Should Cancer Patients Have the Right to Try Experimental Treatments?

No Agreement Among Lawmakers and Medical Experts

Alida Mooreston

Disclosures

June 22, 2017

Gail Biagioni, of Abilene, Texas, was an oncologist's dream patient. Diagnosed with pancreatic neuroendocrine cancer in 2002, her doctors quickly learned that she was determined to approach her disease with grace, strength, and levity. She underwent two major surgeries, including a Whipple procedure, in the course of 2 years. After the second procedure, she gave her surgeon a present. "She handed him a Magic for Beginners kit and said, 'Maybe this will help you stop cutting people in half.' She always kept her humor," remembers Ms Biagioni's daughter, Alicia Andreatta. Doctors gave Biagioni a prognosis of 5 years, and in that time she had multiple surgeries, chemotherapy, and radiation before finally trying experimental drugs in 2006. She died in 2007 after complications from a routine chemo bath led to sepsis. She was 56.

"My mother was grateful for the opportunity to try experimental treatment," says Ms Andreatta. "In her case, it allowed her more time with our family. She lapped up every extra second she had with us, and by participating in an experimental drug therapy program, she felt proud to help others who might be diagnosed with her disease in the future."

Not every cancer patient has access to experimental drug therapies, which is why 36 states to date have passed Right-to-Try (RTT) legislation. This law allows terminally ill patients to try medications that are not yet approved by the US Food and Drug Administration (FDA) but have passed phase 1 of the approval process. It is a controversial topic, one in which patients, doctors, and nurses may find themselves at odds, although they share the same main concern: What is the best way to care for patients?

Right to Try or Right to Live?

The American Society of Clinical Oncology (ASCO) believes that current RTT legislation falls short as written. In a statement released in early April, ASCO called for better patient protections and increased patient access to investigational drug therapies. The organization also laid out numerous recommendations for improving RTT laws, including a more streamlined way for patients to apply for approval of experimental treatment, such as an online portal, and the inclusion of FDA oversight. ASCO believes that the current laws have the potential to put patients at higher risk for harm.

When you are diagnosed with terminal cancer, you should get to choose how you walk the path of your illness.

These recommendations would take time to be implemented, which is the one thing that many advocates of RTT say these patients do not have. When a person has been given just 12 months to live, they cannot afford to wait for stakeholders to agree on every line of RTT law. Kim Van Dyke, a Michigan hospice nurse with more than 23 years of experience, has seen firsthand the effects of cancer, from diagnosis to end-of-life care. She fully supports current RTT legislation. "I don't look at it as a patient's right to try. I see it as a patient's right to live," she explains. "When you are diagnosed with terminal cancer, you should get to choose how you walk the path of your illness."

To ensure that patients are able to make the best choices, Ms Van Dyke stresses the importance of patient education. "The patient needs to be 100% cognitive of their diagnosis and what they are up against. As medical professionals, we do patients a disservice when we fall short of explaining all of their options." Van Dyke says conversations with hospice patients have only solidified this belief. "They say, 'I wish someone explained all of my options in the beginning. Now I'm running out of time and I feel like I've wasted so much of it.'"

That sense of urgency is familiar to many cancer patients. "When you're told you have cancer, you automatically think, 'I'm going to die.'" At the age of 39, Shaunessy Jones of Seattle, Washington, was diagnosed with early-stage cervical cancer. She describes the shock she felt when she got the news. "Someone just told me I have cancer, right? So, now I need answers. What am I doing? What's next? How do I save my own life?"

Still, many doctors do support RTT laws, albeit with stipulations. Dr Ryan Krafft of Arkansas specializes in pain management, including cancer pain and end-of-life care. He offers conditional support of RTT. "Without a doubt, if patients have either exhausted more standard-care regimens or if there are potentially curative therapies that have cleared phase 1, [experimental therapies] should be considered if only palliative treatments remain."

Van Dyke disagrees with these conditions. She believes that the physical and mental state of her hospice patients who have reached the end of the line prevents them from being able to make the most informed choices. "The time for the conversation about experimental drugs is in the first few weeks after diagnosis [with terminal cancer], before the patient is too exhausted from treatment to make an informed decision."

First, Do No Harm

The Hippocratic Oath is a common refrain in the debate about RTT. Some opponents of the law say false hope is harmful. Dr Krafft believes otherwise. "Provided the patient is aware of the potential for unforeseen consequences, I don't think [RTT] goes against the Hippocratic Oath. In terminal situations, 'harm' is a relative term."

Connie Anderson agrees. A Seattle nurse whose career spans more than four decades, Ms Anderson has served on the board of trustees for the Fred Hutchinson Cancer Research Center since the early 1980s and for the past 17 years has been a member of the institutional review board (IRB). The IRB reviews clinical trials using human subjects as participants. She is firm in her support of RTT. "The oath of a doctor should not preclude the wishes of a patient. For many patients, experimental drugs are the last resort, and I respect their choices to try the last-ditch efforts, regardless of the outcomes."

Anderson and Van Dyke both speculate on another reason for many doctors' hesitancy about RTT legislation. "We are such a litigious society that physicians are afraid to not do everything in their power to preserve life," explains Anderson. Van Dyke echoes this theory. "Fear of litigation is huge. As a result, many oncologists shy away from definitive statements. This is the biggest and greatest error we make with terminally ill patients."

It's not a doctor's place to make our ethical decisions, whether they agree or not.

Trust is an important factor in the doctor-patient relationship. Patients rely on their doctors to present all of the options. Ms Andreatta, who watched her mother go through every treatment offered, agrees. "As a patient, you learn to trust your doctors and rely on their knowledge. Therefore, it is their responsibility to inform a patient about every possible avenue of treatment. It's not a doctor's place to make our ethical decisions, whether they agree or not." Indeed, the most fervent advocates for RTT believe that it all comes down to the patients themselves. People with terminal cancer have the right to refuse treatments, so why wouldn't they also have the right to explore every treatment available?

For now, the debate around Right-to-Try and, ultimately, the debate around how to best care for and protect patients, will continue. In the meantime, caregivers can unite in the fight to put patients first. Van Dyke pledges, "As a nurse, I will continue to advocate for people because my passion is that you get to live the life you want to live, the way you want to live it, until the day you can't take another breath. That should be our gift to all patients with cancer."

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