigger emphasis on one-on-one talk therapy and family support made greater strides in recovery.”
Which is more like it.
Well, it is more like it – but questions abound. The media reports were so what people want to hear that it’s hard not to wonder if expectations didn’t drive some of the reporting.

Actually, it’s what I want to hear too. I never didn’t think that a broad intensive focus on the individual and the family with adequate resources [including brief hospitalization when required] along with the careful use of medications was the right approach to these patients. I thought it in the 1970s and in all the years in between. My only recent questions have been whether the RAISE version is the right version and whether it will convince the powers that be to implement some version widely.

Neuroskeptic goes on, finding even more information:

The intervention was in fact a complex mix of family and individual support and therapy, supported activities and employment, and a computerized medication management system called COMPASS.

One of the features of COMPASS is that it recommends doctors to use lower doses of antipsychotics than they otherwise might. The COMPASS manual advises that people suffering their first psychotic episode are more sensitive to antipsychotics, and so lower doses will suffice, compared to chronic schizophrenia patients. However, Kane et al. report no information on dosage so we don’t know if the intervention group were actually taking lower doses than the controls.

So where did the focus on medication dosage come from? Possibly from this NIMH press release from 20th October, the same day the NYT story ran, which says that RAISE
    Featured a team of specialists who worked with each client to create a personalized treatment plan. The specialists offered recovery-oriented psychotherapy, low doses of antipsychotic medications, family education and support…Featured a team of specialists who worked with each client to create a personalized treatment plan. The specialists offered recovery-oriented psychotherapy, low doses of antipsychotic medications, family education and support…Featured a team of specialists who worked with each client to create a personalized treatment plan. The specialists offered recovery-oriented psychotherapy, low doses of antipsychotic medications, family education and support…
Which is technically true, but a little ambiguous. “Offered low doses” could be read as implying “provided low doses”, and presumably the NYT article was based on such a reading, yet there’s no evidence to suggest that the doses provided were actually lower than in the control group. Even if the doses were lower, we don’t know if the low doses were contributing to the better outcomes in the intervention group, because that group got all kinds of other extra treatments as well [e.g. family therapy, supported education]. Theoretically the lower doses might have been harmful if the harm was outweighed by the other beneficial stuff. Or equally, the lower doses might account for all the benefit. We just don’t know.
Reading the actual paper [Comprehensive Versus Usual Community Care for First-Episode Psychosis], there were two conclusions that were clear. First, they brought it off. Working in existing, non-academic centers, they had a program for Initial Schizophrenic Episode patients that worked. The graphs I [somewhat facetiously] called Quality Assurance graphs documented that they retained patients and it helped. With this population, that’s an accomplishment in its own right. The second achievement or finding was that the earlier the intervention, the better the results. So good for them.

Looking over their Manuals [COMPASS, INDIVIDUALIZED RESILIENCY TRAINING] and the NIMH Press Release, I have complaints. The COMPASS Manual is algorithmic and recommends only second generation antipsychotics. I’m not at all sure I agree with that. The metabolic syndrome is not always less ominous than the neurological side effects of the first generation drugs in my hands. And I’m not at all in love with the IRT approach which is not as focused on the Schizophrenic cognitive problems as I would prefer. However, I’m no expert, and there’s plenty of room for iteration in both areas.

But as much as I appreciate Neuroskeptic’s detective work, I don’t buy that "we just don’t know" about the medication doses. I’m suspicious that "we just weren’t told." That data is in some perfectly adequate computer database and there are more than enough statisticians involved in this project to extract it for us. So I’m suspicious that it doesn’t quite show what they want it to show, and  that’s why "we just don’t know." Likewise, that confusing Table 2 in the paper is unnecessarily obtuse. There are a lot more intelligible ways to display the outcome that they didn’t choose. So I smell something fishy, hear something spinning. Time will tell.

If there is "spin" in the reporting of this study, we need to know about it. I personally think that it’s more important for RAISE to be reported completely and honestly than whether it comes out like they [or I] want it to come out. We don’t need some sanitized version of RAISE to tell us we need to turn our attention to a full bodied approach to the treatment of First Episode psychotic patients. We all already know that. What we do need is to have our confidence restored in our research community – that they will honestly and clearly report their findings whether they are clean as a whistle or an unholy mess. Spin is for politicians and pitchmen – not scientists
    October 28, 2015 | 10:24 PM

    My God, I learned that in residency back in 1990, before all these “atypical” antipsychotics hit the market. When you are told at dose “X” that over 90% of receptors are occupied, why the hell are doctors going to “2X”???

    I guess psychotic people have 200% of those receptors in their brains?

    Quick story for a laugh? Back around 2001-02, went to a conference and at a lecture for antipsychotics, i think it was featuring Geodon or Abilify, and at the end, during the question section, I asked genuinely if there should be a tiered system for these meds just based on the side effect profile, and named specifically Zyprexa and Clozaril be third, ie last, for consideration. NOT offending the feature drug of the talk, mind you.

    There were several insulting comments made both directly and per murmuring until the conference leader moved on.

    Cue the last 5 years, with Medical Assistance at least doing this mind you, and what do we have, but a tiered system, mostly based on cost, but, some antipsychotics seen as more acceptable than others.

    Who’s laughing and murmuring now, all those self righteous and pompous assed jerks, who probably each one of them poisoned hundreds of patients with their reckless and unsubstantiated dosing of these meds?

    Oh yeah, we read from some of their victims who comment here and at other blogs who were given what, 40 of Zyprexa, 1000 of Seroquel, 40 if not more of Abilify, 10 or more of Risperdal, and on and on with the new ones too of late.

    I inherited a man on 30mg of Saphris at my current CMHC job. really???

    Oh, that 65 year old man on Saphris.

    Incredible what masquerades as a care provider.

    Found this to educate readers:

    “2.2 Schizophrenia

    ?The recommended dose of SAPHRIS is 5 mg given twice daily. In short term controlled trials, there was no suggestion of added benefit with a 10 mg twice daily dose, but there was a clear increase in certain adverse reactions. If tolerated, daily dosage can be increased to 10 mg twice daily after one week. The safety of doses above 10 mg twice daily has not been evaluated in clinical studies [see Clinical Studies (14.1)].”

    from http://www.drugs.com/dosage/saphris.html

    Read it and weep, I am all dried up from my expended tears of years of impaired peers prescribing…

    Sandra Steingard
    October 29, 2015 | 5:44 AM

    One report quoted John Kane as saying the doses in the experimental group was 20-50% lower than in the TAU group. I suspect this will be presented in a subsequent study.
    I think the story for right now is in understanding better what is in this current paper. What do these statistics mean? What are the implications of the high drop out rates?
    The focus on SGA’s was based on the literature. Schooler and colleagues had done a study comparing risperidone and haloperidol in FEP and this favored risperidone. If I recall correctly, though, that was a Jansen funded study. So we get back to this fundamental problem of industry influence on the data base.

    October 29, 2015 | 6:01 AM
    Katie Tierney Higgins RN
    October 29, 2015 | 9:38 AM

    Just a little squeak from 1crazyoldbat …

    First line treatment for first episode psychosis, where point of encounter with psychiatry is nearly always the ER — which coincidentally, disposes of a pure cohort group; first line treatment IS the major problem here in the U.S.

    My point of encounter as an advocate for young adults caught in the” TMAP net” is consistently muddied by the trauma many young adults ( and all kids) suffer as a result of first line *psychiatric treatment* for first episode psychosis.

    Where are the studies that identify the “interventions” that exacerbate the patient’s symptoms? In the archives of the narratives of psychiatric survivors and in the case books of patient advocates.

    October 30, 2015 | 12:29 PM

    Katie, Jeff Lieberman used an anecdote in a NYT column in August meant to illustrate the problem of “untreated mental illness.” (Forgive the quotation marks, all you better writers, but the term is a euphemism for “unbilled psychiatrists’ hours.”) Your comment brought it to mind. As re-told, with editorializing, at evidencer.org in “Say Something True?”:

    Young man can’t hack college, comes home, doesn’t want to talk to anyone, isn’t violent. A “mobile crisis team” rolls up, creates a no-doubt humiliating experience for the man in front of his parents and siblings, and the next day, the non-violent man stabs both of his brothers with a weapon of convenience, killing one of them. If he’d been visited by Charles Manson the day before, we’d all blame Manson. Why is this crisis team not seen as a likely cause of the man’s first violent crime? I hate to ask, but did they give him a drug?


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