News in Contect

Bioethics News to Watch in 2015

Bioethics is frequently in the news. Even if the word itself doesn’t appear—and it usually doesn’t—bioethics questions and ideas are there, in stories about care near the end of life, health care costs, genetic and genomics testing, assisted reproduction, and other topics related to medicine, health care, and the life sciences. Hardly a week goes by when journalists don’t come to our research scholars for interviews to clarify and give perspective on some new development.

The Hastings Center staff got together at the end of 2014 to discuss major bioethics news of the year. Then we refined the list of topics to focus on news that is developing and therefore is certain or likely to have impact in the year ahead. Here are eight news stories to watch in 2015.

Ebola crisis. The largest Ebola outbreak in history began in March 2014. Since then, more than 20,700 people have contracted the disease, and more than 8,200 have died, according to the World Health Organization. The Ebola crisis has raised numerous ethical questions: When is quarantine warranted? What are the duties of health care workers who treat highly infectious patients, and what is owed the workers themselves? For example, is it ever ethically permissible to forgo cardiopulmonary resuscitation for Ebola patients with uncontrolled bleeding? Should IV fluid replacement be the standard of care for Ebola treatment in Africa, or is it ethically defensible not to offer this potentially life-saving supportive therapy in view of its potential risks to health care providers and to patients themselves? What should be the ethical protocols for trials on experimental Ebola vaccines and drug treatments?

With some trials under way and others set to begin this year, among the questions is whether to use the “gold standard” protocol, a randomized controlled clinical trial, in which a group of participants—Ebola patients and people at high risk of Ebola—receives an experimental treatment and a control group receives “standard of care,” which in this case is relief of symptoms. Experts are split on the question of whether a control group is ethical in such trials, where standard of care carries a mortality rate of up to 70 percent. Organizers of a World Health Organization trial in Guinea and Liberia are not using a control group. However, organizers of a U.S.-government trial are using one on the ground that no one knows whether experimental treatments are better than standard of care. With the Ebola trials being fast-tracked, some results are expected this year.

Health care for undocumented immigrants. On November 20, President Obama issued executive actions concerning undocumented immigrants. They granted up to 5 million of the 11 million undocumented immigrants a deferral of deportation and gave many of them the right to employment. While those who get jobs might also get employer-sponsored health insurance, the executive actions did not extend health benefits to undocumented immigrants under the Affordable Care Act or provide other public benefits. The ACA prohibits undocumented immigrants from purchasing health insurance through the insurance exchanges.

However, some states, including California and New York, allow undocumented immigrants who have secured deferred action status to enroll in Medicaid. In 2015, look for increased attention to solutions to closing gaps in access to health care for undocumented immigrants on grounds of fairness and cost-effectiveness.

Legalizing physician aid in dying. Support for physician aid in dying has been increasing. It is legal in Oregon, Washington, Vermont, Montana, and New Mexico. A Medscape survey of 17,000 physicians in the United States found that 54 percent supported it in 2014, up from 46 percent in 2010. Focus on aid in dying increased last year when Brittany Maynard, a 29-year-old with terminal brain cancer, made a highly publicized move from California to Oregon so that she could legally end her life with medication prescribed by a physician. Until her death on November 1, she advocated for legalized physician aid in dying.

One issue to watch in 2015: Will efforts to expand access to physician aid in dying advance beyond the five states where it is currently legal? Bills have been introduced in several states, including New Jersey and Pennsylvania, as well as in the District of Columbia. In California, two state senators will introduce a bill at a press conference on January 21.

Implications of Hobby Lobby decision. In a much-debated, much-anticipated Supreme Court case, Burwell, Secretary of Health and Human Services, et al. v. Hobby Lobby Stores, Inc., et al., the Supreme Court ruled in favor of two family-owned, for-profit corporations that have religious objections to the Affordable Care Act’s requirement that employment-based group health insurance plans provide access to all contraceptive methods approved by the Food and Drug Administration. Their particular objection is to emergency contraceptive pills and IUDs, which prevent implantation of a fertilized egg, a process that the plaintiffs believe causes abortion. While religious institutions are exempt from the ACA’s contraceptive mandate and nonprofit religious organizations can get around it by requesting a religious accommodation, the government made no such provisions for for-profit corporations. Companies that do not provide contraceptive coverage are subject to a substantial fine.

“The Supreme Court’s ruling could undermine a central goal of the [ACA]: to expand access to health care by creating a system in which access to health care is based on need and not on ability to pay,” says Michael Gusmano, a research scholar at The Hastings Center who studies health care equity, writing in Bioethics Forum.

There are dozens of lawsuits challenging the ACA’s contraceptive mandate and other provisions, and much speculation on the implications of the Hobby Lobby decision.

Other challenges to the ACA. The third challenge to the ACA will reach the Supreme Court this year. King v Burwell concerns the validity of subsidies to help low- and middle-income residents pay for health insurance established under insurance exchanges set up by the federal government in the 37 states that did not establish such exchanges. This case has been called “the most serious challenge to the Affordable Care Act since the Supreme Court found it constitutional more than two years ago.”

The ACA authorizes premium tax credits when health insurance is purchased “through an Exchange established by the State.” The government argues that this applies to federally facilitated marketplaces because the law allows states to rely on these exchanges if they decide not to establish their own. If the Court rules in favor of the plaintiffs, millions of Americans will be unable to afford health insurance. This would disrupt the health insurance market in these states and place additional pressure on their health care safety nets.

Torture and professional ethics. In December, the Senate Committee on Intelligence released a report on the CIA’s detention and interrogation program, which detailed the role of health care professionals, including psychologists contracted to devise “enhanced interrogation techniques.” In response to the report, the American Psychological Association stated that its policy forbids enhanced interrogation techniques. (Physicians for Human Rights, in a detailed review of the report, concluded that “health professionals who participated in the CIA torture program violated core ethical principles common to all healing professions” and called for a federal investigation of all health professionals involved. The American Medical Association stated that physicians must oppose and must not participate in torture for any reason.) Prior to the release of the report, the APA authorized an independent review of allegations that it had worked with the CIA and the U.S. military to develop and implement techniques that constituted torture. The review process is expected to be completed in the first quarter of 2015.

Assisted reproduction concerns. The Food and Drug Administration held public hearings in February 2014 to consider whether to permit human testing of a new method of assisted reproduction that would prevent the transmission of rare diseases and perhaps address some causes of female infertility. At issue was the safety of the technique, called mitochondrial manipulation, and its ethical implications.

The technique creates an embryo with the nuclear DNA (which contains most of the genetic information) from the prospective mother and father and the mitochondrial DNA from a donor without mitochondrial defects. The FDA hearings focused on safety concerns to the women involved and the resulting children, including possible genetic damage. Ethical objections center on the technique’s genetic effect on future generations: unlike other human assisted reproduction technologies, it would alter the germline, meaning that mitochondrial DNA would be passed on by daughters to their offspring. Some people think this kind of genetic alteration oversteps the proper role of humans in procreation and, indeed, evolution. Critics are also concerned that this technology could open the door to producing “designer babies”—children who are not simply free of severe genetic diseases but are also genetically selected for traits such as eye color or intelligence.

Last year, the U.K. announced plans to allow fertility clinics to use mitochondrial replacement.  At the request of the FDA, an Institute of Medicine consensus study on the ethics of this and related techniques was launched in the fall of 2014.

Freezing eggs, freezing time. Apple and Facebook made headlines last year with their controversial decisions to provide female employees with health insurance coverage for egg freezing, a reproductive technique that allows them to defer childbearing by freezing time—storing eggs for future use to protect them from the ravages of aging. The controversy centered on two general points: the benefit itself (Was it right to offer up to $20,000 to induce female employees to focus on their careers instead of motherhood?) and questions about safety and effectiveness. The technique has been used for women with cancer and other medical conditions as a means to conserve their fertility before undergoing treatment. But the American College of Obstetricians and Gynecologists and the American Society for Reproductive Medicine do not endorse egg freezing for healthy women looking to slow the biological clock. Hastings Center scholar Josephine Johnston and author Miriam Zoll, writing in The New Republic, cited studies showing very low rates of live births from the technique and numerous safety concerns, ranging from pelvic and abdominal pain to stroke and death. They also said that there is not enough medical evidence to know whether the chemicals used to freeze eggs “are toxic to embryos and how they effect cell development.”

Despite these concerns, will more companies cover egg freezing? Will medical organizations issue stronger warnings against it?

The Hastings Center has never shied away from the toughest ethical challenges faced by society.

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