beyond unacceptable…

Posted on Monday 20 May 2013

In March, friend Nancy Wilson ran across an article syndicated in multiple small town papers hawking the antidepressant, Viibryd®, with commentary by Madhukar Trivedi – not labeled as an advertisement [the article…, Viibryd® – coming to a hamlet near you…]. Trivedi is at UT Southwestern where he heads their Depression Clinic. She wrote the chairman who responded that she had discussed it with Dr. Trivedi who denied any knowledge of how his name was associated with the article [read skepticism between the lines]. Now we are alerted to a press release from Lundbeck about a new antidepressant, Vortioxetine [Brintellix® or Rexulti®] submitted for approval [FDA, EMA]. Look who it quotes:

Vortioxetine clinical phase III data show significant improvement in symptoms of major depression
  • Takeda and Lundbeck present results from pivotal phase III clinical trials with vortioxetine, an investigational compound for major depression
  • First presentation of results from four pivotal clinical studies of doses of up to 20 mg/day
  • Clinical studies demonstrate efficacy at doses of 15 mg and 20 mg per day including an improvement of overall functioning
  • The safety profile was shown to be consistent with previously completed studies at lower doses
Valby, Denmark, 18 May 2013 – H. Lundbeck A/S [Lundbeck] and partner Takeda Pharmaceutical Company Limited [Takeda] today announced that the companies will be presenting new data on four pivotal studies on vortioxetine, a novel investigational drug under review by the U.S. Food and Drug Administration [FDA] and the European Medicines Agency [EMA] for the treatment of major depression. The phase III data will be presented at the 2013 Annual Meeting of the American Psychiatric Association [APA] in San Francisco, USA.

The objective of these four studies was to evaluate the efficacy and safety profile of vortioxetine in doses ranging from 10-20 mg per day, complementing other studies in the New Drug Application [NDA] submission package that included dose ranges of 5-20 mg per day. Three of the four pivotal studies met the primary efficacy endpoint as measured by the change from baseline of the Montgomery-Åsberg Depression Rating Scale [MADRS] total score at week 8. Statistically significant improvements in overall symptoms of depression were demonstrated, as compared to placebo. A fourth study did not meet the primary endpoint. Results of all four studies provided additional information regarding the safety profile of vortioxetine.

"It is important that we continue to seek new options in depression because, even though there are effective treatments available, many patients remain symptomatic," said Madhukar Trivedi, M.D., professor of psychiatry, UT Southwestern Medical Center. "As a clinician, I’m encouraged by these data. They represent an important addition to the broader clinical profile for vortioxetine and support its potential as a new treatment for patients with MDD."
Dr. Trivedi … serves as scientific advisor for Lundbeck and Takeda.

A search of clinicaltrials.gov and PubMed does not show that Dr. Trivedi was involved with any of the studies registered or published about Vortioxetine [or for that matter Vilazodone (Viibryd®)]. Vortioxetine is a "me too" antidepressant that comes in behind the active comparators in the studies reported, but that’s not my point. Notice the careful wording, "I’m encouraged by these data." This looks for all the world like endorsements for hire to me, a new twist on the KOL motif. It also makes his denial to his chairman look even more suspect. Dr. Trivedi has a special valence for me. It was an article of his that first alerted me several years ago to read the disclosures at the end of every article very carefully [evidence-based medicine I…]. At a time when psychiatry is fighting for credibility, persisting with this kind of behavior is beyond unacceptable…
  1.  
    Berit Bryn-Jensen
    May 20, 2013 | 1:37 PM
     

    “At a time when psychiatry is fighting for credibility…”

    They do not know how to do anything else, dr Nardo. This is how they trained, how they practice their trade. It’s the sea (culture) they swim in, where they will continue swimming, as long as that nutrientrich sea is not drained and dried up. Hitched to neuroscience they may well be on course to repeat history, as hubristic and scientific and blind as in the last century, when two German psychiatrists died with the patients, and dr Gottfried Ewald von Göttingen, who refused to be head of the extermination plans set forth by dr Werner Heyde to the leading psychiatrists in Germany 15th of August 1940, and was asked to leave the meeting, still complied in sending the majority of his patients to be killed. Only a handfull were charged and sentenced at Nüremberg. Most went on practicing medicine and psychiatry, some continued in genetics.
    The dream of ridding the human race of “impurity” i e disability, is the nightmare dream of the disabled, wrote Ernst Klee, a German journalist, the first, I think, to chronicle these dark chapters of modern medicine. Bruno Preisendörfer’s article in Le Monde Diplomatique 3.4.2009 Totschlagen und andere Begabungen, was von Darwin übrig blieb, draws the lines between the ambitions of his country’s Nazi past and the ambitions today of genetics and neuroscience. He coins a wonderful phrase on hollow phrases laden with meaning, yet weak in knowledge.
    Ernst Klee wrote of how the post-war German psychiatrists selfpity pushed pity with their victims off the stage – up untill today…which I was reminded of as I read the selfpitying remarks of the new head of APA on stigmatization of – psychiatrists!!!

  2.  
    May 20, 2013 | 2:03 PM
     

    Ha! I sent a complaint that that article needed to be labeled as an ad to the content distributor.

    Maybe Trivedi has licensed a boilerplate recommendation statement to Lundbeck as part of his contract (“”It is important that we continue to seek new options in depression …. As a clinician, I’m encouraged by these data. They represent an important addition to the broader clinical profile for XXXXX and support its potential as a new treatment for patients with MDD.”)

  3.  
    May 20, 2013 | 2:16 PM
     

    I agree.
    Psychiatrists seem to be blind to the culture of their own profession.

    When it comes to the atrocities of the past, in fairness, most are ignorant.
    But the *culture* that allowed for those atrocities has not changed.
    And those of us who scream, “Never again” are dismissed, marginalized… labeled as anti-psychiatry.

    Jacqui Dillon, Chair of the Hearing Voices Network in England reflects on her own experience with psychiatry and the “last great civil rights movement” -

    http://www.madinamerica.com/2013/05/hearing-voices-network-launches-debate-on-dsm-5-and-psychiatric-diagnoses/

    Duane

  4.  
    Berit Bryn-Jensen
    May 20, 2013 | 2:20 PM
     

    I just checked and saw no answer to Richard Noll to his question – comment 54 in the long and winding road – of why and when there is a linguistic shift from schizophrenia to psychosis.
    After the war it was said that some doctors had avoided the diagnosis, to spare someone’s life, as the schizophrenia-diagnosis was a death-sentence in the occupied territories, (except in “Aryan” Norway and Denmark). But the concept has been criticized for years for lack of validity, reliability, for carrying most stigma, discrimination and pessimism. It’s been discarded by the NGOs Rethink and ISPS, Critical Psychiatrists, Japanese psychiatrists and the international community of survivors and (ex)users of psychiatry as harmful, stigmatizing, linked to a historic load of psychiatry’s most inhumane “treatments” … It’s a hollow word, heavily loaded with the significance of quack-science.

  5.  
    May 20, 2013 | 2:22 PM
     

    To clarify, I agree with Berit Bryn-Jensen.

    When asked to describe her captures, one of the women from the death camp said, “They were all doctors.”

    Duane

  6.  
    May 20, 2013 | 2:31 PM
     

    I think, in many ways, the term “schizophrenia” remains a death sentence.

    A death of the worst kind.
    A death of the human spirit and all hope.

    And to think that the *majority* of people who are diagnosed with this condition naturally recover… The rates go up – 85% with Open Dialogue in Lapland, Finland.

    http://www.youtube.com/user/dmackler58/videos?view=0

    And there was great success with niacin therapy as well; many other therapeutic options that are safe and effective. Once someone is placed on neuroleptics, long-term, all things change, for the worse.

    Duane

  7.  
    wiley
    May 20, 2013 | 4:16 PM
     

    “Video News Releases” are corporate advertising disguised as news segments.

    http://www.sourcewatch.org/index.php/Video_news_releases#How_to_Report_VNRs_to_the_FCC

    As for the possibility that VNRs touting drugs – accounting for many of those produced – may be regulated by the U.S. Food and Drug Administration, Moskowitz was reported stating that it was an issue that “will go away.” “VNRs are free speech. They are not forced down news director’s throats,” he said.

    To repeat myself— I once read about a new drug that was supposed to help with the bad dreams and night terrors that are typical of PTSD on an on-line discussion forum. I asked my V.A. psychiatrist about it. He told me that in testing, it caused necrotizing fasciitis, and so the testing was stopped. Viral marketing even before the FDA approval of a drug is devious and clearly unethical.

    I suspect that the CrazyMeds website is also supported by drug companies. Anyone talking about not taking drugs is banned, and though most talk about how well their drugs work, they also talk about having to change the cocktails regularly and preach patience for all the experiments and acceptance of drugs working and then not as a chronic condition that can only be rectified with more drugs.

  8.  
    Annonymous
    May 20, 2013 | 4:26 PM
     
  9.  
    May 20, 2013 | 7:47 PM
     

    typo – captors

  10.  
    a-non
    May 20, 2013 | 8:47 PM
     

    “The Origins of Coercion in “Assertive Community Treatment” (ACT)”-Tomi Gomory,PhD
    http://www.dbdouble.freeuk.com/HistoryPACT.pdf

  11.  
    Nancy Wilson
    May 20, 2013 | 9:46 PM
     

    In response to my questions about the Viibryd article, the chairman of the department wrote, “The University is not promoting the drug, Viibryd; we do not promote drugs.”

    I just requested a review of Trivedi’s outside employment, via the university’s Ethics and Compliance Hotline: 1-877-507-7319.

  12.  
    Nancy Wilson
    May 20, 2013 | 10:36 PM
     

    Here is the final report I received from the chairman of the department regarding the Viibryd article:

    Dear Ms Wilson,

    I reviewed the material that you sent with Dr Trivedi. He never had any relationship with the entity who wrote the blurb that quoted him. He was never in conversation with them or in a meeting with them. We concluded that this entity took comments that Dr Trivedi made in another context and simply applied them for their own ends. Dr Trivedi has nothing to do with this. Indeed, it is easy on the internet to do this and always important to keep this in mind.

    I am grateful for your vigilance in alerting me to this situation. It is my wish to investigate any of these situations. In this case, Dr Trivedi’s name and words were shamelessly used.

    Best, Carol Tamminga M.D.

  13.  
    Nancy Wilson
    May 22, 2013 | 11:21 PM
     

    Today I was informed that UT Southwestern will be investigating the complaint I submitted to the Ethics and Compliance Hotline on 05/20/13.

    As well, I heard from the UT Board of Regents. The Chancellor’s office will be reviewing the Viibryd article and the Vortioxetine article. The Board representative said they take these things seriously. I like that.

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