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Bioethics News Watch 2016

Gene editing, end-of-life care, ethical oversight of research – these are just some of the many bioethics-related topics that Hastings Center scholars study, write about, and discuss with the press. The Hastings Center staff got together to talk about the major issues developing in bioethics that are certain or likely to have an impact in the year ahead. Here are 10 developments to watch in 2016. We’ll also be tracking the positions of the presidential candidates and their parties on bioethics issues and will report on them throughout the year. 

Gene editing advances. Powerful new gene-editing tools, particularly Crispr-Cas9, make possible as never before the ability to revise the genomes of humans, other animals, and plants for a range of desired effects. These tools promise great benefits: researchers around the world have explored the use of gene editing to treat incurable leukemia, create foods with particular attributes (such as fast-growing salmon), and to design mosquitoes resistant to malaria.   However, gene editing also poses ethical concerns, including ecological risks, and when used in humans, the prospect of eugenics. A landmark international summit on human gene editing last month found the use of human gene editing permissible for basic bench research, such as the study of the underlying biology of human embryos and germline cells (sperm and egg). However, it recommended a moratorium on human germline gene editing that would lead to a pregnancy, because whatever genetic changes are made could be inherited in perpetuity. Look for news about the use of gene editing to understand the basic biology of human reproductive cells, to prevent or treat illnesses, to alter plants and animals in new ways for food and other purposes, to control pests, to prevent transmission of malaria and other diseases, and possibly even  to bring back extinct species. In late spring, look for recommendations on “gene drives” (which use gene editing technology) from a committee of the National Academy of Sciences, Engineering, and Medicine. Toward the end of the year, another National Academies committee will offer policy recommendations on human gene editing. 

Common Rule revisions. For the first time in 25 years, the federal government has proposed major revisions to the Common Rule, the set of government regulations that aim to protect people who participate in research. The proposed rule changes would require researchers to use a shorter, easier-to-read consent form that provides “information a reasonable person would want to know,” obtain informed consent for research on a blood sample or other biospecimen left over from medical purposes, and use a single institutional review board for multisite studies. A goal of these and other proposed changes is to “strengthen the effectiveness and efficiency of the oversight system by making the level of review more proportional to the seriousness of the harm or danger to be avoided.” Public comment on the proposed revisions closed on January 6. Look for news about what changes will be made and when. Some hint about desired changes can be found in the 2,138 comments  

New end-of-life care options. Two changes in Medicare that went into effect on January 1 could improve advance care planning and end-of-life decision-making and care. Medicare began covering advance care planningconversations between patients and doctors or other health care providers. In addition, a multiyear pilot program called the Medicare Care Choices Model gives adult patients who are eligible for hospice the option to continue certain curative interventions while also receiving hospice services reimbursed by Medicare. Previously, such patients had to forgo certain interventions before being admitted to hospice. The pilot recognizes that certain potentially life-sustaining treatments (such as radiation therapy for cancer) may also be effective for pain and symptom management near the end of life. Allowing patients who derive palliative benefit from these interventions to continue to receive them eliminates a barrier to hospice services. Look for news about the impact of the Medicare ACP reform on end-of-life care in primary and acute care settings, and whether it contributes to other systemic improvements. Also watch for evidence from the Medicare Care Choices Model pilot program concerning the impact on length of stay in hospice, patient and family well-being, and hospice operations.  

Legalization of physician aid in dying. Support for physician-assisted dying continues to increase. Last year, California became the fifth – and the largest – state to legalize the practice, passing a law that allows physicians to prescribe a lethal dose of medication for terminally ill patients who want to end their lives. California joins Oregon, Washington, and Vermont, which have similar statutes, and Montana, where physician aid in dying is legal by case law. In New Mexico, however, a lower court decision permitting the practice was overturned on appeal. Legislation to legalize physician aid in dying has been introduced in 22 states. Unlike the laws in the United States, new and pending legislation in other countries do not restrict aid in dying to terminally ill patients. The Netherlands just legalized euthanasia for people with dementiawho had written advance directives that expressed the wish for it should they develop the condition. Pending legislation in Canada could permit physician aid in dying for competent adults who have “a grievous and irremediable medical condition (including an illness, disease or disability) that causes enduring suffering that is intolerable to the individual in the circumstances of his or her condition.” The legislation would put into practice a unanimous decision by Canada’s Supreme Court last year. Look for news about more law and policy initiatives in the U.S. and abroad concerning physician aid in dying.  

More challenges to the ACA. The Affordable Care Act faces hurdles that could limit its implementation. The Supreme Court will hear a challenge to the ACA’s contraceptive mandate – the requirement that group health plans provide access to all FDA-approved contraceptive methods at no cost, or pay a steep penalty. This case, brought by religious nonprofit groups, follows the 2014 Hobby Lobby case in which the Supreme Court ruled that closely held for-profit companies whose owners have religious objections to certain contraceptives could be exempt from the contraceptive mandate. Look for news about the Supreme Court decision in June. Other developments to watch include attempts in Congress to cut funds for the so-called risk corridor program, which supports the state health insurance co-ops. Such funding cuts resulted in the closing of 12 health insurance co-ops in 2015. Be alert to the presidential candidates’ diverse positions on the ACA; the dynamics of their debates over the ACA could influence actions taken by Congress and President Obama this year. In addition, watch for news about the implementation of the ACA’s requirement that companies with 50 or more full-time employees to provide health insurance or pay a penalty. That mandate goes into effect in 2016.   

Expanding immigrants’ access to health care. Most of the 11 million undocumented immigrants living in the United States have no access to health care. They are excluded from the ACA. The result is financial pressure in safety-net health care organizations and ethical challenges to health care professionals seeking to provide good care to undocumented immigrants. Several local governments have devised strategies to address these problems. This year New York City will implement a plan for improving health care access for immigrants, becoming the nation’s largest city to do so. It incorporates recommendations from The Hastings Center and the New York Immigration Coalition (NYIC)Look for news about other cities taking action to improve immigrants’ access to health care services and, more broadly, initiatives for immigration reform.  

Advancing LGBT rights. In a landmark decision last year, the Supreme Court affirmed same-sex marriage as a right protected by the Constitution, and a year earlier President Obama issued an executive order prohibiting federal contractors from discrimination against lesbian, gay, bisexual, and transgender employees. In December, the FDA reversed its lifetime ban on blood donation by gay men.But LGBT individuals face tremendous hurdles in access to health care and basic human rights. Evan Wolfson reminds us that marriage is not the endpoint of civil rights legislation in the U.S. There was extensive media coverage of historic rates of transgender women of color being murdered, as well as prominent coming-out stories, but will it lead to policies that improve health and safety for LGBT people? Look for news about trials of PreP in populations at risk of HIV transmission and more widespread use of the treatment. Also look for continued debates over locker room access for transgender people, and bills that, if passed, would require adjudication of  the genitalia of bathroom users in Indiana, and evolving policies on coverage for gender confirmation treatment in the private insurance markets in the wake of Medicare’s coverage for transition-related treatment.

Curbing opioid abuse. Overdose of prescription and illicit drugs, especially opioids, has reached epidemic proportions.  Deaths from opioids  increased nearly fourfold in the last decade. This health crisis was cited by President Obama in his final State of the Union address and  has gained attention among presidential candidates  on both sides of the aisle. A challenge for public health policy is to balance the needs of patients who are in severe pain with the necessity to reduce abuse and misuse of opioid painkillers. Look for news about Congressional legislation to help curb prescription drug abuse, ideas from the presidential candidates, and guidance from professional groups such as the American Medical Association on strategies to  ensure appropriate prescribing practices . 

DTC health-related genetic testing resumes. 23andMe, the direct-to-consumer genetic testing company, can once again provide health-related genetic information to consumers. The FDA granted approval of one such test last year (a test for carrier status of Bloom syndrome) nearly two years after ordering 23andMe and other companies to stop offering health related tests because of questions about their accuracy. Concerns continue to be raised about transparency to consumers from the DTC companies and the privacy of the results. The American College of Medical Genetics and Genomics recommended that consumers be fully informed about what a test “can and cannot say” about their health and the implications of the results for family members. It also recommended steps to guard the privacy of consumers and their data, including disclosure of whether the data generated from testing “will be sold or shared to third parties” and “ownership of the sample and generated data.” Look for news about more DTC genetic tests for health conditions coming on the market. Also watch for a related development: more genetic research that incorporates social media and Silicon Valleycompanies such as Facebook, Google, and 23andMe, raising questions about informed consent and privacy.

Will health policy address gun safety? “Gun deaths and injuries constitute one of the greatest threats to public health and to the safety of the American people,” stated President Barack Obama after announcing his executive actions to reduce gun violence. With more than 30,000 Americans killed each year by guns, he called for everyone “at every level of government, in the private sector and as citizens” to take action to save lives. While there’s little chance of Congress taking up gun reform this year, ideas are being discussed among in public health and bioethics circles. Look for news about gun violence as a public health issue and the role of health care providers and government policy to help prevent it. Debates about the role of physicians in counseling patients about gun safety have gone on for years, fueled by a Florida law that prohibits health care professionals from asking patients about gun ownership. The issue was explored in detail this month by Hastings Center Fellow Arthur Caplan in Medscape. A Medscape survey of physicians found that 47 percent said that doctors should discuss gun safety with patients, 39 percent said they should not, and 14 percent were undecided. Doctors in favor argued that counseling patients about public health concerns – be they gun safety or seatbelt safety -- is a physician’s duty.  Doctors opposed considered such discussions an invasion of privacy and potentially harmful to the doctor-patient relationship. In the realm of public policy to address gun safety, some experts advocate for improving data collection about gun violence, for example, by making it mandatory to report incidents of gun violence to the Centers for Disease Control and Prevention.