Do you want to start the class by reflecting on what COVID shows us about bioethics? Indiana University identifies some of the ethics of coronavirus at this link. Do you agree with the points they make? NCBI has a long analysis of the relevant ethics principles here. How do you analyze their treatment of the questions? What ethical issues have you confronted based on COVID?
Nine states and D.C.—California, Colorado, Hawaii, Maine, New Jersey, New Mexico, Oregon, Vermont, and Washington--now have physician assisted suicide legislation. Read about Maine's legislation here..
You can learn the details of how each state's laws work at DeathwithDignity.
Canada amended its statute to allow Canadians suffering from severe mental illness to be eligible for medical assistance in dying, MAID. In contrast to the United States, Canada allows MAID for people suffering from chronic pain, even those who will live a long time while suffering that pain. See CanadaLaw.
Would you recommend that the SARCO be made available in the United States? It is a "3D-printed human-sized capsule that can be operated with a press of a button by a user inside to create an airtight lock and to release nitrogen gas," resulting in death. It is available in Switzerland. What would it take to convince you to make it available in the United States? See ReadaboutSARCO for details.
D. Looking Ahead: Can We Be Sure About Brain Death and Vegetative States?
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1. BRAIN DEATH
2. BRAIN DEATH AND PATIENT AUTONOMY
Watch the videos of Jahi McMath.
McMath died in New Jersey on June 22, 2018. Read Yolonda Wilson's commentary on her death, race, and bioethics in the Hastings Center.
Is McMath's case not just about brain death, but about the racial discrimination that occurs throughout the health care system? What do you think of Professor Goodwin's analysis of the case? See Implicit Bias.
Read this medical article to teach you more about the difference between a vegetative state and a minimally conscious state. VegorMin.
Judy Illes has edited a new book on neuroethics, called Neuroethics: Anticipating the Future. The book extends the authors' earlier work and identifies what the future of neuroethics will look like, especially as technology develops. See Neuroethics.
You can see some of this history in the film, Belly of the Beast, Beast.
3. RACISM AND RESEARCH
A Toolkit raising questions about racism and bioethics is available at Toolkit. Where else in this class should racism be introduced or emphasized? Do you agree with the arguments in this BioethicsandBlackLives?
Should the US government apologize to Guatemala?
B. Setting Standards for Research With Human Subjects
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Look at the map to understand what your state says about right to try, RighttoTryMap
Much research now suggests that Patient Decision Aids (PDAs) provide a great deal of assistance to improving informed consent. They empower patients to make better decisions. What would you think of using a PDA? Read about what they are at PDA. Then see PDAs available for a long list of diseases at Disease List.
C. Looking Ahead: Improving Consent In New Circumstances
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1. CAN TECHNOLOGY IMPROVE INFORMED CONSENT?
Watch the following videos on informed consent:
Do electronic consent forms help or hinder informed consent? Could they improve patients' understanding of what they are facing? Would you rather have non-electronic or electronic informed consent? Why? See Mark Robinson's discussion of the ethics of electronic consent at What are the Ethics of Electronic Consent Forms?.
2. APOMEDIATED CLINICAL TRIALS
Compare www.patientslikeme.com (makes money by selling patient information to companies that are developing products) with http://diygenomics.net (brings tools and libraries together for small scale genomics labs for the process of sequence assembly), https://www.inspire.com (receives funding by providing research for life science companies); and http://www.armyofwomen.org (focusing on breast cancer � receives funds from grants and donations).
Visit this website, for an example of how Michigan requires women to read forms on their website, then print out a confirmation page that they read and understood the issues, and bring it to their abortion appointment.
What do you think of this New England Journal of Medicine essay, arguing that the growth of conscience protection in abortion care should persuade health care providers to integrate medication abortion into their primary care practices?
The Court overruled Roe and Casey. An edited new opinion, with bioethical questions about it, is attached. Dobbs.
The FDA has made abortion pills more widely available, including to many more pharmacies. The rule that women pick up the medicine in person will no longer be enforced. See FDA AbortionPills. A Texas group challenged the FDA's 22-year-old approval of the abortion pills, arguing that it lacked authority to do so. It also argues that the Comstock Laws make it illegal to send the pills through the mail. And it argues the drug is not safe. See TexasLawsuit. Do you agree with the FDA's response, described here, FDAResponse? Which side should win this lawsuit?
Abortion rights supporters have challenged laws in North Carolina and West Virginia, arguing that the states impose greater restrictions on pill access than the FDA imposes. North Carolina and West Virginia. What are the best arguments that the parties can make against the states' laws restricting access to the pills?
Two district courts issued conflicting rulings about using medical pills for abortion. In the Northern District of Texas, the judge ruled that the FDA improperly approved the drug twenty years ago, and issued a nationwide injunction against the drug's use. The injunction starts in seven days. In a separate case in Washington State, where Washington was joined by 17 states and the District of Columbia, the FDA was blocked from changing the current legal status of mifepristone. The Washington Attorney General said that the states in the Washington lawsuit would not be bound by the Texas injunction. The Justice Department has appealed the Texas district court ruling to the Fifth Circuit. What do you think will happen there? The NPR article suggests that the Biden administration might move directly to the Supreme Court to resolve this issue. Do you think that would happen? If so, how do you think the current Supreme Court will rule? How would Dobbs affect the possible Supreme Court decision? What do you think of the Texas judge's argument that mifepristone is used to "kill the unborn human"? The two courts' rulings are described in more detail here, NPR Story.
The Fifth Circuit ruled on that FDA case. The court said that the ruling on FDA's original ruling on mifepristone was too late to review now because it was past the statute of limitations. But the other ruling, opposing the FDA's many 2016 decisions to change delivery of mifepristone, was still valid. The doctors have standing because they might have to treat women harmed by the FDA's mifepristone rulings. See FifthCircuitFDA. The Supreme Court is the next step. What do you think they will rule?
The Supreme Court has allowed the FDA'a law to stay as it is for now and asked for comments by Tuesday about whether lower court rulings should take effect while the courts continue to hear the case. Supreme .
On Friday April 21, the Court ruled in a paragraph that there would be no stays on mifepristone while the issue is being litigated in the courts. The case is remanded to the Fifth Circuit. No stays will be allowed until either cert. is denied in the Supreme Court or until the Supreme Court rules on the case if cert. is granted. Justices Thomas and Alito dissented. What do you think of this ruling? DancovAHM.
The Fifth Circuit has ruled that the district court was correct to stay actions taken in 2016 and 2021 by the FDA in making abortion medication more available. Plaintiffs were likely to succeed on their challenges to these actions by the FDA. Judge Ho added that the initial approval of mifepristone should be set aside. Per Supreme Court decision, the Fifth Circuit's decision will not take effect until all appeals of the case are completed. Do you think this is the rule that will go into effect? Why or why not?
The Court has granted cert. on two abortion cases about the abortion pill. The cases are Food and Drug Administration v. Alliance for Hippocratic Medicine, Hippocratic, and Danco Laboratories, L.L.C. v. Alliance for Hippocratic Medicine, Danco. Keep your eyes on these cases as the Court schedules oral argument for them.
The Supreme Court has also granted cert. on an Idaho abortion case that raises the question of the relationship between EMTALA, the federal Emergency Medical Treatment and Labor Act, and Idaho abortion law. The Biden administration argues that EMTALA trumps the state's law and allows abortions to pregnant women who are in a medical emergency. The Court put on hold a state order allowing the abortion to proceed. The oral argument should occur in April. See Amy Howe, Justices take up abortion case pitting state against federal law, SCOTUSblog (Jan. 5, 2024, 6:41 PM), Howe.
The Supreme Court heard oral arguments in the abortion pill case. A summary of the argument is available at FDASum. The oral argument is available at FDAOralArg. Consider the argument made about conscience clauses. If conscience clauses allow medical providers to refuse to provide care that violates their conscience, why do they need to stop the FDA from providing abortion pills to other people? If I in conscience say, I will not use the abortion pill, and I will not treat anyone harmed by using the abortion pill, why does anything have to happen at the FDA? Have conscience clauses resolved all the problems about the abortion pill?
The Indiana Court of Appeals placed an injunction on the state's abortion law, arguing that the state's RFRA requires abortions to be available to religious people. You can read about the dispute INcase.
How do you expect the overturning of Roe to affect IVF? Would early abortion bans also make IVF illegal? Read about it here.
The Alabama Supreme Court heard a case about embryos that were created by IVF. They are stored in a cryogenic nursery where they wait for implantation into the motherfs body. They are stored at very low temperatures. A patient went through an unlocked door into the nursery and took several embryos. They were so cold they burned her hand. The embryos died when she dropped them on the floor. The parents sued for damages under Alabama's wrongful death statute. The trial judge rejected the lawsuit, saying the extrauterine embryos were not protected by that statute. The Supreme Court, however, ruled that the statute "applies to all unborn children, regardless of their location." You can read the opinion at AlabamaSupremes. Several Alabama clinics stopped doing IVS because they were about the legal risks connected with the procedure. Clinics. What would those be? What do you think of NPR's story about the decision's effects on IVF? NPR.
Read the following description of the developments in Alabama about in vitro fertilization, IVF. Alabama.What is your reaction to these developments? How do you think the law should handle IVF arguments that embryos are children?
A 61-year old woman was a surrogate for her granddaughter's birth! See Grandma.
2. ADOPTIVE PARENTS AND FORGOTTEN FATHERS
For more background on Veronica's mother, read WPost. Slate's analysis is available at Slate.
The Supreme Court has granted cert. on the constitutionality of the Indian Child Welfare Act. They combined four cases, and are considering whether there is an anti-commandeering case under the Tenth Amendment, saying the Act takes too much power away from the states. They also consider whether there is an equal protection violation because the statute discriminates on the basis of race. Would the Court's ruling affect a case like Adoptive Couple? The cases are all linked at the following website: Haaland.
What are the ethics of a kidney voucher system? A donor can give his kidney today, and receive a voucher that promises his loved one will receive another kidney when she needs it. The intended recipient does not yet need a kidney at the time the donation is made. Can the donor trust the organ people to deliver on the promise? Is the voucher an enforceable contract? See Donate Today So You Loved One Can Receive a Future Live Donor Kidney.
a. Altruistic NEAD Chains
b. Let the Market Decide
c. Encouraging Donation
What do you think of the morality of Imminent Death Donation, which involves living donors near the end of their lives, and "advocates for non-vital organ donation from the living donor prior to withdrawal of all life-sustaining treatment." Should it make a difference if the living donor is capable or incapable of making the decision to donate? Is this a good way to increase organ donations? Jordan Potter addresses the ethical issues connected with IDD at Imminent Death Donation: Ethical and Practical Policy Considerations.
At the end of Note 6, p. 452, note that the Biden administration has just issued new rules about exemptions from contraception. Religion Clause summarizes the new regulations this way: "The proposed rule changes would eliminate the current exemption for employers and schools that have moral, as opposed to religious objections. The new rules would retain the exemption for employers and universities with religious objections. However, under new arrangements, their employees and students could, in addition to existing options, obtain contraceptive services through an individual contraceptive arrangement with another provider, and without any involvement on the part of the employer or university with religious objections." What do you think of these new regulations? Read about them here.
Scientists study genes in order to determine how diseases are caused. By means of DNA sequencing, Myriad identified two genes, BRCA1 and BRCA2, that cause breast and ovarian cancer. To visualize what the genes look like, go here.
The Federal Circuit's decision is available here: California v Broad. Watch this video to understand the difference between a prokaryote and a eukaryote:
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Moderna and Pfizer are arguing about the patents associated with their COVID-19 vaccines. Moderna alleged three of its patents were violated by Pfizer. How could this difference of opinion about the patents be resolved? For background to this dispute, see TextExplainingCOVIDPatentDispute.
"A rogue scientist in China claims to have edited a gene in two human embryos and implanted them in the mother's womb, resulting in the birth of genetically altered twin girls." Is there anything wrong with that? Why or why not? Why does Prof. Eric Topol call it "a dangerous breach of medical ethics and responsible research and must be condemned"? What is the difference between this procedure and CRISPR? Can you tell the difference? See Editing Babies? We Need to Learn a Lot More First.
Law Professor Henry T. Greely reviews science's appropriate response to He Jiankui's CRISPR use that produced children with edited DNA. Do you agree or disagree with the steps that he says science should take in these situations? The text is available at HowShouldScienceRespond?.
Listen to the Stanford podcast on Gene-editedBabies.
The patent dispute between Broad Institute and the University of California is ongoing. One recent story explained, "Over the years, the USPTO has repeatedly ruled in favour of the Broad, but the CVC team prompted another evaluation of patents covering what will probably be the most lucrative application of gene editing: modifying genomes in eukaryotes, a group of organisms that includes humans and crops. Both CVC and the Broad claimed to be the first to have adapted CRISPR–Cas9 gene-editing for use in eukaryotes, and the case involved poring over lab notebooks and e-mails to work out when each team achieved success. On 28 February [2022], the USPTO determined that the Broad got there first, potentially by a matter of weeks." The article concludes the worth of the patents is still uncertain, and that CRISPR is not the whole story. See NatureArticle.
The Michigan Supreme Court reversed a life-without-parole sentence for Kemo Parks, who was convicted of first degree murder that occurred when Parks was 18 years old. The court ruled that sentence was cruel and unusual in violation of the Michigan Constitution because it did not take account "the mitigating characteristics of youth, specifically late-adolescent brain development." See Parks. Slate ran a podcast about the case, asking Is a 25-Year-Old's Brain Mature?. What do these developments add to your thinking about the role of knowledge about the brain in assessing criminal liability?
How much should physicians participate in the death penalty? Is it an ethical violation for them to assist? Read Prof. Deborah Denno, NEJMText.
Two ministers filed a lawsuit arguing their RFRA rights were violated by an Indiana law that does not allow them to touch the patient condemned to death. They argue it is their religious freedom right to contact the person. Indiana allows only non-contact visits. Will they win their case? Does their patient have a religious freedom right to be touched? See Contact.
What do you think about neuroprediction? Usually courts consider whether a defendant will be a future risk to society. Prof. Kent Kiehl has a test that uses brain age to measure future risk. Brain age considers how much gray matter is in the brain. By studying many brains, the scientists can usually predict who will be rearrested for the commission of another crime. Should such neuroprediction now be used in court? See A Dangerous Brain.
A group of prominent neuroethicists conclude that brain imaging tests can be used to measure people's pain more accurately. Yet it is not yet time to use the evidence to prove or contest pain in court. Do you agree? See Brain Imaging Tests For Chronic Pain.
Read Adrian Owen's new book describing his career in brain research, at Into the Gray Zone.
Nita Farahany, Henry Greely and 15 others provided an interesting analysis of the latest brain research.They explore the ethical limits of using human brain tissue in research. They identify three classes of brain surrogates that raise hard questions. First are organoids, 3D structures that can be built from stem cells. Second is ex vivo brain tissue, in which cells are taken from humans during medical treatment. Third are chimaeras, in which human cells are transferred into animal brains. What limits would you place on such technology? Read their text here.
The New York Times reported on a new technique to improve the health of people who have suffered brain damage. Their patient suffered her injury 18 years ago, and post-injury had a much harder time reading, concentrating, and working, and also suffered from fatigue. The surgeon threaded two electrodes into her thalamus. It was critical for the doctors to place them precisely. The electrodes were attached to a device in the patient's chest that provided active current for 12 hours a day. The woman then scored better on tests and was much less fatigued. What do you think about such a procedure for the millions of people who have suffered brain injury? See Benedict Carey's article at Brain Damaged Woman. Carey then wrote a story about different electronic treatments for the brain. He mentioned this woman's story; E.C.T. (electroconvulsive therapy), an older system that sends seizure through the brain to decrease depression; D.B.S. (deep brain stimulation), an electrode that affects a specific region of the brain; or coupling different regions of the brain to work together. Neural. Are you optimistic or pessimistic about these discoveries?
Is it feminist or sexist to identify differences between male and female brains? Is it feminist to recognize that women's brains are different from men's brains, which is recognized now that researchers pay more attention to women's presence in health care? Or will women be harmed in a sexist manner if scientists find their brains are different from men's brains? You can read about that debate at Male and Female and Neurosexism.
5. Solitary Confinement and the Death Penalty?
6. What is the Practice of Medicine?
Read Dr. Fins' reflections on the death of Terry Wallis and the treatment of brain-injured patients. Do you agree with him? What should the future treatment of brain-injured patients look like? See Fins.
Teacher Resources
