Table of Contents

INTRODUCTION2

DEFINITION OF THE TERMS2

Terminal illness2

Investigational Drugs3

CONTROVERSY OF GIVING TERMINALLY ILL PATIENTS INVESTIGATIONAL DRUGS3

CONCLUSION13

WORKS CITED15

Introduction

A terminally ill cancer patient has the right to refuse treatment, but does that same patient have the right to demand access to investigational therapies? That question has spurred emotional debate from both sides of the issue, ranging from advocates who believe that experimental drugs should be made readily available, to those who argue for restrictions. An article in the December 17 issue of JAMA attempts to provide a framework for a workable and effective balance of access and oversight. (Abigail, 445)

Definition of the Terms

Terminal illness

Terminal illness is a medical term popularized in the 20th century to describe an active and malignant disease that cannot be cured or adequately treated and that is reasonably expected to result in the death of the patient. This term is more commonly used for progressive diseases such as cancer or advanced heart disease than for trauma. In popular use, it indicates a disease which will end the life of the sufferer. (Abigail, 445)

Investigational Drugs

Investigational or experimental drugs are new drugs that have not yet been approved by the FDA or approved drugs that have not yet been approved for a new use, and are in the process of being tested for safety and effectiveness. Patients may decide to seek access to investigational drugs for different reasons. Some patients with serious or life-threatening illnesses seek treatment with investigational drugs if FDA-approved therapies are not working or if their side effects are too severe. Others may have heard about promising early study results for a specific investigational drug, and they might want to learn more. (Appelbaum, 20)

Controversy of giving terminally ill patients investigational drugs

In this report we tried to construct a framework in which the manufacturers are provided with appropriate incentives to allow access to experimental agents, safeguards are in place to ensure that a minimal amount of evidence has accumulated before allowing access, clinical research is not hampered, and patients are protected from aggressive marketing or pricing schemes," said coauthor Cary Gross, MD, associate professor of medicine at Yale University School of Medicine, in New Haven, Connecticut.

We recognize the details are a challenge and it will take commitment and flexibility of all stakeholders to reconsider the current framework of access. Terminally ill cancer patients are often willing to try unproven treatments when standard therapies are either unavailable or have failed to work. However, many are ineligible for clinical trials, and drug access through compassionate-use programs can be procedurally difficult to secure. Thus, access to experimental compounds is extremely limited for many patients, (Appelbaum, 20) Dr. Gross explained.

Two high-profile and pivotal events, the AIDS epidemic of the 1980s and breast cancer advocacy during the 1990s, raised questions about increasing access to experimental drugs and about accelerating the drug-approval process. Most recently, the authors point out, the issue was reinvigorated with Abigail Alliance v. von Eschenbach, a case in which it was argued that government restrictions on access violate the Fifth Amendment's due ...