“We used the Vision of Hope films to generate the content of curricula and spark discussions that are integral to pediatric palliative care training sessions for clinicians working with patients and families affected by chronic, life-limiting conditions,” says Gail Geller, ScD., MHS, who co-directed the Vision of Hope project with Cynda Rushton, Ph.D., R.N.  Both are core faculty members of the Berman Institute.

Living With Sickle Cell Disease: They Don’t Believe Me won the Houston festival’s Platinum Remi Award in the Medical/Health/Fitness/Wellness category.  Like all the short films in the Vision of Hope series, it is aimed at improving the quality of care and giving new hope to adolescents, young adults and families affected by chronic, life-threatening diseases by training their clinicians in the principles and practices of pediatric palliative care.

The film was produced in collaboration with Carlton Haywood, Jr., Ph.D., M.A., and Mary Catherine Beach, M.D., M.P.H., core faculty members of the Berman Institute and research experts on the ethical issues surrounding Sickle Cell Disease treatment.  The film was also received a CINE Golden Eagle Award in 2011.

“Living with the pain and other serious medical complications of Sickle Cell Disease becomes even more frustrating and emotionally painful when healthcare providers don’t believe the patient’s reports of their pain experience,” says Haywood.  “This film sheds light on the impact of these added burdens on patients, and I think the awards it’s won highlight just how powerful and moving it is to hear about these experiences from the patients themselves.  We hope to use these patient voices as tools to enact lasting changes in the quality of the care delivered to people suffering from Sickle Cell Disease.”

Another of the Vision of Hope films, Living With Duchenne Muscular Dystrophy: Many Faces of Hope, was also honored by a CINE Golden Eagle, as well as a Gold Remi Award in Houston. A third film in the series, Living With Duchenne Muscular Dystrophy: An Uncertain Future, was honored by a Bronze Remi Award at the Houston festival and a Bronze Telly Award in 2011.

“What makes these palliative care training programs innovative is that they are experiential, interdisciplinary and relational,” Geller explains.  “Relational learning expands the notion of professional competence to encompass the moral realm of human relationships and experience.  The Vision of Hope videos provide a means to integrate the voices and experiences of patients and families throughout all aspects of the training,” Geller says.

The Vision of Hope documentaries were directed by Nigel Noble of Magic Lantern Media. For more information on the films and curricula, contact Gail Geller (ggeller@jhu.edu) or Cynda Rushton (crushton@son.jhu.edu ).

BI faculty members Nancy Kass, Sc.D., Jeremy Sugarman, M.D., M.P.H., and Holly Taylor, Ph.D., M.P.H., will lead the working group, which will bring together a broad array of investigators from across the university to collaborate on the bioethical and human rights issues of HIV and AIDS research and treatment.

In addition to this working group, the Center will have other transdisciplinary groups or “cores,” including one to address Baltimore’s HIV epidemic; Johns Hopkins University President Ronald Daniels has made investment and engagement in the Baltimore community a priority, saying in his installation address, “We are an island of earned privilege in a sea of pressing need.”

Other groups will focused on Viral Eradication, Substance Abuse, international research and training the next generation of AIDS researchers and biostatisticians, particularly underrepresented minority investigators.  Read more at the Johns Hopkins Bloomberg School of Public Health.

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One of the key recommendations made by the report, Ethical and Scientific Issues in Studying the Safety of Approved Drugs, is that upon approval, each drug have a single, comprehensive, publicly available Benefit and Risk Assessment and Management Plan (BRAMP) to serve as a central, updateable repository of side effects and other information.

“A drug’s full range of risks and benefits become apparent after it is used widely over time, and so it is crucial that the FDA continue to monitor drugs throughout their market life-cycle with a systematic and transparent process,” says committee co-chair Ruth Faden, Ph.D., MPH, director of the Johns Hopkins Berman Institute of Bioethics.

According to the committee, the BRAMP should include a description and benefit – risk assessment of any safety questions that exist when a drug is approved, as well as any that emerge over the course of its market life-cycle, with details on any regulatory actions taken and their results.

The FDA—which asked the IOM to “convene a committee to evaluate the scientific and ethical issues involved in conducting studies of the safety of approved drugs”—already collects much of the suggested information, but the data are scattered across multiple records rather than amassed in one central location. “Decentralized records make it difficult for physicians, policy makers and consumers to easily assess information about risks and benefits that accrue over time,” Faden notes.

The committee recommends postmarket studies when:

• A regulatory decision cannot be made based on existing safety evidence
• The research can be designed and implemented to sufficiently reduce uncertainties about the benefit-risk balance and help inform a regulatory decision
• The results of the research will be used to make a decision in a timely fashion
• The rights and interests of the research participants can be adequately protected

Another key recommendation in the report addresses the significant ethical issues posed by postmarket monitoring. The committee recommends that the FDA establish a new body to provide advice on the ethical challenges that required observational studies and surveillance activities pose.

The report also makes recommendations about how postmarket research should be conducted. The committee found that while randomized controlled trials remain the gold standard for studying drug effectiveness, observational studies have ethical and practical benefits over clinical trials once drugs are on the market. Results can be obtained more quickly, and thus regulatory action can be taken earlier.

The committee’s recommendations build on the FDA’s increased authority through the 2007 Food and Drug Administration Amendments Act to monitor drugs after approval and to act if there are signals of safety issues, Faden notes.

“Our report focuses on how the agency can be proactive, so that when a drug’s risk outweighs its benefit, the FDA will know earlier and respond quickly, while honoring its ethical obligations to protect both public health and research participants,” says Faden.

###

Contact: Leah Ramsay
lramsay@jhu.edu
202-642-9640
Johns Hopkins Medical Institutions

A professor with the Berman Institute and the Johns Hopkins Bloomberg School of Public Health since August 2011, Kahn previously was Director and Professor in the Center for Bioethics at the University of Minnesota, positions he held from 1996-2011.He serves on numerous state and federal advisory panels, including his role as chair of an Institute of Medicine committee that issued a recent, groundbreaking report calling for an end to most biomedical research on chimpanzees, which was immediately adopted by the National Institutes of Health upon its release. Kahn is also an elected Fellow of the Hastings Center and was founding president of the Association of Bioethics Program Directors, a position he held from 2006-2010.

Robert Henry Levi and Ryda Hecht Levi were great supporters of Johns Hopkins University, Baltimore City, and the arts. The Robert. H. Levi Leadership Program in Bioethics and Health Policy was established in 1997.

The endowed professorship traces a long history of royal and private support for academia, including the famous privately endowed Lucasian Chair of Mathematics at Cambridge University, bestowed on Issac Newton in 1669, and later on Professor Stephen Hawking. The endowment of the Levi professorship will ensure the Berman Institute of Bioethics will always be home to a leading mind in the field of bioethics and public policy.

via National Academies Office of News and Public Information

FOR IMMEDIATE RELEASE

Creation of a Central Management Plan for Every New Drug Needed to Strengthen FDA’s Oversight of Approved Drugs’ Safety

WASHINGTON — Although the approval of a new drug is based on evidence that its benefits outweigh its risks, the full range of a medication’s effects may not become apparent until a product has been used by a larger, more diverse population over an extended period of time.  Problems associated with the anti-diabetes drug Avandia, pain reliever Vioxx, and cholesterol-reducing drug Crestor illustrate the challenges and underscore the need for a more systematic and transparent process to collect, assess, and act on data about a medication’s benefit-risk profile throughout its entire “life cycle” from approval until it is no longer marketed, says a new report by the Institute of Medicine.

According to recent estimates, nearly half of all Americans take at least one prescription drug daily and many older people use five or more, noted the committee that wrote the report.  The report’s recommendations build on the new authorities and tools provided to the U.S. Food and Drug Administration through the Food and Drug Administration Amendments Act of 2007, which increased the agency’s capacity to monitor drugs after approval and act if signs of safety problems appear.

One of the committee’s key recommendations is that FDA should create a benefit and risk assessment and management plan for each drug.  This would be a single, comprehensive, publicly available document that serves as a central repository of information for each product from its approval throughout its entire time on the market.  The document should include a description of any safety questions that exist when a drug is approved or that emerge over the course of the product’s use, as well as benefit and risk assessments specific to these questions.  It should also include details on regulatory actions taken on the medication, such as restrictions on its use or the decision to require further research, as well as the results of these actions.  Much of this information is already being gathered by FDA, but it is currently scattered across multiple records.  Putting the information into an accessible format in a single document would make FDA’s commitment to the life-cycle approach concrete and improve its transparency by giving the public easier access to useful data.

There are too many individual factors involved in each case and too great a variety of drugs to provide a single universal set of criteria for determining what should trigger a postmarket study, the committee concluded.  However, it identified some circumstances in which a product’s benefits or risks are particularly uncertain, including “first in class” drugs that have been approved based on surrogate endpoints used previously for other drug classes, and drugs for which several endpoints provide conflicting evidence about risk, such as an anti-hypertensive drug that lowers blood pressure but increases weight.  In such cases, the committee recommended that FDA require safety research after approval or provide a public rationale for why it is not necessary.  Early initiation of such studies could limit the harm done by drugs with risks that are later found to be unacceptable and avoid crises in which the agency is faced with few good options, the committee said.

When deciding whether to require manufacturers to conduct postmarket studies, FDA must balance its ethical obligations to protect the public’s health and to protect research participants.  The agency should require postmarket research only if a regulatory decision cannot be made based on existing safety evidence; the research can sufficiently reduce uncertainties about the benefit-risk balance to help inform a regulatory decision; the results will be used to make a decision in a timely fashion; and the rights and interests of the research participants can be adequately protected.

FDA should ensure that the postmarket studies it requires are conducted in ways that are ethically and scientifically sound.  Continuing advances in electronic health record systems and analytic techniques likely will mean that observational approaches using large data sets will become more important over time, and these approaches could create new ethical challenges, the committee noted.  The agency should seek additional guidance to assure the public that postmarket research and surveillance are being properly overseen, the committee said.

“It is not possible to know what the full range of a drug’s benefits and risks will be until it is used by many different kinds of patients over time, so it is critical that FDA continue to monitor and learn about the effects of drugs after they are marketed,” said committee co-chair Ruth Faden, Philip Franklin Wagley Professor of Biomedical Ethics and executive director, Berman Institute of Bioethics, Johns Hopkins University, Baltimore.  “Our report focuses on how the agency can be proactive so that situations in which a drug’s benefit-risk profile becomes problematic can be detected earlier, and it details how FDA can get the additional information on a drug’s safety in the most ethical and scientifically sound ways when questions arise.”

“We believe that the adoption of a life-cycle approach to drug approval and monitoring will help the agency strengthen its oversight, better tackle these complex decisions, and increase public confidence in the agency’s ability to protect public health,” said co-chair Steven N. Goodman, professor of medicine, health research, and policy, and associate dean for clinical and translational research, Stanford University School of Medicine, Stanford, Calif.  “This will become increasingly important as FDA looks for ways to safely expedite the drug approval process.”

The report was sponsored by the U.S. Food and Drug Administration.  Established in 1970 under the charter of the National Academy of Sciences, the Institute of Medicine provides objective, evidence-based advice to policymakers, health professionals, the private sector, and the public.  The Institute of Medicine, National Academy of Sciences, National Academy of Engineering, and National Research Council together make up the independent, nonprofit National Academies.  For more information, visit http://national-academies.org or http://iom.edu.   A committee roster follows.

Additional Resources:

Report in Brief

Full Report

Project Website

Contacts:

Christine Stencel, Senior Media Relations Officer

Luwam Yeibio, Media Relations Assistant

Office of News and Public Information

202-334-2138; e-mail news@nas.edu

_____________________________________________________________________________

Copies of Ethical and Scientific Issues in Studying the Safety of Approved Drugs are available from the National Academies Press; tel. 202-334-3313 or 1-800-624-6242 or on the Internet at http://www.nap.edu.  Additional information is available at http://www.iom.edu/drugsafetyethics. Reporters may obtain a copy from the Office of News and Public Information (contacts listed above).

#       #       #

INSTITUTE OF MEDICINE

Board on Population Health and Public Health Practice

Committee on Ethical and Scientific Issues in Studying the Safety of Approved Drugs

Ruth R. Faden, Ph.D., M.P.H. (co-chair)

Philip Franklin Wagley Professor of Biomedical Ethics, and

Executive Director

Berman Institute of Bioethics

Johns Hopkins University

Baltimore

Steven N. Goodman, Ph.D., M.D. (co-chair)

Associate Dean

Clinical and Translational Research

School of Medicine

Stanford University

Stanford, Calif.

Alasdair Breckenridge, M.D., F.R.C.P.

Chairman

Medicines and Healthcare Product Regulatory Agency

London, United Kingdom

Lisa Egbuonu-Davis, M.D., M.P.H., M.B.A.

Executive Adviser

Booz Allen Hamilton

Rockville, Md.

Miguel Hernan, M.D., Dr.P.H., Sc.M., M.P.H.

Professor of Epidemiology

School of Public Health

Harvard University

Boston

Grace M. Lee, M.D., M.P.H.

Associate Professor of Population Medicine and Pediatrics

Harvard Pilgrim Health Care Institute

Harvard Medical School and Children’s Hospital Boston

Boston

Michelle Mello, J.D., Ph.D.

Professor of Law and Public Health

Department of Health Policy and Management

Harvard University

Boston

Eric Meslin, Ph.D.

Director

Center for Bioethics, and

Associate Dean for Bioethics

School of Medicine

Indiana University

Indianapolis

Larry I. Palmer, L.L.B.

Professor of Law

College of William and Mary Law School (retired), and

Professor

Department of Health Administration

Virginia Commonwealth University

Richmond

Bruce M. Psaty, M.D., Ph.D.

Professor of Medicine, Epidemiology, and Health Services;

Co-director

Cardiovascular Health Research Unit

School of Medicine

University of Washington; and

Investigator

Group Health Research Institute

Seattle

Tom Tenhave, Ph.D., M.P.H. (deceased)

Professor of Biostatistics

Perelman School of Medicine

University of Pennsylvania

Philadelphia

William Vaughan

Health Policy Analyst

Consumers Union (retired)

Falls Church, Va.

STAFF

Michelle Catlin, Ph.D.

Study Director

From the Provost’s Project on Innovation: An Interview with Jeremy Sugarman, Berman Institute Deputy Director for Medicine, Harvey M Meyerhoff Professor of Bioethics and Medicine.

One common experience among innovators is that sooner or later, they find themselves bumping up against the rules.

For Jeremy Sugarman, it happened early.

Bored in high school but fascinated by the practice of medicine, he trained to become an emergency medical technician (known as an EMT), noting with surprise that his young age was not necessarily a handicap. At 18 he was eagerly embracing the challenges of providing urgent medical care. He recalls vividly the night he went to a woman’s house in response to a distress call. “I went into the house and looked to the left. There was blood on the stairway and blood in the sink. A woman in a nightgown was shouting, “He’s in the back. He’s in the back!” I went back to the bedroom; there was a night table full of medicine bottles, a man lying in the bed, and there was lots of blood on the sheets. I touched him and he was cold—one of the first dead people I’d ever seen. So I called out to the ambulance and said, “Go slow,” because I knew at that point that there was no one to resuscitate.”

Sugarman knew that the role of the EMT—to bring acutely ill patients safely to the hospital emergency department—no longer applied. But what should they do? What was the right thing to do in this situation? The rules dictated that they leave the dead man there in the house alone with his wife. They decided in the end to break the rules, place oxygen on the deceased man, and transport him as a patient to the hospital, never telling the woman that her husband had passed away. In retrospect, Sugarman, M.D., M.P.H., who is now the Harvey M. Meyerhoff Professor of Bioethics and Medicine, is convinced that he made the right decision, an opinion that luckily was seconded when his team arrived at the emergency room with a dead body. “When we got to the emergency room, I apologized to the emergency room physician. ‘We’re sorry about this, but he was there at home. His wife was alone and clearly thought there was something to be done. We weren’t sure what we should do.’ And he said, ‘You did the right thing. I’m used to telling people about this and I can do it as well as it can be done. So thank you for taking care of him and her.’”

All these years later, Sugarman still thinks about the experience. Although they didn’t obey protocol and broke the rules, he observes that with regard to their specific role in that situation, they were poorly equipped to discuss the death of the husband with his wife, something that the hospital staff was much better prepared to do. Even for a high school student, it seemed plainly wrong to just leave a dead man there alone with his wife in the wee hours of the morning. From experiences like this, Sugarman learned at an early age that determining right from wrong in a medical setting is rarely simple or straightforward. The rules will take you only so far. Sometimes going against what you are “supposed to do” is in fact the best option.

As a college student, Sugarman searched for whatever material he could find in bioethics, a field that was still in its infancy at the time. He was stunned by the fact that what little communication about bioethics he could find was frankly so dull. That discovery was driven home in 1982 when, during college, he helped raise $10,000 to host a three-day, university-wide symposium on bioethics at Duke, which attracted tremendous campus interest and brought to Durham some of the foremost thinkers in the field. “I was struck by a couple of things,” he recalls of the experience. “First, that bioethics was of interest to most people across the university. And second, how stunningly boring some of these great scholars were when they spoke to the group. I remember thinking, “These issues cannot be this uninteresting, yet people can make it this boring.’” He knew he had to do something better.

Sugarman decided to pursue this line of questioning despite a general lack of understanding as well as outright disapproval from most of his advisors. He nonetheless prevailed and continued to develop the field of study during medical school, where the issues seemed increasingly pressing and relevant. “When there are multiple options, what is the appropriate course?” he wondered. “How can you best do medicine or engage in science in an appropriate fashion? I thought that clearly these were tough questions that somebody should know how to answer; somebody should know how to figure these out.”

During medical school, Sugarman arranged to learn about not just medicine but also literature, medical history, and philosophy—the “queen of the sciences” as he likes to refer to it. He later earned master’s degrees in philosophy and public health, so that he could internalize the language and approaches utilized by ethicists and health care experts as he tried to unite the fields. In doing so, he began to develop a model of how to approach ethical decision making in the arena of health care and medical science, a model that he expanded over the ensuing years as he became one of the preeminent bioethicists in the world.

Sugarman’s innovative new model was tested and refined in the course of several major controversies, during which he played a critical role in helping to delineate the ethical principles at stake. Two notable examples were the harvesting of umbilical cord blood as a potential source of stem cells and maternal-fetal surgery, in which surgeons attempted to repair spina bifida in utero to minimize the detrimental effects of having an open spinal cord. Each of these thorny problems was approached systematically, using an approach grounded in basic ethical principles, studied empirically to gather relevant facts, and then pragmatically applied to the health care setting in which they existed. It called for collaboration among all the primary groups involved in order to derive consensus opinions and statements, many of which were published as high-profile papers. One issue even prompted JAMA to request “more words” for an article on umbilical cord blood banking, a rarity that Sugarman still laughs about today.

Perhaps it is the natural and inescapable consequence of his training as a physician, but Sugarman emphasizes that it is essential to approach bioethics from a practical perspective. “An important goal of doing bioethics well is to put the brakes on only when the brakes really need to be put on,” he says. He is especially concerned that the brakes not be used as a way to hamper innovation but, instead, to protect innovation so that it can prosper safely and appropriately. “Good bioethics is associated with being involved with scientists who are comfortable exposing their science to ethical inquiry,” Sugarman states. “It’s going to happen sooner or later. We might as well get the ethics right from the beginning.”

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Writing in the journal’s new Viewpoint opinion section, the team supports many of the recently proposed changesto long-standing federal rules governing human subjects research that would allow research oversight to focus more on higher-risk research and streamline oversight for lower risk research. The team asserts, however, that much comparative effectiveness research is also of low-risk to patients and also should be subject to streamlined oversight. Indeed, the proposed regulatory changes ignore this growing and critically important category of low-risk clinical research that compares the effectiveness and safety of different treatments already approved by the U.S. Food and Drug Administration.

“The American public wants and needs to know which of different widely used medications is better for the medical problems they have,” says co-author Nancy Kass, Sc.D., Phoebe R. Berman Professor of Bioethics and Public Health at the Johns Hopkins Berman Institute of Bioethics. “Doing this type of comparative study poses little if any additional risk to the patients who take part compared to their getting usual medical care. We need to make sure the regulatory environment makes it straightforward for doctors, patients, and research institutions to want to do more of this kind of clinical research,” says Kass.

The failure of the proposed changes in human subjects protections, known as the “Common Rule,” to include clinical comparative effective research “serves to perpetuate the view that all clinical research…involves more than minimal risk,” the Viewpoint article states. Kass’ co-authors are Ruth Faden, Ph.D., M.P.H.,director of the Berman Institute, and Sean Tunis, MD, MSc, President and CEO of the Center for Medical Technology Policy, a non-profit organization that brings stakeholders together to identify key topics for comparative effectiveness research.

In July 2011, the Department of Health and Human Services (DHHS) issued an advance notice of proposed changes to the Common Rule and asked for comment on suggested ways to modernize regulations governing any use of human subjects in any kind of research. “This is the first significant proposed change to regulations governing human subjects research in 20 years, so it is crucial that the growing field of clinical comparative effectiveness research, which helps doctors and patients make better treatment choices, is addressed now as well,” says Kass.

The Viewpoint article says revising longstanding federal regulations to focus more on high-risk research and allowing more streamlined oversight for lower risk research ultimately will better provide patients the careful protection they need in that smaller body of science that poses higher risk. The absence of attention to clinical comparative effectiveness research (CCER) in thinking through how ethics oversight should be organized in the future, however, stands to put barriers in the way of these important studies. “Doctors and patients alike have voiced a need for more CCER studies that compare the relative safety and effectiveness of existing and widely used medical options for prevention, diagnosis or treatment,” Kass says.

The proposed rule changes currently exclude CCER, the authors say, despite the fact that “many prospective studies of comparative effectiveness are of a low-risk equivalent to that posed by many behavioral and social science research studies” using surveys, interviews and focus groups. Noting an increase in federal investment recently in comparative research of this sort, the authors agree that “significant advances in CCER will depend on reducing the intensity and burden of oversight.”

One example of the kind of CCER research that could be subject to streamlined review if changes to regulations included CCER, the authors say, would be a study in which patients treated for hypertension were asked at their regular clinical appointment to respond to a detailed set of questions about their lifestyle and how they think their medications are working.

“The timing of the reconsideration of the Common Rule with the rapid increase in investments in comparative effectiveness research highlights the importance of seizing this opportunity to advance the shared interests in ensuring that CCER evolves rapidly and ethically,” the authors state. “Crafting a framework that promotes an appropriate level of oversight for CCER studies that closely simulate routine clinical practice will be essential for the efficient generation of the real world evidence that patients and clinicians require.”

Media Contact: Leah Ramsay202.642.9640 lramsay@jhu.edu

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Addressing Low-Risk Comparative Effectiveness Research in Proposed Changes to US Federal Regulations Governing Research
JAMA. 2012; 307(15): 1589-1590. doi: 10.1001/jama.2012.491
Nancy Kass, ScD; Ruth Faden, PhD, MPH; Sean Tunis, MD, MSc

On July 25, 2011, the Department of Health and Human Services published an advance notice of proposed rule making, outlining potential changes to the federal regulations overseeing human subjects research.¹ These regulations, known since 1991 as “the Common Rule,” have been effective in ensuring that most human research in this country is reviewed prospectively by an institutional review board (IRB) charged with determining that risks of proposed research are minimized and acceptable and also ensuring that individual participants provide informed consent for most types of research before participation.

Some of the proposed changes suggested in the Advance Notice of Proposed Rulemaking (ANPRM) are designed to expand or deepen federal protections, whereas others are intended to reduce the oversight burden on investigators and IRBs for lower-risk research.² These proposed changes, however, do not suggest any specific regulatory changes that would affect comparative effectiveness research—specifically, the increasing body of work …

…Read More

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Lawyer and bioethicist Leslie Meltzer Henry will speak at Johns Hopkins University on the constitutionality of the individual mandate of the Patient Protection and Affordable Care Act, on the same day that the Supreme Court begins hearing oral arguments challenging the law.

Monday, March 26, the Supreme Court will begin hearing oral arguments in what has been called “probably the most important and pivotal case in health law in the last 50 years:” challenges to the Patient Protection and Affordable Care Act.  The law was the centerpiece of the Obama Administration’s legislative agenda and now may play a crucial role is his reelection campaign.

The Johns Hopkins Berman Institute of Bioethics will incorporate this historic case into a timely discussion in our regular Bioethics Seminar Series the same day, as associate faculty member Leslie Meltzer Henry , M.Sc., J.D., tackles a specific question: Is the individual mandate constitutional?

Professor Henry will introduce the audience to the legal issues the Court will be considering. In particular, it will focus on whether the individual mandate, which requires Americans to purchase health insurance or pay a tax, is constitutional.

The seminar will be held in  the Johns Hopkins Bloomberg School of Public Health, 615 N. Wolfe Street, Room W3008, Baltimore, MD 21205.  The seminar is open and free to all, and lunch will be provided.

an excerpt:

Five years ago, the parents of a profoundly intellectually disabled girl born in 1997, known only as Ashley, told the world about a controversial treatment they were using on their child. It included giving her hormones so that she would remain below normal height and weight, as well as surgery, which included a hysterectomy to remove her uterus and a bilateral breast-bud removal to prevent her breasts from developing. Ashley’s mental age was that of a three-month-old. She was unable to walk, talk, hold a toy or change her position in bed. Her parents were not sure she recognised them. There was no prospect of her mental condition ever improving.

The treatment was approved by the ethics committee at Seattle children’s hospital, where it was carried out. It begun when Ashley was six, and was made public when she was nine. The aim of the surgery was to keep Ashley small and light, so that her parents could continue to move her around frequently and take her with them when going out with their two other children. The uterus removal was intended to spare her the discomfort of menstrual cramps; the surgery to prevent the development of breasts aimed to make her more comfortable when she was lying down or had a strap across her chest in her wheelchair. Nevertheless, when it became public, many objected to it. Some said it was “unnatural”, others that it violated Ashley’s dignity, that it was not in her best interests, and that it could lead down a slippery slope of parents “modifying” their children for their own convenience.

Today, Ashley is 14. Her mental condition has not changed, but her size and weight have remained that of a nine-year-old. Her father remains convinced that he and his wife made the right decision for Ashley, and that the treatment made her more likely to be comfortable, healthy and happy. He describes her as “completely loved” and her life “as good aswe can possibly make it”. There seem to be no grounds for holding the opinion that the treatment was not in Ashley’s best interests.

SE Smith responds with a piece entitled “Is the Ashley treatment right? Ask yourself if disabled people are human“

an excerpt:

The so-called Ashley treatment, which Peter Singer wrote about in positive terms earlier today, is a profound violation of human rights and dignity. It reduces disabled children to objects requiring modifications for the convenience of their family members, rather than treating them as human beings with their own agency. News that the treatment is spreading in the wake of the publicity that has surrounded her case, despite opposition from disability rights activists, reveals telling attitudes about disability.

When a working group addressed the ethical issues surrounding the Ashley treatment in 2010, it’s striking they chose to focus on growth attenuation – the portion of Ashley’s procedures intended to keep her undersized for life. Most of the members of the group agreed that growth attenuation was “morally permissible” in certain circumstances, with tight monitoring from ethics committees. A few members argued against it, however, pointing out that growth attenuation is performed more for the convenience of caregivers than for the benefit of the patient.

A light patient is indeed easier to lift and assist with tasks of daily living. By the same token, however, in a framework where all people with disabilities are valued as human beings, there is no need to reduce their size and turn them into “pillow angels” for convenience. Parents who would have trouble with a larger child could benefit from paid caregivers to provide full or part-time assistance, for example. Spaces that are currently inaccessible could become more so with the use of simple measures, such as implementing wheelchair access paths.

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