A Recent Study of Atypical Neuroleptics: “The Results of our Study are Sobering”

Sandra Steingard, M.D.

December 3, 2012

This week, MIA highlighted a recently published study of the four most commonly prescribed neurolpetics.  As noted in the post, the major outcome was that these drugs were not found to be effective or safe.

This important study, co-authored by Dilip Jeste the current president of the American Psychiatric Association, is worth reviewing in greater detail.

The study was modeled to capture clinical practice.  Entry to the study was broad and not limited to a specific diagnostic category.  It is characterized as a study of “older adults” and I admit to some chagrin that this meant anyone over 40.  Diagnoses included schizophrenia, schizoaffective disorder,  and psychosis associated with mood disorder, PTSD or dementia.  It was open to individuals who were either already taking an atypical neuroleptic or had a psychiatrist who was recommending this.

Individuals were admitted to the study if they were willing to be randomized to at least 2 of the drugs studied: olanzapine, risperidone, aripiprazole, or quetiapine.   So a person who was only willing to take, for example, olanzapine and aripiprazole, for example could be included but a person who was only willing to take risperidone could not. These four drugs were selected because they are the most commonly prescribed atypical neuroleptics. Subjects were then assigned to one of the drugs using a technique called equipoise-stratified randomization. Each subject had a list of acceptable drugs and was then randomized to one of the drugs along with all others who had an identical list.

Assessment was single blinded; subjects and their treating physicians knew which drug they were taking but the raters did not.  Ratings were done at baseline and periodically over 2 years.  They were assessed on a variety of measures including time to discontinuation of initial drug, Brief Psychiatric Rating Scale (BPRS) and its psychosis subscale, drug side effects, and metabolic parameters.  A total of 332 individuals consented to the study and completed at least a baseline visit.

The primary outcome – similar to what was used in the CATIE study – was time to discontinuation of the first drug used.  The percentage of patients who stopped the first drug used ranged from 78.6% for quetiapine to 81.5% for aripiprazole.  The average time until discontinuation was 26 weeks. Most people who stopped the first drug were started on another one so early discontinuation does not appear to be secondary to remission of symptoms. Reasons stated for discontinuation included side effects (51.6%) and  lack of effectiveness (26.9%).

What was most striking to me is this line from the study: there was

“no significant change in psychopathology with any of the study atypical antipsychotics

They did not even report the numbers in their report.  (Note: they did report baseline BPRS total score.  Across all groups the mean (and standard deviation) was 40.1 (10.3). This corresponds to a person who would be considered moderately ill according to at least one report.)

Also of note, they discontinued the use of quetiapine after 3.5 years due to a high incidence of adverse side effects.

The one year incidence of metabolic syndrome was 36.5%.

The authors discussion is so compelling, rather than paraphrasing, I will just quote directly:

“the results of our study are sobering.”

“there was no significant improvement in BPRS total or psychosis subscale scores over a 6 month period.”

“the overall risk-benefit ratio for the atypical antipsychotics in patients over age 40 was not favorable, irrespective of diagnosis and drug.”

And finally,

“Shared decision making, involving detailed discussions with the patients and their family members or legal guardians about the risks and benefits of atypical antipsychotics and possible treatment alternatives, as well as of no pharmacologic treatment is warranted.” (bolding mine).

 

We often discuss the serious side effects of these drugs in the context of their presumptive benefit. To reiterate, unless I missed something,  in this study they did not find any benefit.

I want to give a nod to 1boringoldman for also alerting me to this study. His comments on this and many other topics are worth reading.

I wrote previously about another large a study that suggested that these drugs have relatively weak effects.  I am curious to see what the impact of these studies is on accepted practice within psychiatry.  Yesterday, the APA Board of trustees voted to approve the new DSM-5. This will undoubtedly gain significant attention within and outside of our field.  The time and expense that will be devoted to the role out of this edition is enormous. From my vantage point, it seems more important to put our energies into a serious consideration of the impacts and efficacy of the treatments we so readily prescribe than to a diagnostic manual that has so many problems.

Sandra Steingard, M.D.

Anatomy of a Psychiatrist: Dr. Steingard chronicles how she is integrating information from Anatomy of an Epidemic into her community mental health practice. She also discusses changes in Vermont’s mental health system and the influence of pharmaceutical advertising on clinical practice.


A Recent Study of Atypical Neuroleptics: “The Results of our Study are Sobering” Comments RSS

52 thoughts on “A Recent Study of Atypical Neuroleptics: “The Results of our Study are Sobering”

  1. I’ve been anxiously awaiting this post since I read your comment saying that you would be writing about this study. The post is quite good but I really wish that Whitaker would write something about it.

      • In a manner of speaking they did create some spin. After stating the drugs were ineffective for every diagnosis they were tested on in the study, the authors state, “Caution in the use of these drugs is warranted in middle-aged and older patients.” It seems obvious that if the treatment is ineffective, it shouldn’t be “recommended.” Since the negative effects are debilitating and disabling and potentially fatal, stating the drugs are not useful so they should not be used would have been ethical. Instead, the authors urge using caution when prescribing ineffective treatments with fatal risks. That is spin. Informed Consent in this instance would necessitate telling patients the treatments don’t work for most people their age with their diagnosis and telling them about the serious negative effects—somehow, I just don’t think this will be done, do you?

        • I think there will be a moderation in the way these drugs will be used.
          Many drug companies are getting out of the business of CNS drug development so there will not be as much push from the drug companies. After CATIE, there were many commentaries were published that in my opinion spun the data to moderate the main outcome, that the newer drugs offered little advantage over the older ones.
          The challenge for me is that psychosis – for some individuals – can be so frightening and disruptive. I am studying alternative approaches but I – and I think this is true for my colleagues and family members who believe in the effectiveness of drug treatment – need to be able to observe recovery without drug treatment. This will take some time and – for some of us – a leap of faith.

          • A sad thing about the drug companies pulling out of drug research is that many people, especially tardive dyskenisia sufferers, have been relying on the hope that future drugs will come and help them. Most people who would drug their children especially wouldn’t do it unless they had faith that better drugs would be coming every decade, bailing little Johnny out of all the serious drug related problems before they ruin his life.

            The fact that the drug companies are pulling away from drug research, while being a good thing, is the final nail in the coffin for child drugging. It was truly a disaster now. Every problem these kids suffer as a result of the brain damaging effects of the drugs will follow them for the rest of their entire life.

            I also think that after this all happens — a paradigm shift after big pharma pulls out — medicine should openly acknowledge the corruption that had hit it in the 50 years prior. Psychiatry especially should admit that they would never have gone that route from 1955-1965 onward and especially 1980 onward if they had followed good principles of science instead of selling out to the drug companies. They should confess that a whole generation (or two) of their psychiatric treatments was malpractice.

            At the very least the victims should be able to live their life without argument over what screwed them up. A person should be able to say “My life was wrecked by psychiatry when I was a kid” without having to worry about people rolling their eyes.

            Psychiatry really needs to admit these things to the public in the next few years, things that Whitaker’s research has shown they should have known about for many years:

            1) The drugs, especially neuroleptics, cause irreversible brain damage.
            2) As least some people had always done better without drugs, proving they are not essential.
            3) Neuroleptics are chemical straight jackets, plain and simple. The reason they are given to hyperactive or agitated children or to break temper tantrums is the same reason they were ever given to psychotic patients. Thorazine found it’s use in medicine to quiet crowded mental hospitals.

            4)Psychotropic drugs are psychotropic drugs. Psychiatric drugs were never a corrective to brain malfunction.

            5) Psychiatric drugs can cause worse mental and behavioral problems than they intended to treat, especially in children. Kids freaking out on stimulants is most certainly not “bipolar disorder”

  2. I think that the press play an important part in how psychiatric treatment develops. Mr Whittaker point this out in Anatomy of an Epidemic. So it maybe that DSM gets lots of press coverage and this article gets almost none.

    It would be great if someone could get this article some mainstream press attention.

  3. Do you know where we are right now? Where tobacco was after the surgeon general’s report that it causes cancer. Everyone knows there is a problem. Very few know there is a solution.

    What was the solution for tobacco? Raising cigarette taxes so that tobacco companies couldn’t externalize the cost of their pollution as much. Same solution as for stopping big oil, big agra, etc. Add up all the toll of a psych med.

    The $20 billion in settlements so far was just money paid to medicaid. They also need to pay for the cost of early deaths, lost time in the labor force, disfiguration, cognitive damage, our ability to have children and spouses, many of us. They need to pay for all that. And then they’ll be done, and they have won. Because cigarettes keep selling because of illegal developing world marketing, but also because it feels good to smoke. But very little about psych meds ever feels good.

    So sorry if Tina Minkowitz already wrote all this in her reparations post. I haven’t read that one yet.

  4. For anyone who has already read this, I want to note that I just made an addition. Where I talk about the BPRS outcome I added the following:
    (Note: they did report baseline BPRS total score. Across all groups the mean (and standard deviation) was 40.1 (10.3). This corresponds to a person who would be considered moderately ill according to at least one report.

    I was curious why they did not report more on the BPRS changes but I missed that they did report on baseline total scores.

  5. Sandra

    You said above “I do give the authors credit for not trying to spin the data.”

    Think about the implications of this statement. Think about how low our expectations of truth and honesty has fallen when it comes to Biological Psychiatry. These are suppose to be scientists and doctors who have promised to “do no harm” and be dedicated to upholding the truth no matter what the data tells us. Human lives as well as the health of their brains are on the line here.

    Can you image if these results came out about a heart medication or a diabetes medication, do you think the final sentence of a study would have been that doctors need to exercise “caution” in their prescribing?

    In this case atypical anti-psychotic medications are so intimately bound up in the “raison d’etre” for these doctors that they can’t put ethics and the well being of their patients over their investment in Biological Psychiatry as a model of treatment.

    Sandra, this is exactly why some of us on MIA are not “anti-psychiatry” but “anti-Biological Psychiatry” and you should be too. I appreciate your participation here and I hope you play a role in challenging this model of treatment within your field; it needs to be defeated and dismantled.

    Richard

    • Thanks for reading, Richard.
      Spinning occurs in all of medicine. David Healy, Marcia Angell and others have articulated this well. This is not at all a defense of the practice but I think it is a mistake to think that the distortions that have occurred in psychiatry have not occurred elsewhere in medicine.
      I do not have a problem with the way way the authors presented the data (with the exception that I would have wanted to see more of the BPRS data). Others may disagree but if we argue over that point (and I do not think you are arguing with me on this), I think we may risk focusing on the major points of this study.
      I just read the Bracken article on the British Journal of Psychiatry (highlighted in the news column on this site). It captured so much of what I think about psychiatry. I wish that sort of debate and discussion were occurring within American Psychiatry.

      • Sandra,

        The are two differences between psychiatry and other forms of medicine:

        1) Psychiatric drugs are designed to cross the blood brain barrier (no-man’s land), and not only intentionally alter brain chemistry, but alter the mind as well (using subjective guess work, *at best*).

        2) These drugs (along with ECT and incarceration) are used by force. Not the case with other health conditions.

        This makes psychiatry unique – bringing politics and law (or lack thereof) into the equation.

        IMO, psychiatry is not *medical* science, but *political” (junk) science.

        Duane
        discoverandrecover.wordpress.com

        • HGi Duane,

          ///These drugs (along with ECT and incarceration) are used by force. Not the case with other health conditions.///

          1) Are you so sure about that? You may be right in the USA.

          Is it legal in the USA to leave a child to die after a car accident making necessary for survival to put foreign red bloodcells in his body because the parents or a good citizen like yourself oppose blood transfusion on religious or safety reasons?

          NB: When I was a resident in neurosurgery I remember vividly that I had sometimes to fight with some nurses not to transfuse a very pale person with a very low hematocrite telling them that the client would not be keen on a soccer match soon and will have time to make new red blood cells.

          We had dishonest people in France working in blood centers in the past transfusing AIDS virusloaded blood to person having already AIDS virus in their system. It made a big scandal in France with even ministers put to trial. (at that time they thought that it didn’t matter to add viral charge to those already infected and they were wrong)

          NB: I believe blood transfusions should be prescribed with the utmost caution and I would welcome any safer replacment.

          Until then, I do not think that the scandal we had in France on blood banks and the risks involved with any transfusion should make people die of hemorragia after a car accident.

          PS: I knew personaly an honorable Canadian surgeon (not a neursurgeon) who told me that he made contracts with Jehovah Testimony Church belonging clients not to transfuse them during or after an operation taking the risk of letting them die and taking the risks of operating as quickly as possible.

          I would not have liked to take on such clients myself if I had ever qualified as a surgeon but I can understand those people.

          What I cannot understand is people deciding for others that every psych med is negative in health/ risks benefits for everybody.

          What I wouldn’t understand would be a ban on hetero blood transfusion for everybody everywhere- until medical advances making those heteroblood transfusion obsolete that is.

          • Dr. Fulli,

            I’m not an attorney, but here in the U.S., the state(s) are able to exercise some limited control with forced treatment for children that they do not exercise with adults.

            In short, an adult can refuse conventional cancer treatment, in lieu of non-conventional (integrative) medical approaches. This is not always the case with children, where the state can force such treatment, if the child’s life is in danger, irrespective of religious beliefs.

            In the case of psychiatric treatment, it seems quite obvious that the field cannot point to *life-saving* treatment, considering the drugs cause more harm than good, increase suicide rates, and injure the brain, body, mind.

            In short, psychiatry lacks the *science* to force its “treatment on anyone. And yet, it continues to use force – with both adults and children.

            For what it’s worth, I’m not anti-psychiatry.
            I’m pro-freedom, recovery and wellness.

            Bon jour,

            Duane

        • Hi again Duane,

          Hi Duane,

          ///These drugs (along with ECT and incarceration) are used by force. Not the case with other health conditions.///

          2) What do you make about scandals we had in france about children being underfed and deprived of any vaccination and any medical treatment in some communauties who did not believe in allopathic medicine at all but only in diet and homeopathy- as a qualified Homeopath MD I am sorry about the latter.

          To conclude on that argument between us Duane, I will repeat that some of the substitutions for psychiatrists will be just crooks looking for power and/or money and that psychotherapies and unconventional medicine have their dangers too.

          And I will tell you two true personal story:

          A female of Japanese origins pro bono client of mine aged 88 years old had been recovered at the end of 2008 in an academic hospital at my asking for medical investigations. She fell and broke her hip but had such nice bones for her age that the fracture was not the easy to diagnose elderly person’s type (when one foot is fixed at a strange angle at the end of an inferior member suddenly much shorter than the other one): it took me 4 days as a psychiatrist to make the geriatricians understand that my client had broken her hip! And of course, she was put on a lot of medication to make her quiet…

          My second story is that one afternoon some years ago I was at a Parisian medical school taking in knowledge by a well known homeopath MD lecturing there. Suddenly, the man went red in the face and had to stop his lecture in front of MDs and medstudents (In france you have to have an MD to practise homeopathy -on the open that is.)The lecturer asked for some homeopathy remedy and I ask if somebody had there something to measqure his blood pressure. one had it and the blood pressure was so high that I called the cardiology dep and had him admitted for a blood perfusion of allopathic medicine he agrees to. For some reasons, he never thanked me for it and sort of never came close to me at homeopaths meeting where according to him homeopathy can solve every health problems. When I had troubles with the medical board made to me by a psychoanalyst who took advantage of my pro bono onlmy practice, I asked the man to testify that I was a good and energetic doctor for him in an emerbgency and i havce been waiting for years his testimony.

          Also, on that second kind of example, I heard with my own ears a British homeopath – non MD to be honest but having MDs following his teaching) telling at a meeting in Spa (Belgium) that if we gave him money he would find in 4 years the homeopathic remedy for AIDS in West Africa. Some MDS were very taken by him.I had heard the man tell a parisian audience that he could sell sand to an arab and snow to an eskimoo…

          • To clarify: the lecturer in homeopthy had allopathic treatment against an acute very high blood pressure put into his blood circulation-sorry about my poor English.

        • Hi Duane,

          I am the first to be sorry about it but crossing the blood brain barrier is not at all the priviledge of psychiatric drugs.

          Often enough, a good psychiatrist will point out to a colleague in other fields of medicine that their drug treatment is giving a client ill mental health that is not the sign of a mental illness- like for examples a client becoming impotent and sad with a treatment aiming at reducing his blood pressure; a client becoming slightly agressive and hyperactive might have received too high a dosage in a needed hormonal therapy and risk a diagnosis of bipolar etc…

          Obviously treatment for parkinson’s syndromes and seizures cross the blood brain barrier and can give ill health- GSK has been condamned recently by a French appeal court for having not tell the public about the risk of addctive conduct from Park’s treatment with Roquip (ropinirol HCL)-a man had lost his savings and honesty by suffering a gambling addiction and then had suffer from an additional sexual addiction exibiting himself on the internet and elsewhere and being raped:
          http://www.lepoint.fr/sante/effets-secondaires-du-requip-la-condamnation-du-laboratoire-gsk-confirmee-28-11-2012-1534717_40.php

          It tooks seven years to a coiuragous man to fight that battle almost alone!

          I am afraid that psychiatry and psych meds are not so unique.

          Plus, the most destructive brain drug is probably alcohol and some people get psychosis from cannabis. This is why – although I prefer exercice and relaxation, some times homeopathy or acupuncture plus therapeutic education of the person and the family about autism- I very much prefer an Asperger’s syndrome adult taking a very low dose of antidepressant than drinking heavily as so many do to treat social anxiety!

          Thanks for being open to dialogue.
          Ivana

      • Some of us had a lively discussion on the supposed superiority of non psychiatry doctors on another blog:

        http://www.madinamerica.com/2012/11/five-types-of-mental-health-advocates/

        Sorry to repost one of my comments but it is so much to the point of spinning in all fields of medicine:

        http://www.washingtonpost.com/business/economy/anemia-drug-made-billions-but-at-what-cost/2012/07/19/gJQAX5yqwW_story_2.html
        ///The first two drugs of the trio, Epogen and Procrit, were approved by the agency in June 1989 for patients with kidney disease. Amgen made both; Procrit was licensed by Johnson & Johnson. Amgen’s Aranesp would be approved in 2001.

        For a narrow portion of those patients — dialysis patients with anemia so severe they needed occasional blood transfusions — the drugs, if used in limited amounts, did offer a critical benefit, one that doctors say amounted to a revolution in treatment. Patients with severe anemia said it could restore their vitality. The new drugs allowed them to avoid the risks of transfusions, which can carry diseases and raise future complications for transplant patients.

        The trouble would arise as the drugmakers won FDA approval for vastly expanded uses, pushing it in larger doses, for milder anemia and for patients with a wider array of illnesses. Very quickly, the market included nearly all dialysis patients, not just the roughly 16 percent who required blood transfusions. The size of average doses would more than triple. And over the next five years, the FDA would approve it to treat anemia in patients with cancer and AIDS, as well as those getting hip and knee surgery.

        The key to their marketing was the claim that the drugs at higher doses could make patients feel better. By 1994, the drug’s label, approved by the FDA, advertised a range of benefits: “statistically significant improvements for . . . health, sex life, well-being, psychological effect, life satisfaction, and happiness.”

        Those claims, withdrawn 13 years later because they did not meet new FDA standards for proof, would be the basis of television and print advertising campaigns, pitched to people with potentially fatal illnesses.

        The drugs, according to one, offered “Strength for Life.”///

        Ring a bell, anyone on eMIA ?

        To me it sounds like SSRI antidepressants’s criminal marketing.

    • Dear Richard,

      What do you think about”How A Bone Disease Grew To Fit The Prescription”?

      (…) Osteopenia is a condition that only recently started to be thought of as a problem that required treatment. Until the early 1990s, only a handful of people had even heard the word. And to understand how osteopenia was transformed from a rarely heard word into a problem that millions of women swallow pills to treat, you need to go back to the beginning; (…)
      For a long time doctors and researchers were only able to diagnose osteoporosis after a woman experienced a bone fracture. But by the early ’90s technology had evolved, and bone scanners made it possible to determine whether the bones were weak before any fractures occurred.

      The question before the experts in Rome then was this: Since after the age of 30 all bones lose density, how much bone loss was normal? And, how much put women at risk and therefore should be considered a disease?

      (…)”Ultimately it was just a matter of, ‘Well … it has to be drawn somewhere,’ ” Tosteson says. “And as I recall, it was very hot in the meeting room, and people were in shirt sleeves and, you know, it was time to kind of move on, if you will. And, I can’t quite frankly remember who it was who stood up and drew the picture and said, ‘Well, let’s just do this.’ ”

      So there in the hotel room someone literally stood up, drew a line through a graph depicting diminishing bone density and decreed: Every woman on one side of this line has a disease.

      Then a new question arose: How do you categorize the women who are just on the other side of that line?

      To address this issue, Tosteson says, the experts — more or less off the cuff — decided to use the term osteopenia. Tosteson says they created the category mostly because they thought it might be useful for public health researchers who like clear categories for their studies. They never imagined, she says, that people would come to think of osteopenia as a disease in itself to be treated. The chairman of the meeting, John Kanis, of the WHO Collaborating Centre for Metabolic Bone Diseases, says the same thing.

      Nevertheless, 17 years later Banghauser, of Richmond, Va., a woman whose bone density is just a hair away from that of the average healthy 30-year old, is not only medicated for osteopenia but literally spends her days worried about breaking a bone.

      “I used to run marathons, and I would fall and trip on broken sidewalks,” she told me. “And you know initially before I had this diagnosis I didn’t think anything of it. But now every time I fall I get up and think, ‘Oh, good, I haven’t broken anything.’ ”

      “I’m much more aware of making sure I lift my feet up and I don’t trip on the sidewalks, but you know, if I didn’t know that I had osteopenia, maybe I wouldn’t be so cautious.”

      So how did osteopenia change from a category for public health researchers into a condition that millions of women swallow pills to treat?

      The answer to that question starts with a man named Jeremy Allen, who lives in a sprawling home in Pennsylvania (…).

      http://www.npr.org/2009/12/21/121609815/how-a-bone-disease-grew-to-fit-the-prescription

        • Sandra,

          As adult psychiatrist interested in trying to help Asperger’syndrome persons when they ask for it (they suffer often from ill mental health but rarely from mental illness );I like this last example much because it shows how a new non-psychiatric disease can be invented by a committee like those of the DSMs and then be exploited by the drug industry.

          You have very good journalists in the USA unlike in France!

          PS: Sorry about cluttering uo your blog with too many comments but I am interested in discussing antipsychiatry on MIA because in France the autistic persons (and families) are often the victims of psychoanalysts (psychiatrists and psychologists) but also of money making and /or power seeking people who surf on antipsychiatry with simplistic ideas and false promises.

        • Hi, I loved the article and the ensuing disscussion. As a grad student in Social Work I remember reading Szaz and Foucault. I also remember working on a psych unit and the docs trying to find a blood marker for depression.
          The standard addage then is that psychiatry is in the middle ages compared to some other forms of medicne. I also have been in the Mental Health Coommnity and have found the treatment through drugs and therapy in and out patient to be less than stellar to say the least. I have only recently come to this website and others and I have ten years of regret for following the bad advice and treatment. Once a psychiatrist at our Community Mental Health Center tried to ask all of the staff to try a neuroleptic none of us did. There was never any support for discontinuatioin of meds. Having lived through several short and long term periods of psychosis brought on by really exteme stress I think medication was the only option. However I think it should only be used if nothing else is working. In my state there are no alternative mental health treatment or professionals. I think the peer assisted crisis format is a wonderful idea.
          I think we are following in the steps of the anti smoking movement. My other concern is that Wall Street has siphoned off the best and the brightest. The quality of Mental Health professionals is getting bad as compared to the sixties when doing good was something to pin a career on. My husband works as a Mental Health professional and the environment is awful. They literally cannot find qualified people to work in the case management jobs. My children actively tell any of their friends never to go into any helping profession due to stress and low pay. So many things are against this but I am so heartened to have this and other conversations going on! Please keep up this vital work!

  6. This study sounds familiar, except that the same sort of thing was done in the early psychosis program that my son was enrolled in for two years. I reached the same conclusions as Dilip Jeste – amazing – and I haven’t even got an M.D. or a Ph.D. Patients don’t have time for a bunch of academics to get their act together. The program my son attended insisted that everybody take not one, but two drugs in what the doctors considered “low doses,” because two drugs at low doses were considered more effective than one. Metabolic weight gain? Of course. Discontinuation of one drug and then substituting a new one because the patient wasn’t improving was the norm. But, much as I insisted that one ineffective drug would do (since two ineffective drugs seemed like overkill), I was merely a bystander. So, I don’t really get what all the fuss is about with this latest study. It doesn’t matter what drugs were studied, they would get more or less the same results with others.

    • Thanks for the comments.
      Were the results of the study in which your son participated ever published? I would be interested in reading more about it.
      This study seems to be important because it was published by a respected research team and it counters accepted practice and understanding within the field.

      • Sandra,
        On reviewing my comment, I can see it is misleading. My son was enrolled in a hospital outpatient program that ran for a maximum of 18 months. (My son, not getting better, was allowed a few months more.) My suspicion is that the patients provided research fodder for the aspirations of the psychiatrist who ran, and still runs, the program. He loved clozapine, and the virtues of clozapine were regularly mentioned by the staff in passing. (No surprise, my son was soon switched to clozapine.) We live in Switzerland, and Novartis, a Swiss multinational, has the patent on clozapine, if patent is the correct word. Is it merely a coincidence that everyone in the program appeared to be on clozapine? Europeans don’t seem to be as into research as much as Americans are, but I suspect the program keeps data on the patients. They just don’t publish. I don’t know if this kind of program exists in North America. My strong suspicion is that the patients provided research fodder.

          • Being unethical doesn’t mean it does not happen. It does. In my opinion, off label prescriptions of psychotropic drugs, particularly prescriptions which are not based on clinical trial evidence, or even minimally supported by data about the drugs’ safety and effectiveness, (which is more common than not, in psychiatry) is Human Experimentation. Calling it “Off Label” instead of calling it what it is, is deceptive, and I believe it is done to deceive. This off label prescribing is theoretically supposed to be based on actual evidence of safety and efficacy, even if it is not from drug trials, the drugs have been in use for a very long time and STILL there is not the evidence available that what is being done in Standard Clinical practice is supported by EVIDENCE. So haw the hell did this become a STANDARD PRACTICE? By a quasi-democratic practice called voting. A group of people gathered and voted on their educated opinions—this is not a scientific or a medical endeavor; it does not even resemble science or ethical medcine. It is a dishonest and not at all ethical use a consensus of subjective opinions in place of the empirical data which should be the foundation of any and all medical standards of care. What are the Standards of Care in psychiatry, ie. practice parameters, treatment algorithms, etc. if they are not science-based ethical medical standards? What they are is an affirmative defense for criminal medical malpractice. In effect, and in fact, Human Experiemntation without the knowledge or the consent of the participants is standad practice for treating psychiatric diagnoses.

          • Dear Sandra,
            I agree it would be unethical to conduct a study without consent, but what about the kinds of programs like these, that have access to plenty of data on their patients in this case going back to 1983), I believe. They can publish the data after the fact, I assume, without asking permission of patients who are no longer in the program. Part of the reason I used the term “research” is because, in order for the hospital to promote its program, it needs to demonstrate a particular standard of care that is supposedly supported by evidence that the patients get better when adhering to the program. Not sure I’m making sense, so I’ll stop now.

  7. Duane,

    ///In the case of psychiatric treatment, it seems quite obvious that the field cannot point to *life-saving* treatment, considering the drugs cause more harm than good, increase suicide rates, and injure the brain, body, mind.///

    I feel that,on the general population level, psychiatric drugs might do more harm than good but I really don’t know because some people want pills and a quick -fix and may be would use more street drugs to get relief or put themselves into dangerous gourou hands- you do not seem to be one to me but those people do exist.

    Actually, what I have been doing since 1989 has been to try and help on a pro bono basis some people escaping escapable psychiatric drugs and psychiatric labels using a gynacologist hormonal prescription sometimes, psychotherapy, support and education about diet and about sleep among other things , homeopathy, exercise you name it.

    I found, in particular, ludicrous that the DSM5 will consider acute grief not contradictory with a diagnostic of major depression (and even more that they would suppress Asperger’s syndrome from the American classification).

    Also, cheap estrogen (plus progesterone for the women still having their uterus) hormonal therapy should be considered so dangerous when many women -and the more so when they are autistic- get a bipolar diagnosis and more dangerous treatment like neuroleptics.

    Still, I always told some people to go and see a colleague psychiatrist prescribing allopathic drugs because my experience is that some people benefit greatly from psychiatric drugs.

    I also believe that some premature deaths by suicide can be prevented by ECT as I already wrote on Pr Healy’s blog.

    Ignoring that a very severely depressed mother or father can kill herself and her children (“altruistic suicide” is this called in French) is just unpreofessional for somebody working in health care and I am sure you know that.

    NB: I am not saying that antidepressant or ECT are the solution her: hormonal treatment or social housing or legal support against an abusing spouse can be the solution.

    As I already mentioned on Corinna ‘s blog that a French psychiatrist has been put to trial in Marseilles for not having prescribed neuroleptics in a depot form and not having kept in the hospital a man with a history of violence and of stopping his medication who stopped one more time his neuroleptic treatment and killed his mother’s partner. And that colleague had non only tried to hospitalize the man when he came as an outpatient to consult her but she had taken the difficult ethical step to call the mother telling her son was dangerous to her partner and the police as well in order to have the client safe at a hospital.

    As disgusted as I was (and still am) with the paternalism of French psychiatrists in general when I took on pro bono work for people not in need of a psychiatric label and treatment in 1989 and as disgusted I was (and still am) in 1986 with the psychiatrist academics ‘s manner to conduct ” silly monoaminerhgic simplistic or dishonest on bad pharma payroll biological psychiatry researches” -with the only exception of epidemiologists-

    I find just not acceptable to pretend that nobody can ever be helped by psychiatric drugs and forced hospitalization and even ECT in desperate cases and that anybody can be helped by peer support or professionals like yourself.

    I find recovery a nice aim but a dead person cannot recover. Can she?

    To provide availability for peer support and professionnal like yourself is a good and fine thing but you are not going to make it mandatory and send the police to people’s homes because they do not want to use your services or Corinna’s. Or are you?

    (Some non-psychiatrists healers can be as paternalistic as your average French psychiatrist -not that you seem to be one to me.)

    • No, I’m hardly “paternalistic”.
      In fact, I have some strong libertarian tendencies – adults should be allowed to make their own decisions.

      Unfortunately, when it comes to psychiatric treatment we do not have *fully-informed* consent. We are not even close!

      And, people are not told of *options* – non-drug, safe and effective options.

      Duane

      • Hi Duane,

        ///adults should be allowed to make their own decisions.///

        How right could you be Duane!

        And I would add that adults should be allowed to make their own decision for their children but should never be allowed to make decisions for elderly parents able to consent no matter how poor or frail those parents can be.

        Taking psychiatric drugs or having ECT are just that to my mind: an option and not one I recommend myself if I see another possibility.

        I cannot think that activists denying to anyone in any circonstance the right to ask for psychiatric drugs -or even to agree to ECT in desperate cases are pro freedom.

        For example, I heard an autistic advocate doing a PhD and raising children telling that risperidone had been a great help during a discussion at a meeting organized by autistic persons for autistic persons were I felt privileged to have been invited last summer in GB (AUTSCAPE).

        Who I am and who are you to tell that intelligent person wrong?

        Some elderly people risk to lose living in their own home or in a pleasant retirement home when they are too vocal and energetic about some persecutory ideas they have got from voices in their head. When everything else has failed it might be difficult not to propose a few drops of haloperidol to get the person free of the voices to see if it works and what are the side-effects…

        Other elderly people want to drink coffee all day long and after diner, watch TV a lot instead of taking fresh air and exercise during the day and watch TV at night in their beds, eat heavy diner and take psychiatric drugs to sleep when benzodiazepines are very dangerous…

        A very vocal ECT opponent and innovative thinker for sure about “labeling” , a psychologist, Pr. David Bentall who wants for GB psychologists the right to prescribe dangerous psychiatric drugs without any medical training wrote in one of his books that nothing could have saved a client of his who hanged himself in the middle of a divorce on the evening his children were celebrating Christmas with his estranged wife- after having trying to hang himself shortly before he succeeded at it.For myself, I think mandatory hospitalization for the time beings until the end of the divorce procedure or ECT should have been proposed to the man after he first tried to hang himself around Christmas which is often a very difficult time for those without a family in good shape.

        2) Every society has to draw a line between individual freedom and safety of the population at large (or the children’s safety when parental authority is concerned).

        Sadly, in France the former president, Nicolas Sarkosy, pushed strongly for insuring the safety of the population at large against the rights of the mentally ills each and every time a violent crime by a mentally ill person was in the news and many people do not believe in France that the justice system is independent enough from the government…
        ( I must write on their behalf that the French psychiatrists – as paternalistic as they can be from an Italian point of view, so to speak- are on the whole fighting against that move but they lost with the public opinion.)

        It might be different in the USA because you have better journalists and better organized activists but even in a free country of your reality or of your dreams, the line has to be drawn somewhere.

        As I have already written to Corinna, I am sure that –law and judges permitting it – many psychiatrists in many countries will be more than happy to leave yourself or Corinna West the responsibility to look after in a caring and healing of any very delusional person who told his psychiatrist how urgent it is for his step father to be dead…

        Nice to have had a dialogue with you.
        I wish you a nice holiday seasons and a happy new year 2013 Duane.

        Ivana

        • Dear Ivana

          you seem to be confusing several issues here:

          1 the dangers of non-medical practitioners who offer treatments to mentally distressed people such. Sometimes they are called Quacks. In another post you mentioned Scientologists and some would consider them to be one type of Quack

          2 the issue of freedom of choice, ie should patients be allowed to make informed choices about treatments and how much influence should Dr’s have in making these decisions?

          3 under what guidelines should Dr’s prescribe certain treatments. How reliable are the current guidelines? Who develops these guidelines and why?

          4 what are the best proven treatments for people showing extreme mental distress? How do these compare to current popular treatments?

          5 medical conditions and medical drugs that produce mood disturbances and psychosis which then often gets treated by psychiatrists. Something which I am sure does happen, and indeed happened to a friend of mine, but which is not the majority of cases.

          6 the morality of forced treatments in cases of extreme mental distress.

          I find it all rather confusing. I am not sure if all of these points are raised by the original post, in this case by Sandra. Although I could answer all of the points you raise (because I like to exercise my mind and show I can use it think sometimes) once I had thought about what you were raising and how the examples you raise point to various issues it would be a lot of hard work think it all through.

          You obviously want to debate these issues but I’m not sure this is the right forum for you to get all your questions answered to your satisfaction

          • Hi John,

            My brocken English must be at fault there, John, since you didn’t understand that I was answering Richard’s and Duane’s comments.

            I hope that my conversing with Duane from Texas, Richard and Stephen gives me more satisfaction than my answers to them grieve you.

  8. Sandy, thank you for bringing us the news of this important study.

    This is a mainstream study. It’s big, with over 300 participants, and one of the authors is Dilip Jeste, the current president of the American Psychiatric Association. Nobody could claim that it was somehow fringe science.

    I think this is good for my legal practice, but there are questions that I’m not clear on how they fit in with what we do.

    First, I’m not sure about dosages. For instance in Risperidone, the drug I’m most familiar with dosing of, the mean dose was 1.8 milligrams, which is considerably lower than what they give most of our clients. It’s unclear whether a higher dose would have led to better results, although it’s worth noting that the treating docs were allowed to raise the dose as part of the study; I think we can infer from this that anyone who thought a higher dose was needed administered a higher dose.

    Second, it appears that the study participants were all or primarily outpatients, which would leave the door open for the state to argue that someone requiring an emergency inpatient admission can be distinguished from the participants of this study. This might also play into the discussion of dosing.

    Third, while the study finds essentially no benefits from the drugs, I don’t read it to say anything about the course of the subjects’ condition after meds were discontinued, which would be useful for cases involving continued treatment.

    We’ve reached the point where almost every week there’s a new revelation of the shortcomings of psychiatric drugs and practices. Any psychiatrist, particularly in the involuntary system, who is not seriously reevaluating his or her practices is seriously neglecting his or her professional and moral responsibilities.

    • Any time that a patient in the state hospital where I work refuses to take the toxic drugs, which is their only treatment, the psychiatrists threaten to take them to court and have them committed for another 45-180 days. They are certainly not reevaluating anything at this point, other than their power to coerce people into doing what they want them to do. I agree with you that they better start doing so because who know, eventually there may be lawsuits brought against numerous psychiatrists for the lack of proper treatment.

      • I Stephen,

        To look on the bright side, that study will come to the rescue of any psychiatrist not keen on prescribing those neuroleptics to any elderly person – be it because that psychiatrist thinks that cheap haloperidol works better often on the voices and smelling of poison of the elderly and not everybody gets marked neurological adverse effects from it or because that psychiatrist doesn’t want to prescribe any neuroleptics at all to the client if he can help it.

        Always nice to discuss things with you Stephen since you are open to dialogue and you do not defend the same fixed views times and times again and you have interesting experience to share. I would recommend everyone to read your full discussion with Alice Keys including your fond memory of the family doctor of your childhood and I am glad you wrote to Alice Keys, among other things of the utmost interest:

        ///One of the things I’ve decided is that it’s not only the biopsychiatrists, or psychiatrists in general, that have to answer some difficult questions and be held to accountability.///

        http://www.madinamerica.com/2012/11/but-its-just-the-way-things-are/

        You often write about the experience of someone working in a USA psychiatric hospital but not as a psychiatrist and some thing is fascinating to me about it:
        only psychiatrists seem to behave badly in the hospital where you work!

        I think, Stephen , that the USA America really is God chosen country if you are blessed there with only psychiatrists being to blame and nurses and support staff wonderfully dedicated to their task!

        To be absolutely frank, Stephen, although it was not my main reason to stop working in the psychiatry hospital care in 1989, some of the French nursing staff and support workers in psychiatry were very problematic to work with for me:

        Most nurses had a great sense of duty and were very humane and pleased to work in psychiatryand I learned more from some of them: a good nurse observation had even lead me to my research subject.

        That kind of attitude might not exist where you work or in the USA at large but, for example, I met more than once in France with some nurses and support workers who would say “the schizo in room X “ or “ the depression in room Y “instead of a name after the client had been hospitalized for some times with the numerous occasion a nurse or a support worker has to check and write the patients’ names. It was not unusual then and it is still frequent in France nowadays to hear the non doctor staff speak meanly of the family. To tell you a true story, once a social worker refused to do her job when I asked her about finding financial and humane support for a family telling me that first she had her children who where on school holiday and she had to be home a lot and second, since it was the mother’s fault if the son was “a schizo”, money struggling single mother or not, that woman could keep him at her home without help and at her expenses and not the taxpayer ‘s for as long as possible!

        To come back to neuroleptic prescroption, some psychiatric nurses and nurses helpers put their safety and comforts first and were making light of the drugs side-effects: It was so easy for nurses wanting a good nap on a chair or to play cards with colleagues at night – to blackmail the psychiatrist on call into overprescribing dangerous drugs for a new client or even into prescribing physical restraint with the argument that the nursing staff or another patient will be physically hurt in the next hours of the night by the emergency patient..A French TV documentary in 2010 has shown me an even worst king of nurse ‘s behavior with a nurse coming into an argument with a young woman asking to go in the garden and smoke with some warm clothes under her psychiatric in-client thin pajamas and a man nurse answering in a very vulgar way that either she had to froze if she wanted to smoke. The young woman protested and got vocal and ended up under physical restraints with a neuroleptic injection in her bottom decided by the woman nurse who came to the rescue and explaining to the man that the client was in a dissociative state and, believe it or not, the reporters and cameras presence where known to the nurses…

        Luckily, I can put here a link in English about support staff being involved in incredibly sadistic criminal attitudes against vulnerable people.
        // (…)Last week six people were jailed for their role in abusing patients at the private hospital near Bristol after an investigation by BBC’s Panorama.
        “What has been exposed by Panorama is utterly intolerable and has to come to an end,” Mr Lamb told the Commons. (…)///
        http://www.bbc.co.uk/news/uk-20140421
        ///(…) A BBC Panorama programme last year showed footage of patients being wrestled to the floor to be restrained, the use of water-based punishment and unequal games of strength which the patients could not possibly win.
        An undercover reporter managed to get a job as a support worker and filmed colleagues tormenting, bullying and assaulting patients during five weeks at the hospital last year.
        He was sent in after the owners, Castlebeck Ltd, and the Care Quality Commission failed to respond to disclosures by a whistleblower.
        (…).///
        http://www.thisisbristol.co.uk/Damning-report-scandal-Winterbourne-View/story-16668258-detail/story.html

        Have a nice and resting holiday seasons and a happy new year 2013 Stephen.

        Ivana

      • Dear Stephen,

        I think you should write your own blog on MIA because you are blessed with a talent with words in conveying a unique experience and point of view, many interesting experiences on mental health to share and a gentle very humane modest and rich thinking about it all worth reading and rereading.

        Please accept my apologies for having ignored on 12 08 12 at 10:51 that you indeed wrote about unprofessional conduct of nurses:

        http://www.madinamerica.com/2012/12/do-diagnoses-injure-people/
        (…) when I would just get to sleep this one nurse would come in and shine the light in my face! With that kind of treatment you never get any sleep. One night I told her that if she shined her light in my face or the face of my roommate again I was going to get up and moon her. She ran down to the nurses’ station and wrote in my chart that I threatened to beat the s..t out of her. The charge nurse came to ask me why I was threatening her staff. When I asked what she was talking about she stated what the nurse had written in my chart. My roommate, who was awake at the time and heard exactly what I’d told the nurse originally about mooning her spoke up in my defense and quoted me exactly. The charge nurse told him to stay out of it because it was none of his affair. Of course, psych patients can’t be trusted because we always lie you know. I demanded for three days that her comment be removed because it was a blatant lie. They refused. I said that I wanted what I’d actually said entered into the file below her comment. They refused. So, in my record it stands that I threatened a staff person! You can’t win with these people.(…)///

        I am thankful for MIA to exists for many reasons, Stephen, but reading your comments and having a dialogue with you is not the least of it.

        All the best to you Stephen.

        Ivana

    • Hi Jack,
      Thanks for reading and commenting.
      1. 1.8 mg of risperidone is on the low side but this is a drug where the effective dosage range has actually gone down over time. I agree that since the study allowed flexible dosing suggests that this was the dose the the physicians though was optimal.
      2. I agree that a study of outpatients may be less applicable to inpatients. No one study proves anything. We still have the short term, double blind RCT’s which consistently find that these drugs are more effective than placebo. I know you are aware of Leucht’s recent metanalysis which reports that these drugs are as effective as many other drugs used in medicine. Also, since some people were on medications when they entered, perhaps maintaining at the same level was an OK outcome. I would have wanted to see more information on this and I have written to the corresponding author to request this.
      3. I agree that we do not know what happens when the drugs are stopped. I believe it was also Leucht who published a recent meta analysis of the drug discontinuation studies which was consistent with earlier reports that there is a higher rate of relapse when the drugs are stopped vs. when they are continued. However, not everyone relapses when they are stopped and some relapse even when they are continued so it is a minority of people who seem to benefit from continuing. We just do not know who they are.

      We try to balance the results of these studies with our individual experiences with people.

      I am going to be putting together a presentation for the residents on my current thinking on this. I can send you the slides when I have them.
      Sandy

      • Hi Sandra,
        /// I know you are aware of Leucht’s recent metanalysis which reports that these drugs are as effective as many other drugs used in medicine.///

        One could argue that the non psychiatric drugs had not been honestly and cleverly tried either and that even ethically conducted in good faith metanalysis ( fair selection of the studies considered good enough to be included in the metanalysis, taking into accounts the probability for negative studies founded by Big Pharma not being published, and fair selection of outcome criteria etc..) are not an easy task after decades of drug marketing interfering with TCS publishing in any field of medicine and academic selection got wrong in medical schools with too much impact given to the number of publications in top journals when good science takes long thinking beforehand and long studies before publishing.

        (///Why Most Published Research Findings Are False
        http://www.plosmedicine.org/article/info:doi/10.1371/journal.pmed.0020124///)

        And for a concrete example of non-psychiatric “Bad Pharma” involved in RCT:

        ///A seemingly small mistake in a paper in The New England Journal of Medicine (NEJM) landed a Danish physician-researcher in hot water last month after a German company threatened to sue him for potential losses that could run in the millions of dollars. The exchange prompted media consternation in Denmark over whether academic freedom was being censored, but the researcher, Anders Perner of Copenhagen University Hospital has corrected the error, which occurred in the publication of a study of a widely used drug to prevent shock, and thereby averted legal action. Still, the episode has shone a light on a therapy that some researchers say may be doing more harm than good, despite its widespread use.(…).///
        http://news.sciencemag.org/scienceinsider/2012/08/squabble-over-nejm-paper-puts-sp.html

        PS: I benefited from a good enough education in pharmacology and neurology in my youth and for 33 years I had shared the life of one of my former professor of medicine, François Lemaire, an Intensive care French academic who had been chief Editor of “Intensive Care” (a European journal) and editor of the review of the Am Thoracic Association. My very bright and not money seeking (estranged now) husband and the good teaching I received in Roma, Paris and Oxford saved me from believing those antipsychiatrists who present our discipline as doomed in opposition to “whiter than white “ non psychiatric medicine-even at the worst times when Bad Pharma and the simplistic monoaminergic theories were the ” only path available” for those aware of the shortcomings of the psychoanalysts.

        It is sad but comforting for psychiatrists who care for their clients to know that we are not the devil’s face of medicine some antipsychiatrists want us to appear compared to other doctors-

        when it would have been so easy for us to choose another specialty with clients easier to help and deal with (urology being hard to beat for the grateful clients easy as a whole with othopedy, ophtalmology and dermatology coming close in my experience of medical student) and even make more money for the money seeking doctors -at least in France where earnings come from doing any kind of labtest or procedures, not from talking.

        Anyway, when has a simplistic dichotomist’s potent political idea be true and safe long term in history in any field?

        Thank you for being a model of an intelligent not paternalistic psychiatrist who-in my own views- has also the courage to keep honest and not advertise her own easy path to mental health and happiness following your own method…

        Your clients and residents are very lucky indeed to have you !

        I wish you a pleasant holidays seasons ans a happy new year 2013 full of satisfactions for yourself, your family and your clients.

        Ivana.

        • Thanks for your kind comments. I am aware of Leucht’s paper and I find that it is damning with faint praise to say psychiatric medications are as effective as some of these other commonly prescribed drugs. I think you have made this point in your comments that there is over promoting in all branches of medicine. I just do not derive my comfort from the “But they do it too!” argument.
          I do not believe all of these medications are worthless. As I have written in other posts, I still prescribe. I just think that the data base is distorted and if one can generalize, the field has not been forthcoming about this.

          • Dr Steingard,

            Either you are a better person than I am or you are stronger, possibly both.

            I can only congratulate you sincerely on not needing comfort from the “but they do it to (in the other fields of medicine )”.

            Still, when a meta-analysis compare psychiatric drugs with drugs used in other fields of medicine, one has to keep those facts in mind before letting that meta-analysis comforting “pills dispensers psychiatrists USA style”-so to speak.

            Plus, many of your readers are made believe on other blogs that the world would be better without any psychiatric drugs and psychiatrists…

            I find that irresponsible for many reasons;

            All the best to you and your good work.

            Ivana.

      • And remember that relapse after discontinuation does not mean the drug was working. It may well mean that the brain has adapted to the drug’s presence by becoming dysregulated in the opposite direction, and that withdrawing medication simply brings that dysregulation to the fore. It might prove that the drugs themselves are causing harm to the patients’ brains, as Whitaker so eloquently argues in his book.

        It seems the real comparison group is those who never took the neuroleptics in the first place or who discontinued relatively quickly. If those people are doing no worse than those who took the drugs, we can conclude that the drugs are probably ineffective. I know there is a potential selection bias of the less affected being more likely to refuse or discontinue medical treatment, but I don’t know that that point has ever been effectively established. But regardless, treatment ought to have a significant positive effect. If we’re reduced to arguing about whether the untreated group might not have been as bad as the treated group, we’re already talking about treatment effects that are probably pretty negligible, otherwise, the difference would still be observable.

        —- Steve

        • Hi Steve,

          ///If we’re reduced to arguing about whether the untreated group might not have been as bad as the treated group, we’re already talking about treatment effects that are probably pretty negligible, otherwise, the difference would still be observable.///

          Please, do not ignore the fact that the studied groups are precisely that , groups of a very diverse lot of people.

          Dr Steingart wrote, I think , something close:

          ///However, not everyone relapses when they are stopped and some relapse even when they are continued so it is a minority of people who seem to benefit from continuing. We just do not know who they are.///

          We really need to attract to psychiatry very bright residents hoping that in the future bright new ideas will lead to a better understanding of whom can benefit from psychiatry drugs.

          (Actually, a researcher with a troubling ethical conduct in the past like Pr. Charles Nemeroff might sell himself well to the “grants givers” because he propose futur clinical or labs tools predicting who wwill benefit from antidepressants-seems to me.)

          All the best to you Steve for thinking hard and interestingly.

          Ivana.

          • Hi again Steve,

            Of course, “Science without conscience is only the ruin of the soul” from Rabelais a XVIe century French physician and writer applies to psychiatric residents and psychiatry researchers and really bright honest people with a soul do oversimplify issues.

            I was implicit to my mind that we need to attract very bright people with a soul to become psychiatrists and researchers in psychiatry.

          • Hi once again Steve,

            I meant to write 12 13 12 at 6:20 am that very bright people with a soul do not oversimplify issues – and of course not that they oversimplify issues like politicians of any kind, “physician academic politicians” included.

            (Sorry about that but my the MIA “little reply window” is “full of red” when I write in English with my paris baseed computer between typing in French.)

  9. I’m both amused and aghast at studies that use time to discontinuation as a primary (or the primary) outcome. I wonder if they have ever included placebos in discontinuation studies.

    (Or candy or ice cream, for that matter. A small dose, e.g. 1/2 cup, of Ben & Jerry’s every day — rotate the flavors, individualized to person’s preference — would score very well on time to discontinuation for most people, without too much metabolic impact. It might help improve a variety of other scored measurements too.)

    • I am interested in knowing more about what you find shocking and amusing about these studies.
      I remember being surprised at the design of the CATIE study. They were meant to capture an aspect of “real world” practice but they are predicated on the notion that treatment with drugs should be long term to be effective. In that context, the hope is that a drug will be effective and long term maintenance is a good thing. If one does not buy into that premise, then the design makes no sense. These studies have utility because within the context of current accepted practice, they make sense and they can therefore be useful iin influencing accepted practice.
      I like your idea of a Ben & Jerry’s control. On a more serious note, I believe more of these studies need active controls arms – using a drug that psychiatrists do not believe to be effective but that has side effects.
      Thanks for reading and commenting.

    • Hi Phil,

      Actually, one of the oldest trick in spinning data in clinical trials has always been to just ignore the cases of discontinuation of treatment and the cases that didn’t came for follow up since discontinuation often means that the treatment didn’t delivered his promises to do more good than harm.

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