Experimental Medicine

Downloads:

Download Summer 2014 PDF

Experimental Medicine

A Question of Timing

by Christina M. H. Powell

Jim had been through surgery, radiation, and a few rounds of chemotherapy. In his mid fifties, he had a teenage son and daughter he hoped to send to college. In spite of his treatments, his cancer returned. Now his doctor thought a new experimental drug might prolong Jim’s life, but he wasn’t sure Jim would qualify for participation in the clinical trials using the drug. Without the drug, the doctor predicted Jim had only a few months to live.

Should patients like Jim be granted access to experimental medicines if they do not qualify for clinical trials? Terminally ill patients push for access, but regulatory agencies and many medical doctors worry the vast majority of experimental drugs may have no benefit to a patient and can be harmful. Unfortunately, by the time a beneficial drug receives regulatory approval, it may be too late. The selection process for clinical trials can feel frustrating and confusing to patients and their loved ones. How can you minister to people alternating between hope and disappointment at the news of possible life-saving treatments?

Seeking Hope

Hope is a precious commodity for terminally ill patients and their families. Any treatment that promises a cure or prolonged life seems worth exploring. For patients who have exhausted conventional treatment methods, alternative treatments and experimental medicines may become the last sources of hope. Many times friends and extended family members comb Internet sites looking for news of treatments emerging in clinical trials. When they find something promising, they naturally want to pursue it.

In many cases, the treatment is available only through certain clinical trials. Treatments shown to work in other countries may not be available in the United States if they have not yet received Food and Drug Administration (FDA) approval, a process that takes years. Most terminally ill patients seeking new treatments have a timetable of months or weeks. The prospect of a bureaucratic roadblock thwarts hope.

In 1999, a 19-year-old named Abigail Burroughs was dying from head and neck cancer. Her oncologist thought an experimental drug called Erbitux would shrink the tumors. But since the drug had not yet received FDA approval, the treatment was denied. Abigail died in 2001, three years before Erbitux gained approval. The Abigail Alliance, an advocacy group for terminally ill patients, sued to change the FDA policy. The group achieved a temporary victory that was overturned by the U.S. Supreme Court in early 2008.¹

Avoiding False Hope

The FDA exists to protect patients from harmful and ineffective drugs, while speeding access to useful medicines. Once a medicine proves promising through laboratory and animal studies, teams of doctors design a series of clinical trials. The initial goals of these trials are to identify harmful side effects and determine the correct dosage.

To obtain useful information about the medicine, doctors carefully screen participants. Patients and their disease progression must fit within specific parameters. For instance, the presence of a secondary disease could disqualify a patient. This selectivity is in the best interest of both present and future patients. However, for a dying patient excluded from a study, failing to fit certain criteria means dashed hope. The process may not seem fair to a patient who is willing to take on more risks than doctors will allow.

Patients and their family members may struggle to understand the reasoning behind these decisions. However, experimental medicines are unproven. Instead of prolonging a patient’s life or providing a cure, the medicine may prove fatal or create more medical problems than it solves. Doctors protect patients from false hope when they withhold medicines with unknown effects. Access to experimental medicines is not a right. Furthermore, doctors must consider the needs of future patients who benefit from a well-designed clinical trial that uncovers potential side effects and defines risks.

Of course, ethical tension exists between ensuring safety and approving a medicine in a timely manner. The goal is to minimize unnecessary delays while gathering scientifically meaningful results. Good study design excludes patients only for medically relevant reasons. Unfortunately, scientific standards sometimes disqualify patients who might benefit from access to a medication. Unexpected study results may delay the approval process. Yet understanding the basis of those results protects patients.

Ministering Hope

Pastors and chaplains ministering to terminally ill patients and their families can provide wisdom along with hope. While you may not have a deep knowledge of the regulatory approval process for a new drug or treatment, you can encourage patients to trust God and accept that processes in the medical establishment exist for good reasons. Your presence can provide comfort in the midst of turmoil.

King David spoke of trusting in God in times of fear (Psalm 56:3,4), and Solomon warned against leaning on your own understanding (Proverbs 3:5). James said Christians should ask God for wisdom in difficult circumstances (James 1:5). Paul taught the Colossians, “Let the peace of Christ rule in your hearts … ” (Colossians 3:15, NIV). These biblical principles can help patients and their loved ones weather the emotional rollercoaster of sorting through potential treatment options. When frustrations mount, you can reassure them that God’s plans for their lives will prevail.

Ultimately, you have a hope to offer that surpasses anything medicine can promise. The spiritual hope of eternal life is “an anchor for the soul, firm and secure” (Hebrews 6:19, NIV). John explained the essence of the Christian belief, “And this is the testimony: God has given us eternal life, and this life is in his Son. Whoever who has the son has life … ” (1 John 5:11,12, NIV).

The patient’s reality may be that his or her earthly life is drawing to a close, with no miracle treatment on the horizon. For the believer, however, hope rests in the promise of spending eternity with Christ. This hope can bring peace regardless of the medical outcome.

Notes

1. Rae, SB., Moral Choices: An Introduction to Ethics (Grand Rapids, Michigan, Zondervan, 2009), 235.