Category: Blog

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 13^th-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 13^th-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 10^th
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.

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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

 

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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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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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.  

The labor and delivery process has evolved immensely over the years in the types of procedures and use of medication. More patient focused than ever, the trends towards natural water births, pre-planned C-sections, and hiring doulas are likely to continue. However, while the physical toll a woman experiences in giving birth is obvious, the emotional and psychological burden is often carried alone and in secret. Women are talking about their struggles with postpartum depression and the traumas associated with giving birth. In lawsuits, women’s claims include being forced to undergo painful invasive vaginal procedures against their consent, feeling imprisoned to a bed for hours at a time, and even having their birthing plan completely ignored by staff. All of these indicate abuse at the hands of doctors and nurses whose primary focus is the birth of a child and not the woman in labor. Women should have the right to make choices about their bodies. This type of “obstetric violence” has led to an uptick in diagnoses of postpartum PTSD, which is often misdiagnosed as postpartum depression. 

This trauma has led a growing number of women to turn to alternative birth plans that avoid hospitals and put the mother in control of her birthing process. Many of these birthing plans occur in a tub or pool, filled with warm water, and incorporate types hypnotherapy and calming techniques to ensure a smooth and serene process. Proponents of this movement include midwives, who are trained in child birthing, and doulas, who assist and advocate for birthing women during the process, who emphasize that healthy women with uncomplicated pregnancies are usually more satisfied with the process than their previous births in hospitals. Natural water birth is praised for having lower cost, more freedom to choose medications or methods, less pain/anxiety, a comfortable and peaceful setting, and a personal connection to the process. However, critics argue that for difficult births, women who insist on natural water birth put both themselves and their baby at a higher risk for complications, or even death. If there is distress, bleeding, or other unknown conditions, the ability to get help and necessary care is more difficult and will take longer. In the UK, doctors are discussing a consent requirement for vaginal pirths beacause the risks of vaginal birth are so high and debating whether it should be the default option. Others discourage the notion that “natural birth is fulfilling while unnatural birth is traumatic” because it disenfranchises women who want to make the choice to have a C-section or epidural as part of their labor and delivery process. Regardless, experts agree natural water birth is a safe and successful birthing plan when well planned and executed. 

Unfortunately, across the United States laws are being passed that constrict a pregnant woman’s opportunity to choose a natural birth. Many doctors refuse to indulge in a natural water birth, which forces women to seek out midwives to facilitate their birthing plan. Twenty-three states refuse to license midwives, driving up the cost of natural water birth and making it less safe for those who insist on it. Like abortion, placing obstacles on water births do not stop them from happening. Some states, like Arkansas and Arizona, even require “vaginal assessments” prior to clearing a woman for a water birth, which is comprised of a series of STD testing and invasive vaginal examinations that a woman giving traditional vaginal birth in a hospital does not have to undergo. New York has attempted to reduce the number of water births by minimizing the number of facilities that would be prepared to facilitate them to three, for the entire state’s population. The effect of this is to limit the freedom of a women to control their birthing plans by requiring them to jump through hoops, increase costs, wait on impossibly long wait lists, and in some cases, even jeopardize her own safety just to exert any authority on the extremely painful and intimate process of bringing a child into the world. It is time for state laws to catch up with modern birthing practices and to give women the power to make their own decisions about their bodies as they give birth.