Monthly Archives: March 2018

Round Two: Right-To-Try Legislation Passes in House

Last Wednesday, the House of Representatives passed a bill that aims to give terminally ill patients the “right-to-try” drug treatments that have not yet been approved by the Food and Drug Administration (FDA). The Trickett Wendler, Frank Mongiello, Jordan McLinn, and Matthew Bellina Right to Try Act of 2018, introduced as H.R. 5247, received a majority vote of 267 to 149. The previous week, the bill failed to receive the required two-thirds majority vote in the House to proceed. As reintroduced, the bill required only a simple majority vote to pass.

During debate on the House floor Wednesday, Representative Frank Pallone Jr. (D-N.J.), the top Democrat on the House Energy and Commerce Committee, asserted that allowing patients to access investigational treatments that have only completed a phase 1 clinical trial would expose patients to treatments with little or no efficacy data. The American Cancer Society Cancer Action Network (ACS CAN), along with over 75 organizations representing millions of patients, expressed concern and opposition to the bill, saying not only would it remove FDA approval and consultation, but it would also fail to increase access to promising therapies since the bill does not address primary barriers to access to investigational therapies. ACS CAN further stressed opposition since the proposed bill would remove FDA’s role in consultation on dosing, route of administration, dosing schedule, and other safety measures under the current program.

Proponents of the legislation, such as House Energy and Commerce Committee Chairman Greg Walden (R-Ore.), note that 38 states have right-to-try legislation and point to additional monetary federal support. Supporters maintain that the bill strikes the right balance for patients and their safety, arguing that those with a terminal illness should have every tool at their disposal. However, critics of the legislation fear it could lead to a slippery slope of bypassing FDA regulations. Holly Fernandez Lynch, a professor of medical ethics at the University of Pennsylvania, said the bill probably would not increase access to investigational drugs beyond what the FDA already allows. According to Professor Lynch, “[t]he bigger challenge is this attack on the FDA’s very reason for existence.”

The bill will now move back to the Senate for approval. Last August, the Senate approved similar legislation. If approved, the Trickett Wendler, Frank Mongiello, Jordan McLinn, and Matthew Bellina Right to Try Act of 2018 would introduce legislation across state lines. Whether the federal bill will increase access to unapproved treatments for terminal patients remains an open question.

 

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Ride-Sharing Services Take-On Liability Balancing Act

Ambulance rides in the U.S. are expensive. The most recent data from the U.S. Government Accountability Office revealed they can range from $224 to $2,204. Recent figures suggest ambulance bills can be as high as $3,500 and depending on your insurance plan, you could be footing the entire bill. For some patients, even when experiencing a non-life-threatening illness, calling an ambulance is the only option because they lack transportation. To avoid these high costs, people are turning to ride-sharing services like Uber and Lyft to get to the hospital for a fraction of the price, according to a new unpublished study. This option might actually be beneficial in non-life-threatening situations. However, individuals who use ride-sharing services for serious emergencies simply to save money could raise serious liability concerns and leave drivers asking themselves whether this is in their job description.

Uber and Lyft discourage drivers from transporting individuals to the hospital. In an attempt to shift liability away from the company, Uber has published statements such as “Uber is not a substitute for law enforcement or medical professionals. In the event of any medical emergency, we always encourage people to call 911.” But this is easier said than done when an individual gets into the car and time is of the essence. While some drivers consider these trips as good deeds, others simply feel obligated to transport these individuals to the hospital. The bottom line is ride-sharing drivers are unequipped to deal with emergency health situations. Ambulances are equipped with comprehensive medical technology and life-saving devices, whereas even the most hospitable Uber drivers may offer candy and a phone charger. Even when a customer gets into a Lyft seemingly healthy, drivers are still taking on the risk if the customer’s condition takes a turn for the worst before reaching the hospital. In one instance, a woman whose destination was the hospital got into the car seemingly healthy, only to request the driver to pull over minutes into the ride to get sick on the side of the road.

So, what happens if a customer’s condition worsens as a result of opting for an Uber or Lyft over an ambulance? Attorneys argue that it is unlikely someone would bring suit against an Uber driver for not providing adequate medical treatment because fault would be difficult to prove, and the driver may not be equipped to pay a large settlement or damages. In addition, it is difficult to sue the ride-sharing company directly through employer liability because drivers are hired as independent contractors, so the company is able to shift liability away from them. However, attorneys are recently taking a different approach against these companies, arguing that the drivers were acting as the company’s agent, and therefore the company cannot avoid liability. Attorneys argue that drivers really don’t have control over their individual ride-sharing business. Rather, ride-sharing companies control fares and impose guidelines for how drivers should conduct business before, during, and after rides. If the drivers do not conform, they receive warnings and ultimately risk termination. Since ride-sharing companies do not want the issue of whether drivers are independent contractors or agents decided in court, they settle with the customers that bring suit.

Despite arguments against calling an Uber over 911 in the event of a life-threatening emergency, ride-sharing services are still finding avenues to enter the health care stage. Uber recently launched a new initiative, Uber Health, designed to increase patient access to reliable transportation to doctor appointments. Missed appointments are unfortunately common in the U.S., with 3.6 million Americans missing or delaying appointments due to a lack of reliable transportation. These missed appointments cost the health care system $150 billion annually. The Uber Health dashboard allows healthcare providers to schedule rides for their patients to and from appointments. In addition, the platform is completely HIPPA-compliant, so patient confidentiality is preserved. This progressive move is helpful in the midst of increasing health care cost, but the question still remains whether calling an Uber over 911 is really worth the discount.

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Implications of Abandoning Abortion

On February 27, 2018, Vice President Pence predicted that abortion could become illegal within “our time.” While attending a luncheon hosted by the Susan B. Anthony List & Life Institute, an anti-abortion institute, Pence hypothesized:“[i]f all of us do all we can, we can once again, in our time, restore the sanctity of life to the center of American law.”

Given the controversial nature of abortion in the United States, Pence’s comment normally would not amount to any concern over the legality of abortion. However, speculations of such policies, specifically the Supreme Court overturning Roe v. Wade, have been circulating since the 2016 campaign. During the 2016 campaign, then-candidate Donald Trump was asked if there should be a punishment for women who chose to have abortions, he responded, “there has to be some form of punishment… there has to be some form.” More recently, these concerns of abandoning Roe arose during Justice Gorsuch’s nomination. Although now-Justice Gorsuch said he would “have walked out the door” if President Trump had asked him to overturn Roe, Vice President Pence’s comment is a reminder that in the current political state anti-abortion legislation may become an inevitable reality.

In Roe, the landmark case in abortion rights, the Supreme Court held that a woman has the right to have an abortion. Although Roe and its subsequent case law have placed restrictions on when and how a woman can get an abortion, today, the choice still remains with the woman to decide if she wants an abortion. Roe and the legalization of abortion were important for more than just the right to choose. The legalization of abortion also allows states to regulate the safety of abortion procedures themselves so long as they do not impose an undue burden, or substantial obstacle, on a woman trying to get an abortion.

Keeping abortion legal keeps abortion safe. States have legitimate interests in the health and safety of pregnant women, as well as the potential life of the unborn child, and thus are able to regulate abortion procedures. Between the criminalization of abortion and Roe, it is estimated that up to 1.2 million illegal abortions were performed per year in the United States. During this period, women with means had several options for an illegal abortion: leave the country and have a medical abortion abroad, or find a physician willing to perform an abortion. And even in these cases, safety was not guaranteed. Both options were expensive and largely inaccessible to women without means. Women who could not afford to pay off a doctor or leave the country resorted to back-alley procedures and home remedies, such as inserting knitting needles and coat hangers into their vaginas. These methods often resulted in serious injury, infection, and death.

Due to medical advances, abortions have become significantly safer since its inception thousands of years ago. In fact, Justice Ginsburg discussed how safe abortion now is in her concurrence in Whole Woman’s Health v. Hellerstedt. Today, states may impose reasonable standards on facilities that perform abortions to protect the safety and wellbeing of the patients. Medical abortions performed in hospitals and clinics have a 0.5% incidence of major complications. Moreover, in 2013, out of the nearly one million abortions performed, only four women died of complications arising from abortion.

Although mortality and incidence of injury related to abortion has decreased in the U.S., globally, between 4.7% and 13.2% of maternal deaths can still be contributed to “unsafe abortion.” The World Health Organization defines unsafe abortion as “when a pregnancy is terminated either by persons lacking the necessary skills or in an environment that does not conform to minimal medical standards, or both.” The WHO cites the legality and availability of abortion as two of the major barriers for women to obtain a safe abortion.

If Vice President Pence is correct, and abortion becomes illegal within “our time,” the need for abortions will not cease, the ability to obtain an abortion will not end, and the number of abortions performed per year will not be zero. What will change is the access to safe abortions. “The abortions will continue regardless of whether it’s legal or not legal – as it always has.”

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Access to Mental Health Care in Prisons

Mental illness continues to be stigmatized in the United States, making it difficult for people to discuss and to pursue help. Like mental health, incarceration is a branding topic that often carries with it negative connotations and judgments. Both of these matters are significant and deserve research, awareness, and reform alone; however, the issue of mental health in prisons is one that encompasses both of these issues and must be addressed. The lack of access to services for incarcerated individuals is devastating.

One of the main objectives of incarceration is isolation and separation from the outside world. Because of this, the institutions must provide their inmates with everything essential like food, water, bedding, etc. At what point does the law draw the line between what is essential and what is not? What does this mean for mental health?

The U.S. has the highest rate of adult incarceration among the developed countries, with 2.2 million currently in jails and prisons. Those with mental disorders have been increasingly imprisoned over the last thirty years, most likely due to the deinstitutionalization of the state mental health system. Correctional institutions have become de facto state hospitals, with more seriously and persistently mentally ill inmates in prisons than in all state hospitals in the United States. In cases like Ruiz v. Estelle, U.S. courts have clearly established that prisoners have a right to receive medical and mental health care.

In order to meet this need, it is important to examine options and solutions inside the prisons. Often, state correctional departments have agreements with state departments of mental health to have professionals come into the prisons and provide acute care. Having these mental health professionals come to prison helps address many issues including the lack of ability to transport inmates to outside facilities, understaffed and under trained prison personnel, and lack of resources in general.

Suicide is the third leading cause of death in U.S. state and federal prisons. Suicide-prevention programs in prisons are of increasing importance to mental health professionals, correctional administrators, health care providers, legislators, attorneys, and others as they seek to rehabilitate offenders and avoid the multi-million dollar lawsuits that result from inmate suicides. Suicide prevention efforts must extend beyond the mental health staff of prison facilities, and begin to include guards, administrators, and custodial staffs.

Another important measure is a change of perspective on punishment as a whole. There has been an increase in the use of diversion programs such as mental health and drug courts across the country. These courts work with mental health and substance abuse treatment providers to assist those who struggle with these problems. In order to participate in this treatment alternative, a person must first plead guilty to a crime and be subject to incarceration. Although these alternative routes have many advantages and a great focus, evaluations of mental health and drug courts have shown questionable success and significant challenges.

Another alternative is the use of pre-booking diversion. A pre-booking diversion plan is is one that identifies low-level offenders and redirects them from jail and prosecution by providing linkages to community-based treatment and support services. This alternative requires the efforts of both a law enforcement and social services. When possible, individuals who do come in contact with police should be diverted to other options like treatment before they are ever faced with arrests, charges, and sent to the police station for booking.

Overall, the need for prison-based mental health treatment is profound. It is important we focus our efforts inside the prisons with the staff, health care providers, and inmates in order to create a safer environment. It is also important we move away from the system of punishment, and instead consider alternatives to incarceration in order to rehabilitate and prepare these individuals for life in the community.

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