September 16, 2019

California shouldn't expand the market for women's eggs

[Cross-posted from the San Francisco Chronicle]

By Lisa Ikemoto and Diane Tober

Medical researchers would be allowed to buy women’s eggs under a bill being considered by the Legislature this week. As pro-choice, feminist scholars, we are deeply troubled by this legislation.

Proponents of AB922, backed by the American Society for Reproductive Medicine and authored by Assemblywoman Autumn Burke, D-Marina Del Rey (Los Angeles County), point out that human eggs, sperm and embryos are in demand for research on fertility, stem cells, cloning and gene editing. They claim the only way to meet the growing demand is to increase supply by paying women for their eggs. California law allows such compensation for fertility purposes, but women donating eggs for research may be reimbursed only for their expenses.

The arguments for the legislation ignore the repercussions for prospective donors. While the bill claims, “Concerns that women will be exploited if compensated for providing human oocytes for research have not borne out” in other states, we can find no support for this statement.

A thriving egg trade depends on recruits in financial need. People who are likely to be screened out of the fertility market, which favors white donors and class markers such as higher education, may well qualify as research donors. That means AB922 will affect a range of low-income women, women of color and gender-non-conforming people with ovaries.

Proponents claim that hormonal stimulation for egg retrieval is safe. Yet there is no conclusive longitudinal data on the health effects of egg harvesting despite reproductive-health advocates’ repeated calls for studies. Without adequate research on the health effects of egg retrieval, informed consent is impossible.

Fresh evidence for the troubled state of egg donation comes from research that one of us (Tober) conducted with over 350 women who provided eggs for fertility purposes. The majority of participants reported that financial need was a primary motivation for their egg donations. Their average age was 24; the youngest were 18. Many were students burdened by educational debt or with incomes below the federal poverty level.

The majority of participants reported being assured that complications from the procedure are “extremely rare” or occur in “less than 1%” of cases. But the number who experienced substantial health effects belies these statements. The complications included hospitalization with severe ovarian hyperstimulation syndrome, ovarian torsion requiring removal of an ovary, surgical mishaps and internal bleeding, pain and bloating requiring at least a week away from work, and hormonal disruptions. Two 24-year-old women in the study suffered critical ovarian hyperstimulation and almost died of organ failure.

Supporters of AB922 say laws protecting human research subjects will cover those who provide eggs. But egg providers aren’t like other research subjects because they’re providing material for research unrelated to their own health. Their reactions to repeated hormone injections and surgical egg retrieval are not what’s being studied.

The law requires institutional review boards to ensure that the benefits of studies outweigh the risks to human subjects. But such boards may not weigh the risks to egg providers as seriously as they do those to typical human research subjects. In addition, risk-benefit analyses vary from institution to institution.

This bill is opposed by a number of state and national reproductive rights, women’s health, LGBTQ rights and public interest organizations. Even with amendments made last week, AB922 emphasizes scientific enterprise while ignoring the humanity of women who provide research materials. We need not sacrifice human safety to advance science.

Lisa Ikemoto is a professor at the UC Davis School of Law. Diane Tober is an assistant adjunct professor at UCSF’s Institute for Health & Aging, Bixby Center for Global Reproductive Health and department of anthropology, history and social medicine.



May 4, 2016

Zubik v. Burwell: Women and Religion in the Market

Cross-posted from JURIST.

The US Supreme Court heard oral arguments in Zubik v. Burwell on March 23, 2016, six years to the day the Affordable Care Act (ACA) became law. The petitioners, a group of religious organizations, have challenged the ACA's contraceptive coverage requirement. The challenge is a free exercise claim under the Religious Freedom Restoration Act (RFRA) [PDF], a federal statute. The court has now heard four challenges to the ACA.

The contraceptive coverage requirement is part of a broader provision that requires coverage for preventive health care without cost-sharing. This provision serves the ACA goals of improving health care access and reducing health care disparities among populations. Even small co-pays create barriers to health care. The ACA emphasizes the importance of preventive health care by removing that barrier.

Cost-sharing mechanisms like co-pays reflect the fact that health care services are delivered in a commercial market. The ACA coverage requirement applies to FDA-approved contraceptives. Prices for drugs and devices in the US are among the highest in the world. Contraceptives are distributed within that market. Recent stories about the role of profit-motive in pharmaceutical pricing highlight new cancer drugs and Hepatitis C drugs that cost several hundred thousand dollars a year. Plain old oral contraception, the most widely used contraceptive, can cost close to $1,000 per year for those without insurance coverage. Intrauterine devices, a type of long-acting reversible contraception, typically cost $500 to $1,000. Those amounts are less than 1 percent of the highlighted examples, but they are a great deal more than many can afford. Because most FDA-approved methods are available on a prescription-only basis, obtaining contraception also requires the time and cost of visiting a doctor. Oregon and California have enacted law making some contraceptives (the pill, the ring and the patch) available over-the-counter, with a pharmacist prescription. Those laws make the doctor's visit, and the accompanying costs, unnecessary for most. People without coverage, however, will still face out-of-pocket costs for the contraceptives.

The contraceptive coverage requirement applies to employers who provide health insurance as a benefit. The Zubik petitioners are religious organizations who hire employees and run colleges. Their employees and students rely on petitioners for health insurance access, but do not all share the petitioners' religious objections to contraceptive use. The ACA provides accommodation for religious employers, which removes petitioners from the responsibility of paying for coverage and yet makes coverage available to employees and students. Petitioners, however, claim that submitting the one-page form to obtain the accommodation makes them complicit in providing contraceptives.

The arguments were fascinating. You can listen to or read [PDF] them. RFRA requires that petitioners show the contraceptive coverage requirement imposes a substantial burden on free exercise of religion. If petitioners can do that, the government must justify the burden by showing that the contraceptive coverage requirement is based on a compelling state interest and that there is no less restrictive means of achieving that interest. The justices and lawyers spent much of oral argument addressing the substantial burden requirement. In an exchange with Justice Kagan, Paul Clement, representing petitioners, distinguished between an authorization form and an opt-out form. Clement seemed to suggest that an opt-out form would not make petitioners complicit, while an authorization form would, and thus, substantially burden free exercise. Much of the substantial burden argument turned into a battle of analogies. Noel Francisco, also representing petitioners, characterized the coverage requirement as "seizing control." The most bandied-about analogy was "hijacking"-as in, by requiring contraceptive coverage, the government is hijacking the religious employers' benefit plans. Chief Justice Roberts fully embraced the hijacking analogy. In the meantime, Justices Sotomayor and Kagan challenged Clement on petitioners' analogy to military objectors during war. Clement agreed that laws penalizing conscientious objectors substantially burdened objectors' free exercise, but asserted the objectors had to affirmatively object, while petitioners should not have to in order to obtain accommodation.

Donald Verrilli represented the US government in arguments. (Because he is the US Solicitor General, the justices call him "General Verrilli.") He argued that the procedure for obtaining an accommodation would not substantially burden petitioners' free exercise of religion. He and Justice Alito spent some time in the weeds about the fact that employers with self-insured plans must submit not one, but two pieces of paper. The existing accommodation exempts religious employers from paying for contraceptives regardless of whether the plan is fully insured or self-insured. So the only difference is, in fact, the extra piece of paper.

Verrilli marshaled his time to address petitioners' proposed alternatives to the existing accommodation. Petitioners' briefs proposed that rather than obtaining contraceptive coverage through employer-sponsored or student insurance, employees and students could use Medicare, Medicaid, Title X, contraception-only insurance policies or individual policies purchased in the insurance marketplaces. Some of these proposals do not exist. For example, insurers do not offer contraception-only policies. Even if available, a separate policy might very well offer a different provider network than a petitioner's plan. All of the proposals, including individual policies, would raise barriers to access and undermine the purpose of requiring preventive care coverage without cost-sharing. None, as Verrilli pointed out, are available under existing law. Access to Medicare, Medicaid, Title X and the marketplaces would require significant amendment of eligibility laws.

Near the end of Verrilli's allotted time for argument, Sotomayor returned to the conscientious objector analogy. She distinguished conscientious objectors in wartime from the Zubik petitioners' challenge to the accommodation. In Sotomayor's view, conscientious objectors do not trigger regulatory power over third parties, but the effects of Zubik petitioners' request would rebound on petitioners' employees and students. Sotomayor's distinction points to the origins of the RFRA. Congress enacted RFRA in response to a 1989 Supreme Court decision called Employment Division v. Smith. The late Justice Scalia wrote the majority opinion, in which the court stated that the Constitution's Free Exercise Clause did not excuse an individual from complying with a generally applicable law. In other words, the Constitution does not require accommodation for those whose religious beliefs place them in conflict with the law. Scalia's opinion listed examples-laws requiring military service, payment of taxes and vaccination. RFRA passed with bi-partisan support. Many supporters worried that the Supreme Court had peeled back protection for members of minority religions whose beliefs are more likely to differ from majoritarian norms underlying law. In Smith, for example, the court rejected free exercise claims by two Native Americans who were fired and denied unemployment benefits after using peyote in a religious ceremony. Before Smith, the court had recognized free exercise claims by a member of the Seventh-day Adventist Church who was fired for refusing to work on Saturday, the Adventist Sabbath. In those two cases, exempting the religious claimants from state unemployment compensation laws did not interfere with others' rights. Exemption may have inconvenienced the state unemployment office, but it did not produce interference with third party rights.

With Scalia's death, it seems very likely the eight justices may split. Questions and statements in oral argument, as well as prior votes, indicate that Roberts, Alito, Thomas and perhaps Kennedy will hold that the existing accommodation violates petitioners' statutory rights under RFRA. Ginsburg, Breyer, Kagan and Sotomayor, on the other hand, seem likely to find no violation.

In the meantime, the court has taken an unusual step. On March 29, the court issued an order [PDF] directing the parties to file additional briefs. The briefs are to address "whether and how contraceptive coverage may be obtained by petitioners' employees through petitioners' insurance companies, but in a way that does not require any involvement of petitioners beyond their own decision to provide health insurance without contraceptive coverage to their employees." The Order includes an example for the parties to consider. What if petitioners contracted with an insurer and informed the insurer that they did not want to include contraceptive coverage and the insurer notified employees that it would "provide cost-free contraceptive coverage and that such coverage is not paid for by petitioners and is not provided through petitioners' health plan." The example echoes a hypothetical that Clement and Francisco used in arguments. They posited an "uber-insurance policy" that provides contraceptive coverage to all women in the US, as a counterpoint to the alleged hijacked plans offered by petitioners to employees and students. In essence, they described a private single-payer plan for contraception. Both the court's example and the uber-policy scenario rely on the fictional existence of contraceptive-only plans. Even if petitioners and five justices will this type of plan into existence, it would require significant government intervention in the market, as well as two forms of insurance and the possibility of two different provider networks for petitioners' employees and students.

The order and the question it poses signals what the vote will hinge on. More specifically, it indicates Kennedy's attentiveness to the complicity concerns and the fact that RFRA does not permit religious claimants to hijack the government's administrative and regulatory systems to implement an accommodation. The court may split along other lines, as well. Ginsburg asked whether religious organizations should necessarily receive the same protection under RFRA as a church. Kennedy asked whether a church organization should be treated the same as a university. As noted, petitioners consist of both church-affiliated organizations and religious universities. The questions suggest that universities may be less likely to receive accommodations that impose burdens on third parties. On the other hand, Ginsburg and Kennedy's questions may just have been aimed at Francisco's sweeping assertions about the RFRA's scope of protection for free exercise.

What should be notable is that because the parties to the case are religious employers and the federal government, people who use contraceptives-mostly women, are positioned as third parties. Yet, the so-called third parties have a significant stake in this case: health, autonomy and equality. When you set aside the analogies and hypotheticals, the case positions women between the privatization of health care and the religious beliefs of others.