Top Bioethics News Stories (Fall-Winter 2021)

“FDA Faces Critical Test with Alzheimer’s Drug Decision”

by Bob Herman, Axios, June 4, 2021

The FDA will soon decide the fate of Biogen’s experimental Alzheimer’s drug. But there is one glaring issue—there is no conclusive evidence the drug effectively treats the crippling neurological disease. Why it matters: This will be one of the FDA’s most important decisions in years. The outcome will show whether the federal agency sides with the overwhelming scientific consensus that the drug isn’t proven to work, or with an industry and a patient population desperate for anything to be approved. (https://tinyurl.com/bdemf575)

“Newly Disclosed FDA Documents Reveal Agency’s Unprecedented Path to Approving Aduhelm”

by Matthew Herper, Damian Garde, and Adam Feuerstein, STAT News, June 22, 2021

The document dump follows weeks of bracing criticism of the FDA, which departed from regulatory precedent to approve Biogen’s treatment. Instead of judging Aduhelm based on its effect on the progression of Alzheimer’s, for which the evidence is debatable, the agency approved the drug based on its ability to remove brain plaques called beta-amyloid, which are believed to contribute to the disease. (https://tinyurl.com/346pymyz)

The U.S. FDA broke precedent and its own standards for approving Alzheimer’s drug candidates by going against the near-unanimous recommendations of an independent advisory committee and approving Biogen’s aducanumab (trade name: Aduhelm). Usually, drugs that are fast tracked for approval have not undergone Phase 3 clinical trials, but aducanumab has, and, importantly, it failed to show efficacy in one of two Phase 3 trials. The other trial showed that the drug decreased beta-amyloid plaque in the brain, but it did not show a notable difference in the progression of Alzheimer’s disease. The drug is priced at $56,000 per year. The FDA panel may have approved the drug in hopes that it spurs more research into antibody therapies for Alzheimer’s, and some panel members may have had ties with Biogen.

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“Facebook Knows Instagram Is Toxic for Teen Girls, Company Documents Show”

by Georgia Wells, Jeff Horwitz, and Deepa Seetharaman, The Wall Street Journal, September 14, 2021

The Instagram documents form part of a trove of internal communications reviewed by the Journal, on areas including teen mental health, political discourse and human trafficking. They offer an unparalleled picture of how Facebook is acutely aware that the products and systems central to its business success routinely fail. The documents also show that Facebook has made minimal efforts to address these issues and plays them down in public. (https://tinyurl.com/4wppskjt)

Former Facebook employee Francis Haugen released thousands of pages of documents, first to The Wall Street Journal, and then to various other media outlets, showing that Facebook, Inc. (now Meta Inc.) knows Instagram contributes to poor mental health in teen girls. This is despite Zuckerberg’s testimony before Congress that the company did not find a clear correlation between teens and mental health. The company also knows, though it did not make public, that globally Facebook is used to incite violence and promote genocide. Facebook and Instagram have been a hub for human traffickers, and state actors have gamed the algorithms to manipulate public opinion through propaganda campaigns. This has spurned a bi-partisan Congressional investigation into the unethical business practices of Meta and other social media companies.

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“Unprecedented Texas Abortion Ban Goes into Effect”

by Oriana Gonzalez, Axios, September 1, 2021

A law that bans abortions after six weeks, including in cases of rape and incest, went into effect in Texas on Wednesday. Why it matters: The law, one of the most restrictive abortion bans in the U.S., prohibits the practice after a fetal heartbeat is detected—before many people know they are pregnant. It also incentivizes individuals to sue anyone suspected of helping a woman obtain an abortion—and awards at least $10,000 to people who do so successfully. (https://tinyurl.com/yjmhsu6m)

A Texas law, S.B. 8, went into effect in September 2021 that bans most abortions after the detection of a heartbeat, or at about six weeks gestation. The Department of Justice asked the U.S. Supreme Court to temporarily block the law until oral arguments were heard by the Court. The Court ended up not blocking the law, but it did fast track the timeline to hear oral arguments. The Texas law is enforced via lawsuits brought by private citizens to anyone aiding and abetting an abortion. After hearing oral arguments, the Court left the Texas law in place but said abortion providers have a right to challenge the law in federal court. The Court also limited which state officials can be sued. The passage of this law was spearheaded by John Seago, Trinity alum (MA Bioethics ’16) and legislative director of Texas Right to Life.[1]

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“Forensic Database Challenge over Ethics of DNA Holdings”

by Quirin Schiermeier, Nature, June 15, 2021

The YHRD, which was first released online in 2000, is now widely used across the world to help solve sex crimes and settle paternity cases. Holding more than 300,000 anonymous Y-chromosome profiles, it shows how particular genetic markers are fingerprints of male lineages in more than 1,300 distinct global populations. It can point to the likely geographic origin of mystery males, as in the Kollum case, but is now more often relied on to calculate the weight of evidence against a male suspect whose Y-chromosome DNA profile matches traces found at a crime scene. (https://tinyurl.com/2zvyxswz)

Several articles in 2021 pointed to the problems of genomic studies and DNA collection without proper consent, particularly when that data came from police crime scenes or suspects. Furthermore, large databases, such as the Y-Chromosome Haplotype Reference Database (YHRD), could potentially be used for ethnic profiling and surveillance. Several papers in top tier journals, such as Nature, have either retracted or flagged papers over concerns that the data used in the studies had ethical issues. The Intercept reported that 8 out of 24 board members at the journal Molecular Genetics and Genomic Medicine (Wiley) resigned after controversy over ethics concerns regarding genetics papers from China. Many of these papers have co-authors from the police or military.[2]

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“China’s Gene Giant Harvests Data from Millions of Women”

by Kirsty Needham and Clara Baldwin, Reuters, July 7, 2021

A Chinese gene company selling prenatal tests around the world developed them in collaboration with the country's military and is using them to collect genetic data from millions of women for sweeping research on the traits of populations, a Reuters review of scientific papers and company statements found. (https://tinyurl.com/2rm3bn54)

Earlier in the year, Reuters reported that BGI Group’s prenatal screening test, one of the most popular in the world, collects women’s genetic and health information into a database that could be used for genetic technologies, surveillance, and profiling. Many women did not realize that their genetic data and their medical histories were being stored in a database and say that had they known, they would not have used the test. The Wire China, a subscription-only publication on China business, published a profile of BGI in March highlighting the company’s COVID-19 tests and its ties to the Chinese government and the People’s Liberation Army. BGI’s technology was instrumental in completing the Human Genome Project in 2001.[3]

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“Drug Overdose Deaths, Fueled by Fentanyl, Hit Record High in U.S.”

by Jon Kamp and Julie Wernau Wall Street Journal, November 17, 2021

The U.S. recorded its highest number of drug-overdose deaths in a 12-month period, surpassing 100,000 for the first time in the shadow of the coronavirus pandemic, according to the Centers for Disease Control and Prevention. There were an estimated 100,306 drug deaths in the 12 months running through April, the latest CDC data show. This marks a nearly 29% rise from the deaths recorded in the same period a year earlier, indicating the U.S. is heading for another full-year record after drug deaths soared during the Covid-19 pandemic. (https://tinyurl.com/2b3sahbu)

The U.S. has had an ongoing problem with drug overdose deaths due to opioids, which only became worse during the pandemic. In 2021 over 100,000 people died from drug overdoses, led by bootlegged fentanyl. New York approved a controversial solution to the overdose problem by authorizing supervised injection sites where people can bring their own drugs and use sterile syringes. The sites have personnel equipped with anti-overdose medication.[4] Another solution that other states have tried is to restrict prescriptions for opioids. However, as STAT News reported in July 2021, a study in the NEJM found that 90% of the health systems surveyed gave Black patients fewer and less potent pills than white patients, further perpetuating health inequalities for pain management.[5]

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“A Pivotal Mosquito Experiment Could Not Have Gone Better”

by Ed Yong, The Atlantic, June 10, 2021

Dengue fever is caused by a virus that infects an estimated 390 million people every year, and kills about 25,000; the World Health Organization has described it as one of the top 10 threats to global health. It spreads through the bites of mosquitoes, particularly the species Aedes aegypti. Utarini and her colleagues have spent the past decade turning these insects from highways of dengue into cul-de-sacs. They’ve loaded the mosquitoes with a bacterium called Wolbachia, which prevents them from being infected by dengue viruses. (https://tinyurl.com/bdenct3z)

“In a Major Decision, WHO Recommends Broad Rollout of World’s First Malaria Vaccine”

by Helen Branswell STAT News, October 6, 2021

The World Health Organization, acting on the advice of its scientific advisers, announced Wednesday that it would recommend a broad rollout of a much-needed malaria vaccine, saying pilot testing had shown that it was safe and could be effectively deployed in remote and rural settings. The decision, which was announced by WHO Director-General Tedros Adhanom Ghebreyesus, marks a landmark moment in the fight against malaria, for which no other vaccines exist. (https://tinyurl.com/mr4xst59)

Mosquito-borne illnesses kill about half a million people per year, with close to 400,000 deaths due to malaria and 40,000 deaths due to dengue fever. Malaria is caused by a parasite that infects the mosquito, which is then spread to humans through a mosquito bite. Dengue is a viral infection also transmitted through mosquitoes. The vaccine for malaria, Mosquirix, is geared toward children under five years old, whose immune systems are less able to fight off a malarial infection. The vaccine does have some drawbacks, namely that it requires several doses and has an efficacy of 30% against severe malaria. Additionally, the vaccine prevents clinical malaria, but it does not prevent transmission from mosquito to human. Research involving genetically engineered mosquitoes showed that it stops the localized spread of dengue fever. The species of mosquito that carries the disease, Aedes aegypti, was infected with a parasite that prohibits the engineered mosquito from carrying the dengue virus. However, some question the consequences of releasing genetically engineered mosquitos into the wild.

References

[1] Emma Green, “What Texas Abortion Foes Want Next,” The Atlantic, September 2, 2021, https://www.theatlantic.com/politics/archive/2021/09/texas-abortion-ban-supreme-court/619953/; “Bioethics Alum John Seago Fights for Pro-Life Legislation”, Trinity International University, November 13, 2021, https://www.tiu.edu/news/archive/bioethics-alum-john-seago-fights-for-pro-life-legislation/.

[2] Mara Hvistendahl, “Mass Resignation at Scientific Journal over Ethically Fraught China Genetics Papers,” The Intercept, August 4, 2021, https://theintercept.com/2021/08/04/dna-profiling-forensic-genetics-journal-resignations-china/.

[3] Brent Crane, “Jolly Gene Giant,” The Wire China, March 21, 2021, https://www.thewirechina.com/2021/03/21/jolly-gene-giant/.

[4] Jennifer Peltz, “NYC Oks Safe Sites for Drug Use, Aiming to Curb Overdoses,” Associated Press, November 30, 2021, https://apnews.com/article/health-new-york-new-york-city-1f61d20529965ded7fef3fcee5f39d1e.

[5] Claudia Lopez Lloreda, “In the Same Health System, Black Patients Are Prescribed Fewer Opioids than White Patients,” STAT News, July 21, 2021, https://www.statnews.com/2021/07/21/black-patients-prescribed-fewer-opioids-white-patients/.