September 22, 2020

The history of eugenics in the United States leaves todays migrant women vulnerable, arguesBrianna Theobald, an assistant professor of history at theUniversity of Rochester, in aWashington PostMade by History op-ed.

Theobald writes in response to a whistleblower complaint, one claiming that a migrant detention facilitythe Irwin County Detention Centerhas been the site of egregious reproductive injustices,including alleged coerced hysterectomies.

The author of Reproduction on the Reservation: Pregnancy, Childbirth, and Colonialism in the Long Twentieth Century(University of North Carolina Press, 2019), Theobald argues that the structural vulnerability of detained migrants leaves them susceptible, as has historically been the case for many marginalized communities, to a range ofreproductive abuses, as well as to medical neglect and inadequate care.

According to Theobald, these alleged abuses occur in systems that are driven by dangerous ideas about racial hierarchies and eugenic interventions. She writes that todays allegations of coerced hysterectomies and sterilization echo the history of eugenics and neo-eugenics, noting that:

Prominent eugenicist Charles Davenport defined the practice of eugenics as the science of the improvement of the human race by better breeding.Eugenics gained popularity in the United States in the early 20th century, appealing broadly across the political spectrum because it promised a scientific solution to social problems stemming from industrialization, urbanization, immigration and changing gender norms.

Theobald further explains the now-discredited notion of eugenics: The theory held the human race could be improved by encouraging the reproduction of fit individuals, specifically the white middle-class families whose declining fertility rates had become the source of much anxiety, and discouraging the reproduction of individuals believed to possess undesirable traits.

She then outlines several cases of sterilization targeting marginalized populations in US history, including ontheCrow Reservation in Montana in the 1930s and in California prisons during the late 1990s and early 2000s, while highlighting the ongoing work of the reproductive justice movement.

Tags: Arts and Sciences, Brianna Theobald, Department of History

Category: Voices & Opinion

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Detained migrants susceptible to a range of reproductive abuses and medical neglect - University of Rochester

September 22, 2020

Researchers find that having a sexy mindset makes people perceive potential partners as way more attractive.

Theres something to rose-tinted glasses after all.

A group of psychologists at the University of Rochester and the Israeli-based Interdisciplinary Center (IDC) Herzliya discovered that we see possible romantic partners as a lot more attractive if we have what the scientists call a sexy mindset. Under the same condition we also tend to overestimate our own chances of romantic success.

The researchers examined what would happen if a persons sexual system is activatedthink feeling friskyby exposing test subjects to brief sexual cues that induced a sexy mindset. Such a mindset, the team found, reduced a persons concerns about being rejected, while simultaneously inducing a sense of urgency to start a romantic relationship.

The US-Israeli team noticed that people often have overly optimistic views when it comes to a potential partner and their own chances of landing a date. Their latest research, published in the Journal of Social and Personal Relationships, sought to explain the biased perception. Its precisely this bias, the team concluded, that may provide people with the necessary confidence to worry less about rejection and instead motivate them to take a leap of faith to pursue a desired romantic relationship without hesitation.

If people anticipate that a partner shares their attraction, it is that much easier to initiate contact, because the fear of rejection is lessenedcoauthor Harry Reis, a professor of psychology and the Deans Professor in Arts, Sciences & Engineering at Rochester

People are more likely to desire potential partners and to project their desires onto them when sexually aroused, says lead author Gurit Birnbaum, a social psychologist and associate professor of psychology at the IDC. Our findings suggest that the sexual system prepares the ground for forming relationships by biasing interpersonal perceptions in a way that motivates human beings to connect. Clearly the sexual system does so by inspiring interest in potential partners, which, in turn, biases the perceptions of a potential partners interest in oneself.

Having evolved over millennia, the sexual behavioral system of humans ensures reproduction and survival of the species by arousing sexual urges that motivate us to pursue mates. Success depends on targeting the right potential partners who are not only perceived as desirable but also as likely to reciprocate our advances. In previous studies the researchers found that people often refrain from courting desirable possible partners because they fear rejection.

Forming stable sexual relationships had, and continues to have, a great deal of evolutionary significance, says study coauthor Harry Reis, a professor of psychology and the Deans Professor in Arts, Sciences & Engineering at Rochester.

If people anticipate that a partner shares their attraction, it is that much easier to initiate contact, because the fear of rejection is lessened, says Reis. One of the main purposes of sexual attraction is to motivate people to initiate relationships with potentially valuable, and valued, partners.

Across three experiments the team discovered that sexual activation helps people initiate relationships by inducing them to project their own desires onto prospective partners. In other wordsyou see what you want to see if youve been sexually primed.

To test the effects of a sexy mindset, the team exposed participants across three sperate studies either to sexual (but not pornographic) stimuli or to neutral stimuli. Next, the participants encountered a potential partner and rated this partners attractiveness and romantic interest in them. Participants interest in the partner was self-reported or evaluated by raters.

In the first study, 112 heterosexual participants, aged 20 to 32, who were not in a romantic relationship, were randomly paired with an unacquainted participant of the other sex. First, participants introduced themselves to each other by talking about their hobbies, positive traits, and future career plans while being videotaped. Then the team coded the videotaped introductions for nonverbal expressions of so-called immediacy behaviorsuch as close physical proximity, frequent eye contact, and flashing smilesthat indicates interest in initiating romantic relationships. They discovered that those participants exposed to a sexual stimulus (versus those exposed to the neutral stimulus) exhibited more immediacy behaviors toward potential partners and perceived the partners as more attractive and interested in them.

For the second study, 150 heterosexual participants, aged 19 to 30, who were not in a romantic relationship, served as a control for the potential partners attractiveness and reactions. Here, all participants watched the same prerecorded video introduction of a potential partner of the other sex and then introduced themselves to the partner while being videotaped. The team coded the videotapes for attempts to induce a favorable impression. Just as in the first study, the researchers found that activation of the sexual system led participants to perceive potential partners as more attractive as well as more interested in a romantic relationship.

In the third study, the team investigated whether a participants romantic interest in the other participant might explain why sexual activation affects perceptions of others romantic interest in oneself. Here, 120 heterosexual participants, aged 21 to 31, who were not in a romantic relationship, interacted online with another participant, who in reality was an attractive opposite-sex member of the research team, in a get-to-know-each-other conversation. The participants rated their romantic interest in the other person as well as that persons attractiveness and interest in them. They found again that sexual activation increased a participants romantic interest in the other participant, which, in turn, predicted perceiving the other as more interested in oneself. Having active sexual thoughts apparently arouses romantic interest in a prospective partner and encourages the adoption of an optimistic outlook on courting prospects with a partner, concluded the researchers.

Sexual feelings do more than just motivate us to seek out partners. It also leads us to project our feelings onto the other person, says Reis. One important finding of the study is that the sexual feelings need not come from the other person; they can be aroused in any number of ways that have nothing to do with the other person.

Yet, theres also the obvious possible pitfall: when sexual feelings are present, people tend to assume that the other person shares their attraction, whether warranted or not, notes Reis. Or you end up kissing a lot of frogs, adds Birnbaum, because a sexy mood makes you mistake them for princes.

Birnbaum and Reis have spent the last few decades studying the dynamics of human sexual attraction. In a 2019 study, the duo found that when people feel greater certainty that a prospective romantic partner reciprocates their interest, they will put more effort into seeing that person again. Furthermore, people will rate the possible date as more sexually attractive than they would if they were less certain about the prospective dates romantic intentions.

The research team for the latest study, which was supported by the Binational Science Foundation (BSF) also included Mor Iluz, Einat Plotkin, Lihi Tibi and Ronit Hematian at the IDC, and Moran Mizrahi at Ariel University.

Tags: Arts and Sciences, Department of Psychology, Gurit Birnbaum, Harry Reis, research

Category: Society & Culture

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Like rose-colored glasses, a 'sexy mindset' helps you see what you want to see - University of Rochester

Eight months into the COVID-19 pandemic, healthcare systems have been stretched to their limits after over half a million deaths, and the global economy has taken a hit unseen since the Great Depression. Until this point, the desperate international community has viewed a vaccine as the cure-all to the crisis. Such vaccines typically require up to ten years of research and testing before reaching the market. Still, scientists internationally are racing to create a safe and effective COVID-19 vaccine by next year. With more than 165 vaccines currently in development and 32 already in human trials, it has become clear that top vaccine-manufacturing nations are already competing to secure early access.

Though global health solutions warrant a coordinated global response, international cooperation to fight COVID-19 has been absent. With national interests beating out global cooperation, the global race to a coronavirus vaccine has morphed into something of a scientific gold rush with geopolitical undertones. In this risky game of vaccine nationalism, the scramble to a pandemic solution poses top-down consequences: a dangerous playing ground for major powers unchecked ambitions, and one that only breeds human insecurity.

With vaccine nationalism, self-interested states undertake a me-first approach to the development and distribution of vaccines and vie to secure doses of the vaccine for their own citizens before they are made available to the rest of the world. This nationalistic behaviour has been observed during COVID-19, with countries pumping the most money into their home teams.

When it comes to creating the vaccine, the US has opted to take an America Alone stance, which only further affirms the US abdication of global leadership. Acting on his pledge to deliver an American vaccine by the end of the year, President Trump in April announced that the US would be embarking on Operation Warp Speed, a federal initiative to coordinate efforts and fast-track the development of a coronavirus vaccine. Through this operation, the US has cut billion-dollar advance deals with pharmaceutical and manufacturing companies for exclusive access to millions of doses. For many observers, Trumps Operation Warp Speed translates as an extension of his America First political agenda. Accordingly, with the US retreat from multilateralism, the overarching assumption in the international community is that Trump will seek to vaccinate Americans first with an American vaccine.

While vaccine nationalism alone poses a credible threat to populations around the globe, it also serves as a dangerous proxy for geopolitical tensions. The race to develop a COVID-19 vaccine holds great rewards for the victor; achieving such a prominent scientific victory would signify economic recovery and national glory. Inevitably, this pursuit has resulted in the deep politicization of vaccine development. While public health should indeed be paramount for leaders, adopting a zero-sum approach does more harm than good.

At the forefront of COVID-19s nationalistic vaccine-geopolitics is the rivalry between the worlds two superpowers, the US and China. Since the outbreak of the pandemic, the US has underscored an accusatory China-virus rhetoric that has only succeeded in pushing the rapidly deteriorating US-China relationship into a dangerous phase unlike anything seen in fifty years. In competing quests for political glory, both superpowers are deviating from the multilateral path, opting instead to pour resources en masse into their respective national vaccine efforts. For the US, winning the race before the presidential election would fulfill Trumps America First agenda and secure a victory to boast over China. For China, on the other hand, the pandemic presents a unique opportunity to repent for its initial failures in Wuhan; a chance to project its soft power, rebuild its influence, and brand itself as a responsible nation, in contrast to the Western democracies that have demonstrated reprehensible pandemic responses. Beijings urgency has been highlighted in its plans to vaccinate its soldiers first, a military-civil fusion between the vaccine developer CanSino and the Peoples Liberation Army. To be the first to the coronavirus vaccine would mean cementing Chinas position as a viable candidate for global leadership a role it has sought to fill in Americas place.

Other authoritarian rivals like Russia have also engaged in vaccine nationalism. For the Kremlin, being first to the vaccine is a matter of national prestige as it tries to assert the image of Russia as a global power of stature capable of competing with the US and China. On July 17, Russian drugmaker R-Pharm announced a licensing deal with British pharmaceutical manufacturer AstraZeneca to transfer the entire process for full reproduction of the University of Oxfords COVID-19 vaccine in Russia. Russias AstraZeneca deal follows accusations from the Canadian, British, and American governments of the Kremlins attempt to steal vaccine data. While the Russian government denies these charges, the allegations draw attention to Russias nationalistic behaviour amid the pandemic. Not only does Russias AstraZeneca deal secure its doses of a potentially successful Oxford vaccine, but it also complements the nations attempts to produce its own. This proved to be the case when, on August 11, Russia announced that it was the first country to secure regulatory approval of its vaccine, Sputnik-V an alarmingly quick, albeit rushed feat that has created worry among many members of the international community.

While these countries are doing what it takes to compete for the cure, the lower-level outcomes prove rather contradictory to the principles of global public health and vaccine development. Such projects typically entail a collaborative effort between multiple parties from different countries not one in which wealthy nations in pursuit of political clout fail to ensure human security.

With developed nations erecting barriers to vaccine access, the issue of vaccine distribution has become a challenge of supply and demand. The most proximate consequence of vaccine nationalism sees a disproportionate burden placed onto the worlds vulnerable populations as the coronavirus cure becomes a private good inaccessible to both developed and developing nations.

Known for its notoriously high drug prices, the United States provides a prime example of vaccine nationalisms shortcomings in wealthy countries. Medical monopolies hold the power to steer vaccine distribution and threaten to limit supply. Thus, Americans in need become priced-out. As the Trump administration attempts to buy exclusive rights to a coronavirus vaccine, it is very possible that it will be priced far too high for many Americans. In February, US Secretary of Health and Human Services Alex Azar told Congress that the government will not intervene to guarantee the affordability of COVID-19 vaccines for Americans. In such a case, with a lifesaving vaccine inaccessible to many underinsured and marginalized communities, only more lives will be lost.

For developing countries with less bargaining power and resources, populations are left insecure as major powers rush to hoard vaccine doses. Such a failure of the international community was observed during the swine flu pandemic in 2009, when wealthier countries monopolized the initial supply of the vaccine. A repeat of the tragedy poses numerous consequences; for one, poorer nations will be forced to watch as their wealthier counterparts deplete supplies, allowing high-risk people to go unprotected in the interim of vaccine replenishment. The pressures of vaccine nationalism may even force desperate countries to block the export of vital vaccine components, leading to the breakdown of supply chains. In short, vaccine nationalism, in its paradoxical neglect of public welfare, only succeeds in extending the pandemic.

The threat of vaccine nationalism is well recognized, as some countries and health organizations have taken it upon themselves to develop preventative mechanisms. One of the most prominent of these efforts is the COVID-19 Vaccine Global Access (COVAX) Facility, a fund that, much like the US, invests into vaccine candidatesthis time on behalf of the rest of the world. While such initiatives bring an optimistic light to COVID-19 and the possibility of global cooperation, the dire reality of the situation is that the latent ability of any nation to jeopardize access to the vaccine only succeeds in undermining the collective effort thus extending the pandemic. As long as vaccine nationalism persists, nobody is safe until everybody is safe.

Featured Image: This untitled image is in the public domain

Edited by Nina Russell

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'Me First!': Vaccine Nationalism and the Tragedy of Human Insecurity - The McGill International Review

A prisoner shines a light from a window at an LA ICE detention center.

Last week, Dawn Wooten became the latest whistleblower regarding the treatment of migrants inside US Immigration and Customs Enforcement (ICE) facilities. A former detention center nurse, Wooten filed a claim with the Department of Homeland Security claiming that mass hysterectomies were being performed on women without their full consent and sometimes, without their knowledge.

These allegations rightfully shocked many, as politicians, celebrities and social media users drew comparisons between ICE conditions and Nazi Germany. But forced sterilization in America is not a random imitation of Nazi's eugenic history; it's a vile continuation of our own. In fact, it was California's mass sterilization in the 1920s, then recorded by the Eugenics Record Office, that in part helped form Hilter's blueprint for racial purification in Germany. Eugenics is the belief that the human species can be improved by preselecting those with "desirable" traits to reproduce in an effort to "breed out" disease, criminal traits, and mental illness.

In the early 1900s, sterilization in America thrived through federally funded programs used to control growing Asian and Mexican immigrant populations in the west and Black populations in the south. Originally targeting "undesirable" genes in people with criminal records and mental illnesses, it strategically evolved to include immigrants, people of color, and low-income citizens soon after. These programs purposefully sought out the most vulnerable communities, with victims who legally and financially could not fight against a government that had already predetermined their fate.

Below is a brief timeline of our country's history with sterilization, which has disproportionately affected women of color for more than 100 years.

The Eugenics movement enters the American political and economic system in an effort to eliminate "unfavorable" genetics of people with disabilities and those perceived as "socially inferior."

Michigan is the first state to introduce a compulsory sterilization bill. It does not pass.

Pennsylvania passes a sterilization bill that is later vetoed.

Indiana becomes the first state to legally pass eugenics laws and mandate sterilization of the "feebleminded," criminals, and "imbeciles."

By this year, 12 states, including California, Connecticut, and Washington, have some form of sterilization legislation in place.

By this time, 3,000 people have already been involuntarily sterilized in the country since the eugenics movement began.

Virginia's Eugenical Sterilization Act is signed into law under the guidance of Dr. Albert Priddy, the first superintendent of the Virginia Colony for Epilectics. Later that year, Priddy presents 18 subjects (all women) for a sterilization case study. The first proposed subject is Carrie Buck a 17-year-old pregnant girl who was raped by her foster family's nephew.

In Buck v. Bell, the Supreme Court approves the sterilization of individuals in all public institutions showcasing characteristics of "imbecility, epilepsy, and feeblemindedness." This included Priddy's first subject case, Buck, who became the first patient in America to face a legally mandated sterilization.

Sterilization begins in Puerto Rico. Approximately one-third of all Puerto Rican women were sterilized up until the 1970s.

Elaine Riddick, a 14-year-old Black girl in North Carolina is recommended for sterilization by a social worker after being raped. Her procedure is signed with an "x" by her illiterate grandmother, who was not informed of the procedure.

A five-person committee in North Carolina begins a sterilization program that lasts 45 years, sterilizing over 7,600 women, children, and men of color.

Two Black, mentally disabled sisters, Mary Alice Relf, 14, and Minnie Relf, 12, are sterilized without consent in Alabama after doctors tell their illiterate mother they were receiving birth control shots.

The Relf v. Weinberger case draws nationwide attention to the 100,000-150,000 people being involuntarily sterilized each year across the country.

By this year, 20 to 25 percent of Indigenous women have undergone forced sterilization in America since 1970.

In Madrigal v. Quilligan, the Supreme Court sides with Los Angeles County USC Medical Center, refusing to acknowledge coercion used to sterilize 10 female Mexican-American patients, despite a whistleblower going on the record.

By this year, California is responsible for 20,000 sterilization procedures, the highest number of any state.

Since 2006, almost 150 female prisoners in California have been secretly and illegally sterilized.

The Eugenics Compensation Act is signed into law to provide protections and reparations for victims.

As you can see, this is a devastating history, and one that isn't widely known. These eugenics methods were intentional tactics to disrupt the history and lineage of families and cultures. This drive to control marginalized groups, especially women of color, still has roots in our reproduction rights and decisions today.

If you're interested in learning more about America's history of sterilization, documentaries are a great place to start. I recommend watching The Eugenics Crusade (available on PBS and Amazon Prime) about the origins of eugenics and its role in American history. To learn how sterilization affected women specifically, No Ms Bebs (available on PBS) is a documentary about California's history of sterilizing Latina women, and Belly of the Beast is a documentary about the recent sterilizations in California's female prisons, premiering next month.

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America's Ugly History With Selective Sterilization Against Women of Color - POPSUGAR

Less than a year after I went to Naples, the Metropolitan Museum received The Martyrdom of St. Ursula on loan. I was able to see it side by side with The Denial of St. Peter, which is in the Mets collection. Because we know he died not long after, we cannot help reading these paintings through the lens of a late style, as works that convey both the tremendous skill of the artist and his sense of hurry. They are paintings of great economy and psychological depth. The fear in St. Peters eyes, the grief on St. Ursulas face: Was this the insight of a man who knew his life was almost over? Its tempting to think so. But Caravaggio expected to recover from his injuries of the previous year. He expected a pardon from the pope. Even with a large body of work behind him already, he was only 38. He must have thought he was just getting started. He wasnt moving from life into death, like John the Baptist. He was moving from death back into life, like Lazarus. So he thought; so he hoped.

It was in the summer of 1610 that Caravaggio received word that a pardon was being arranged for him in Rome, with the involvement of his old patron Cardinal Scipione Borghese. He left Naples on a felucca, a sailing boat, in the middle of July, taking three paintings with him as presents for the cardinal. A week later, he was in Palo, a coastal fort town 20 miles west of Rome, from which he presumably planned to make his way to the city. But something went wrong in Palo. On disembarking, Caravaggio got into a scuffle with the officers of the fort and was arrested. The felucca set sail without him but with his paintings still on board. It headed north to the coast of Tuscany, to the small town of Porto Ercole. Possibly there was another passenger to drop off. When Caravaggio was released, days later, he hurried over land in the direction of Porto Ercole, a days ride. Upon arrival, he collapsed in an exhausted heap. The felucca arrived around the same time.

It was a hot July day in 2016 when I headed to Porto Ercole. My train from Rome passed by Palo after about 30 minutes and arrived in Orbetello-Monte Argentario an hour and a half later. I imagined it could have been a fever-inducing journey in July 1610. I stayed in Orbetello and took a taxi from there the following morning, across a spit of land that ends in the promontory of Monte Argentario, on the southern side of which is Porto Ercole. I had breakfast at a cafe on the rocky beach. A quartet of visitors was seated near me, two of them, from their accents, American. One American was an older man. Well maybe this guy will win the election, and he can put an end to all that, the man said. Political correctness is just crazy. Youre not even allowed to compliment anyone anymore. Theyll cry sexual harassment. He held forth with the attitude of one who wished to be overheard. He complained about his ex-wife. The other three companions nodded sympathetically.

Caravaggio never painted the sea. I search his oeuvre in vain for a seascape; vistas of any kind are rare. We can address only what has survived of his work, and in what has survived, there are no swells, no waves, no oceanic calms, no shipwrecks or beaches, no sunsets over water. And yet his final years made a chart of the sea, and his ports of call were all literal ports, portals of hope, of which Porto Ercole was the final, unanticipated stop. Hes buried somewhere there, perhaps on the beach, perhaps in a local church. But his real body can be said to be elsewhere: the body, that is, of his painterly achievement, which has gone out to dozens of other places around the world, all the places where wall labels say d. 1610, Porto Ercole.

He was a murderer, a slaveholder, a terror and a pest. But I dont go to Caravaggio to be reminded of how good people are and certainly not because of how good he was. To the contrary: I seek him out for a certain kind of otherwise unbearable knowledge. Here was an artist who depicted fruit in its ripeness and at the moment it had begun to rot, an artist who painted flesh at its most delicately seductive and most grievously injured. When he showed suffering, he showed it so startlingly well because he was on both sides of it: He meted it out to others and received it in his own body. Caravaggio is long dead, as are his victims. What remains is the work, and I dont have to love him to know that I need to know what he knows, the knowledge that hums, centuries later, on the surface of his paintings, knowledge of all the pain, loneliness, beauty, fear and awful vulnerability our bodies have in common.

I walked down to the harbor in Porto Ercole. Small boats in their neat dozens bobbed on the water, and I asked one of the waiting men to take me out. The air was clear, the water a deep blue with faint hints of purple. For the second time on my journey, I got into a boat. We zipped along, and when the boatman took his shirt off, I did the same. He seemed to be in his early 50s, and he said he had always lived in Porto Ercole. He spoke little English. When I told him I was from New York, he grinned and gave me a thumbs up. Oh, New York! he said. We were a couple of miles out. Did he know of Caravaggio? Of course he did. He pointed to the beach. Caravaggio! he said, still smiling.

I signaled to him to cut the engine. It sputtered to a stop, and the silence came rushing in, so that the only sound was that of the waves lapping at the hull as the boat rose and fell on the Mediterranean.

Teju Cole is a writer and photographer. He wrote the magazines National Magazine Award-nominated On Photography column from 2015 to 2019. His novel Open City won the PEN/Hemingway Award in 2012 and the Internationaler Literaturpreis in 2013 and was on the short list for the National Book Critics Circle Award. His photo book Blind Spot was a finalist for the Paris Photo-Aperture Foundation First PhotoBook Award in 2017. Cole is a 2018 Guggenheim fellow and teaches writing at Harvard.

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In Dark Times, I Sought Out the Turmoil of Caravaggios Paintings - The New York Times

INDIANAPOLIS, Sept. 20, 2020 /PRNewswire/ -- Eli Lilly and Company (NYSE: LLY) today announced Verzenio (abemaciclib) in combination with standard adjuvant endocrine therapy (ET) significantly decreased the risk of breast cancer recurrence by 25 percent compared to standard adjuvant ET alone for people with hormone receptor-positive (HR+), human epidermal growth factor receptor 2-negative (HER2-) high risk early breast cancer (HR: 0.747; 95% CI: 0.598, 0.932; p = 0.0096). This statistically significant benefit was consistent across all pre-specified subgroups and corresponds to a 3.5 percent difference between arms (92.2 percent in the Verzenio arm and 88.7 percent in the control arm) at two years. These results are from a preplanned interim analysis with 323 IDFS events observed in the intent-to-treat population across both arms, including 136 in the Verzenio arm and 187 in the control arm. The data were presented today in the Presidential Symposium at the European Society for Medical Oncology (ESMO) 2020 Virtual Congress and simultaneously published in the Journal of Clinical Oncology.

Safety data from monarchE were consistent with the known safety profile of Verzenio and no new safety signals were observed. At the time of analysis, approximately 70 percent of patients in each arm were still on the two-year treatment period. The median follow up was approximately 15.5 months in both arms. The median duration on Verzenio was 14 months.

"This is a major milestone for people living with high risk HR+, HER2- early breast cancer potentially one of the most notable treatment advances in the last two decades for this population of breast cancer patients," said Stephen Johnston, M.D., Ph.D., Professor of Breast Cancer Medicine and Consultant Medical Oncologist at The Royal Marsden NHS Foundation Trust (London, U.K.) and lead investigator for the monarchE trial. "Abemaciclib added to adjuvant endocrine therapy significantly improved invasive disease-free survival in women and men with HR+, HER2- early breast cancer at high risk of early recurrence, and if approved could represent a new standard of care for this population."

monarchE randomized 5,637 patients with HR+, HER2- high risk early breast cancer from more than 600 sites in 38 countries. High risk was defined by cancer that spread to the lymph nodes, a large tumor size, or high cellular proliferation (as determined by tumor grade or Ki-67 index). Patients were treated for two years (treatment period) or until meeting criteria for discontinuation. After the treatment period, all patients will continue ET for five to 10 years, as clinically indicated.

"We are excited that Verzenio has demonstrated a clinically meaningful reduction in the risk of recurrence for people with HR+, HER2- high risk early breast cancer, and Lilly would like to thank the patients and investigators around the world who made this trial possible," said Maura Dickler, M.D., vice president, late phase development, Lilly Oncology. "The results on invasive disease-free survival are significant and provide hope for people with high risk early breast cancer living with concerns of recurrence. Lilly will submit these results to regulatory bodies around the world as soon as possible and we look forward to being able to offer Verzenio as a new treatment option for these patients. We are proud of the way monarchE builds on the vast body of clinical evidence established for Verzenio."

The addition of Verzenio to endocrine therapy also resulted inan improvement in distant relapse-free survival, or the time to developing cancer that has spread to other parts of the body. The combination reduced the risk of developing metastatic disease by 28 percent (HR: 0.717; 95% CI: 0.559, 0.920), with the largest reductions occurring in rates of metastases to the liver and bone. This treatment benefit was consistent across all prespecified subgroups. Two-year distant relapse-free survival rates were 93.6 percent in the Verzenio arm and 90.3 percent in the control arm.

"The results of monarchE are welcome news for our community," said Jean Sachs, MSS, MLSP, CEO of Living Beyond Breast Cancer. "Up to 30 percent of people with hormone receptor-positive early breast cancer may have a recurrence, so this finding is an exciting development for those with high risk hormone receptor-positive, HER2- early breast cancer, especially because the trial included women of any menopausal status as well as men."

Overall survival results were immature and monarchE will continue through the completion date, estimated for June 2027. At the time of the interim analysis, the IDFS results are considered definitive. All patients on monarchE will be followed until primary analysis and beyond to assess overall survival and other endpoints. Lilly will submit the monarchE data to regulatory authorities before the end of 2020.

About the monarchE StudymonarchE is a Phase 3, multicenter, randomized, open-label trial that enrolled 5,637 patients with HR+, HER2- node-positive, high riskearly breast cancer. Patients were randomized 1:1 to Verzenio (150 mg twice daily) plus standard adjuvant endocrine therapy or standard adjuvant endocrine therapy alone. Patients were treated for two years (treatment period) or until meeting criteria for discontinuation. After the treatment period,all patients will continue on endocrine therapy for five to 10 years, as clinically indicated. The primary objective is invasive disease-free survival (IDFS)defined according to the Standard Definitions for Efficacy Endpoints (STEEP) criteria. In adjuvant breast cancer trials,thisincludes the length of time before any cancer comes back, a new cancer develops or death. Secondary objectives include distant relapse-free survival, overall survival, safety, pharmacokinetics and health outcomes.

High risk was specifically defined as women (any menopausal status) and men with resected HR+, HER2- invasive early breast cancer with either 4 pathologically positive axillary lymph nodes (ALNs) or 1 to 3 positive ALNs and at least one of the following high-risk features: primary invasive tumor size 5 cm, histological grade 3 tumor, or central Ki-67 index 20%. If applicable, patients must have also completed adjuvant chemotherapy and radiotherapy prior to enrolling and have recovered from all acute side effects.

About Early Breast CancerBreast cancer is the most common cancer among women worldwide.1 An estimated 90 percent of all breast cancer is diagnosed at an early stage.2 Approximately 70 percent of all breast cancers are HR+, HER2-, the most common subtype.3 Even within this subtype, HR+, HER2- breast cancer is a complex disease, and many factors such as if the cancer has spread to the lymph nodes and the biology of the tumor can impact the risk of recurrence. Approximately 30 percent of people diagnosed with HR+ early breast cancer are at risk of their cancer returning, potentially to incurable metastatic disease.4

About Verzenio (abemaciclib) Verzenio (abemaciclib) is an inhibitor of cyclin-dependent kinases (CDK)4 & 6, which are activated by binding to D-cyclins. In estrogen receptor-positive (ER+) breast cancer cell lines, cyclin D1 and CDK4 & 6 promote phosphorylation of the retinoblastoma protein (Rb), cell cycle progression, and cell proliferation.

In vitro, continuous exposure to Verzenio inhibited Rb phosphorylation and blocked progression from G1 to S phase of the cell cycle, resulting in senescence and apoptosis (cell death). Preclinically, Verzenio dosed daily without interruption resulted in reduction of tumor size. Inhibiting CDK4 & 6 in healthy cells can result in side effects, some of which may be serious. Clinical evidence also suggests that Verzenio crosses the blood-brain barrier. In patients with advanced cancer, including breast cancer, concentrations of Verzenio and its active metabolites (M2 and M20) in cerebrospinal fluid are comparable to unbound plasma concentrations.

Verzenio is Lilly's first solid oral dosage form to be made using a faster, more efficient process known as continuous manufacturing. Continuous manufacturing is a new and advanced type of manufacturing within the pharmaceutical industry, and Lilly is one of the first companies to use this technology.

INDICATION Verzenio is indicated for the treatment of HR+, HER2- advanced or metastatic breast cancer:

IMPORTANT SAFETY INFORMATION FOR VERZENIO (abemaciclib)

Diarrhea occurred in 81% of patients receiving Verzenio plus an aromatase inhibitor in MONARCH 3, 86% of patients receiving Verzenio plus fulvestrant in MONARCH 2 and 90% of patients receiving Verzenio alone in MONARCH 1. Grade 3 diarrhea occurred in 9% of patients receiving Verzenio plus an aromatase inhibitor in MONARCH 3, 13% of patients receiving Verzenio plus fulvestrant in MONARCH 2 and in 20% of patients receiving Verzenio alone in MONARCH 1. Episodes of diarrhea have been associated with dehydration and infection.

Diarrhea incidence was greatest during the first month of Verzenio dosing. In MONARCH 3, the median time to onset of the first diarrhea event was 8 days, and the median duration of diarrhea for Grades 2 and 3 were 11 and 8 days, respectively. In MONARCH 2, the median time to onset of the first diarrhea event was 6 days, and the median duration of diarrhea for Grades 2 and 3 were 9 days and 6 days, respectively. In MONARCH 3, 19% of patients with diarrhea required a dose omission and 13% required a dose reduction. In MONARCH 2, 22% of patients with diarrhea required a dose omission and 22% required a dose reduction. The time to onset and resolution for diarrhea were similar across MONARCH 3, MONARCH 2, and MONARCH 1.

Instruct patients that at the first sign of loose stools, they should start antidiarrheal therapy such as loperamide, increase oral fluids, and notify their healthcare provider for further instructions and appropriate follow-up. For Grade 3 or 4 diarrhea, or diarrhea that requires hospitalization, discontinue Verzenio until toxicity resolves to Grade 1, and then resume Verzenio at the next lower dose.

Neutropenia occurred in 41% of patients receiving Verzenio plus an aromatase inhibitor in MONARCH 3, 46% of patients receiving Verzenio plus fulvestrant in MONARCH 2 and 37% of patients receiving Verzenio alone in MONARCH 1. A Grade 3 decrease in neutrophil count (based on laboratory findings) occurred in 22% of patients receiving Verzenio plus an aromatase inhibitor in MONARCH 3, 32% of patients receiving Verzenio plus fulvestrant in MONARCH 2 and in 27% of patients receiving Verzenio alone in MONARCH 1. In MONARCH 3, the median time to first episode of Grade 3 neutropenia was 33 days, and in MONARCH 2 and MONARCH 1, was 29 days. In MONARCH 3, median duration of Grade 3 neutropenia was 11 days, and for MONARCH 2 and MONARCH 1 was 15 days.

Monitor complete blood counts prior to the start of Verzenio therapy, every 2 weeks for the first 2 months, monthly for the next 2 months, and as clinically indicated. Dose interruption, dose reduction, or delay in starting treatment cycles is recommended for patients who develop Grade 3 or 4 neutropenia.

Febrile neutropenia has been reported in <1% of patients exposed to Verzenio in the MONARCH studies. Two deaths due to neutropenic sepsis were observed in MONARCH 2. Inform patients to promptly report any episodes of fever to their healthcare provider.

Severe, life-threatening, or fatal interstitial lung disease (ILD) and/or pneumonitis can occur in patients treated with Verzenio and other CDK4/6 inhibitors. Across clinical trials (MONARCH 1, MONARCH 2, MONARCH 3), 3.3% of Verzenio-treated patients had ILD/pneumonitis of any grade, 0.6% had Grade 3 or 4, and 0.4% had fatal outcomes. Additional cases of ILD/pneumonitis have been observed in the post-marketing setting, with fatalities reported.

Monitor patients for pulmonary symptoms indicative of ILD/pneumonitis. Symptoms may include hypoxia, cough, dyspnea, or interstitial infiltrates on radiologic exams. Infectious, neoplastic, and other causes for such symptoms should be excluded by means of appropriate investigations.

Dose interruption or dose reduction is recommended in patients who develop persistent or recurrent Grade 2 ILD/pneumonitis. Permanently discontinue Verzenio in all patients with grade 3 or 4 ILD/pneumonitis.

Grade 3 increases in alanine aminotransferase (ALT) (6% versus 2%) and aspartate aminotransferase (AST) (3% versus 1%) were reported in the Verzenio and placebo arms, respectively, in MONARCH 3. Grade 3 increases in ALT (4% versus 2%) and AST (2% versus 3%) were reported in the Verzenio and placebo arms respectively, in MONARCH 2.

In MONARCH 3, for patients receiving Verzenio plus an aromatase inhibitor with Grade 3 increases in ALT or AST, median time to onset was 61 and 71 days, respectively, and median time to resolution to Grade <3 was 14 and 15 days, respectively. In MONARCH 2, for patients receiving Verzenio plus fulvestrant with Grade 3 increases in ALT or AST, median time to onset was 57 and 185 days, respectively, and median time to resolution to Grade <3 was 14 and 13 days, respectively.

For assessment of potential hepatotoxicity, monitor liver function tests (LFTs) prior to the start of Verzenio therapy, every 2 weeks for the first 2 months, monthly for the next 2 months, and as clinically indicated. Dose interruption, dose reduction, dose discontinuation, or delay in starting treatment cycles is recommended for patients who develop persistent or recurrent Grade 2, or Grade 3 or 4, hepatic transaminase elevation.

Venous thromboembolic events were reported in 5% of patients treated with Verzenio plus an aromatase inhibitor as compared to 0.6% of patients treated with an aromatase inhibitor plus placebo in MONARCH 3. Venous thromboembolic events were reported in 5% of patients treated with Verzenio plus fulvestrant in MONARCH 2 as compared to 0.9% of patients treated with fulvestrant plus placebo. Venous thromboembolic events included deep vein thrombosis, pulmonary embolism, pelvic venous thrombosis, cerebral venous sinus thrombosis, subclavian and axillary vein thrombosis, and inferior vena cava thrombosis. Across the clinical development program, deaths due to venous thromboembolism have been reported. Monitor patients for signs and symptoms of venous thrombosis and pulmonary embolism and treat as medically appropriate.

Verzenio can cause fetal harm when administered to a pregnant woman based on findings from animal studies and the mechanism of action. In animal reproduction studies, administration of abemaciclib to pregnant rats during the period of organogenesis caused teratogenicity and decreased fetal weight at maternal exposures that were similar to the human clinical exposure based on area under the curve (AUC) at the maximum recommended human dose. Advise pregnant women of the potential risk to a fetus. Advise females of reproductive potential to use effective contraception during treatment with Verzenio and for at least 3 weeks after the last dose. There are no data on the presence of Verzenio in human milk or its effects on the breastfed child or on milk production. Advise lactating women not to breastfeed during Verzenio treatment and for at least 3 weeks after the last dose because of the potential for serious adverse reactions in breastfed infants. Based on findings in animals, Verzenio may impair fertility in males of reproductive potential.

The most common adverse reactions (all grades, 10%) observed in MONARCH 3 for Verzenio plus anastrozole or letrozole and 2% higher than placebo plus anastrozole or letrozole vs placebo plus anastrozole or letrozole were diarrhea (81% vs 30%), neutropenia (41% vs 2%), fatigue (40% vs 32%), infections (39% vs 29%), nausea (39% vs 20%), abdominal pain (29% vs 12%), vomiting (28% vs 12%), anemia (28% vs 5%), alopecia (27% vs 11%), decreased appetite (24% vs 9%), leukopenia (21% vs 2%), creatinine increased (19% vs 4%), constipation (16% vs 12%), ALT increased (16% vs 7%), AST increased (15% vs 7%), rash (14% vs 5%), pruritus (13% vs 9%), cough (13% vs 9%), dyspnea (12% vs 6%), dizziness (11% vs 9%), weight decreased (10% vs 3%), influenza-like illness (10% vs 8%), and thrombocytopenia (10% vs 2%).

The most common adverse reactions (all grades, 10%) observed in MONARCH 2 for Verzenio plus fulvestrant and 2% higher than placebo plus fulvestrant vs placebo plus fulvestrant were diarrhea (86% vs 25%), neutropenia (46% vs 4%), fatigue (46% vs 32%), nausea (45% vs 23%), infections (43% vs 25%), abdominal pain (35% vs 16%), anemia (29% vs 4%), leukopenia (28% vs 2%), decreased appetite (27% vs 12%), vomiting (26% vs 10%), headache (20% vs 15%), dysgeusia (18% vs 3%), thrombocytopenia (16% vs 3%), alopecia (16% vs 2%), stomatitis (15% vs 10%), ALT increased (13% vs 5%), pruritus (13% vs 6%), cough (13% vs 11%), dizziness (12% vs 6%), AST increased (12% vs 7%), peripheral edema (12% vs 7%), creatinine increased (12% vs <1%), rash (11% vs 4%), pyrexia (11% vs 6%), and weight decreased (10% vs 2%).

The most common adverse reactions (all grades, 10%) observed in MONARCH 1 with Verzenio were diarrhea (90%), fatigue (65%), nausea (64%), decreased appetite (45%), abdominal pain (39%), neutropenia (37%), vomiting (35%), infections (31%), anemia (25%), thrombocytopenia (20%), headache (20%), cough (19%), leukopenia (17%), constipation (17%), arthralgia (15%), dry mouth (14%), weight decreased (14%), stomatitis (14%), creatinine increased (13%), alopecia (12%), dysgeusia (12%), pyrexia (11%), dizziness (11%), and dehydration (10%).

The most frequently reported 5% Grade 3 or 4 adverse reactions that occurred in the Verzenio arm vs the placebo arm of MONARCH 3 were neutropenia (22% vs 2%), diarrhea (9% vs 1%), leukopenia (8% vs <1%), ALT increased (7% vs 2%), and anemia (6% vs 1%).

The most frequently reported 5% Grade 3 or 4 adverse reactions that occurred in the Verzenio arm vs the placebo arm of MONARCH 2 were neutropenia (27% vs 2%), diarrhea (13% vs <1%), leukopenia (9% vs 0%), anemia (7% vs 1%), and infections (6% vs 3%).

The most frequently reported 5% Grade 3 or 4 adverse reactions from MONARCH 1 with Verzenio were neutropenia (24%), diarrhea (20%), fatigue (13%), infections (7%), leukopenia (6%), anemia (5%), and nausea (5%).

Lab abnormalities (all grades; Grade 3 or 4) for MONARCH 3 in 10% for Verzenio plus anastrozole or letrozole and 2% higher than placebo plus anastrozole or letrozole vs placebo plus anastrozole or letrozole were increased serum creatinine (98% vs 84%; 2% vs 0%), decreased white blood cells (82% vs 27%; 13% vs <1%), anemia (82% vs 28%; 2% vs 0%), decreased neutrophil count (80% vs 21%; 22% vs 3%), decreased lymphocyte count (53% vs 26%; 8% vs 2%), decreased platelet count (36% vs 12%; 2% vs <1%), increased ALT (48% vs 25%; 7% vs 2%), and increased AST (37% vs 23%; 4% vs <1%).

Lab abnormalities (all grades; Grade 3 or 4) for MONARCH 2 in 10% for Verzenio plus fulvestrant and 2% higher than placebo plus fulvestrant vs placebo plus fulvestrant were increased serum creatinine (98% vs 74%; 1% vs 0%), decreased white blood cells (90% vs 33%; 23% vs 1%), decreased neutrophil count (87% vs 30%; 33% vs 4%), anemia (84% vs 33%; 3% vs <1%), decreased lymphocyte count (63% vs 32%; 12% vs 2%), decreased platelet count (53% vs 15%; 2% vs 0%), increased ALT (41% vs 32%; 5% vs 1%), and increased AST (37% vs 25%; 4% vs 4%).

Lab abnormalities (all grades; Grade 3 or 4) for MONARCH 1 were increased serum creatinine (98%; <1%), decreased white blood cells (91%; 28%), decreased neutrophil count (88%; 27%), anemia (68%; 0%), decreased lymphocyte count (42%; 14%), decreased platelet count (41%; 2%), increased ALT (31%; 3%), and increased AST (30%; 4%).

Strong and moderate CYP3A inhibitors increased the exposure of abemaciclib plus its active metabolites to a clinically meaningful extent and may lead to increased toxicity. Avoid concomitant use of the strong CYP3A inhibitor ketoconazole. Ketoconazole is predicted to increase the AUC of abemaciclib by up to 16-fold. In patients with recommended starting doses of 200 mg twice daily or 150 mg twice daily, reduce the Verzenio dose to 100 mg twice daily with concomitant use ofstrong CYP3A inhibitors other than ketoconazole. In patients who have had a dose reduction to 100 mg twice daily due to adverse reactions, further reduce the Verzenio dose to 50 mg twice daily with concomitant use of strong CYP3A inhibitors. If a patient taking Verzenio discontinues a strong CYP3A inhibitor, increase the Verzenio dose (after 3 to 5 half-lives of the inhibitor) to the dose that was used before starting the inhibitor. With concomitant use of moderate CYP3A inhibitors, monitor for adverse reactions and consider reducing the Verzenio dose in 50 mg decrements. Patients should avoid grapefruit products.

Avoid concomitant use of strong or moderate CYP3A inducers and consider alternative agents. Coadministration of strong or moderate CYP3A inducers decreased the plasma concentrations of abemaciclib plus its active metabolites and may lead to reduced activity.

With severe hepatic impairment (Child-Pugh Class C), reduce the Verzenio dosing frequency to once daily. The pharmacokinetics of Verzenio in patients with severe renal impairment (CLcr <30 mL/min), end stage renal disease, or in patients on dialysis is unknown. No dosage adjustments are necessary in patients with mild or moderate hepatic (Child-Pugh A or B) and/or renal impairment (CLcr 30-89 mL/min).

AL HCP ISI 17SEP2019

Please see full Prescribing Information for Verzenio.

About Lilly Oncology For more than 50 years, Lilly has been dedicated to delivering life-changing medicines and support to people living with cancer and those who care for them. Lilly is determined to build on this heritage and continue making life better for all those affected by cancer around the world. To learn more about Lilly's commitment to people with cancer, please visit http://www.LillyOncology.com.

About Eli Lilly and Company Lilly is a global health care leader that unites caring with discovery to create medicines that make life better for people around the world. We were founded more than a century ago by a man committed to creating high-quality medicines that meet real needs, and today we remain true to that mission in all our work. Across the globe, Lilly employees work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to communities through philanthropy and volunteerism. To learn more about Lilly, please visit us at lilly.com and lilly.com/newsroom.P-LLY

Lilly USA, LLC 2020. ALL RIGHTS RESERVED.

Verzenio is a trademark owned by or licensed to Eli Lilly and Company, its subsidiaries, or affiliates.

This press release contains forward-looking statements (as that term is defined in the Private Securities Litigation Reform Act of 1995) about Verzenio (abemaciclib) as a treatment for patients with breast cancer and reflects Lilly's current beliefs. However, as with any pharmaceutical product, there are substantial risks and uncertainties in the process of development and commercialization. Among other things, there can be no guarantee that future study results will be consistent with the results to date or that Verzenio will receive additional regulatory approvals or be commercially successful. For further discussion of these and other risks and uncertainties, see Lilly's most recent Form 10-K and Form 10-Q filings with the United States Securities and Exchange Commission. Except as required by law, Lilly undertakes no duty to update forward-looking statements to reflect events after the date of this release.

1World Health Organization. Breast cancer: prevention and control. https://www.who.int/cancer/detection/breastcancer/en/index1.html. Accessed: September 8, 2020.

2Howlader N, et al. SEER Cancer Statistics Review, 1975-2013. http://seer.cancer.gov/csr/1975_2013/. Accessed: September 8, 2020.

3Howlader N, Altekruse S, Li C. US incidence of breast cancer subtypes defined by joint hormone receptor and HER2 status. J Natl Cancer Inst. 2014;106(5).

4Reinert T and Barrios CH. Optimal Management of Hormone Receptor Positive Metastatic Breast Cancer in 2016. Ther Adv Med Oncol. 2015;7(6):304-20.

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Verzenio Significantly Reduced the Risk of Cancer Recurrence by 25% for People with HR+, HER2- High Risk Early Breast Cancer - PRNewswire