In 2001, Abigail Burroughs lost her battle to cancer at the age of 21. After exhausting all conventional treatment options, her oncologist urged the Food and Drug Administration to allow Abigail to try Erbitux. At the time, Erbitux was not formally approved by the federal regulatory agency, and Abigail was denied a potentially life-saving treatment option.
Ten days before she passed, Abigail spoke with a television news crew, hoping her story would inspire changes to the FDAs restrictions on experimental drug access. This is not just about me, she said. I am trying to help so many others.
Tragically, there are so many others in her situation. In her new book, "The Right to Try," Darcy Olsen estimates that over 25,000 die each year while waiting for federal regulators to approve lifesaving drugs for those terminally ill with cancer.Abigails struggle and story became the impetus for right to try legislation. These reforms give terminally ill patients access to potentially lifesaving medication before the drugs are approved by the FDA.
Right to try laws have spread quickly. Since 2001, 37 states have enacted right to try laws. From 2005 to 2014, the FDA received almost 9,000 applications to try experimental drugs as a last resort. Fortunately for the patients, the agency now rarely denies access.
Abigails message appears to have brought hope and reform where previously there were none. Her family has since created an organization to further this cause, the Abigail Alliance for Better Access to Developmental Drugs. Recent legislation goes even further, aiming to cut the FDA out of the process completely.
Senate Bill 204 would allow patients with terminal illnesses to receive experimental drug access with only the permission of the drug provider, physician, and state government. Access without FDA involvement would lower unnecessary hurdles where options, and time, are short.
The bill passed in the Senate but faces steep opposition in the House. Among those against the bill is New Jersey Representative Frank Pallone, who remarked, The legislation being proposed could expose critically ill patients to greater harm. Others, including, consumers group Public Citizen, warn the bill will provide false hope to patients.
Pallone and other opponents of the bill have good intentions. They are also harmful and misguided.
First, there is the safety concern.
The bill authorizes only treatments which pass phase 1 of the FDAs approval process. Phase 1 tests for a drugs safety. If the opponents of the bill are concerned about safety, perhaps they should be concerned about the FDA approval process and less so about the treatment.
Physicians consistently find effective uses for drugs without the FDAs approval. So-called off-label drug prescriptions physician-directed use of medications for purposes other than their FDA-approved use account for about 25 percent of all prescriptions. They are especially common for treating cancer.
For all their concern about potential harm from the legislation, Pallone and like-minded pundits show disquieting ignorance about the success of off-label prescription-writing. Their claim that such reforms provide false hope is especially disturbing.
Right to try laws were enacted to provide hope! Such legislation provides dying patients with more treatment options, albeit risky ones. Without right to try, there is no hope for these patients.
But who is to determine what false hope is? The FDA does not test drugs for hope. Further, what expertise does the FDA possess to determine something so subjective as hope?
The FDA is not a physician who knows a patients medical history. The FDA does not know why the other treatment methods failed, or why both parties feel experimental drugs are worth trying despite the risk. The FDA does not suffer and die while waiting for a regulatory agency to determine if a last hope effort to live is worth the risk.
What is truly false hope for the terminally ill is to leave life-and-death decisions to politicians and federal regulators. Allowing them unwarranted and unneeded influence only works to deny these patients from a chance to prolong their life. The alternative, although less risky, is certainly worse.
|Raymond J. March is a Research Fellow at the Independent Institute and Assistant Professor of Economics at San José State University.|