Has the FDA Abandoned Its Off-Label Promotion Ban?
On Tuesday, the FDA entered into a settlement agreement in Amarin Pharma v. U.S. Food & Drug Administration, allowing Amarin to promote a prescription drug for off-label use, so long as its promotion is truthful and non-misleading. The Amarin Settlement seems to be an abandonment by the federal government of protecting the public from off-label prescriptions. But these settlement were just the cost of doing business for the drug companies, while they continue rake in huge profits from the continued off-label prescribing of drugs, which does not diminish after the settlements. Of course, anything that is false or misleading is still grounds for charges, but that is a far harder case to make. I think the ban against off-label promotion is dead for all practical purposes.
Celebrating Dorothea Buck’s 100th Birthday
Mainstream psychiatrists celebrated the 100th birthday of their hero Kraepelin. Let us celebrate the 100th birthday of our Dorothea Buck, remember the many victims of psychiatric treatment, and stay together against violent psychiatric behavior and for humanistic support for people in distress.
Update on the Star*D Report
Two months ago, I wrote a post about a New Yorker article that reported that 67% of the depressed patients in the STAR*D trial...
New York Attorney General’s Office Should Take a Bow For GlaxoSmithKline’s Record Breaking Fine
I was glad to see that the New York Times' reporters covering GlaxoSmithKline's $3 billion settlement tipped their hat to former New York Attorney...
Study 329’s Authors: Should Those Who Live in Glass Houses Throw Stones?
For the past several years whenever a critical essay has come along examining the work of Irving Kirsch and his colleagues I have made an effort to examine the validity of the proposed arguments. Kirsch and his colleagues used the Freedom of Information Act to gain access to the unpublished trials of antidepressants and then pooled the clinical trial data – both published and unpublished ─ and analyzed it as a single data set. It is common for pharmaceutical companies to only publish those studies that find their products effective, and to withhold the negative studies, making it difficult to reach accurate conclusions by examining only the published data. Kirsch and his colleagues have reported that in the company sponsored clinical trials, the SSRIs only marginally outperform placebo, with the difference being statistically different but not clinically significant.
Britney: In the Name of Health
So many of us young women believed the people who told us we needed them to make us healthy, who told us that without them, we’d be at the mercy of untameable "disease."
Pain Management in Modern Times: Does This Sound Familiar?
A little ways back, a close family member of mine saw an orthopedist for chronic hip/knee issues. He described it as a positive experience. He was very pleased with the time spent and thoroughness of the physician and staff, both through conversation and scans done to determine what was wrong. He went in expecting the worst — a joint replacement recommendation — but instead came out with a prescription for advanced pain relief and reassurance that his joints looked much better than expected. As we talked further, though, he admitted being surprised that there was little conversation around lifestyle issues or other treatment options.
Changing Trends of Childhood Disability, 2001-2011
On August 11, Pediatrics, the official journal of the American Academy of Pediatrics, published an article that was based on data derived from a random selection of families concerning their health problems or concerns. Surprisingly, the incidence of disability due to physical conditions declined by 11.8%, while disability due to mental/neurodevelopmental conditions increased by 20.9%. The highest increases were among children under the age of 6, and children from more advantaged homes. At least part of the reason for this stems from the fact that while the prevalence of physical disability is limited by the prevalence of the particular pathology in question, no such limitation applies to "psychiatric disabilities."
Response to “The Marketing of Serotonin” on BMJ
The BMJ article on The Marketing of Serotonin has stirred some interest. There are some highly technical comments on the BMJ site but of course the key point behind the piece is the rather obvious fact that twenty-five years ago many people were saying it was all a myth. The extraordinary Michael Leunig nailed it twenty years ago in the sketch above. (Leunig is wonderful across the board and razor sharp on medicine and mental health).
January 17, 2011
Bob--
About a month ago, I started caring for a fifty-five year old Filipino woman. She speaks English well, though with a heavy accent. She...
And Now For the Rest of the Story
Check out the story that appeared on August 30 on CNN.com titled “Growing Up Bipolar,” and the one on August 31 in the New...
Whose Recovery Is This?! Helping Families Heal
Last night I had the privilege of attending my first Family Den with other Mother Bears like myself—parents, spouses, siblings and adult children. All of us have family members who have experienced mental health challenges. All of us had a story to tell.
Mourning: Death, Loss, Trauma, & Psychotherapy – The Universal Agent for Recovery and Change
There are no set rules for grief. It takes however long it takes, sometimes years, sometimes more. Grieving operates on its own time. The very idea that the DSM-5 gives a two-week grace period before diagnosing a ‘biological depression’ is obscene on the face of it, never mind the handing out of Prozac. Other psychiatrists would like to push the window all the way to three or even four weeks. How compassionate. There is no place for antidepressants, ever
Children are Vulnerable Targets on the Algorithm Superhighway
It is close to midnight and a group of eight high-level CFOs from the major pharmaceutical companies sit anxiously around a conference table. They all have binders with TransCelerate BioPharma written boldly in black across the cover. TransCelerate is a consortium born in 2012, whose mission is to accelerate the development of new drugs and bring them quickly to market. There are two reasons for the high level of anxiety that the CFOs in the above meeting are feeling; first, the research and development of new drugs has been slower than predicted and profits not as massive as hoped for. The second reason is alarming; NIMH may soon start cutting research funding and the pharmaceutical companies have depended upon their liaison with NIMH for funds and for political leverage.
Life Lessons and Trauma Informed Care
My first real introduction to the world of madness and “mental illness” was when I was 21 years old and I left home to start my mental health nurse training. Reflecting on my own experiences has led me to consider how the trauma of participating in the psychiatric system can affect the way we care for others.
Rock Bottom: When You Are in Your Darkest Moment
The one big lie that your mind will tell you when you are in that dark night: I am never going to feel okay again. This is the lie that drives people to self-destruction. It’s also the lie that keeps dynamic, complicated individuals captive in a system that says: your struggle is a permanent and defining feature of your brokenness.
Letters from the Front Lines
Dear Bob--
I've had a couple of remarkable conversations, not with my own patients, but with friends and acquaintances asking me for advice. Each example...
Philosopher Raymond Tallis – Challenging Pop Neuroscience
There's a widespread belief in psychiatric and mental health circles that human experience can be reduced to the biology of brain chemistry -- the "medical model." But this is just the tip of the iceberg: our whole society is in the grips of a faddish pseudo-science of "neuromarketing," "neuropolitics" "neurotheology," and 'neuroeconomics."
When I Grow Up, I Want to be a Psychiatrist: Redefining the Profession for...
A few days ago, I was sitting next to my wife on the couch reading Spark: The Revolutionary Science of Exercise and the Brain written by John Ratey, a professor of Psychiatry at Harvard University. As the title states, it goes well beyond the adage that exercise is good for you, and takes a much deeper, and more scientific look at how research in this area can be (and is in certain places) used to address all kinds of everyday needs. I found myself saying out loud, “Now this what psychiatry should be doing.”
Important New Book— “Outside Mental Health: Voices and Visions of Madness”
The central question that Will Hall asks is: What does it mean to be called crazy in a crazy world? The answers Hall receives in more than 60 interviews and essays from ex-patients, scientists, journalists, artists, and dissident psychiatrists and psychologists restores the full range of color to our humanity. Outside Mental Health reminds us that perhaps the most pathetic aspect “inside mainstream mental health” is how simplistic, boring, and reductionist it is—when our natures are so very complex, fascinating, and non-reductionist.
Boycott The DSM-5: Anachronistic Before Its Time
When plans for the DSM-5 were first announced about ten years ago, most folks’ reaction was “Why?”. Many of us asked that same question several times as the publication date for the new tome kept on getting pushed back. Finally, the curtain enshrouding the DSM-5 Task Force and its several committees began to part and proposed revisions/additions began to appear on its website. To our dismay, we found our question answered.
All Real Living is Meeting
In recent weeks I have taken part in some very powerful meetings at my work place, the Family Care Foundation. By "powerful" I mean that they have been both moving and demanding, Many people who did not know about us before seeing Daniel Mackler´s movie, Healing Homes, have contacted the Family Care Foundation looking for a place where it is possible to get off pharmaceuticals, and to be supported. Even more importantly, they are longing for a place where they are met as a human being, amongst other human beings.
Me & The Meds: The Story of a Dysfunctional Relationship
Those of us who question psychiatry’s relationship with medication may be be dismissed as ‘Pill Shamers’ or branded as irresponsible and dangerous voices by those who are convinced medication is the only way of treating someone’s ‘illness’. The debate can feel like a fight between two intractably opposed sides, giving the impression that we must either be ‘for’ or ‘against’ medication. Unfortunately the information and space needed to explore our complex relationship with medication – as practitioners and people – is in short supply, making the concept of informed choice a bad joke. Over the next two years, we will bring together a book made of contributions from people who have successfully taken control of their use of medication.
Rethinking Diagnosis
Imagine that you got upset. Is it very remarkable that I can “diagnose” that you are upset? After all, you are clearly upset. What expert thing did I accomplish by agreeing with you that you were upset? Or imagine that you are angry. Is it very remarkable that I can “diagnose” that you are angry? After all, you are clearly angry. Have I added anything meaningful by saying “I diagnose that you are angry” instead of “You seem angry”? “You look upset” is the simple, truthful thing to say and “I diagnose that you look upset” is a piece of self-serving chicanery.
My Favorite Fears and How They May Serve Us
As I’ve worked in the system in a peer support role I’ve become aware that I’m at risk of being "ideologic." In some ways, being involved in the c/s/x movement has felt like joining a new church. I don’t actually think there’s anything wrong with this; as was the case in my religious community, we are united around something that we believe in strongly and feel a responsibility to bring to the world. Being part of a group like this is empowering, inspiring, and hopeful. But it also scares me.