As we noted in February, legislators in Minnesota proposed a bill earlier this year to restrict research practices in psychopharmacology.  Namely, the bill intended to prohibit researchers from enrolling people that have been committed for a mental illness by a court order in clinical trials.  The measure was prompted by instances of reported abuse, particularly the story of Dan Markingson.  The legislation, referred to as “Dan’s Law,” was recently signed into law and will go into effect August 1.

For more information about Dan’s Law, please see Christopher Lane's blog entry, When Drug Trials Go Terribly Wrong: Lessons From a Bereaved Mother, in Psychology Today.

People with psychiatric disabilities participate less in socially meaningful activities than others.  For example, they have lower levels of employment, have lower educational attainment, have fewer and less satisfying social relationships, and are less physically active and engaged in satisfying leisure activities.  Traditional explanations have focused on the illness and subsequent symptoms as the source of the “disability.”  

Disability rights advocates have protested that such explanations are victim-blaming and reflect ancient biases against people with disabilities.  They offer alternative explanations that instead focus on person-environment interactions.  Impairment (physical, sensory, cognitive, or psychiatric) is respected as unique and valued individual variation that is either accommodated within environments, or not.  Such an orientation is at the heart of the Rehabilitation Services Act and the Americans with Disabilities Act (ADA) that, among other things, require the development and access to technologies that assist people adapt to environments and require environments to adapt to individual differences.  The ADA was the foundation of the groundbreaking Olmstead decision in which the U.S. Supreme Court found that unnecessary institutionalization of persons with cognitive and psychiatric disabilities who could otherwise live in the community with proper supports, is a violation of their constitutional rights.       

Following this line of thinking, the University of Pennsylvania Collaborative on Community Integration (www.upennrrtc.org) conducts research on the environmental barriers that limit the participation of persons with psychiatric disabilities and identifies supports that address their needs.  Our research has found that people with psychiatric disabilities are segregated in the most socially disadvantaged communities.  This finding might partly explain their high rates of substance use and involvement in the criminal justice system, and low employment, like others who reside in such communities.  We have found that college students with mental illnesses report high levels of prejudice and discrimination and are less connected to the campus environment and people, which might partly account for their higher rates of withdrawal.  We have found that mothers with psychiatric disabilities are almost three times more likely to lose custody of their children despite the limited research showing higher rates of abuse and neglect, anecdotal evidence of negative stereotypes and prejudice, and lack of parenting support programs.  And we have found that the Olmstead decision was followed by a slowdown, rather than acceleration, in deinstitutionalization of the approximately 55,000 citizens around the country who are hospitalized due to a mental illness - subsequent data indicate a return to institutionalization began in 2004.

Our work has found that people with psychiatric disabilities vote nearly as much as the general population (around 50%) and that 80% indicate being very or extremely religious/spiritual, again, the same as the general population.  However, we also discovered that individuals report little support or encouragement from mental health providers to be active as citizens or congregants, and have raised awareness about the laws that can limit their ability to vote (present in 37 states) and that they are near the bottom of the list of groups that religious leaders seek to engage.   

We have also found that Internet-based peer support groups in which persons with psychiatric disabilities provide information and support to one another is not harmful.  And have identified promising approaches toward assisting persons in developing natural supports outside the mental health system, and found that such supports may be helpful in the area of employment.

Our Center has recently been re-funded to further examine barriers and supports that affect community participation.  For example, we are examining whether access to community resources affects community participation, and trying to better understand the factors that affect the community participation of individuals who are newly released from jails and prisons.  We are also further expanding our efforts to develop supports that promote full participation in post-secondary education, as parents, and in controlling where resources are spent in order to maximize recovery and full participation.

The ultimate mission of the Center is to utilize our longstanding, reciprocal collaborations among persons with psychiatric disabilities, providers, policymakers, and other stakeholders to ensure that current research findings in this area are utilized in national, regional, and local behavioral health policies, supports, and practices.  Thus far we have been buoyed by our successes, but recognize that continued change is needed in how people with psychiatric are viewed, and the extent to which environments and the people in them move to actively include them as full citizens and provide the necessary supports for them to do so.  

Mark S. Salzer, Ph.D. is an associate professor in the Department of Psychiatry at the University of Pennsylvania and an investigator in the VISN 4 Mental Illness Research, Education, and Clinical Center at the Philadelphia VA Medical Center.  He is the Director of the University of Pennsylvania Collaborative on Community Integration funded by the National Institute on Disability and Rehabilitation Research.

Following the success of last year's pilot, the ScattergoodEthics Program is now preparing for the second annual Scattergood Summer Institute for the Applied Ethics of Behavioral Health.  The Summer Institute will be held over Thursday, July 23 and Friday, July 24, at the Center for Bioethics on the University of Pennsylvania's campus in Philadelphia (3401 Market Street, Suite 320).  All professionals in and students of mental and behavioral health, including psychologists, psychiatric nurses, social workers, school counselors and police and fire department psychologists, are invited to attend.

The Summer Institute will include exciting programming on the latest developments in mental and behavioral health, presented by local and regional practitioners and leaders in the field.  An invitation and brief summary of the agenda for the Summer Institute are attached as PDFs below. Please continue to check the Events page for details and up-to-date information about the 2009 Summer Institute.

The registration form is also attached as a PDF.  If interested in attending the Summer Institute, please print the form, fill it out and mail it to the address listed.

Please feel free to direct any questions about the Summer Institute to the ScattergoodEthics Program or our Program Manager, Dr. Angelique Reitsma.

At a conference that the University of Pennsylvania held last May on the treatment of alcoholism sponsored by the ScattergoodEthics program an odd dilemma came into focus.  The dilemma makes it very clear why more attention has to be paid to ethics in the treatment of mental illness.

Many of the speakers pointed out that there was ample evidence that there are drugs that are effective in taking away the cravings to drink that promote relapse in alcohol dependent persons.  Naltrexone, which is sold under the trade names Depade and Revia and in an extended release version called Vivitrol, has been shown in many studies by many groups in the United States and other nations to be a very safe drug that is highly effective in treating alcoholism.  Yet, relatively few programs that treat chronic alcoholics use the drug.  Why?

In most situations where there are drugs to ‘treat’ diseases they don’t get used because they are difficult to take, have nasty side-effects, cost too much or simply don’t work very well.  Not so for Naltrexone.  It works, it is safe and it does not cost all that much.  A three-month supply runs about $750 which is peanuts compared to the price of in-patient drug addiction programs or other drugs routinely used to treat cancer, myasthenia gravis, Parkinson’s, or migraines.

How strong is the evidence for the efficacy and safety of Naltrexone?  There were two large-scale, randomized trials of Naltrexone that showed very impressive results in 1992.  Since that time many studies have been done which confirm its efficacy in reducing the frequency and severity of relapse to drinking.  In 1999 Dr. Robert M. Swift wrote at the conclusion of a major review article in the New England Journal of Medicine,

“Drug therapy should be considered for all patients in whom alcohol dependence is diagnosed who do not have medical contraindications to the use of the drug and who are willing to take it.  Of the several drugs studied for the treatment of alcohol dependence, the evidence of efficacy is strongest for naltrexone…” (Swift, Drug Therapy for Alcohol Dependence, NEJM, 1999:1488)

In 2006 the NIAAA of the NIH reported that,

“the medication naltrexone and up to 20 sessions of alcohol counseling by a behavioral specialist are equally effective treatments for alcohol dependence when delivered with structured medical management, according to results from "Combining Medications and Behavioral Interventions for Alcoholism" (The COMBINE Study). Results from the National Institutes of Health-supported study show that patients who received naltrexone, specialized alcohol counseling, or both demonstrated the best drinking outcomes after 16 weeks of outpatient treatment."

Naltrexone works just as well as intensive behavioral counseling in getting people to stop drinking or cut back on their drinking.  

So what is going on here?  After more than 15 year of evidence in leading journals a lot of people with alcohol problems are not being offered Naltrexone or other drugs.  Even if those professionals treating alcoholics don’t want to give up on counseling and social support why aren’t more providers prescribing Naltrexone, along with counseling, to help control the craving for alcohol?

The answer is ethics or, more particularly, ethical attitudes about drinking and what needs to be done to stop alcohol abuse.

For many decades the treatment of alcoholism in the United States has been built around the generation of sufficient will-power in the drinker to stay abstinent and sober—for a lifetime.  Alcoholics Anonymous and many other out-patient and in-patient treatment programs try to give the abusive drinker the tools of self-regard and self-control that will let them stop drinking.

There is nothing wrong with that approach, but it does not work for everyone.  Might some people do better with a combination of drug therapy along with counseling or social support for a time?  And if counseling or in-patient care are not options due to cost issues or access problems then shouldn’t Naltrexone be tried on its own when that is a possibility or the only possibility?

The only possible reason for the failure to make greater use of Naltrexone and other drugs useful in the treatment of alcoholism is moral.  Americans including American health care professionals often see alcohol abuse as an issue of willpower not biological addiction.  The cure for a lack of will is therapy that can stimulate and rebuild willpower—something not associated with drugs but with counseling along with community and peer support.

There may well be aspects of personal responsibility and willpower that shape the emergence of alcohol abuse for many or even the majority of those who abuse.  But, it is not ethical to adhere to the view that efficacious drug therapy cannot be utilized as part of treatment because drug therapy is seen as either antithetical to self-control or because it is seen as some sort of ‘short cut’.

There are some ethicists who hold the view that only authentic or earned experiences are legitimate (Kass, 2002; President’s Council 2003).  If you don’t suffer and sweat then you have not earned your right to abstinence.  Or perhaps if you don’t suffer and sweat then your abstinence will not endure.  These arguments are not persuasive and may actually be doing grave harm in the treatment of alcohol abuse.

There is no evidence that the efficacy of Naltrexone is less than that of counseling and peer support based interventions.  Nor is there any evidence that both cannot be combined successfully.  And there is no basis at all for the claim that somehow using a drug as therapy makes the result any less legitimate than any other form of treatment.  To hold this view is to argue that only those who survive the flu or HIV or polio through natural immunity deserve to live while those who take vaccines or drugs are somehow ‘cheating’.

Some of those who favor the greater use of Naltrexone and other drugs in the treatment of alcohol abuse tend to believe that if they provide the evidence of safety and efficacy then changes in treatment will follow.  But, after more than fifteen years of compiling evidence that change has not happened.  If it is to happen, if drug therapy is to play a greater role in the treatment of alcohol and other addictions in the future then it only will be a combination of scientific evidence and ethical argument that permit this to happen.

Further reading

CP O'Brien.  Prospects for a Genomic Approach to the Treatment
of Alcoholism.   Arch Gen Psychiatry, February 1, 2008;
65(2): 132-3.

L. Kass.  Life Liberty and the Defense of Dignity.  San Francisco,
Encounter Books: 2002.

RF Anton.  Naltrexone for the management of alcohol dependence. NEJM, 359,7, 2008: 715-21

RM Swift.  Drug therapy for alcohol dependence.  NEJM, 340, 1999: 1482-90.

SH Williams.  Medications for treating alcohol dependence. American Family Physician.  72, 9, 2005: 1775-80

The President's Council on Bioethics Beyond Therapy: Biotechnology and the Pursuit of Happiness. Washington, D.C., October 2003 http://www.bioethics.gov/reports/beyondtherapy/

Dr. Caplan is the Emanuel and Robert Hart Professor of Bioethics and Director of the Center for Bioethics at the University of Pennsylvania. He is also the Primary Investigator of the ScattergoodEthics Program and has contributed to the Commentary before.  For more information about the conference on treatments for alcoholism hosted at the University of Pennsylvania last spring, please click here.

Following the success of 2007’s “Addiction” project, The Alzheimer’s Project will premiere tomorrow night on HBO.  The project will include a documentary series, supplemental films, a companion book published by Public Affairs Books and a website to serve as a central resource for information about this debilitating disease.  HBO will use all of its channels and other media platforms to support its national, community-based information campaign.

Alzheimer’s Disease, a fatal condition characterized by the irreversible loss of memory and cognitive function, affects nearly five million Americans.  Those numbers will likely grow as the baby-boomers age, since age is the single greatest risk factor for developing the disease.  There is currently no cure, but scientists, researchers and healthcare providers are working toward developing new treatments and preventive measures.  The Alzheimer’s Project will investigate the medical aspects of Alzheimer’s Disease, in addition to the personal experience of the illness, through such films as “Momentum in Science” and “Grandpa, Do You Know Who I Am?”

The Alzheimer’s Project is a collaboration between HBO Documentary Films and the National Institute on Aging at the National Institutes of Health.  For more information about the series, please see The Alzheimer's Project website or read the New York Times’ previews here and here.

Since publishing The Lily Pond: A Memoir of Madness, Memory, Myth and Metamorphosis in the fall of 2008, Mike Barnes has given a number of presentations on mental health, treatment and recovery.  Several of these talks are available free for the public on his blog here.

According the Mr. Barnes, the talks, like the book, "explore the vast subject of mental illness from many perspectives including treatment and hospitalization; childhood and family experiences; psychotherapy and caregiving."  Professionals, educators and researchers in mental health or individuals with a personal interest in mental health issues may find the talks of particular value.

Additional information about The Lily Pond is also available on his blog at this link.

The International Journal of Feminist Approaches to Bioethics will publish a special issue devoted to topics in psychiatry and feminist ethics.  The guest editors of the issue will be Jennifer Hansen, Nancy Potter and Jennifer Radden, ScattergoodEthics' Visiting Scholar of 2009.  Details about the publication, including information about submitting articles for the issue, have been provided by the editors below.

Vol. 4, No. 1: IJFAB Special Issue: Feminist Perspectives on Ethics in Psychiatry

Guest Editors: Jennifer Hansen, Nancy Potter and Jennifer Radden

In the last 10-12 years, bioethicists and scholars working in the intersection of philosophy and psychiatry have turned their attention to the unique ethical questions that emerge out of the practice of psychiatry. A brief perusal of bioethics journals yield quite a number of essays dedicated to applied ethics questions in psychiatry, grappling with the unique problems of patient competency, informed consent, and paternalism that arise when dealing with psychotic or dementia patients.

Research has focused on “gendered” diagnostic categories as well, and on prevalence rates showing gender patterns. From clinical portraits of personality traits such as borderline and multiple personality disorder or anti-social behavior, other theorists have reasoned that we need to radically rethink our intuitions about personhood. Finally, the explosion of activity in neuroscience has precipitated with it the new field of ‘neuroethics,’ wherein ethicists contemplate the social and ethical consequences of technological innovations such as brain imaging and psychotropic drugs.

Central to the focus of this issue is the question: how do feminist psychiatric ethics differ from mainstream psychiatric ethics? Part of the answer to this question involves making explicit the commitments and challenges that feminist analyses pose to mainstream psychiatric practice. For example, what sort of power differentials play out in the doctor-patient relationship?; what sexist (classist and racist) assumptions play out in psychiatric diagnoses as well as more fundamentally in psychiatric nosology?; how equal is access among women of color and of working class women to mental health services?; and how do ethnocentric assumptions underpin the medical model and thereby fail many

non-Western communities?: The primary concern of feminist analyses also fundamentally implicates the intersection of race, class, gender and sexuality in the access to and delivery of mental health services.

Possible topics for this volume include:

• The degree that classification and conceptualization of mental illnesses in psychiatry challenge or reaffirm pervasive gender binaries, (e.g., the characterization of Gender Identity Disorder as involving discordant sexual and gender traits)

• Historical and cultural tropes and associations that align women and the feminine with disorder and deficiency

•   How oppressive conditions, including social roles and expectations, shape explanations of certain disorders such as depression

• Sexual exploitation by male practitioners of female patients

• Postmodernist challenges to gender informing feminist therapeutic treatment for disorders such as Borderline Personality Disorder

• Possible social correlates, such as the rise in single mother managed households with the rise in the medicalization of children

• Explorations about why unequal access to mental health care disproportionately affects women of color and immigrant communities

• Analyses of why evidence suggests middle class and upper middle class women are over diagnosed, while working class women and women of color are under treated

• The social consequences of failing to take account of the gendered and racialized aspects of mental illness

Deadline for Submission : March 1, 2010

For more information, please contact Jennifer Hansen: jhansen@gettysburg.edu

For general information about the IJFAB, please click here.

The Scattergood Program for The Applied Ethics of Behavioral Health is proud to introduce its new Program Manager. On April 1st, 2009, physician-bioethicist Dr. Angelique Reitsma from the University of Pennsylvania Center for Bioethics stepped into this position. Dr. Reitsma has been an Associate Fellow at the University of Pennsylvania’s Center for Bioethics for over three and a half years.

Dr. Reitsma is a bioethicist who first came to the Center as a Visiting Scholar, teaching a course on International Perspectives in Bioethics to the Master of Bioethics students. She stayed on as an Associate Fellow and Lecturer, teaching in the Department of History and Sociology of Science and serving as guest faculty in other courses, including several in the School of Medicine. During her tenure at Penn, she continued to work with mentor and colleague Jonathan Moreno on several research projects, on topics including national security and neuroethics, and the ethical issues generated by new resuscitation techniques for cardiac arrest victims.

Before she came to Penn, Dr. Reitsma was at the University of Virginia, where she obtained her Master’s Degree in Biomedical Ethics. During and after her graduate studies, she worked at UVa’s Center for Biomedical Ethics as a Research Associate (with Dr. Jonathan Moreno, renowned bioethicist). Together with Dr. Moreno, she obtained a grant for a two-year multi-disciplinary project to develop ethical guidelines for innovative surgery, which resulted in multiple publications, including a website and a book (2006). She also collaborated on a program designed to develop ethical guidelines for safe practice management of HIV- and Hepatitis-infected physicians who perform invasive procedures.

In 2006 Dr. Reitsma served as a member of a centralized IRB in Columbia, Maryland, which gave her insight into the workings of commercial human subjects research review. She currently serves as the Chair for a Data Safety Monitoring Board (DSMB) charged with periodically assessing the safety and efficacy of a device studied in an FDA-sponsored clinical trial.

Dr. Angelique Reitsma was trained as a physician in her native Netherlands, where she was also involved in teaching bioethics to medical students at Utrecht University, her alma mater. After she completed her medical training, she came to the United States where she obtained her U.S. medical degree as well. She has ample experience with and is widely published in bioethics, specifically medical professionalism, surgical research ethics, human subjects research, animal experimentation, and international bioethics.

Well-versed in policy development and with organizing and managing major multi-disciplinary research collaboratives, including conference organization and book editing, Dr. Reitsma is looking forward to applying her previous experiences to her new position as Program Manager of the ScattergoodEthics Program.  She aims to lead the program to the next level, bringing it to the forefront of the field of applied ethics in behavioral health .

As a mother of two children attending a Quaker school and a regular attendee of the Sunday meetings, she is striving to manage the program in the spirit of Thomas Scattergood to the best of her ability.  Please join us in wishing Dr. Angelique Reitsma a successful and fruitful tenure as our new Program Manager!

Bloomberg News reported yesterday on a recent development in the ongoing dialogue about the relationships between pharmaceutical companies and healthcare providers.  Senator Charles Grassley (R) of Iowa has begun investigating the National Alliance for Mental Illness, a nonprofit, grassroots mental health organization, for potentially unethical financial ties to drug companies.  The Senator contends such ties could undermine the credibility of the organization as an independent, academic advocacy group.

Senator Grassley's efforts to minimize conflicts on interest in the healthcare industry have already led pharmaceutical companies, academic institutions and private practitioners to change some of their practices.  As Bloomberg News notes, for example, the American Psychiatric Association has  decided to decline financial backing from the pharmaceutical industry for its annual conferences and many academic institutions have begun disclosing their researchers' financial ties.

For more information about the investigation, please see the Bloomberg News article here.

Parents face an ethical dilemma when their children are diagnosed with attention deficit/hyperactivity disorders (ADHD). On the one hand medications may help calm and focus children whose conditions interfere with acquiring basic reading, math and social skills. On the other hand, stimulant medications come with health risks. Growth can be stunted.  Children with undiagnosed co-morbid mood disorders who take stimulants can become agitated and manic, so much so that they are prescribed antidepressants, anticonvulsants and antipsychotics with more worrisome side-effect profiles than stimulants.

Decision-making has recently gotten tougher. A recent study failed to show long-term benefits flowing from medicating children with stimulants such as Ritalin, Concerta, and Adderall. The latest data from the National Institute of Mental Health Multimodal Treatment Study of Children with ADHD (MTA) published in the March 2009 Journal of the American Academy of Child and Adolescent Psychiatry, demonstrate no long-term benefits after eight years to medication or medication combined with behavioral therapy over therapy or community care.  The measurable value of medication seemed to drop off after 24 months in study children.

The MTA was a longitudinal study of 579 children diagnosed with ADHD, conducted by an interdisciplinary team of researchers.  The MTA released initial study results in 1999: to wit, children diagnosed with ADHD did better with medication or with medication combined with behavioral therapy, than with therapy and/or community care alone. Psychiatrists who medicated children in reliance on the MTA may be confronted with patients who still carry the diagnosis of ADHD based on DSM-IV criteria and who are still more likely than typical teens to fall prey to substance abuse (17.4 percent versus 7.8 percent) and delinquency (27.1 percent versus  7.4 percent).

Stimulants were never marketed as a cure for ADHD, but some parents have believed their children would be better off in the long run from an early childhood medication intervention.  It is theoretically possible that medication has long-term advantages for important subsets of ADHD diagnosed children.  I have spoken to high-achieving university students who believe Adderall has persistently helped them achieve the “A” grades.

Parents should seek expert advice on behalf of their children. But because long-term benefits of ADHD drugs have yet to be systematically demonstrated, parents must take it upon themselves to carefully reassess the risks of giving their children medications.

First, parents should always attempt to discern whether medications prescribed for their children have been tested in children, and whether any major studies support the conclusion that drugs tested on adults are also safe and efficacious for children. Second, parents should attempt to ferret out clinicians’ and researchers’ biases   Parents and their advocates should be aware that researchers may knowingly or unknowingly downplay evidence that medications do or not work.  Third, although parents appropriately search for solutions and hope, they should avoid placing too much faith in the early results of a longitudinal study.

Finally, and sadly, parents should keep in mind that the world of pediatric psychiatry has been scandalized by allegations of conflicts of interest.  Harvard University’s Dr. Joseph Biederman’s research purports to show that aggressive intervention in children diagnosed with ADHD can prevent later substance abuse.  But Beiderman has been under fire since February of this year for promising Johnson and Johnson in advance that his research would establish the efficacy of their antipsychotic preparation Risperadal in children with mood disorders. Also this year, federal authorities began investigating Dr. Beiderman for allegedly unlawfully concealing conflicts of interest---accepting $1.6 million in undisclosed drug company payments.

More and more children are being diagnosed with ADHD, as the market for stimulant and non-stimulant ADHD drugs approaches the $3 billion dollar mark.  Parents previously committed to medication interventions would ideally reassess in light of the MTA ADHD study results. The solid evidence needed to firmly support a parental decision to risk stimulants has not been found. Perhaps the right thing for parents to do is not to medicate at all.  Yet ADHD symptoms can include severe prolonged tantrums, aggression, dangerous well-meaning impulsivity and school failure.  In severe cases like these, parents may feel they have no choice but to medicate and deal with the consequences that stem from medical decisions that seem to offer disregulated children a chance at a normal life.

Dr. Allen is Henry. R. Silverman Professor of Law and Professor of Philosophy at the University of Pennsylvania Law School.  She is an expert on privacy law, bioethics, and contemporary values, and is recognized for her scholarship about legal philosophy, women’s rights, and race relations.