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Maryland wants to Decriminalize Suicide.

The issue of suicide as a felony has resurfaced. This time, however, the discussion isn’t centered around physician-assisted suicide. Instead, the focus is the criminality of attempted suicide. In February 2019, a 56-year-old man in Maryland plead guilty to a count of “attempted suicide” and was sentenced to a three-year suspended jail sentence, and two years of probation (Washington Post, 2019). Oddly enough, this is only one of ten attempted suicides that have been prosecuted in Maryland in the past five years (Washington Post, 2019).   

Suicide as a criminal offense dates back to 13th-century English common law, where suicide was considered a crime against “God and the King” (Washington Post, 2019). Early common law held suicide as punishable by ignominious burial on the highway, and by forfeiture of goods and chattels (Markson, 1969). This common law rule was initiated after America declared its Independence from Britain in 1776. However, many states eliminated the common law by total reliance on statutory law, whereby suicide was ignored and the common law against suicide was made ineffective (Wright, 1975). Still, several states maintained the common law principle that suicide was, in fact, a crime (Wright, 1975).

State courts continued to be confronted with this issue, and faced with the question of how suicide should be dealt with in the law. Many states have refrained from decriminalization based on the opinion that criminalization will deter suicide attempts, or at least provide grounds for involuntary hospitalization or treatment.

This debate has spanned from 13th-century common law all the way to 2019, where Del. David Moon (D-Montgomery) recently passed a bill to decriminalize the act in Maryland (Washington Post, 2019). Moon highlighted that one of the reasons prosecutors still resort to using this dated law is to get people into involuntary hospitalization and treatment. His bill received criticism from lawmakers who feared this would garner support to legalizing physician-assisted suicide; however, suicide prevention groups vocalized their support, noting it may help shift the discourse to prevention and de-stigmatization rather than punishment. After much debate, Moon’s bill decriminalizing attempted suicide in Maryland was passed in April, 2019. This ruling may re-ignite conversations in states like Virginia, where attempts to decriminalize attempted suicide have failed.

This discussion goes beyond the specific issue of decriminalization of suicide attempts, and raises important questions about how the justice system should deal with mental illness. Moon notes that “if we keep enabling the law enforcement function to take over the public health function, we are never going to fix [these mental health issues]” (Washington Post, 2019). Suicide is currently the 10th leading cause of death in the United States, and is continuously on the rise (National Institute for Mental Health, 2019). Is the best way to combat this public health issue to criminalize the act? While it is undisputed that suicide prevention and deterrence is of the utmost importance, it is questionable how continued criminalization of attempt will achieve this. If anything, it may incentivize attempters to use more lethal means to ensure they do not survive and be faced with criminal charges. Even more, this may actually prevent people with suicidal ideation from getting help on their own volition for fear of criminal repercussions. As we become more aware of mental illness as a public health concern, it is important to explore even the most well-meaning efforts for prevention under a critical eye, and assess the consequences of dealing with mental illness through the criminal justice system.


Source: https://www.washingtonpost.com/local/md-politics/attempted-suicide-can-be-prosecuted-in-maryland-del-moon-wants-to-change-that/2019/02/04/1c040148-24d7-11e9-ad53-824486280311_story.html

 

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Increased Regulatory Scrutiny of Pharma Mergers & Acquisitions Raises Concerns for the Industry

This year has been another significant year for consolidation within the biopharmaceutical industry. There has been an estimated $208 billion in transactions ; including Bristol-Myers’ $74 billion acquisition of Celgene in January to AbbVie’s $63 billion acquisition of Allergan in June which allows large biopharmaceutical companies to dominate the broader deal landscape in the industry. There are emerging signs, however, that the government is beginning to take a closer look at biopharmaceutical consolidation, pushing for divestments or potentially blocking the deals in court.

Signs of greater regulatory scrutiny have been most evident within the pending acquisition by Roche of Spark Therapeutics. Roche entered into an agreement to purchase Spark Therapeutics in February for $4.8 billion. Spark Therapeutics currently markets the only FDA approved gene therapy, Luxturna, which is used to treat certain retinal eye diseases. Roche is hoping to take advantage of other gene therapy treatments developed by Spark, particularly their hemophilia A research which Roche believes will complements their own hemophilia treatment, Hemlibra. Despite being a relatively small transaction in terms of size, both the Federal Trade Commission (FTC) and the Competition and Markets Authority (CMA) in the United Kingdom have taken note of the transaction, with the CMA filing an ‘Initial Enforcement Order’ to temporally block the transaction from being completed. Just this past week, Roche extended the deadline for shareholders of Spark Therapeutics to tender their shares to approve Roche’s acquisition, the seventh time that Roche has pushed back the tender offer deadline for Spark Therapeutics.

There is little official mention of what concerns the FTC and the CMA have with Roche’s acquisition of Spark Therapeutics, but some analysts point to the potential overlap between the two companies’ hemophilia business and may push Roche to divest Hemlibra to obtain approval for the Spark Therapeutics acquisition. Some feel this is an unusual step for the FTC to request, particularly in light of the robust existing market for hemophilia products. Analysts, however, point to the consent degree between Bristol-Myers and the FTC that permit their acquisition of Celgene if Bristol-Myers chose to divest rights to Otezla, a drug to treat psoriasis, to Amgen for $13.4 billion. Otezla was considered one of Celgene’s most profitable products, expected to generate $2.3 billion in annual sales by 2023. Given that Amgen already has a strong psoriasis pipeline, including Enbrel and Amgevita, a biosimilar to AbbVie’s Humira, some were confused as to why the FTC permitted Amgen to acquire Otezla.

AbbVie’s pending acquisition of Allergan did not raise the degree of early scrutiny that the Bristol-Myers-Celgene transaction did, but this trend is starting to move. In September, the FTC sent an additional ‘Request for Additional Information’ letter to AbbVie, delaying the completion of the transaction at least an additional thirty days. AbbVie has kept with the early-2020 date as when the transaction will be finalized. A number of consumer advocacy groups have requested the FTC intervene in the pending transaction. They point specifically to AbbVie’s manufacturing of Humira, which continues to be the best-selling drug in the world. Humira continues to invite scrutiny due to its high price, set at $58,612 in 2017. Allergan also markets Botox, primarily used for cosmetic purposes. These advocacy groups are concerned that another large biopharmaceutical tie-up will raise the prices of a greater drug portfolio, particularly in light of Humira’s expiring patent in 2023.

Increased biopharmaceutical consolidation continues to raise concern among Congress. Last month, Sen. Amy Klobuchar (D-MN) and eight senators sent a letter to FTC Commissioner Joseph Simons requesting the FTC take greater scrutiny of these transactions and ensure that any anti-competitive activities are remedied. Sen. Klobuchar, along with Sens. Cory Booker (D-NJ), Kamala Harris (D-CA), Elizabeth Warren (D-MA) and Bernie Sanders (I-VT)[sk1]  are all competing to be the 2020 Democratic presidential nominee. Given the continued focus on the price of prescription drugs, both in Congress and by President Trump, the FTC may push for larger divestments and more aggressive consent decrees to limit future price increases among acquired companies.


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Hospital Mergers: Impacts on Patients, Pricing, & Antitrust Concerns.

Over the past year, mergers and acquisitions across industries are seeing a spike while appropriations to the antitrust division of the Department of Justice have remained the same. Included in this most recent spate of mergers are hospital systems. Hospitals are merging at record rates and PricewaterhouseCoopers predicts hospital system mergers to continue to grow. As hospitals continue to merge, they have started to form new conglomerates in the healthcare industry. One recent example is the merger between Catholic Health Initiatives and Dignity Health, forming CommonSpirit Health.

CommonSpirit Health has sites across 21 states, 150,000 employees and over $30 Billion in revenue. With 90 percent of Metropolitan Statistical Areas considered highly concentrated for hospitals as of 2016, these mergers beg the question of whether patients are benefitting. Furthermore, what are the anti-trust implications of highly consolidated regional hospital systems?

A new study from the American Hospital Association claims “hospital acquisitions are associated with a statistically significant 2.3% reduction in annual operating expenses at acquired hospitals.” The American Hospital Association suggest that by combining administrative functions among hospital systems they can pass these savings onto patients. However, a recent class-action lawsuit against Sutter Health disputes this notion. Sutter Health – a Northern California health system – is accused of using its market dominance to drive up the cost of services. With such a high level of regional market control, hospital systems like Sutter Health use “all-or-none” contracting with insurance companies to demand higher prices for services. These costs trickle down to patients with higher premiums and co-pays.

Patient advocates attribute the Sutter Health lawsuit to lax anti-trust practices when it comes to hospital mergers. While anti-trust officials have the time and resources to focus on blockbuster industry mergers such as CVS-Aetna, smaller mergers among regional hospitals and healthcare service providers go unnoticed. An example of such mergers is Anne Arundel Medical Center and Doctors Community Health System merging to form Luminis Health in Maryland. These regional mergers often evade the eyes of regulators and patient advocates warn of their potential to drive up costs by dominating regional markets and rarely if ever lower costs.

An industry-funded study [ST1] from Deloitte points out, however; that mergers and acquisitions in health systems lead to investments and improvements on acquired facilities and lower operating costs. This same study also pointed to specific improvements in patient reducing patient mortality, reducing wait times and reducing readmissions. These are all factors anti-trust officials should consider when deciding whether to challenge a merger. Anti-trust officials simply don’t have the resources to analyze these deals;leaving patients footing the bill for increased costs. Hospital costs continue to remain the largest overall share of healthcare spending in the United States. To lower healthcare costs and improve patient outcomes, it is time for regulators to examine these regional health system mergers and their vast implications on patient outcomes and pricing.

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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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Zulresso: The First and Only Drug Approved to Treat Postpartum Depression


In March, the FDA finally approved Sage Therapeutics’ drug Zulresso (brexanolone) as the first drug intended to treat postpartum depression (PPD) in adult women. Before Zulresso, the only drug used to treat PPD was anti-depressants. Compared to anti-depressants, which could take weeks to regulate PPD symptoms, Zulresso improves symptoms within days. The approval of Zulresso marks a crucial milestone for women who have long suffered from PPD.

Having a baby is supposed to be a joyous occasion, however, within days, or even hours, many women feel depressed. Some women experience the less severe form of the “baby blues” while others suffer from severe and life-threatening PPD. PPD is a major form of depression that occurs in about 1 in 9 women after childbirth. PPD symptoms vary but often include feelings of extreme sadness, anxiety, suicidal thoughts, and severe doubts about the mothers ability to care for her baby. All women are susceptible to PPD because PPD does not manifest itself in one “type” of person, i.e. specific race, culture, etc. Some experts believe that PPD is more prevalent than reported because not all women talk about or seek treatment for PPD. Zulresso is the first drug to provide hope to the millions of women who suffer from this disorder. 

Yet, although Zulresso seems like a saving grace, it is still a drug that comes with serious risks. The FDA reported that serious risks, like excessive sedation or sudden loss of consciousness, occurred after taking Zulresso. Because of these risks, Zulresso was approved with a Risk Evaluation and Mitigation Strategy (REMS). A REMS program helps ensure FDA that the benefits of the drug outweigh its risk and that patients taking the drug are safe. In Zulresso’s case, the REMS program makes Zulresso available only through an intravenous (IV) injection that must be administered and monitored by a health care provider. Since Zulresso takes a total of 60 hours to administer,the REMS program requires patients to be continually monitored the entire administration period. In addition, all patients must be registered and complete counseling before taking Zulresso. 

However, a drug this powerful won’t come cheap. A one-time infusion of Zulresso is expected to cost $34,000 before discounts. For many women without insurance, Zulresso may be unattainable. However, since Zulresso has been clinically proven to be effective for PPD, many women will find its price worth it. Even Sage’s chief executive officer, Jeff Jones, acknowledged the high price of Zulresso, and said that “Zulresso’s medical benefits will overcome any concerns about cost and delivery.” 

Zulresso is expected to launch in late June, and Sage Therapeutics is already working on creating centers for women to have access to the drug. Although the nation is excited about Zulresso, Sage Therapeutics is already working on another fast-acting antidepressant pill that could treat postpartum depression too. However, Zulresso and Sage Therapeutics might have some competition from Marinus, a company also developing and testing a drug to treat PPD. Competition or not, the approval of Zulresso means that fewer women have to suffer and many more women can enjoy motherhood.  

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