Author: Katie Wahl

On Wednesday, March 21^st, 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 13^th. 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.

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.”

As children we are all told to trust our doctors; they are the people who cure our ailments and keep us healthy. Therefore, we trust our doctors with our most private and intimate problems. A shared story among the Larry Nassar sexual abuse survivors is that they placed their trust in him as their doctor to heal them, and he violated that trust. Larry Nassar, the former USA Gymnastics doctor, was sentenced to 40 to 175 years in prison after he pled guilty to ten counts of sexual assault. Over 150 women gave impact statements at his sentencing hearing, and nearly all of them asked for a sentence that would set a precedent that manipulation of trust and sexual abuse by a doctor will not be tolerated.

Medical Obligations and Malpractice

“[You] used up every ounce of innocence not only abusing me but the oath you took when becoming a doctor to respect the privacy of your patients and not play God”

One survivor noted in her testimony that Nassar took an oath as a doctor to respect the privacy of his patients and he had violated the trust of all of his patients and their families when he committed sexual assault. Another survivor began her testimony began by stating that Nassar breached his duty of care to her and did not follow the medical regulations he was under.

Although the standards for medical care vary by state, in general, doctors have a duty of care to their patients. Medical malpractice is defined as a violation of the standard of care from that injures the patient. The American Medical Association’s “Principles of Medical Ethics” lay out the ethical obligations of physicians; these include, but are not limited to, respecting human dignity, patients’ rights, and standards of professional conduct. All doctors swear the Hippocratic oath before they become begin to practice medicine; the oath calls for doctors to protect the privacy of his patients, to do no harm, and to not play God.

Sexual abuse breaches a doctor’s duty to his patient, legally, ethically, and morally. If you want to see how your state manages doctor sexual abuse cases please see http://doctors.ajc.com/states/

Consequences of Sexual Abuse for Doctors

“Talk is worthless to me… we need to demand real change and we need to be willing to be able to fight for it. It is clear now that if we leave this up to these organizations, history is likely to repeat itself”

While doctors are subject to the law, their oath, and medical board regulations, to not have sexual relations with a patient a study done by the Atlanta Journal –Constitution found that of the nation’s 2,400 doctors that were publicly disciplined for sexual misconduct with a patient, half still have their medical license today. Even more, when a medical board is composed chiefly of physicians, a doctor accused of sexual abuse is more likely to be allowed to continue practicing. Sexual abuse by doctors is often brushed off as rare; however, as Nassar’s case has shown us, rare does not mean unimportant, rare does not mean infrequent, and rare does not mean unpunishable.

Allegations of sexual abuse against Nassar began in the 1990s; however, the Michigan state disciplinary board did not revoke Nassar’s medical license until April of 2017, nearly nine months after The Indianapolis Star published an investigation of USA Gymnastics’ handling of sexual abuse and a formal complaint against Nassar had been filed with the MSU police; not to mention nearly twenty three years after dozens of sexual abuse allegations.

Effects of Sexual Abuse for Survivors

“For me, it was a girl getting out her gun and laying it on the bed just to remind herself that she has control over her own life”

Sexual assault is undeniable married to mental health impacts. Among survivors of sexual abuse, anxiety, depression, and PTSD are common diagnoses. The women who testified several discussed the lasting mental health issues they now suffer from as a result of the abuse. Anxiety, depression, and eating disorders are only the tip of the iceberg of conditions that the survivors mentioned in their testimony. Several of the survivors mentioned that they currently seek counseling to cope with the effects of their abuse, others detailed suicidal thoughts, and one mother discussed how Nassar’s abuse contributed to her daughter’s depression and eventual suicide in 2009.

Nassar is the most recent and the most infamous example of a doctor abusing his privilege to treat patients with abuse and how our system can perpetuate the cycle of malpractice and abuse.