Issues in Informed Consent 01/27/2011Posted by ALT in Mental Health Research, Patient Rights and Advocacy.
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A friend asks you if you would like to go to a movie. Odds are good that before you say yes or no, you’re going to need to know some additional information – who all is going, is the popcorn any good, does the movie involve Will Smith battling an alien creature, etc.
That’s informed consent: data-driven decision making.
You, the person who has been propositioned, need access to a body of knowledge that will allow you to effectively weigh the risks and benefits before agreeing to anything.
If your friend didn’t answer your questions accurately, or worse yet, withheld important information purposely in order to elicit a particular response, you’d probably be upset. It was his responsibility to supply you with the most accurate information possible about what to expect; to do anything less would be dishonest, unethical.
Informed consent is a legal matter when it comes to medicine and research. Before a doctor proposes a particular course of treatment, he needs to inform the patient of all known risks and benefits – this could include information from both scientific research/clinical trials, and qualitative or experiential knowledge of the treatment from actual practitioners and consumers. Likewise, before a participant can be enrolled into a study like the national evaluation, they need to know exactly what to expect from their participation and what the purpose of the study and the value of their contributions to it are. A doctor or researcher who fails to help the patient or participant give true informed consent is committing a grave violation of trust, not to mention a criminal offense that is subject to malpractice lawsuits.
Below are a few illustrations of some of the moral and ethical issues surrounding the informed consent process. How can researchers and doctors take these incidents as “lessons learned,” improving their practice and the relationships of trust and communication they have with the public?
In 1951, Henrietta Lacks, a poor African American woman living in Baltimore, Maryland, learned that she had cervical cancer. During surgery at Johns Hopkins Hospital, a portion of her cervix, including a large tumor, was removed. Unbeknownst to her or her family, cells from this sample were reproduced in a laboratory at the hospital, becoming HeLa, the world’s first immortal cell line – cells that can be reproduced endlessly in the lab without dying. Her cells were used in the creation of the polio vaccine, planted near nuclear test sites, sent into outer space… all without the knowledge of her family. HeLa cells were the beginning of the multi-billion dollar biotechnology industry, and vials of HeLa are still bought and sold today, for about $200 apiece (no profits from the sales or commercialization of HeLa have gone to the Lacks family).
The family was unaware of the second life Henrietta had taken on for nearly 20 years. And their relationship with the scientific community since has been plagued by misunderstanding and abuse.
The New York Times has written a nice piece about the Lacks, and there is also an excellent BBC documentary on the topic, called The Way of All Flesh.
The question is – how could researchers and scientists ethically allow this kind of misunderstanding and obfuscation to occur? And are abuses like this happening today?
Capable of Consent?
When is a person capable of judging for him or herself the risks and benefits during an informed consent process? There are some clear examples of people who aren’t capable of doing it – a 3-year-old child, or a person in a coma, for example. The issue of competency when it comes to consent is not always so clear cut, however. Take the case of Paul Henri Thomas:
In June 1999, Paul Henri Thomas thought clearly enough to sign a consent form, giving his doctors permission to place electrodes near his temples and send jolts of electricity through his brain as part of his treatment at Pilgrim Psychiatric Center.
He underwent the painful and controversial electro- shock procedure three times, on June 9, 11 and 14. But after that third treatment, he had refused to submit to it again.
That’s when his doctors began saying Thomas, 49, no longer had the mental capacity to make decisions on his own, so they obtained a court order to force the electroshock therapy upon him.
The revelation of a kind of Catch-22-the strange circumstance that Thomas was fine when he consented to the procedure but mentally incompetent when he refused it-took center stage at a hearing [on March 15, 2001] to determine whether doctors may again shock Thomas against his will.
Thomas, who has been a patient at Pilgrim since May 1999, is challenging the state’s application to continue giving him shock treatments-a controversial form of therapy to treat a variety of mental illnesses. Thomas contends he is not mentally ill.
At the third day of Thomas’ hearing yesterday, his attorney questioned a witness for Pilgrim.
“In June he was competent to consent and received three treatments, and some time after that he became incompetent. Is that correct?” asked Kim Darrow, an attorney for the state Mental Hygiene Legal Service, which is representing Thomas.
“I’m unable to answer that,” responded Dr. Robert Kalani, Pilgrim’s associate medical director.
But State Supreme Court Justice W. Bromley Hall swiftly cut off Darrow’s line of questioning, saying Thomas’ capacity to make decisions about his health may have changed since he consented to the treatment.
“There are a lot of people walking around with capacity for whatever,” Hall said in the Central Islip courtroom. “The fact that you have capacity today doesn’t mean you will have capacity tomorrow,” he added, prompting gasps from Thomas’ supporters…
Testimony ended with Darrow asking Kalani, given that Thomas has called the procedure “torture” and “evil,” how has it improved his life.
“Do you think you have improved the quality of life for Mr. Thomas?”
“I think we have,” Kalani answered.
Tags: ECT, FDA, Lisa Andre, NY Times, survivor voices
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January 23, 2011: the New York Times published an article about the upcoming FDA review of the “risk level” of electroshock devices (read it here). In effect, this will be a review of the procedure – Electroconvulsive Therapy [ECT] to its supporters and Electroshock Treatment [EST] to detractors - itself. Although the therapy in its modern form has been practiced since 1937, the first clinical trials or formalized research on its efficacy were not done until the 1970s (and even these were small and not up to current FDA standards). A FDA grandfather clause has prevented the electroshock devices from being subjected to the rigorous review process now in place for all other medical devices.
The push is to reclassify electroshock devices to the “medium risk” level, a class that includes syringes and surgical drills. This would almost certainly facilitate a more widespread practice of this very controversial therapy, which is already on the rise in the US - about 100,000 American per yer receive the treatment.
New York Times author Duff Wilson lavishes attention on psychiatrists in favor of the procedure, but only begrudgingly allows for even the existence of an opposition. Two quick (and mostly paraphrased) quotes from Dr. Peter Breggin and Dr. John Breeding give a brief snapshot of detractors’ arguments against EST.
But where are the quotes from actual people who have received the treatment?
Given that very little actual research has been done on the topic, it seems doubly important to access the wisdom that does exist – experiential and qualitative knowledge gained through actual encounters with EST, its benefits (if any), and its side effects.
So, in the true spirit of systems of care (letting the client speak and make decisions for him/herself), here is a bit of that all-important client voice so conspicuously absent from the New York Times piece.
The Missing Voices
Linda Andre, who received ECT in the early ’80s at the age of 25:
Before shock, patients are specifically told by our doctors that we won’t lose our memory, or that if we do, any permanent loss will be only for the time of the treatment itself, and that any other erased memories will come back. About permanent loss of cognitive abilities, doctors say nothing. Thus the double horror: having lives and abilities erased, not only without any warning, but after being assured that it couldn’t happen. And then when it does, the same doctors just keep assuring you that it didn’t happen.
As if we were so crazy that we don’t even know what we remember and what we don’t remember; I guess that’s what they think.
Here’s what was erased: most of the knowledge and skills accumulated during my college education, my college graduation, a graduation party no one else who attended it will ever forget, my entire relationship with the love of my life, the other important relationships in my life in whole or in part, my career as a writer and scholar, two foreign countries, trips to California, Vermont, Massachusetts, and possibly any number of other states, the reason for the end of a friendship with someone I do remember loving very much, the death of a friend’s brother, the location and contents of a safe deposit box to which I hold the key, and more, much more than I will ever know…
Shock bears about as much relation to gentle and gradual normal human forgetting as being killed in a war does to dying of old age. Shock kills memories blindly and randomly. It makes no difference how important the memory was in the first place, or whether it was a bad or good memory. You can’t get your memories back by tricks like going to the place where they happened. They don’t come back, ever…
One of the saddest things frequently said about survivors of ECT is that someone is ‘just never the same again.’ There’s even a name for this in the literature: the ‘taming effect.’ Whether or not it is possible to define exactly what’s missing, something essential to one’s humanity and personality – some part of one’s birthright – has been destroyed. Creativity is especially vulnerable. Shocked artists no longer create, musicians can no longer play. Spatial, mechanical, and mathematical abilities can be compromised. Each person will be most affected by the loss of what she valued most highly…
My life was stolen. No words can really describe it. Memory. Loss. Forgetting. None of them come close.
And somewhat more famously, Ernest Hemingway, who received ECT in 1961 and committed suicide shortly thereafter:
Well, what is the sense of ruining my head and erasing my memory, which is my capital, and putting me out of business? It was a brilliant cure but we lost the patient….
Sally Clay, who received ECT in 1967:
Nearly 20 years ago, I underwent 30 shock treatments at the Institute of Living in Hartford, Connecticut. As a result I lost two full years of memory. I have one child, a daughter, and the two years that were wiped out in my memory were the years when she was two and three years old; those memories are irreplaceable… My memories are clear and detailed back to the age of 2 and a half. But when it comes to those two critical years before I received shock treatments, my mind remains blank…
Doris Heikila, who received ECT in 1980:
It’s been 7-8 years since I had them [shock treatments], the long term damage is there and it’s not coming back… I can no longer fill out applications. I’m not able to retain anything I might learn, I read and the next minute it’s gone. I can’t follow written instructions, I become confused. Just the other day I had to fill out an application for Food Stamps. I couldn’t do it. I started to cry. Something so simple and it deals with current things, I just couldn’t handle it…
I feel doctors should tell people that are about to have ECT that sometimes, some of the brain is damaged and not all memory might come back. If I had thought for one minute I might of lost any of my memory forever, I would not of went through with it!
I’d also like to tell you that since the ECT I lost my first husband, I have hardly any memory of him, we were married 10 years.
I can no longer remember from day to day. When I’m lucky enough to find work, it’s mass confusion and I usually don’t last too long.
For more accounts of ECT from people who have experienced the therapy, check out the ECT 1st person project where hundreds of accounts are stored online in an easy-to-access format.
A new approach to stigma: MAD pride 01/11/2011Posted by ALT in Mental Health News, Patient Rights and Advocacy.
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In my experience with “mental health care” [I will always put that in quotations... always] consumers and providers, a common concern is stigma. Stigma, defined as “a mark of disgrace or infamy; a stain or reproach, as on one’s reputation,” is too often directly coupled with a mental health diagnosis, and can affect both the “labeled” individual and his family or loved ones. Manifested in a variety of ways – from disparaging looks to actual discrimination in school and the workplace – stigmatization is an all-too-common phenomenon for many mental health care consumers and providers.
The self-proclaimed “MAD pride movement” is using some creative strategies to address the stigma issue. Its members start from a positive place – pride in their self-worth, and a refusual to accept a diagnosis as an inherent “defeat” – in their struggle to reframe attitudes about mental health. Here is an excerpt from a 2009 Newsweek article detailing some aspects of their ideas:
Listening to Madness;
Why some mentally ill patients are rejecting their medication and making the case for ‘mad pride.’
By: Alyssa Quart
We don’t want to be normal,” Will Hall tells me. The 43-year-old has been diagnosed as schizophrenic, and doctors have prescribed antipsychotic medication for him. But Hall would rather value his mentally extreme states than try to suppress them, so he doesn’t take his meds. Instead, he practices yoga and avoids coffee and sugar. He is delicate and thin, with dark plum polish on his fingernails and black fashion sneakers on his feet, his half Native American ancestry evident in his dark hair and dark eyes. Cultivated and charismatic, he is also unusually energetic, so much so that he seems to be vibrating even when sitting still.
I met Hall one night at the offices of the Icarus Project in Manhattan. He became a leader of the group–a “mad pride” collective–in 2005 as a way to promote the idea that mental-health diagnoses like bipolar disorder are “dangerous gifts” rather than illnesses. While we talked, members of the group–Icaristas, as they call themselves–scurried around in the purple-painted office, collating mad-pride fliers. Hall explained how the medical establishment has for too long relied heavily on medication and repression of behavior of those deemed “not normal.” Icarus and groups like it are challenging the science that psychiatry says is on its side. Hall believes that psychiatrists are prone to making arbitrary distinctions between “crazy” and “healthy,” and to using medication as tranquilizers.
“For most people, it used to be, ‘Mental illness is a disease–here is a pill you take for it’,” says Hall. “Now that’s breaking down.” Indeed, Hall came of age in the era of the book “Listening to Prozac.” He initially took Prozac after it was prescribed to him for depression in 1990. But he was not simply depressed, and he soon had a manic reaction to Prozac, a not uncommon side effect. In his frenetic state, Hall went on to lose a job at an environmental organization. He soon descended into poverty and started to hear furious voices in his head; he walked the streets of San Francisco night after night, but the voices never quieted. Eventually, he went to a mental-health clinic and was swiftly locked up. Soon after, he was diagnosed with schizophrenia. He was put in restraints and hospitalized against his will, he says. For the next year, he bounced in and out of a public psychiatric hospital that he likens to a prison. The humiliation and what he experienced as the failure of the medication were what turned him against traditional treatment. Since then, Hall has been asking whether his treatment was really necessary. He felt sloshily medicated, as if he couldn’t really live his life.
Hall and Icarus are not alone in asking these questions. They are part of a new generation of activists trying to change the treatment and stigma attached to mental illness. Welcome to Mad Pride, a budding grassroots movement, where people who have been defined as mentally ill reframe their conditions and celebrate unusual (some call them “spectacular”) ways of processing information and emotion.
Just as some deaf activists prefer to embrace their inability to hear rather than “cure” it with cochlear implants, members of Icarus reject the notion that the things that are called mental illness are simply something to be rid of. Icarus members cast themselves as a dam in the cascade of new diagnoses like bipolar and ADHD. The group, which now has a membership of 8,000 people across the U.S., argues that mental-health conditions can be made into “something beautiful.” They mean that one can transform what are often considered simply horrible diseases into an ecstatic, creative, productive or broadly “spiritual” condition. As Hall puts it, he hopes Icarus will “push the emergence of mental diversity.”
Embracing “mental diversity” is one thing, but questioning the need for medication in today’s pill-popping world is controversial–and there have been instances in which those who experience mental extremes harm themselves or others. Icaristas argue that some of the severely mentally ill may avoid taking medication, because for some the drugs don’t seem to help, yet produce difficult side effects. And while some side effects like cognitive impairment are surely debilitating, others are more subtle, such as the vague feeling that people are not themselves. Icaristas call themselves “pro-choice” about meds–some do take their drugs, but others refuse.
Mad pride has its roots in the mad-liberation movement of the 1960s and ’70s, when maverick psychiatrists started questioning the boundaries between sane and insane, and patients began to resist psychiatric care that they considered coercive. But today the emphasis is on support groups, alternative health and reconsidering diagnostic labeling that can still doom patients to a lifetime of battling stigma. Icarus also frames its mission as a somewhat literary one–helping “to navigate the space between brilliance and madness.” Even the name Icarus, with its origin in the Greek myth of a boy who flew to great heights (brilliance) but then came too close to the sun (madness) and hurtled to his death, has a literary cast.
Although Icarus and Hall focus on those diagnosed as mentally ill, their work has much broader implications. Talking to Hall, I was acutely aware just how much their stance reflects on the rest of us–the “normal” minds that can’t read through a book undistracted, the lightly depressed people, the everyday drunks who tend toward volatility, the people who “just” have trouble making eye contact, those ordinary Americans who memorize every possible detail about Angelina Jolie.
After all, aren’t we all more odd than we are normal? And aren’t so many of us one bad experience away from a mental-health diagnosis that could potentially limit us? Aren’t “normal” minds now struggling with questions of competence, consistency or sincerity? Icarus is likewise asking why we are so keen to correct every little deficit–it argues that we instead need to embrace the range of human existence.
While some critics might view Icaristas as irresponsible, their skepticism about drugs isn’t entirely unfounded. Lately, a number of antipsychotic drugs have been found to cause some troubling side effects.
There are, of course, questions as to whether mad pride and Icarus have gone too far. While to his knowledge no members have gravely harmed themselves (or others), Hall acknowledges that not everyone can handle the Icarus approach. “People can go too fast and get too excited about not using medication, and we warn people against throwing their meds away, being too ambitious and doing it alone,” he says.
But is this stance the answer? Jonathan Stanley, a director of the Treatment Advocacy Center, a nonprofit working to provide treatment for the mentally ill, is somewhat critical. Stanley, who suffers from bipolar illness with psychotic features, argues that medication is indispensable for people with bipolar disease or with schizophrenia. Stanley’s group also supports mandatory hospitalization for some people suffering severe mental illness–a practice that Icarus calls “forced treatment.”
Scholars like Peter Kramer, author of “Listening to Prozac” and “Against Depression,” also take a darker view of mental extremes. “Psychotic depression is a disease,” Kramer says. As the intellectual who helped to popularize the widespread use of antidepressants, Kramer is nonetheless enthusiastic about Icarus as a community for mad pride. Yet he still argues that mental-health diagnoses are very significant. “In an ideal world, you’d want good peer support like Icarus–for people to speak up for what’s right for them and have access to resources–and also medication and deep-brain stimulation,” he says.
For his part, Hall remains articulate, impassioned and unmedicated. He lives independently, in an apartment with a roommate in Oregon, where he is getting a master’s in psychology at a psychoanalytic institute. He maintains a large number of friendships, although his relationships, he says, are rather tumultuous.
Nevertheless, it’s not so easy. Hall periodically descends into dreadful mental states. He considers harming himself or develops paranoid fantasies about his colleagues and neighbors. Occasionally, he thinks that plants are communicating with him. (Though in his mother’s Native American culture, he points out, this would be valued as an ability to communicate with the spirit world.)
On another night, I had dinner with eight Icarus members at a Thai restaurant in midtown Manhattan. Over Singha beer, they joked about an imaginary psychoactive medication called Sustain, meant to cure “activist burnout.” It was hard to imagine at the dinner what Hall had suffered. While he and his “mad” allies were still clearly outsiders, they had taken their suffering and created from it an all-too-rare thing: a community.
Anatomy of an Epidemic, in a nutshell 01/10/2011Posted by ALT in Mental Health News, Mental Health Research.
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Robert Whitaker, an award-winning and highly respected science writer and journalist, published Anatomy of an Epidemic in 2010. In the book, he uses methods of scinetific research and investigative journalism to critically explore why the number of Americans disabled by mental illness has increased so dramatically in the past 50 years (the number is nearly 4 million today!).
Just in case you don’t have enough time to sit down and read an entire book today, here is an informative lecture from Whitaker where he discusses some of the most important research he uncovered in the process of writing his book. He talks specifically about children and the use of psychotropic drugs. He also talks about principles and importance of evidence-based medicine.
What do you think about the points he raises? Is using evidence like the kind he found in his research important for treating childhood mental illness?