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The Right to Try

On Wednesday, March 21st, the House passed H.R. 5247, the “right-to-try” bill. The bill gives terminally ill patients the federal “right-to-try” drugs that have been approved for Phase 1 clinical trials, but are still unapproved by the Food and Drug Administration (FDA).

The Senate unanimously passed a similar version of the right-to-try bill in August but the House subsequently rejected this bill on March 13th. The recently passed bill, H.R. 527, is the updated version of the original right-to-try bill. The vote passed by a 267 to 149 vote. Currently, different versions of right-to-try legislation exist in 39 states. The recently passaged legislation expands this right to the federal level.

In its simplest form, the right-to-try gives dying patients access to potentially life saving drugs that they would otherwise not be able to try. On average it can take the FDA 10-15 years to test and approve a drug. The lengthy process is due to the three phases of clinical trials and bureaucratic application and approval procedures.

In practice, doctors and their patients can bypass the stringent, and lengthy, FDA process for drug approval and deal directly with pharmaceutical companies to gain access to unapproved drugs, once the drugs have undergone preliminary safety testing. Most frequently, right-to-try is utilized on behalf of cancer patients who want to be enrolled in clinical trials.

In addition to increasing patient access to unapproved drugs, right-to-try laws also relieve doctors and pharmaceutical companies of liability should there be negative effects of the drugs. Right-to-try laws also prohibit the FDA from using data from right-to-try patients in negative outcome analysis.

Critics have two main critiques of the bill. First, critics are concerned over the safety of the experimental drugs and their potentially negative effects on patients who are not healthy enough to receive the treatment. Second, they argue that right-to-try is merely “feel good” legislation because the right to try is unnecessary. The FDA currently has a version of right-to-try called, Expanded Access or Compassionate Use. Both right-to-try and the FDA program allow terminally ill patients to try drugs that have yet to be approved by the FDA. According to the FDA, 99% of requests for Expanded Access are approved; however, this percentage does not include the number of requests that are dismissed because they did not meet FDA requirements.

With the restrictions and requirements the FDA imposes, less than 3% of those who want experimental treatment are approved. Right-to-try advocates stress the importance of expanding the access of potentially life saving drugs to the remaining 97% of patients who want to try them.

The Goldwater Institute, a libertarian think tank, was the driving force behind the right-to-try bill. The Goldwater Institute states that “everyone deserves the right to try,” as people possess the fundamental right to try to save their own lives. Since the bill’s inception, the bill has gained notable support from Vice President Pence and President Trump. Trump publically supported the bill at the State of the Union in January, “People who are terminally ill should not have to go from country to country to seek a cure,” he said. “I want to give them a chance right here at home. It’s time for Congress to give these wonderful, incredible Americans the right to try.”

The Goldwater Institute lays out the necessities for the right-to-try.

  1. Most terminal patients cannot participate in clinical trials because they are too ill to be selected;
  2. Most terminal patients do not have access to these treatments once the clinical trials are over;
  3. The FDA’s Expanded Access plan is insufficient because it is time-consuming, expensive, and involves a complicated application process;
  4. The FDA approval process takes too long to approve promising medications and in some cases can take more than ten years;
  5. Patients should not have to ask the government for permission to save their own lives.

For these reasons and more the right-to-they has become a powerful piece of legislation on patient rights. The latest version of the bill will now go to the Senate to be disused, and hopefully passed.

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Narcan: Legality of Third-Party Prescribing?

This week, the United States Surgeon General issued an advisory, urging more Americans to begin carrying the opioid overdose-reversing drug, naloxone. The last time the Surgeon General issued such an advisory to the American public was more than a decade ago, focusing on the hazards of alcohol consumption during pregnancy—perhaps a signal that the opioid crisis is worse than the public recognizes.

Narcan, one of the more popular brand name drugs, temporarily reduces the effects of an opioid overdose and can restore normal breathing to a person suspected to have overdosed. It comes in the form of a nasal spray, making it simple for untrained users to administer. Now, Narcan is widely available in pharmacies across the United States, including CVS and Walgreens. Though only some states permit the sale of Narcan over-the-counter, most now even permit family members of drug users to receive Narcan without a prescription at pharmacies.

As nearly 91 Americans die each day from an opioid overdose, President Donald Trump has declared the opioid crisis a public health emergency. However, the widespread availability of Narcan, especially in states where it is available over-the-counter, presents interesting legal questions. Access to Narcan was limited until state legislatures provided specific statutory protections for nonmedical personnel to possess and administer the drug to persons suspected of an overdose. This practice, called “third party prescribing,” permits physicians and medical personnel to dispense Narcan, or other similar drugs, to a person other than the one at risk for overdose.

As regulation of the medical profession typically falls to the states themselves, a physician generally can legally prescribe a drug to his patient when it is (1) in good faith, (2) in the usual course of professional practice, and (3) for a legitimate medical purpose. Nevertheless, in the absence of federal action to combat the opioid crisis, states have enacted legislation that increases access to these potentially life-saving opioid overdose-reducing drugs. Such legislation reduces liability for the prescribers, dispensers, and administrators, thereby attempting to increase the availability to Narcan to affected consumers who may fear the stigma of requesting their own prescription, or who may lack the funds or health insurance to access Narcan themselves. Fortunately, the drug has no abuse potential, but still requires individuals to seek medical attention immediately following the administration of the drug. Since Narcan is only a temporary solution, the symptoms of an overdose may return and require immediate medical attention.

As more states attempt to reconcile with the widespread opioid epidemic, the federal government needs to take a firmer stand. By enacting federal legislation to provide Narcan and similar drugs over-the-counter, the government can increase the availability of the drug and prevent opioid-related deaths. The federal government can also permit community distribution, which often involves supplying the drugs to addicts without cost, as well as require federal assistance programs to cover the costs of Narcan. Overall, the number of synthetic opioid-related deaths has reached 200,000, and the federal government must act to combat this epidemic—sooner rather than later.

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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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