Author Archives: Elizabeth Raterman

HIV Criminalization in the United States

Since the onset of the AIDS epidemic in the early 80s, public health officials and lawmakers have proposed legislative approaches to prevent HIV transmission at both the national and state level. lawmakers have tried to address this issue using punitive measures by enacting laws that criminalize high-risk behaviors linked to negligent HIV exposure. Twenty-five states criminalize behaviors that increases the risk for HIV exposure; and some states include low-risk behaviors like oral sex. Most of these laws were enacted before the emergence of antiretroviral therapy, and the laws do not account for other preventative measures such as condom use and pre-exposure prophylaxis (PreP).

States also criminalize intentional STD exposure, but typically result in short sentences (rarely exceed thirty-four months). Similarly, all states have assault and battery laws and other criminal statutes that can be used to prosecute high-risk behaviors that can lead to negligent HIV exposure. Despite its intention, state laws further sanction and stigmatize those with HIV. In addition to criminalizing certain behaviors, state law also determines the maximum sentences for violating HIV-specific statutes. The CDC reports that eight states issue sentences for HIV-specific violations between eleven and twenty years in prison; while two states impose longer sentences (greater than twenty years), and two may impose up to life in prison.

LGBTQ advocates outline how many of these laws were rooted in homophobia but gained traction by claiming to promote public health. Not only do they have a disproportionate effect on LGBTQ individuals, but these laws have a disparate impact on women and people of color. Aware of this discriminatory effect, the California legislature introduced Senate Bill 239 in February 2017. This bill reduces HIV transmission from felony to misdemeanor and repeals mandated criminal penalties for donating blood, organ, and breast milk while being HIV-positive. Unfortunately, not many states have followed suit.

Experts in AIDS research have long resisted these laws, claiming that they are ineffective and unwarranted. Linda-Fail Bekker, a professor of medicine at the Desmond Tutu HIV Foundation says, “in many cases, these misconceived laws exacerbate the spread of HIV by driving people living with, and at risk of, infection away from treatment services.” The science of dispelling HIV stigma is insufficient to end HIV criminalization. Lawmakers must consider the overarching human rights principles and advance public health efforts and education to adequately address the criminalization of HIV in the US.

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The Disproportionate Impacts of Obstetric Violence on Minority Women

Serena Williams is a superstar tennis player and a force to be reckoned with, especially after sharing her harrowing postnatal experience. Williams has a history of pulmonary embolisms, and the day after giving birth to her daughter via C-section, she had trouble breathing and believed she was experiencing a blood clot. After Williams alerted a nurse, the nurse suggested Williams’s pain medication left her confused and instead insisted a doctor perform an ultrasound on her legs. Doctors ignored Williams, who knew she needed a CT scan and heparin drip. This dismissal of Williams’ concerns delayed the discovery of several blood clots in her lungs and a large hematoma in Williams’ abdomen, near her C-section wound; she was placed on six-week’s bedrest following this event. Williams’ deeply upsetting interaction with her doctors is not uncommon for new mothers in the days following childbirth, especially among minority women.

Between 700 and 900 women die yearly from complications stemming from pregnancy and childbirth. For every death, there are a handful of women who suffer life-threatening birth injuries. There is a notable racial disparity in the figures, and black women are seventy-five percent more likely to experience a traumatic birth compared to white women. Traumatic birth experiences often result from obstetric violence, a notion that encompasses disrespectful attitudes from doctors, discrimination from care providers, and lack of consent for treatment. In 2016, the American College of Gynecologists published a committee opinion outlining that a “decisionally capable” woman has the right to refuse certain treatments while she is in labor. Furthermore, the College strongly discouraged “manipulation [and] coercion” to influence a woman’s treatment decision. Although this opinion offers guidance to practitioners, it is not binding, and many women nonetheless face varying forms of obstetric violence.

Obstetric violence is especially severe for women of color due to the widespread discrimination within the maternity care field. The CDC notes that Black women in the US are three times more likely to die from childbirth-related issues than white women. Across the country, the maternal mortality rate has risen to 17.3 maternal deaths per 100,000 births. The United States is one of only a select handful of countries where the maternal mortality rate is worse now than it was 25 years ago.

Anecdotal evidence from doulas in Milwaukee and Washington, D.C., both cities that support a large low-income and Black population, reveals how doctors often justify acts of obstetric violence by feigning paternalistic worry and falsely claiming either the mother or infant were in danger. Additionally, it is well-established that black women fare worse in pregnancy, and growing evidence points to a low quality of care in hospitals where black women seek maternal care, which are often found in highly segregated areas. Research has also indicated that women who deliver in these hospitals are more likely to have complications from birth-related embolisms and hysterectomies. Black women believe their concerns are not addressed by their healthcare teams; for many women of color, the news of a baby evokes fear rather than joy because these women know of the alarming trends and how treatment teams may disregard their wishes and concerns.

In the wake of the CDC and WHO data on obstetric violence and maternal mortality rates, legislators have signed H.R. 1318/S. 1112, which supports states to put an end to preventable maternal deaths. Additionally, Senator Kamala Harris introduced the Maternal Care Access Reducing Emergencies Act meant to promote training programs for healthcare professionals that would address implicit biased based on stereotypes. Until the legislation takes effect, organizations like Improving Birth and Birth Monopoly will continue advocating for women who have faced obstetric violence.

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Tracing the History of Forced Sterilization within the United States

When many people hear the phrase “forced sterilization,” they rarely associate the practice with the United States, or if they do, they believe this was something the country did more than a century ago. Unfortunately, however, coerced and forced sterilizations have been occurring since the early 1900s and have seen their most recent iterations as “voluntary” procedures offered for a reduced prison sentence. Coerced sterilization occurs when financial or social incentives or intimidation tactics are employed to compel an individual to undergo the procedure. In comparison, forced sterilization happens when a person does not know she is undergoing the procedure, has no opportunity to provide consent, or gives consent under duress.

In 1907, Indiana became the first state to successfully pass a mandatory forced sterilization law, and California and Washington followed suit a few years later. Throughout the first half of the twentieth century, the public generally supported sterilization of the mentally handicapped. In 1927, the Supreme Court ruled in Buck v. Bell that forced sterilization did not violate the Constitution. In his opinion in Buck, Justice Holmes explicitly argued for eugenics, which Nazi propaganda then cited the opinion as a basis for Germany’s forced sterilization programs.

Public sentiment surrounding sterilization began to shift following the 1940s, but the trend changed when the Nixon administration dramatically increased Medicaid-funded sterilization of low-income Americans, specifically targeting people of color and those with HIV/AIDS. This funding, combined with a federal commitment to family planning and community health, led to widespread sterilization abuse in the United States from the late 1960s to the mid-1970s. For example, the North Carolina Eugenics Board sterilized 7,600 mentally handicapped women between the 1940s and 1970s. The increase of reproductive health clinics at this time overwhelmingly benefited middle-class white women, but minority working-class women faced stigma and a family planning model that lacked standardized consent protocols, which created an environment “ripe for coercion.”

The story of the Relf sisters, who were teenagers sterilized without consent in 1973 in Alabama, mobilized many women to address forced sterilization. As the case went to trial, it was found that the girls’ mother believed she was consenting to birth control for her daughters, but because she could not read, she mistakenly signed a sterilization release. In reaction to this story, African American and Native American women throughout the United States came forth with similar allegations, and, in Relf v. Weinberger, a federal district court judge estimated that 100,000 to 150,000 low-income women had been sterilized during the early seventies. The call to action grew as awareness of the practice increased, and health departments in major cities began revising their guidelines for sterilizations, which included reviewing the consent notice and fully informing patients of the permanence of the procedure. Some jurisdictions, like North Carolina, even established governmental entities to identify victims of forced sterilization and compensate them.

Despite this, forced sterilization still occurs today, although it is reframed as a voluntary option in exchange for a reduced prison sentence. In May 2017, a Tennessee judge signed a standing order allowing inmates in White County to receive jail credit if they underwent either a vasectomy for males or a Nexplanon implant for females. Thirty-two women and thirty-eight men underwent sterilization during the three months Judge Benningfield’s order was in effect. Though Tennessee later introduced a bill that would forbid judges from approving a reduced sentence if it is conditioned upon sterilization, other states are not responding with similar legislation. In February 2018, an Oklahoma woman, who was a prior drug addict, received a shorter sentence for a federal counterfeiting offense after undergoing surgery to prevent further pregnancies. The sentencing judge, Stephen Friot, defended his decision, saying that the Supreme Court “has yet to recognize a constitutional right to bring crack- or methamphetamine-addicted babies into this world.” Actions and sentiments like Judge Friot’s demonstrate how eugenics practices in the United States have evolved and continue to violate an individual’s bodily autonomy and human rights on the whole.

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The FDA and Insulin: Biologic and Biosimilar Pricing

The United States is the most expensive market for biologic drugs, including insulin, despite initiatives devised by the Food and Drug Administration (FDA) and the Affordable Care Act. For more than a decade, the biosimilars market in the US has lagged behind the European market, whose medicines are as much as 80 percent cheaper. The Biologics Price Competition and Innovation Act (BPCIA), a provision in the 2010 Affordable Care Act, authorized the FDA to create a new regulatory scheme to approve biosimilars, which are products designed to work like biologics that have already been licensed. In 2015, the FDA approved the first biosimilar, Basaglar (a type of insulin), and by 2017, there were three marketed biosimilars and two more that had been approved. The development of biosimilars is intended to increase competition among biologic manufacturers and drive down prices and making products like insulin more accessible.

Despite the BPCIA and approval of biosimilars like Basaglar, the cost of insulin has continued to skyrocket, and the FDA proposed a new classification system to address soaring prices. In December, FDA Commissioner Scott Gottlieb unveiled a plan to classify insulin as a biologic as opposed to its previous classification as a drug. In doing so, biosimilar drug makers will be enabled to develop biosimilars that can be substituted for the original biologic. Although Gottlieb’s proposal will likely not go into effect until March 2020, the new classification scheme could create competition in what is currently a limited marketplace of insulin, thus driving down the cost for the millions of Americans with diabetes.

As of now, the insulin market is dominated by three manufacturers: Sanofi, Novo Nordisk, and Eli Lilly. Due to their market dominance, these three companies have driven up the cost of insulin, which has tripled between 2002 and 2013 and doubled between 2012 and 2016. Sanofi, Novo Nordisk, and Eli Lilly have faced immense scrutiny due to the price hikes, and criticism peaked when Minnesota Attorney General Lori Swanson filed a legal salvo against the manufactures for their “deceptive” practices. With the issue of insulin pricing entering the public eye, it is clear changes must be made.

Gottlieb’s proposal, designed to implement the intent of Congress, will address pricing standards in three ways. The first step is to extend the anti-evergreening provisions, which are meant to prevent manufacturers from having exclusivity and forestalling competition, to the newly deemed biologics and biosimilars. The next step is to address patent exclusivity and to stop twelve years of exclusivity once the current terms expire. Lastly, the proposal intends to offer guidance to current manufacturers when they submit a New Drug Application for approval under the Food, Drug, & Cosmetic Act (FDCA). This guidance will offer standards for transitioning a product from the drug pathway to the biologic pathway so that it meets the requirements of the Public Health Safety Act and section 505 of the FDCA. With these changes afoot, the FDA and Congress will hopefully make strides in addressing the current high cost of insulin and allow for new biosimilar manufacturers to enter the market, thus significantly benefitting the millions of Americans with diabetes.

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