BIOETHICISTS LEAD CALL FOR PUBLIC DEBATES ON FUTURE USES OF STEM CELLS
Science is running ahead of public debate and guidelines to grapple with use of stem cell-derived eggs and sperm.

“Because derived gamete research will require the creation and destruction of human embryos, this line of research will be morally objectionable to those who imbue human embryos with full moral status, and those objections must be addressed,” the authors state.

In their paper, the Hopkins-led team described an analysis of the current state of pluripotent stem cell science and suggested a framework for the debates that need to take place. There was consensus by the authors that policymakers should not restrict scientific inquiry solely because ethical or moral disagreement exists about the use of these cells. Instead, they offered recommendations for guidelines that would be the focus of social debate. Among them were that restrictions should be specific to those aspects of the technology that are deemed morally unacceptable in a given nation or state; and that specific consent should be required of tissue donors whose cells will be used to derive gametes for use in reproduction. This approach would rule out using for reproduction any tissue from fetuses, minors and the deceased. Consent, they said, need not be required in situations involving laboratory studies that produce no embryos.   

Assuming that reproductive use of stem cell-derived gametes does occur, the health of women carrying the resulting fetuses, and of children born to them, should be monitored rigorously and tracked in long-term studies.

 

Pluripotent stem cell-derived gamete research brings together several of today’s most contentious ethical issues, including the use of embryonic stem cells, the increasing ability to identify and understand risks associated with particular parts of the human genome, advanced reproductive technologies to treat infertility and interest in “human enhancement.”

Other authors of the paper are Peter J. Donovan of the University of California, Irvine; John Harris of the University of Manchester; Robin Lovell-Badge of the MRC National Institute for Medical Research; Julian Savulescu of the University of Oxford; and Ruth Faden, Director of the Johns Hopkins Berman Institute of Bioethics in Baltimore.

Regenberg AC, Hutchinson LA, Schanker B, Mathews DJH (2009) Medicine on the fringe: cell-based interventions in advance of evidence.  Stem Cells Express, published online May 21, 2009.

 

Stem cell-based interventions (SCBIs) offer great promise, however, there is currently little internationally-accepted, scientific evidence supporting the clinical use of SCBIs. The consensus within the scientific community is that a number of hurdles still need to be cleared. Despite this, SCBIs are currently being offered to patients. This paper provides a content analysis of materials obtained from SCBI providers. We find content that strains credulity, and almost no evidence of SCBIs being delivered in the context of clinical trials. We conclude that until scientific evidence is available, as a general rule, providers should only offer SCBIs in the context of controlled clinical trials. Clients should be aware that the risks and benefits of SCBIs are unknown, that their participation is unlikely to advance scientific knowledge, and they are likely to become ineligible to participate in future clinical trials of SCBIs. We recommend steps to promote patient education and enhance global oversight.

 

ABSTRACT

According to many researchers, it is inevitable and obvious that psychiatric illnesses are biological in nature, and that this is the rationale behind the numerous neuroimaging studies of individuals diagnosed with mental disorders. Scholars looking at the history of psychiatry have pointed out that in the past, the origins and motivations behind the search for biological causes, correlates, and cures for mental disorders are thoroughly social and historically rooted, particularly when the diagnostic category in question is the subject of controversy within psychiatry. This is obscured by neuroimaging studies that drive researchers to proclaim 'revolutions' in psychiatry, namely in the DSM. Providing neuroimaging evidence to support the contention that a condition is 'real' is likely to be extremely influential, as has been extensively discussed in the neuroethics literature. This type of evidence will also reinforce the pre-existing beliefs of those researchers or clinicians who are already expecting a biological description. The uncritical credence given to neuroimaging research is an ethical issue, not in its potential for contributing to misdiagnosis per se but because of the motivations that often drive this research. My claim is that this research should proceed with an awareness of presumptions and motivations underlying the field as a whole, in addition to an explicit focus on the past and potential future consequences of classification and diagnosis on the groups of individuals under study.

 

Introduction

Neuroimaging has been, and will continue to be, enormously influential in psychiatry. There are many critical examinations of neuroimaging, particularly focusing on the communication of neuroimaging findings to the public, and the need for more cautious and careful qualification of results in the midst of a great deal of excitement and hopes for the uses of this technology. ¹At the same time, research in psychiatry is evolving into a new stage, in which neuroscientific findings, including those from neuroimaging, are becoming incorporated in ways that are just now becoming possible by virtue of advances in technology. ²  There are a number of familiar issues at the intersection between psychiatry and neuroimaging research that are not unique to this area, but there are enough distinctive features to warrant its own separate consideration. To draw these features out, I will focus on cases in which neuroimaging evidence is being used in nosological debates about controversial diagnostic categories, where the ethical issues are particularly pronounced. I will also discuss certain historical issues in nosology that bear upon the current state of the field, particularly focusing on the Diagnostic and Statistical Manual of Mental Disorders (the DSM), with the overall goal of conceptually analyzing the ethical and epistemological value of neuroimaging in psychiatry.

 

I will be referring to biological psychiatry, by which I only mean to distinguish the increasingly prominent group within psychiatry who conceptualize mental disorders as brain diseases that originate from 'heredity, chemical imbalances, and metabolic irregularities'. ³  In addition, although I will at times discuss psychiatry in general in order to give a context, most of the ethical issues pertain to certain areas of psychiatry and a few specific purported disorders in particular: namely, those that are on the boundary between normal and abnormal, and are controversial both within the discipline itself and in mainstream culture. Although it is often argued that value-judgments are irreducibly a part of psychiatric classification, ⁴  and one would be hard pressed to dispute this in general, there is no agreement on which judgments should be considered valid, or even how to assess various types of evidence, specifically with respect to 'laboratory values or other etiological criteria'. ⁵  It may be that neuroimaging will contribute to discovering the etiology of psychiatric disorders. But my claim is that this research should proceed with attention to the past and potential future consequences of classification and diagnosis on the groups of individuals under study.

 

I will end by discussing the relevance of this discussion to patients. Briefly, what is not obvious in many neuroimaging studies is the fact that mere abnormality or deviation from the norm does not entail pathology. ⁶  By failing to acknowledge this essential point, many studies reinforce and perpetuate the medical model of mental illnesses, by declaring that, for example, ADHD brains that look different from 'normal' brains on a brain scan are in need of treatment. ⁷  Despite the fact that the 'normal' brain, particularly the functional, active brain, has yet to be characterized, ⁸  neuroimaging studies describe 'anomalous' patterns and structures, seemingly confirming the validity of the psychiatric disorder under investigation. I suggest that an understanding of the broader context in which neuroimaging is performed, particularly the unintended effects of a system like the DSM, would foster a robust view of ethical research in psychiatry.

 

Full Text:  HTML  ,  PDF

 

Correspondence to   Alison Boyce, Senior Research Project Coordinator, Johns Hopkins Berman Institute of Bioethics, 624 N. Broadway, Hampton House 349, Baltimore, MD 21205, p: 410-502-2312. Email: aboyce@jhsph.edu

 

Science communication receives significant attention from policy makers, research institutions, practitioners and scholars. It is a complex and contentious topic that encompasses a spectrum of issues from the factual dissemination of scientific research to new models of public engagement whereby lay persons are encouraged to participate in science debates and policy. 

 

Over the past several decades, the complexities of science communication have been magnified by institutional, social and technological change. Science increasingly is interdisciplinary, bureaucratic, global in scale, problem-based and dependent on private funding. This latter trend, in particular, raises issues of public trust in science, which studies have shown is diminished by researcher and institutional affiliation with the private sector, especially in the area of biomedicine.

 

Technology has also transformed the nature of the media system, creating an abundance of cable television, Internet and digital resources for the public to inform themselves about science and its social implications. With these new outlets, highly motivated individuals have a greater ability to learn about science and to become involved in collective decision-making⁵. Yet media fragmentation also means that if individuals lack an interest in science, they can very easily avoid science media altogether. There is a general concern that reduced quality of reporting by some media sources, primarily television and online, may have negative impacts, such as demands for inappropriately hyped medical services.

 

Full Article (Berman Institute's Gail Geller is a coauthor of this article.)

 

 In the target article,  Kon (2009)  classifies empirical research in bioethics into four hierarchical categories:  Lay of the Land, Ideal versus Reality, Improving Care, and  Changing Ethical Norms. This attempt is not the first to categorize this growing literature.

 

For example, in 1999, Hope described six ways that empirical research contributes to medical ethics, recognizing that philosophical arguments often depend on facts. First, are empirical research findings that identify new issues and perspectives. Second, are assessments of the effectiveness of different interventions. Third, are surveys regarding beliefs. Fourth, are data regarding different states of health. Fifth, are assessments of the costs of healthcare. Sixth, are examinations of actual decisions.

 

In 2001, in  Methods in Medical Ethics, Sulmasy and Sugarman described eight ways in which empirical research contributes to bioethics: 1) purely descriptive studies; 2) testing established or new norms; 3) descriptions of facts relevant to normative arguments; 4) slippery slope arguments; 5) assessing likely consequences; 6) the empirical testing of normative theories; 7) case reports; and 8) demonstration projects.

 

In 2005, Solomon identified ten relationships between empirical research and conceptual scholarship, which she lumped into three categories: 1) facilitating the move from ethical analysis to ethically justified behavior; 2) enhancing ethical analysis and justification; and 3) generating new ethical concerns. The first category includes documenting gaps between espoused ideals and actual practice; revealing the nature of individual moral reflection and level of personal skill at ethical analysis; describing the institutional and environmental context that mediates moral action; and providing data to stimulate individual and institutional moral accountability. The second includes testing consequentialist claims; validating, refuting, or modifying principles in light of their relevance to moral agents; and recognizing the relevance of otherwise neglected ethical principles. The third includes identifying and documenting new moral problems; more clearly specifying acknowledged problems; and clarifying causal mechanisms.

 

New York Times Op-ed, May 10, 2009 By Ruth Faden, Anne Drapkin Lyerly and Maggie Little   

 

When diseases like swine flu hit, pregnant women are especially at risk. And yet we know surprisingly little about how to treat them. In its guidelines for the antiviral drugs Tamiflu and Relenza, the Centers for Disease Control and Prevention says that pregnant women infected or at high risk for infection should take the recommended adult dosage: "Pregnancy should not be considered a contraindication" to taking the drugs, because the benefits of treatment "likely outweigh the theoretical risks of antiviral use." But we don’t know whether this is true. Concerns about the ethics of performing drug studies on pregnant women mean we know far less about how to treat them. It is perfectly possible that the standard adult dose of antivirals will not work in the pregnant body.... (continued)    

Baltimore Sun, Op-Ed

By Ruth Faden and Jonathan D. Moreno

May 1, 2009

It's a name only a policy wonk could love: comparative effectiveness research. But get ready to hear a lot about it; it could save your rights as a patient - and maybe even your life. If opponents have their way, it could be the bogeyman that brings down health care reform.  

Using false and misleading scare tactics, Conservatives for Patients Rights, a group opposed to comprehensive health care reform, announced last week a $1 million ad attacking comparative effectiveness.  

However, an emerging consensus of strange bedfellows - from insurance companies to the Institute of Medicine to patients rights advocates - all support making a national investment in research to compare the effectiveness of drugs, devices and diagnostic procedures, and sharing the information that results with physicians and patients. The enthusiasm for comparative effectiveness research is also strong in the Obama administration and among health care leaders in Congress.  

Comparative effectiveness research could have a profound, positive effect on how medical decisions are made. Currently, there are three main drivers in medical decision-making: advertising and promotion by drug and device companies; coverage decisions by insurance companies; and medical science and experience. The first two, as we all know, can work against the interests of patients. They are supposed to be balanced by the third driver - medical science and experience. The problem is that, for many important medical decisions, there is no medical evidence about which treatments or which diagnostic tests work best for which patients.  

In those cases, because doctors and patients lack objective facts about what's best, they often can't challenge the other two powerful forces.  

For instance, what kinds of patients with low back pain require back surgery and which recover with physical therapy alone? Which of the many drugs for high cholesterol or osteoporosis are best for whom? Definite answers to these questions could make a huge difference in peoples' lives. For example, a recent comparative effectiveness study found that patients with multi-vessel coronary artery disease who had stents implanted did much better with blood flow tests and angiography than with angiography alone.  

Comparative effectiveness would allow patients and doctors to make decisions together based on the best possible scientific evidence, giving patients real choices based on solid information. An uninformed choice is like no choice at all.  

It would also improve the quality of the medical care that patients receive, not only by identifying what works best but also by identifying what doesn't work at all - and even more importantly, what causes more harm than good. So comparing treatment effectiveness helps physicians to honor another moral value at the heart of medicine, along with that of informed choice: do no harm.  

Critics charge that comparative effectiveness research will lead to "one-size-fits-all" guidelines that cater to a non-existent average patient for the sake of making the system more efficient. In fact, patients will be empowered by rigorous, evidence-based recommendations that are specific to the needs of particular patient groups. Research on comparative effectiveness would provide data to help each patient make the best possible choice with his or her doctor.  

Patients want the right to make decisions with their doctors in order to pursue what is in their own best interests. Choosing blindly is an empty right; choosing with evidence respects patients' rights and enhances quality. This is a case in which good ethics demands good facts.  

Professor Ruth R. Faden is director of the Johns Hopkins Berman Institute of Bioethics. Jonathan D. Moreno is a professor of ethics and medical ethics at the University of Pennsylvania  and is a senior fellow at the Center for American Progress.

Authors 

P. S. Duggan;  A. W. Siegel;  D. M. Blass;  H. Bok;  J. T. Coyle;  R. Faden;  J. Finkel;  J. D. Gearhart;  H. T. Greely;  A. Hillis;  A. Hoke;  R. Johnson;  M. Johnston;  J. Kahn;  D. Kerr;  P. King;  J. Kurtzberg;  S. M. Liao;  J. W. McDonald;  G. McKhann;  K. B. Nelson;  M. Rao;  A. Regenberg;  K. Smith;  D. Solter;  H. Song;  J. Sugarman;  R. J. Traystman;  A. Vescovi;  J. Yanofski;  W. Young; D. J. H. Mathews  

 

Abstract

The prospect of using cell-based interventions (CBIs) to treat neurological conditions raises several important ethical and policy questions. In this target article, we focus on issues related to the unique constellation of traits that characterize CBIs targeted at the central nervous system. In particular, there is at least a theoretical prospect that these cells will alter the recipients' cognition, mood, and behavior—brain functions that are central to our concept of the self. The potential for such changes, although perhaps remote, is cause for concern and careful ethical analysis. Both to enable better informed consent in the future and as an end in itself, we argue that early human trials of CBIs for neurological conditions must monitor subjects for changes in cognition, mood, and behavior; further, we recommend concrete steps for that monitoring. Such steps will help better characterize the potential risks and benefits of CBIs as they are tested and potentially used for treatment.

 

American Journal of Bioethics - Neuroscience 9(5) 31-36

In addition to serving as the Berman Institute's Deputy Director for Medicine, Dr. Sugarman is the Harvey M. Meyerhoff Professor of Bioethics and Medicine, Professor of Medicine, and Professor of Health Policy and Management at Johns Hopkins University. Dr. Sugarman conducts both theoretical and empirical research in medical ethics. His work concentrates on informed consent, research ethics, and the ethical issues associated with emerging technologies.

PRIM&R News Release (Click Here)

Latest Issue of PEBS News Roundup Available  

 

Two University of Florida scientists are part of the multicenter team of researchers that made the discovery, which could pave the way for better treatments that target the disease, according to findings published Wednesday in the journal  Nature.

"What makes our study so important is that although neuroblastoma accounts for 7 percent of childhood cancers, it is responsible for 15 percent of deaths in children with  cancer," said Wendy London, Ph.D., a research associate professor of epidemiology, biostatistics and health policy research at the UF College of Medicine and a member of the UF Shands Cancer Center. "This paper adds yet another gene in the pathway that could lead to tumorigenesis (tumor formation) of neuroblastoma."

Neuroblastoma forms in developing  nerve cells, with tumors most often found on a child's adrenal gland. It's the most common form of cancer in babies and the third most common childhood cancer, according to the American Cancer Society.

Led by John J. Maris, M.D., director of the Cancer Center at The Children's Hospital of Philadelphia, researchers performed what's known as a genome-wide association study to uncover errors in DNA that could be associated with neuroblastoma.

New York has become the first state to allow taxpayer-funded researchers to pay women for giving their eggs for embryonic stem cell research, a move welcomed by many scientists but condemned by critics who fear it will lead to the exploitation of vulnerable women.

The Empire State Stem Cell Board, which decides how to spend $600 million in state funding for stem cell studies, will allow researchers to compensate women up to $10,000 for the time, discomfort and expenses associated with donating eggs for experiments.

"We want to enhance the potential of stem cell research. If we are going to encourage stem cell research as a solution for a variety of diseases, we should remove barriers to the greatest extent possible," said David Hohn, vice chairman of the board's two committees that endorsed the move. "We decided to break some new territory."

The little-noted decision two weeks ago puts New York at odds with policies in every other state that provides funding for human embryonic stem cell research and with prevailing guidelines from scientific organizations, including the National Academy of Sciences.

 

First up for the Senate Health, Education, Labor and Pensions Committee, which Dodd is heading in Sen.   Edward M. Kennedy's absence, were amendments to improve quality and efficiency. But the debate quickly shifted to more contentious issues including the overall cost of enacting President Barack Obama's top domestic priority of reshaping the nation's health care system to bring down costs and extend insurance to 50 million Americans who lack it.

 

"You could end up with a bill that's easily headed to a $2 trillion price tag," complained Sen.   Judd Gregg, R-N.H., as he offered an amendment that would require proof that various quality measures such as training and identifying best practices would actually save money.

 

The committee rejected his amendment, as Sen.   Barbara Mikulski, D-Md., contended it would be "throwing sand in the gears."

 

 

Members of the President’s Council on Bioethics were told by the White House last week that their services were no longer needed and were asked to cancel a planned meeting, a council staff member said Wednesday.

The council was disbanded because it was designed by the Bush administration to be “a philosophically leaning advisory group” that favored discussion over developing a shared consensus, said Reid Cherlin, a White House press officer.

President Obama  will appoint a new bioethics commission, one with a new mandate and that “offers practical policy options,” Mr. Cherlin said.

The council was appointed by President   George W. Bush  in November 2001, in the wake of his decision to let government-financed scientists begin research with human   stem cells , but only with existing cell cultures.

 

With the H1N1 flu outbreak now elevated to pandemic level, a new article in the Canadian Medical Association Journal reports that oseltamivir (Tamiflu®) and zanamivir (Relenza®) are relatively safe drugs for use in pregnant and breast-feeding women.

Pregnant women, especially those in the third trimester, are at high risk of serious complications from the H1N1 A influenza virus.

The study was conducted by researchers from the Motherisk Program at The Hospital for Sick Children (SickKids) in Toronto and the Japan Drug Information Institute in Pregnancy in Tokyo, Japan

For treatment or prevention during the current pandemic, "oseltamivir appears to be the drug of choice because there are more data on its safety in pregnancy," writes Dr. Shinya Ito, Head of the Division of Clinical Pharmacology and Toxicology at SickKids. Zanamivir can be used, although there is less data available about its safety in pregnant women. Neither drug appears to affect the growth and development of the fetus, although ongoing data collection is important. The groups at high risk of flu-related complications from the novel H1N1 influenza are the same as those for seasonal flu – pregnant women, children under 5 years, the elderly and others such as those with chronic lung conditions.

 

Climate change is already reshaping the United States, according to a new federal report that predicts global warming could have serious consequences for how Americans live and work.

 

Hotter temperatures, an increase in heavy downpours, and rising sea levels are among the effects of "unequivocal" warming, concludes the  report  (pdf) by the U.S. Global Change Research Program. Winters are now shorter and warmer than they were 30 years ago, with the largest temperature rise -- more than 7 degrees Fahrenheit -- observed in the Midwest and northern Great Plains.

Open Access Publisher Accepts Nonsense Manuscript for Dollars    (The Scholarly Kitchen)

 

The manuscript, entitled “ Deconstructing Access Points ” was submitted on January 29th, 2009, to   The Open Information Science Journal (TOISCIJ), a journal that claims to enforce peer-review.