REPOST: Civil Society Statement to the Organizers of the Second International Summit on Human Genome Editing

Posted on Jan 23, 2019

This post originally appeared on the Center for Genetics and Society’s website on November 28, 2018.

To add your signature, please sign here or email your name and affiliation to info@geneticsandsociety.org .

The undersigned individuals and organizations wish to express our dismay and outrage at He Jiankui’s claims of creating genetically engineered babies. Though these claims are unverified, his actions violate a key provision of the concluding statement issued at the First International Summit on Human Gene Editing in 2015, that such dangerous experiments should not proceed until there was broad societal consensus in their favor. 

That statement was intended to reassure civil society that the scientific community could regulate itself and prevent such reckless behavior. If the organizers of this week’s summit in Hong Kong wish to demonstrate that science is not out of control, and is worthy of public trust, now is the time for them and the rest of the international scientific community to act.

We urge that they (1) condemn in clear terms the rogue actions of the researcher who has taken it on himself to make a hugely consequential decision that affects all of us; and (2) call on governments and the United Nations to establish enforceable moratoria prohibiting reproductive experiments with human genetic engineering.

Such policies are necessary in order to ensure that we do not get into a runaway international competition for primacy in reproductive genetic engineering, leading to a new form of eugenics.  If the summit and other scientific bodies do not act, it will fall to civil society and policy makers to do so, in order to ensure the avoidance of disastrous consequences for global society.

  • David King, Human Genetics Alert
  • Marcy Darnovsky, Center for Genetics and Society
  • Katie Hasson, Center for Genetics and Society

To add your signature, please sign here or email your name and affiliation toinfo@geneticsandsociety.org .

INDIVIDUAL SIGNATORIES (Affiliation for Identification Purposes Only)

  1. Elisabeth Abergel, PhD, Department of sociology, Université du Québec à Montréal (UQAM)
  2. Gen Acuna, Toronto Non-GMO Coalition; Kids Right To Know
  3. Roberto Andorno, PhD, University of Zurich, Switzerland
  4. George J. Annas, JD, MPH, Center for Health Law, Ethics & Human Rights, Boston University School of Public Health
  5. Dr. Michael Antoniou, King’s College London
  6. Lisa Archer, Friends of the Earth, US
  7. Simone Bateman, Emeritus Senior Researcher CNRS (Paris, France)
  8. Françoise Baylis, PhD, Dalhousie University, Halifax, Canada
  9. Claire Beaudevin, PhD, CNRS, Paris France
  10. Diane Beeson, PhD, Professor Emerita, CSU East Bay
  11. Emily Smith Beitiks, PhD, Associate Director, Paul K. Longmore Institute on Disability, San Francisco State University
  12. Kara Bensley, PhD, UC Berkeley School of Public Health
  13. Jennifer Berman Diaz, Founder, Toronto Non-GMO Coalition
  14. Rajani Bhatia, PhD, University at Albany
  15. Claire Bleakley, President, GE-free NZ in Food & Environment
  16. Catherine Bliss, PhD, UCSF Social Behavioral Sciences
  17. Lars Bolund, PhD, BGI/Lars Bolund Institute of Regenerative Medicine, Qingdao, China and Department of Biomedicine, Aarhus University, Denmark
  18. Catherine Bourgain, PhD, Sciences Citoyennes and Inserm Human Geneticist
  19. Paula Braveman, MD, MPH, University of California, San Francisco
  20. W. Malcolm Byrnes, PhD, Department of Biochemistry and Molecular Biology, Howard University College of Medicine, Washington, DC
  21. Erika M. Brown, MPH, UC Berkeley School of Public Health
  22. Alexander M. Capron, JD, University Professor and Professor of Law and Medicine, Keck School of Medicine, University of Southern California
  23. Alana Cattapan, PhD, Johnson Shoyama Graduate School of Public Policy, University of Saskatchewan
  24. Katayoun Chamany, PhD, Mohn Family Professor of Natural Sciences and Mathematics, Eugene Lang College at The New School
  25. Gail Chester, Breaking the Frame, London
  26. Daniel Cook, PhD, School of Community Health Sciences, University of Nevada Reno
  27. Marsha J. Tyson Darling, PhD, Professor & Director, Center for African, Black & Caribbean Studies, Adelphi University
  28. Katherine Weatherford Darling, PhD, Department of Social Science, University of Maine at Augusta
  29. Marcy Darnovsky, PhD, Center for Genetics and Society
  30. Roni Diamant-Wilson, PhD
  31. Donna Dickenson, PhD, Emeritus Professor of Medical Ethics and Humanities, University of London
  32. Ole Doering, PhD, Institute for Global Health, Berlin, Germany
  33. Katherine Drabiak, JD, Assistant Professor, College of Public Health, University of South Florida
  34. Elaine Draper, PhD, JD, Professor of Sociology and Director, Law and Society Program, California State University, Los Angeles
  35. Justine Durrell
  36. Irina Ermakova, Professor of Biology, Moscow, Russia
  37. George Estreich, Author
  38. Dr. Fleur Fisher, Former Head of Ethics, Science and Information at British Medical Association (1991-96)
  39. Kevin Fitzgerald, S.J., PhD, Creighton University School of Medicine
  40. Sarah Forthal, Columbia University
  41. Joan H. Fujimura, PhD, Martindale-Bascom Professor of Sociology, University of Wisconsin, Madison
  42. Katy Fulfer, PhD, Assistant Professor of Philosophy and Women’s Studies, University of Waterloo
  43. Alexander Gaguine, Appleton Foundation
  44. Ben Gaia, Dialatree New Zealand
  45. Emily Galpern, MPH, Public Health Consultant
  46. Rosemarie Garland-Thomson, PhD, Professor of English & bioethics, Founding Director, Disability Studies Initiative, Emory University
  47. Landon J. Getz, PhD Candidate, Dalhousie University
  48. Alan  Goodman, PhD, Professor of Biological Anthropology, Hampshire College
  49. Laurie Goodman, PhD, Editor-in-Chief GigaScience
  50. Samantha D. Gottlieb,  PhD, MHS, Medical Anthropologist
  51. Zelka Linda Grammer, GE Free Northland, Aotearoa/ NZ
  52. Rosann Greenspan, PhD, Executive Director, Center for the Study of Law and Society, University of California, Berkeley
  53. Jeremy Gruber, JD, Former President, Council for Responsible Genetics
  54. Hille Haker, PhD, Richard McCormick Endowed Chair of Ethics, Loyola University Chicago
  55. Jaydee Hanson, Policy Director for Human Genetics, International Center for Technology Assessment
  56. Janet A. Hart, MA, PhD, MCPHS University, Boston, Massachusetts
  57. Michael Harvey, DrPhH, Assistant Professor of Public Health, San Jose State University
  58. Katie Hasson, PhD, Center for Genetics and Society
  59. Richard Hayes, PhD, Executive Director emeritus, Center for Genetics and Society
  60. Alexandra Henrion Caude, PhD, Science-En Conscience and Inserm Human Geneticist
  61. Sabrina Hermosilla, PhD, Columbia University
  62. Elisabeth Hildt, PhD, Illinois Institute of Technology
  63. Craig Holdrege, PhD, Director and Senior Researcher, The Nature Institute of Ghent, NY
  64. Nina Holland, Corporate Europe Observatory
  65. Lisa C. Ikemoto, JD, UC Davis School of Law
  66. Patricia Jennings, PhD, Professor of Sociology, CSU East Bay
  67. Chris Kaposy, PhD, Associate Professor of Bioethics, Memorial University
  68. Trica Keaton, PhD, Dartmouth College
  69. David King, PhD, Human Genetics Alert
  70. Brewster Kneen, Economist and author
  71. Regine Kollek, Prof., Hamburg University
  72. Nancy Krieger, PhD, Harvard T.H. Chan School of Public Health
  73. Liz Kroboth, MPH, Lecturer, San Francisco State University
  74. Sharon Labchuk, Earth Action Canada
  75. Martine Lappé, PhD, Science, Technology, and Society Program, California Polytechnic State University, San Luis Obispo
  76. Heather Lee, No More GMOs Toronto
  77. Martha Livingston, PhD, Chair and Professor, Public Health, SUNY Old Westbury
  78. Leah Lowthorp, PhD, University of Oregon
  79. Calum MacKellar, PhD, Director of Research, Scottish Council on Human Bioethics
  80. Laura Mamo, PhD, Health Equity Institute Professor, San Francisco State University
  81. Rev. Bronica Martindale-Taylor, BA, Health Educator
  82. Becky A. McClain, Alliance for Humane Biotechnology
  83. Noémie Merleau-Ponty, Department of Sociology, University of Cambridge
  84. Miroslav  Mikolasik, Member of the European Parliament
  85. Jessica Milne, MPH, Research Foundation of CUNY
  86. Alexandra Minna Stern, PhD, University of Michigan
  87. Jon  Muller, Secretary, GE-free NZ in Food & Environment
  88. Stuart Newman, PhD, Professor of Cell Biology & Anatomy, New York Medical College
  89. Trang Quynh Nguyen, Assistant Scientist, Department of Mental Health, Johns Hopkins Bloomberg School of Public Health
  90. Judy Norsigian, Co-founder and Board chair, Our Bodies Ourselves
  91. Osagie K. Obasogie, PhD, JD, Haas Distinguished Chair and Professor of Bioethics, UC Berkeley Joint Medical Program, School of Public Health
  92. Archana Pandya, OpenGlobalRights
  93. Brendan Parent, JD, Director of Applied Bioethics, New York University
  94. Stuart Parkinson, Dr, Scientists for Global Responsibility, UK
  95. Elena Pasca, Philosopher, Editor of Pharmacritique, Founder of the AVEAG Victim Association, France
  96. Helena Paul, Co-Director, EcoNexus
  97. Hervé Perdry, PhD, Human Geneticist, Université Paris-Sud
  98. Beth N. Peshkin, MS, LCGC, Pellegrino Center for Clinical Bioethics at Georgetown University, Washington, D.C.
  99. David Petrasek, PhD, Associate Professor, Graduate School of Public and International Affairs, University of Ottawa
  100. Angel Petropanagos, PhD, Quality Improvement Ethicist, William Osler Health System
  101. Bob Phelps, Executive Director, Gene Ethics, Australia
  102. Catherine Powell, Alliance for Humane Biotechnology
  103. Carolyn D.  Prouty, DVM, Faculty, Public Health and Health Sciences, The Evergreen State College
  104. Rhadika Rao, JD, Professor of Law and Harry & Lillian Hastings Research Chair, University of California, Hastings College of Law, San Francisco, California
  105. Elizabeth Reis, PhD, Macaulay Honors College, CUNY
  106. Claire  Robinson, Editor, GMWatch
  107. Ann Rojas-Cheatham
  108. Hilary Rose, PhD, Professor Emerita of Social Policy, University of Bradford
  109. Lisa Rubin, PhD, New School for Social Research
  110. Jade S. Sasser, PhD, University of California, Riverside
  111. Marsha Saxton, PhD, Director of Research, World Institute on Disability;  Lecturer, Disability Studies Program, UC Berkeley
  112. Pete  Shanks, Author
  113. Tom Sheahen, PhD, Director of the Institute for Theological Encounter with Science and Technology
  114. Stephen Shmanske, PhD, Emeritus Professor of Economics, California State University, East Bay
  115. MaryAnn Sorensen Allacci, PhD, Projects for Environmental Health, Knowledge, & Action, Inc.
  116. Malcolm Steinberg
  117. Tina Stevens, PhD, Alliance for Humane Biotechnology
  118. Alexander Stingl, Collège d’études mondiales
  119. Yeyang Su, a concerned member of our shared humanity
  120. Sun Wenyu, MD, Wuhan Institute of Virology, CAS
  121. José A. Tapia, MD, MPH, PhD(Econ), Associate Professor, Department of Politics, Drexel University
  122. Peter Taylor, PhD, Director, Science in a Changing World graduate track, University of Massachusetts at Boston
  123. Jacques Testart, Biologist, Honorary Senior Researcher Inserm (Paris, France)
  124. Jim Thomas, ETC Group
  125. Sheila R. Tully, PhD, Department of Anthropology, San Francisco State University
  126. France Winddance Twine, PhD, Professor of Sociology, University of California, Santa Barbara
  127. Mary Anne Urlakis, MA, PhD, Executive Director & Co-Founder, Donum Vitae Institute
  128. Britta van Beers, VU University Amsterdam Law School
  129. Ernst Ulrich von Weizsäcker, PhD, Honorary President, The Club of Rome and Past Co-Chair, International Resource Panel, UNEP
  130. Gabriele Werner-Felmayer, PhD, Medical University Innsbruck, Austria
  131. Alice Wong, Founder and Director, Disability Visibility Project
  132. Britt Wray, PhD
  133. Alicia Ely Yamin, JD, MPH, Georgetown University Law Center and Harvard TH Chan School of Public Health
  134. Weilan Ye, PhD, Head of the Vascular Biology Program, Molecular Oncology Division, Genentech Inc.
  135. Silvia Yee, Disability Rights Education and Defense Fund (DREDF)
  136. Luming Zhou, PhD, Department of Pathology, University of Utah

Individual Signatures Received after December 1, 2018

  1. Haiming Chen, PhD, Director of the Center for Global Governance and Law, Xiamen University of Technology, China
  2. Boris Pinto, Bosque University
  3. Lilia Wang, A Caring Global Citizen
  4. Qing Huang, Ms
  5. Suman Sahai, Uttaranchal
  6. Margarida Silva, Portuguese Catholic University
  7. Kaliris Salas-Ramirez, CUNY School of Medicine
  8. Katie Stoll, Genetic Support Foundation, Washington
  9. Ana Perincic
  10. Mahendra Singh, PhD, Freelance Science communicator (www.mahendrasingh.co), India
  11. Ruha Benjamin, PhD, Associate Professor of African American Studies, Princeton University
  12. Jo Ann Egan
  13. Mylene Botbol Baum, PhD, UCLouvain


  1. Canadian Friends Service Committee (Quakers)
  2. Center for Genetics and Society
  3. Earth Action Canada
  4. FOODwatch Western Australia
  5. Friends of the Earth, Australia
  6. Friends of the Earth, US
  7. GE Free Northland, Aotearoa/NZ
  8. GE-free NZ in Food & Environment
  9. Genetic Support Foundation
  10. GM Watch
  11. Human Genetics Alert
  12. Sciences Citoyennes
  13. Scientists for Global Responsibility, UK
  14. Vigilance OGM, Canada
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Toxic Breastmilk: When Substance Abuse Relapse Means Death for Baby

Posted on Jan 23, 2019

This post originally appeared on the Harvard Law Bill of Health on November 15, 2018.http://blog.petrieflom.law.harvard.edu/2018/11/15/toxic-breastmilk-when-substance-abuse-relapse-means-death-for-baby/

Recently, a nursing mother in Pennsylvania made national headlines when her infant died from ingesting a combination of fatal drugs through breastmilk.  According to the coroner’s report, the infant died from a combination of methadone, methamphetamine, and amphetamine toxicity. The Bucks County District Attorney charged the mother, Samantha Jones, who also has a two-year old child, with criminal homicide. According to published reports, Jones was undergoing Medication Assisted Treatment (MAT) and receiving doses of methadone to treat her addiction to opioid painkillers.

Multiple commentators swiftly voiced opposition to the District Attorney, decrying the criminal charges against Jones, arguing it is “highly problematic” to levy criminal charges against a person undergoing treatment for Substance Use Disorder.

This case represents broader questions woven in the current opioid crisis: Is the criminal justice system merely punishing people for addiction? Who should be held accountable for such tragic outcomes against the most vulnerable members of society – infants and children? Do persons with addiction retain any choice over their actions? And lastly, what is the significance that Jones continued to engage in polysubstance abuse despite receiving Medication Assisted Treatment?  To note, the American College of Obstetricians and Gynecologists adopt the position that new mothers with Opioid Use Disorder who are engaged in MAT and wish to breastfeed can do so as long as they do not relapse.

Earlier this year, the Massachusetts Supreme Court in Eldred v. Massachusettsemphasized the criminal justice system does not punish persons with SUD for their addiction or relapse, but instead for involvement with a specific crime that directly impacts the safety and welfare of society, which may be motivated or influenced by drug abuse.  In Jones’s case, her relapse and decision to breastfeed her infant delivered a lethal dose of controlled substances into his system, resulting in his death. For others with opioid addiction this could include a variety of potential crimes, such as diversion and sale of opioid medications (including prescribed opioid medications used in MAT, like methadone or buprenorphine), fatal motor vehicle accidents caused by driver impairment, or child neglect by persons struggling with opioid addiction. Damage caused by these crimes and the consequences of drug abuse reverberate significant harm to other people society that is not diminished simply because the person committing the crime was impaired by the influence of drugs.

We have an ethical responsibility to use the law to protect the public’s safety and welfare while also considering whether our current treatment model offers appropriate care and compassion to persons with addiction. From a health law and ethics standpoint, this requires examining whether the scientific and medical evidence matches policy recommendations.

Media coverage of high profile cases, such as the Samantha Jones case and Eldred v. Massachusetts highlight fissures in the dominant model for treating persons with Opioid Use Disorder.  What’s troubling is that Jones did reach out for treatment. How could such an outcome happen? Growing evidencesuggests that our current approach is not working: many people who are funneled into MAT and taking methadone and buprenorphine are not recovering.

Policy rhetoric classifying addiction as a chronic brain disease minimizes psychological and social factors that contribute to addiction, marginalizing the importance of addressing personal circumstances and reasons for drug use. People with addiction can engage in self-reflection, retain free will, and can relearn mechanisms to respond to triggers of drug use.  Telling people with addiction that they have a chronic brain disease and will face a lifetime of struggle and relapse is not only unsupported by current evidence finding that most people with addiction recover without treatment, but it may also contribute to helplessness and despair.  Even if drug abuse induces changes in the brain that can erode self-control, these changes are not permanent.  Neuroscience shows abstinence not only reverses damage from substance abuse, but produces new learning and growth in the brain.

The National Institute of Drug Abuse and the Office of National Drug Control Policy tell us that MAT constitutes the most effective form of treatment, arguing it is misconception that such treatment substitutes one substance use disorder for another.  Few have questioned this assertion, but we should.  Even if MAT may indeed work for some, we need to ask the critical questions of why numerous patients receiving a replacement opioid become desperatefor higher doses, report seeking , and the majority continue to abuse opioidsand other substances such as alcohol, cocaine and cannabis.

Across the country, research and media reports show us glimpses of a larger problem: people are receiving a replacement opioid, but are still engaged in substance abuse and not receiving comprehensive treatment. In an Alabama case, Taylor v. Smith, the judge aptly summarized that the treatment facility provided methadone to the patient “not in lieu of illegal drugs, but in additionto them.” Patients who experience side effects like depression, fatigue, memory loss, and cognitive impairment may attempt to stop medication, only to encounter painful withdrawal and no clear plan from their treatment provider to address their dependence on a new powerful drug. Being impaired not only affects the patient’s ability to work, engage in family activities, and recover, but also impacts public safety and welfare.

This care is neither compassionate nor humane, and both patients and society deserve better. This unspeakable tragedy shattered a family, and it is incumbent upon us to ask the tough questions. Instead of merely calling for more access to treatment, we need to scrutinize what constitutes effective treatment and positive outcomes: being enrolled in MAT or merely reducing polysubstance abuse cruelly demonstrated the insufficiency of these criteria.

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Public Comments to Singapore’s Bioethics Advisory Committee on Mitochondrial Replacement Therapy

Posted on Jul 26, 2018

In the Spring of 2018, Singapore issued a call for Public Comments on the topic of whether it should repeal the country’s current prohibition against germline modification of embryos and permit an exception for Mitochondrial Replacement Therapy.


See the story here and here.


In response, I submitted Public Comments against modifying Singapore’s law, arguing science, policy, and ethics supports a continued prohibition against Mitochondrial Replacement Therapy.


A copy of my Comments to the Singapore Bioethics Advisory Committee are here:

 Drabiak Mitochondrial Genome Replacement Technology Public Comments.

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As Genetic Testing for Breast Cancer Gene Mutation Expands, Questions Arise About Treatment Decisions

Posted on May 18, 2018

This post originally appeared on The Conversation on May 3, 2018.


The Food and Drug Administration recently announced its authorization that permits genetics testing company 23andMe to market a test for gene mutations associated with risk of breast and ovarian cancer.

In response, 23andMe CEO Anne Wojcicki asserted that the test represents a “major milestone in consumer health empowerment.”

Media articles following this announcement made it clear even if the test provides an accurate result, there are significant limitations for 23andMe’s version of the test about which consumers should be aware. Notably, 23andMe discloses that the test only provides information on three genetic variants found on the BRCA1 and BRCA2 genes known to be associated with a higher risk for breast, ovarian and prostate cancer in people of Ashkenazi Jewish descent.

According to the FDA, most mutations that would increase an individual’s risk are not detected by the test, including mutations that may occur in other patient populations.

As a health law professor and bioethicist, here are some things I think that patients should know about genetic tests and how to think about risk.

A bit about assessing risk

Research shows that women overestimate their risk of cancer and overestimate the potential of dying of cancer. This anxiety may prompt women to seek aggressive interventions even when they do not have cancer. In one study, 32.9 percent of women without a BRCA mutation who received a false positive (indicated they had cancer when in fact they did not) on a screening test for ovarian cancer and had no ovarian cancer opted for surgical removal of their ovaries, or an oophorectomy.

It is imperative to address this anxiety and situate what a cancer risk means for patients.

For starters, it is important to know that the chance of having a BRCA mutation is exceedingly rare, with only about 0.2 percent of population affected. Put another way, in a room of 500 women, only 1 would have a BRCA mutation that increases her baseline risk of breast and ovarian cancer. But even this woman with a BRCA mutation may never develop breast or ovarian cancer during her lifetime. In fact, 90 to 95 percent of most cancer diagnoses can be attributed to environmental and lifestyle factors, not an inherited faulty gene.

According to the Fred Hutchinson Cancer Research Center, up to one-third of cancer-related deaths are due to obesity and sedentary lifestyle. “Exercise is one of the most important actions you can take to help guard against many types of cancer,” experts at Fred Hutchinson say. A trial published in JAMA Internal Medicine confirmed the strength of dietary modification to drastically reduce risk of breast cancer. This information should be empowering. Many patients have much more control over certain – but not all – risks than they may have thought.

These discussions raise broader questions about how we treat patients regardless of whether they have an increased risk of cancer based on genetic testing or fall into a high risk category based on family history. For patients to make meaningful health decisions, they must have accurate information that includes understanding the risks and benefits of each choice.

Implications for overtreatment

Overtreatment that stems from anxiety not only leads to unnecessary and potentially harmful interventions for the patient, but it implicates physician liability. Traditionally, oncologists may favor an aggressive approach, offering and recommending interventions as a means to avoid malpractice litigation arising from patient perception that a physician could have intervened sooner. Aggressive treatment prompted by a patient’s anxiety requires further scrutiny specifically because each preventive intervention entails serious risks.

To note, 23andMe does caution that its test results should not be used on their own to make medical decisions. Women who test either positive or negative should still follow up with their physicians, both 23andMe and the FDA say.

If a woman has a BRCA mutation that increases her risk of cancer, the physician would likely recommend a risk-reducing measurerecommended by the National Cancer Institute: chemopreventionpreventive mastectomy with reconstruction, and surgical removal of ovaries and fallopian tubes, called salpingo-oophorectomy.

In the majority of cases, women who undergo mastectomy also opt for implant reconstruction, and women who undergo salpingo-oophorectomy begin taking synthetic hormone replacement therapy.

In my research, I’ve read countless clinical practice guidelines, FDA meeting minutes, congressional hearing transcripts, and case law.

Here’s what I’ve learned: The potential for cancer risk reduction is only the first part of the equation. Yes, these interventions recommended by the National Cancer Institute do reduce risk for breast and ovarian cancer. But they also increase risk of other potentially debilitating or deadly conditions.

Many physicians agree the trade-off of reducing risk of cancer is worth it. But some physicians and patients may not be aware that physicians and clinical practice guidelines may downplay, omit or dismiss risks entirely in a manner that does not necessarily correspond to scientific evidence, but may be informed by financial conflicts of interest.

Health empowerment requires a much broader conversation of what patients – both with and without a BRCA mutation – can do about their risk of cancer. On a population level, I believe everyone should have information on how to reduce cancer risk through diet and lifestyle interventions. Let’s continue the conversation of how to address patient anxiety to prevent needless overtreatment, aim for communication that accurately portrays what risks mean, and determine whether recommended interventions that pose significant risks offer sufficient clinical benefits.

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Hawaii’s New End-of-Life Law: Do the Additional Safeguards Withstand Scrutiny?

Posted on May 18, 2018

This post originally appeared on The Hastings Center Bioethics Forum on May 4, 2018.


Last month, Hawaii became the seventh state, with the District of Columbia, to legalize physician-assisted suicide. Similar to some of the other state laws, Hawaii’s Our Care, Our Choice Act permits competent adults with a terminal illness and a diagnosis of less than six months to live to obtain a lethal prescription to use to take their own lives. Proponents assert the new law, in addition to giving patients a measure of control, autonomy, and dignity, also contains rigorous safeguards. Despite this rhetoric, Hawaii’s law, like legalized PAS in general, raises troubling implications for the standard of care and for transparency. It also highlights the immense power of a lobby, Compassion & Choices, to strategically politicize language and control the public discourse to make legal change appear to result from organic social shifts rather than orchestrated actions.

Terminology matters: framing a lethal prescription as a viable and even desirable alternative to addressing shortcomings in palliative and hospice care obfuscates that “care” and “choice” mean supplying vulnerable patients with a medication to end their life. Under the prevailing medical standard of care, patients who report feeling depressed, a burden to others, trapped, or hopeless, or are struggling with managing their medical condition would ordinarily trigger intervention to address risk factors for suicide. However, lobbyists’ use of euphemistic language may incrementally change how physicians and public health professionals respond to patients who express suicidal thoughts.

Understanding the patient’s psychological condition is important because research in Oregon has found that patients considering PAS have concerns relating to loss of autonomy, ability to engage in activities that make life enjoyable, and loss of dignity. (Contrary to popular belief, excruciating pain is not a substantial factor in patient decisions to seek PAS.)  Under Hawaii’s law, however, a patient may obtain a consultation via telehealth. While telehealth promises to reduce cost and increase efficiency to address other health care issues, we should pause to consider the sufficiency and ethics of a remote consultation with patients to discuss their motivations and screen for potential problems.

I take issue with what I see as a pro forma requirement. It looks like a protection, but it’s not designed to address underlying issues such as a patient’s depression and whether it could be relieved. Patients facing psychological, social, or existential concerns deserve compassion in the form of reassurance, social support, and practical solutions to address feeling like a burden on others. Needing connection and validation throughout our life–and especially at our most vulnerable when we require assistance from others–translates to knowing that we are meaningful and loved.

Dr. Herbert Hendin and Dr. Kathleen Foley perhaps framed it best: patients desperately need relief from mental and physical distress, and without such relief, they would rather die. Relieving patients’ distress requires enabling and supporting a medical system and standard of care that permits physicians the time and reimbursement to address patient desperation and ambivalence and to offer solutions and referrals to competent providers.

Because of the construction of Hawaii’s law, we are unlikely to know how physicians counsel patients on alternatives and screen patients’ decision-making ability. As in Oregon, the Hawaii State Department of Health will collect limited records, which are confidential and not legally discoverable. While this protects patient privacy, the lack of transparency undermines any claims refuting abuse: we simply cannot know the content of these conversations. We do have access to a select few private medical conversations published in the media, which prompted critics to assert that limited recordkeeping enables patients to go physician-shopping and have brief pro forma discussions.

As a society, we should be skeptical of a practice that arose from lobbying and relies on politicized language to fundamentally alter the physician’s traditional role and the standard of care. I posit Hawaii’s “rigorous safeguards” constitute hollow promises.

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Engineering Consensus in the Development of Genome Editing Policy

Posted on Mar 14, 2017

This commentary was originally published as an Essay on the Hastings Center Bioethics Forum here.


In the past few weeks media outlets have been reporting on the release of Human Genome Editing: Science, Ethics, and Governance from the National Academies of Science, Engineering, and Medicine. The report concluded that following more research, it would be ethical to initiate clinical trials using heritable, germline genome editing for therapeutic purposes subject to a set of conditions. Described by some as a “fantastic development,” this declaration effectively lifted the nonbinding temporary moratorium from the International Summit on Human Gene Editing in 2015.

Although the lengthy report suggests extensive deliberation, it glosses over troubling scientific evidence pertaining to risks of gene editing and stands in stark contrast to the current widely held view in many countries against human germline modifications.

Scientists have referred to potential human germline modifications using gene editing tools as elegant, accurate, and precise, which connotes an exact application to correct a deficiency. This focus marginalizes the complexity of intervening environmental and other epigenetic factors, and presumes that editing technology constitutes the rational, and only, solution toward progress.

After all, who would want to cause “unnecessary misery” and prevent medical advancement?  Placing the ethos of suffering and survival at the forefront of the debate appeals to the very core of what we want from medicine and technology: better health, more certainty in prognosticating outcomes, and the deep primal yearning to have “healthy” genetically related children. The problem arises when the genomic model becomes the sacrosanct idol, and opposing it is attributed to misinformation and unsubstantiated fears.

In the past few years, scientists and bioethicists have discussed the serious potential risks involved with gene editing, such as mosaicism, off-target effects, and incomplete editing.  Last July, Stat News highlighted growing evidence that there may be more off-target effects that originally predicted. Discussion of potential errors presumes that scientists have sufficient information to target the correct part of the genome to “fix.”  However, biologist Stuart Newman  has suggested that this preliminary assumption may not be correct, because variants classified as pathogenic may not be harmful in all individuals.

These limitations reinforce what many scientists and scholars have observed: that germline modifications will always carry a margin of risk. The question then becomes, who the policy discussions accurately characterize the weight of the scientific evidence and explore nuances contained in that model of risk?  Recently, the United States approached a similar quandary, whether to permit germline modification via mitochondrial replacement therapy. Unlike some who have praised this model as a pathway to inform gene editing, I see troubling parallels between the policy evolution of mitochondrial replacement therapy and gene editing, which should give us pause.

Back in 2014, scientists convened before the FDA to discuss mitochondrial replacement therapy, describing the inability to predict safety and assess latent risks and listing potentially insurmountable hurdles arising from intricacies of mitochondrial biology. Numerous statements from participants cautioned against the lack of evidence pertaining to safety and efficacy, the potential to cause abnormalities, and the gravity of risk involved.  Despite these warnings based on scientific considerations, the National Academies of Science, Engineering, and Medicine recently concluded that conducting clinical trials for mitochondrial replacement therapy is ethically permissible. Although the process for both mitochondrial replacement therapy and gene editing provides the appearance of deliberation, it reveals a disconnect between the state of the science and the characterization of the science while obscuring likely motivational drivers: the pursuit of scientific prestige and capturing a highly lucrative commercial market.

Presuming the inevitability of gene editing in the U.S. also fails to situate our nation within the international context.  Many countries, including Canada, Germany, France, Switzerland, Sweden, and Italy, have adopted legislation prohibiting germline intervention on human embryos for implantation. In some of these nations, germline modification constitutes criminal violation subject to fines and or imprisonment. Prohibiting and criminalizing an action communicates its egregiousness, potential for harm, and social unacceptability in these nations  Unlike the alarmist rhetoric that the U.S. is falling behind and failing to invest in promising genomic technologies, these laws demonstrate the opposite: many countries acknowledge the lure of technology, but renounce risky experiments that cross the historical bright line of manipulating future generations.

As UNESCO’s International Bioethics Committee  has cautioned, neither professional accolades nor market forces should drive the adoption of genomic technologies.  It is crucial to not only step back to assess chasm between the very significant risks pertaining to germline modification and the National Academies current stance, but also to ask why the policy deliberations have been so swift to affirmatively declare that the benefits would outweigh these risks in future clinical applications.


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